COVID19 (COVID19 (MODERNA)) (1201) on
12/24/2020 the resident was sleepy and stayed in bed most of the shift.
He stated he was doing okay but requested pain medication for his legs
at 250PM. At 255AM on 12/25/2020 the resident was observed in bed
lying still, pale, eyes half open and foam coming from mouth and
unresponsive. He was not breathing and with no pulse No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
had mild hypotension, decreased oral intake, somnolence starting 3 days
after vaccination and death 5 days after administration. He did have
advanced dementia and was hospice eligible based on history of
aspiration pneumonia. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) My
grandmother died a few hours after receiving the moderna covid vaccine
booster 1. While I don?t expect that the events are related, the
treating hospital did not acknowledge this and I wanted to be sure a
report was made. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident
in our long term care facility who received first dose of Moderna
COVID-19 Vaccine on 12/22/2020, only documented side effect was mild
fatigue after receiving. She passed away on 12/27/2020 of natural causes
per report. Has previously been in & out of hospice care, resided
in nursing home for 9+ years, elderly with dementia. Due to proximity of
vaccination we felt we should report the death, even though it is not
believed to be related. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient died within 12 hours of receiving the vaccine. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) After
vaccination, patient tested positive for COVID-19. Patient was very
ill and had numerous chronic health issues prior to vaccination.
Facility had a number of patients who had already tested positive for
COVID-19. Vaccination continued in an effort to prevent this patient
from contracting the virus or to mitigate his risk. This was
unsuccessful and patient died. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) At
the time of vaccination, there was an outbreak of residents who had
already tested positive for COVID 19 at the nursing home where patient
was a resident. About a week later, patient tested positive for COVID
19. She had a number of chronic, underlying health conditions. The
vaccine did not have enough time to prevent COVID 19. There is no
evidence that the vaccination caused patient's death. It simply didn't
have time to save her life. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Prior
to the administration of the COVID 19 vaccine, the nursing home had an
outbreak of COVID-19. Patient was vaccinated and about a week later she
tested positive for COVID-19. She had underlying thyroid and diabetes
disease. She died as a result of COVID-19 and her underlying health
conditions and not as a result of the vaccine. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) 1/1/2020: Residents was found unresponsive. Pronounced deceased at 6:02pm No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Two days post vaccine patient went into cardiac arrest and passed away. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) syncopal episode - arrested - CPR - death No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident
exhibited no adverse events during 30 minute monitoring following
vaccine administration. Resident found without pulse at 1900. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Redness and warmth with edema to right side of neck and under chin. Resident was on Hospice services and expired on 1.1.21 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) 12/30/2020
07:02 AM Resident noted to have some redness in face and respiration
were fast. Resident vital signs were abnormal except blood pressure.
Temp at the time was 102.0 F taken temporal. Resident respirations were
22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident
is made comfortable in bed. Notified triage of change in condition also
made triage aware of resident receiving Covid vaccination yesterday
morning. Resident appetite and fluid consumption has been poor for few
days. 12/30/2020 07:32 AM Received order from agency to administer
Acetaminophen 650mg suppos rectally due to resident not wanting to
swallow anything including fluids, medications and food. This writer
administered medication as NP ordered. Will monitor for effectiveness
and adverse effects if any. 12/30/2020 08:41 AM Received new orders to
obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained
today. Notified family of resident having temperature and vital signs
excluding b/p that was abnormal. Family was thankful for call and
inierated to nurse that family does not want resident sent to hospital.
Did educate family on benefits of Hospice services, but family
persistant on continued daily care provided by nursing staff. Requests
visits if decline continues. Family assured if resident continues to
decline, facility will accomandate resident family to be able to be at
bedside when time comes to do so. NP ordered IVF and IV Levaquin on
12/31/20. Family chose at that time to sign for Hospice services and not
have resident provided with IVF or IV Antibiotics No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Found deceased in her home, unknown cause, 6 days after vaccine. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) DEATH ON 1/4/2021, RESIDENT RECIEVED VACCINE ON 1/2/20 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident
had body aches, a low O2 sat and had chills starting on 12/30/20. He
had stated that they had slightly improved. On 1/1/21 he sustained a
fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the
NOC shift his O2 sat dropped again. He later went unresponsive and
passed away. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Fever, RespDepression & COVID positive REMDESIVIR (EUA) 200 mg x1 then 100 mg daily No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed
for full 15 minutes post-injection. No complaints when asked during
observation. Released. Subsequently, vaccine clinic staff learned from
the patient's supervisor that on Jan 4, 2021 that the patient had
expired on Jan 2, 2021. By report from the supervisor, the patient was
found dead at his home. The patient's primary care provider was unaware
of his death when contacted by this reporter today (Jan 6, 2021).
Electronic Medical Record without any information since the vaccination. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) resident expired 1/1/2021 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident expired 1/3/21 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) At
approximately, 1855, I was alerted by caregiver, resident was not
responding. Per caregiver, she was doing her rounds and found resident
in bed, unresponsive, mouth open, observed gurgling noises and tongue
hanging out of mouth. This primary caregiver observed resident at
baseline and ambulating after dinner at approximately, 1800 less than an
hour prior to incident. This PCG called 911 for EMS and gave report of
incident. Resident was taken to Medical Center Emergency Department.
At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan
and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per
RN, resident was still unresponsive and was admitted to Medical Center
for observation and comfort measures. This primary caregiver reported to
RN, resident recently received the first dose of COVID-19 vaccine on
1/2/21. Primary caregiver received a call from Castle RN at 0700,
resident expired at 0615. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Deceased No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
did not report any signs or symptoms of adverse reaction to vaccine.
Patient suffered from several comorbidities (diabetes and renal
insufficiency). Patient reported not feeling well 01/06/2021 and passed
away that day. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) had
a vaccination on 12/31/2020 late morning passed away early morning
01/01/2020. This is a 93 year old with significant heart issues. EF of
20% among other comorbidities. He died suddenly approximately 0430, it
is unlikely it was related to receiving the vaccine. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) No
adverse effects noted after vaccination. Patient with cardiac history
was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns,
eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds
upon auscultation. CPR and pulse was regained and patient was
breathing. Patient sent to Hospital ER were she remained in an
unstable condition had multiple cardiac arrest and severe bradycardia
and in the end the hospital was unable to bring her back. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident passed away in her sleep No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
had been diagnosed with COVID-19 on Dec. 11th, 2020. Symptoms were
thought to have started on 12/5/2020. Received Moderna vaccine on 12/23.
Unexpected death on 1/8/2021. Resuscitation attempts unsuccessful No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
patient was found deceased at home about 24 hours after immunization.
Date of Death:: 12/29/2020; estimated time of death 6:00pm No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
received vaccine on 1/4/2021. He was in Hospice for CHF and renal
failure, but was able to get up in his wheelchair and eat and take
medications and talk. On 1/5/2021 am, he was noted to be very lethargic
an could only mumble, could not swallow. No localizing neurologic
findings. He was too lethargic to get up in chair. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Notified today that he passed away. No other details known at this time. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Medical docter state patient has a acute cardiac attack No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Death No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
received COVID vaccination around 12:15pm. Patient was monitored for
the appropriate amount of time by nursing staff. Patient passed away at
2:15pm. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) "1-2-2021
10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021
Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry,
daughter found her deceased at 3:30 pm. Dr. at
hospital said it was ""cardiac event"" according to death certificate." No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Staff
reported that patient was found Friday morning (Jan 8) sitting at a
table with his head tilted forward and unresponsive to verbal or
physical stimuli. Staff lowered patient to floor and started CPR. EMS
was called and continued CPR at scene, however they were not able to
revive patient. Patient was pronounced dead at the scene. Staff written
statements following the death of patient show that he had a fall about 1
hr. prior. It is unknown if this fall contributed to patient's death.
An autopsy has been requested. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
resident resides in an independent living facility/apartment. The
reporter at the center was informed by his daughter he was not feeling
well on 1/1/2021 (specific symptoms could not be ascertained). He
reportedly went to be COVID tested on 1/1/2020 and observed to be
deceased in his apartment on 1/2/2020. I do not have confirmation of his
COVID results, although the reporter indicates his daughter reports his
test was positive. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
received COVID-19 (Moderna) vaccine from the Health Department on
afternoon of January 8, 2021 and went to sleep approximately 2300 that
night. Was found unresponsive in bed the following morning and
pronounced dead at 1336 on January 9, 2021 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient was reported to be deceased at home by law enforcement on 1/7/21 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient was found unresponsive at home with SpO2 20% 1/2/2021 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient received the 1st dose of Moderna and was found deceased in her home the next day. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) RESIDENT 1ST DOSE OF MODERNA VACCINE ADMINISTERED ON 01/04/2021 AT 8:30PM, RESIDENT FOUND UNRESPONSIVE ON 01/05/2021. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
received the vaccine on 12/22/20 without complication. It was reported
today that the patient was found unresponsive and subsequently expired
at home on 1/11/21. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
facility had positive cases of COVID when we were able to begin
vaccinating residents. Within about a week of vaccination, patient was
tested positive for COVID. He was 91 years old and his immune system
did not have the time to allow the vaccine to begin working before
exposure. His age was a major contributing factor to his death. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
facility had positive cases for COVID 19 when the vaccine was received
and administered to patient. With her advanced age and chronic
conditions, she did not have time to build immunity between the time of
vaccination and her testing positive. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
facility had a number of positive COVID 19 cases prior to patients
vaccination. Due to her advanced age, chronic condition, and exposure,
patient did not have the time to build immunity after exposure before
becoming positive. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Pt expired due to possible cardiac arrest. Unsure if this was vaccine related. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) patient reported expired 1/7/2021 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
vaccinated on 12/28. Approximately one day later, develops cough and
on azithromycin x 1 week. On 1/3, patient develops left-sided weakness
and aphasia. Taken to the hospital, tested COVID+, required intubation
-- acute hypoxic respiratory failure secondary to COVID - on H&P.
Patient died on 1/4/21 at 7:20am. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient
received her vaccination on 1/12/21 administered by pharmacy*+. She
expired on 1/12/21 an approximately 7:30pm. Resident did not have any
adverse reactions and was a hospice patient. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) "Patient
was found ""acting abnormal"" on 1/9/2021 at 1215. VS HR 20-30's. EMS
activated. EMS arrived and patient was found pulseless in PEA/ asystole,
CPR and ACLS initiated and then transported to the MC. Unsuccessful
resuscitation and expired on 1/09/2021 at 1348. Clinical impression
Cardiopulmonary arrest." No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Staff
walked into resident's room around 10:00am and noted resident's left
side of his face was flaccid. Nurse was called and upon assessment
resident noted to have an unequal hand grasp with left worse. He was
able to talk but was mumbled and hard to understand. Physician, hospice,
and family were notified. Resident had a stroke at 10:06 am on
1/8/2020. He lost all ability to use his left side. Resident passed away
on 1/11/2020. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) The
patient passed away today, 1/13/2021. She was a hospice patient. She
showed no adverse effects after receiving the vaccine on 1/12/2021. This
morning she woke up as normal and during her morning shower she had a
bowel movement, went limp and was non-responsive. The patient passed
away at 7:45 am. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) This
person was found to be deceased on routine rounds during the night,
3am. No symptoms of reaction noted post vaccine. No injection site
reaction. No reports of any allergic reaction. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Pt collapsed at home approx 5:30 pm and died No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient died on 1/21-2021 No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Patient died. A friend called to let us know. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) Resident found unresponsive and without pulse at 05:45am. No prior vaccinations for this event.
COVID19 (COVID19 (MODERNA)) (1201) 51
year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became
increasingly hypoxic around 1800hours 1/7/2021. He was transported to
hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021
he decompensated further, and after discussing with family and
palliative care, He was changed to comfort care. He expired on
1/12/2021@2325 at medical center. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Vaccine
administered with no immediate adverse reaction at 11:29am. Vaccine
screening questions were completed and resident was not feeling sick and
temperature was 98F. At approximately 1:30pm the resident passed away. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Spouse awoke 12/20 and found spouse dead. Client was not transferred to hospital. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Within
24 hours of receiving the vaccine, fever and respiratory distress, and
anxiety developed requiring oxygen, morphine and ativan. My Mom passed
away on the evening of 12/26/2020. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) RESIDENT CODED AND EXPIRED No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Injection
given on 12/28/20 - no adverse events and no issues yesterday; Death
today, 12/30/20, approx.. 2am today (unknown if related - Administrator
marked as natural causes) No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Death by massive heart attack. Pfizer-BioNTech COVID-19 Vaccine EUA No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) pt
passed away with an hour to hour and 1/2 of receiving vaccine. per
nursing home staff they did not expect pt to make it many more days. pt
was unresponsive in room when shot was given. per nursing home staff
pt was 14 + days post covid No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) pt
was a nursing home pt. pt received first dose of covid vaccine. pt
was monitored for 15 minutes after getting shot. staff reported that pt
was 15 days post covid. Pt passed away with in 90 minutes of getting
vaccine No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) pt
received vaccine at covid clinic on 12/30 at approximately 3:30, pt
vomited 4 minutes after receiving shot--dark brown vomit, staff reported
pt had vomited night before. Per staff report pt became short of breath
between 6 and 7 pm that night. Pt had DNR on file. pt passed away at
approximately 10pm. Staff reported pt was 14 + days post covid No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident
received vaccine per pharmacy at the facility at 5 pm. Approximately
6:45 resident found unresponsive and EMS contacted. Upon EMS arrival at
facility, resident went into cardiac arrest, code initiated by EMS and
transported to hospital. Resident expired at hospital at approximately 8
pm No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident received vaccine in am and expired that afternoon. Tetanus toxoid
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident
became SOB, congested and hypoxic requiring oxygen, respiratory
treatments and suctioning. Stabilized after treatment and for the next
72 hours with oxygen saturations in the 90s. On 1/3/2021 was found
without pulse and respirations. Resident was a DNR on Hospice. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Fever, Malaise No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "The
resident received is vaccine around 11:00 am and tolerated it without
any difficulty or immediate adverse effects. He was at therapy from
12:36 pm until 1:22 pm when he stated he was too tired and could not do
anymore. The therapist took him back to his room at that time and he got
into bed himself but stated his legs felt heavy. At 1:50 pm the CNA
answered his call light and found he had taken himself to the bathroom.
She stated that when he went to get back into the bed it was
""abnormal"" how he was getting into it so she assisted him. At that
time he quit breathing and she called a RN into the room immediately. He
was found without a pulse, respirations, or blood pressure at 1:54 pm.
He was a DNR." No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Vaccine
12/30/2020 Screening PCR done 12/31/2020 Symptoms 1/1/2021 COVID test
result came back positive 1/2/2021 Deceased 1/4/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4, No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Vaccine
given on 12/29/20 by Pharmacy. On 1/1/21, resident became lethargic and
sluggish and developed a rash on forearms. He was a Hospice recipient
and doctor and Hospice ordered no treatment, just to continue to
monitor. When no improvement of codition reported, doctor and Hospice
ordered comfort meds (Morphine, Ativan, Levsin). Resident expired on
1/4/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) LTCF
Pfizer Vaccine clinic conducted 12/29/2020 Vaccine lead received a call
indicating that a staff member deceased somewhere between 1/3/2021 and
1/4/2021. Cause of death is unknown, and an autopsy is being
performed. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Vaccine
received at about 0900 on 01/04/2021 at her place of work, Medical
Center, where she was employed as a housekeeper. About one hour after
receiving the vaccine she experienced a hot flash, nausea, and feeling
like she was going to pass out after she had bent down. Later at about
1500 hours she appeared tired and lethargic, then a short time later, at
about 1600 hours, upon arrival to a friends home she complained of
feeling hot and having difficulty breathing. She then collapsed, then
when medics arrived, she was still breathing slowly then went into
cardiac arrest and was unable to be revived. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) The
resident was found deceased a little less than 12 hours following COVID
vaccination, and he had had some changes over the last 2 days. He was
96 and had been on hospice care for a little while. Noone noticed any
side effects from vaccine after it was given No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient
did not display any obvious signs or symptoms; the vaccination was
administered at approximately 10:00 AM and the patient continued
throughout her day without any complaints or signs of adverse reaction.
Patient was helped to bed by the nursing assistant estimated at around
9:00 PM. The facility received notification from the lab around 11:00 PM
that the patient's COVID-19 specimen collection from Sunday, 1/3/21,
detected COVID-19. When the nursing staff went to the room to check on
the resident and prepare her to move to a COVID-19 care area the patient
was found unresponsive, no movement, no chest rises, noted
regurgitated small amount of food to mouth left side, lying on left
side. Pupils non reactive. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) coughing
up blood, significant hemoptysis -- > cardiac arrest. started day
after vaccine but likely related to ongoing progression of lung cancer No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Expired 1/05/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "Pt
last seen at 1200 by nurse for ID band check. No visible signs of
distress noted. Pt states ""I just want to be left alone"". 1230 nurse
was called to pt room. Pt was noted unresponsive, no pulse and
respiration noted. CPR started immediately, at 1239 first shock given.
1245 EMT took over, at 1319 EMT called time of death" No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient developed hypoxia on 1/4/2021 and did not respond to maximal treatment and passed way on 1/5/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) patient declined 12/30/2020 and was transferred to hospital where he did not respond to treatment and passed away 1/4/2020 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient
was vaccinated at 11am and was found at the facility in his room
deceased at approximately 3:00pm. Nurse did not have cause of death No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) vomiting
later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21.
Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest,
died 01/07/21. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) 3:07
pm lung sounds diminished oxygen sats 68%, oxygen applied Oxygen sats
remained low for next 36 hours ( patient on Hospice care ) expired 6:22
am 1-8-21 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/6/2021. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient received first dose of vaccine on 12/28, developed COVID-19 infection shortly thereafter and expired on 1/4/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Cardiac event, 2 days after vaccination, patient expired. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) 1/7-21
- Received second dose of pfizer covid-19 vaccine 1/8/21 - Fever,
dizziness, headache 1/10/21 0250 was found not breathing. EMS performed
CPR and patient deceased No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) RECIEVED VACCINE 1/8/21 EXPIRED UNEXPECTED 1/10/21, NO ADVERSE REACTIONS NOTED No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) The
patient had an apparent cardiac arrest on 12/23/20 and was admitted to
the ICU. He was taken off of life support on 12/30/20. He had known
cardiac disease. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient died, I have a copy of his vaccination card No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "Staff
member checked on her at 3am and patient stated that she felt like she
couldn't breathe. 911 was called and taken to the hospital. While in
the ambulance, patient coded. Patient was given CPR and ""brought
back"". Once at the hospital, patient was placed on a ventilator and
efforts were made to contact the guardian for end of life decisions.
Two EEGs were given to determine that patient had no brain activity.
Guardian, made the decision to end all life saving measures. Patient
was taken off the ventilator on 1/9/2021 and passed away at 1:30am on
1/10/2021. The initial indication from the ICU doctor was the patient
had a mucus plug that she couldn't clear." No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Acute anterior MI with death No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Patient
went to bed around 11pm on Saturday PM and sometime between then and
1:30am on Sunday morning got up and went into the living room without
waking up her husband (which is normal). At 1:30am, the husband got up
to use the restroom and she was out of bed then, but the husband did not
know if she was having any problems at this time. When he got up at
7:45am, she was in the recliner and did not move or anything, which is
normal for her. At 8:45am, the husband went back into the living room
and tried to wake his wife and that is when he noticed there was no
pulse and he called 9-1-1 at this time. EMS got on scene and did CPR
for 30 mins and she was pronounced dead at 9:21am. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident died suddenly and expectantly on 01/05/2021 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Death;
This is a spontaneous report from a contactable Physician. An elderly
male patient received BNT162B2 (COVID vaccine), via an unspecified route
of administration on an unspecified date in Dec2020 at single dose for
COVID-19 immunisation. The patient's medical history and concomitant
medications were not reported. The patient experienced death in Jan2021.
It was unknown if an autopsy was performed. It was unknown if any
treatment was received for the event. It was unknown if the patient was
diagnosed with COVID prior vaccination or if the patient had been tested
for COVID post vaccination. Seriousness criteria for the event was
reported as death and hospitalization. Pfizer is a marketing
authorization holder of [COVID vaccine] in the country of incidence or
the country where the product was purchased (if different). This may be a
duplicate report if another marketing authorization holder of [COVID
vaccine] has submitted the same report to the regulatory authorities.
Information about lot/batch number has been requested.; Sender's
Comments: Current information is very limited for full assessment.
Further information such medical history, concomitant medications,
concurrent illness and event term details especially death cause and
autopsy results are needed for meaningful evaluation. The impact of
this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate
action in response, will be promptly notified to Regulatory Authorities,
Ethics Committees and Investigators, as appropriate.; Reported Cause(s)
of Death: Death No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) COVID-19;
COVID-19; Pneumonia; respiratory failure; This is a spontaneous report
from a contactable consumer. An 80-year-old female patient received
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an
unspecified route of administration on 02Jan2021 for COVID-19
immunization. Medical history included Alzheimer's and others. No known
allergies. Concomitant medications included unspecified medications. The
reporter's mother in law was tested for COVID-19 at a nursing facility
on 25Dec2020 and she was negative. On 02Jan2021, she received the first
dose of Pfizer vaccine. On 04Jan2020, she developed a high fever, needed
oxygen and was positive for COVID-19. Date of death was 04Jan2021. The
cause of her death was listed as pneumonia, respiratory failure and
COVID-19. No autopsy performed. No treatment received. No one knew if
the vaccination contributed to her death. It was hard to know if her
death was due to the administration of the vaccine or it exacerbated the
COVID19 symptoms which led to her death. Since this was unknown, it
could have been a possibility. The reporter wanted to give us this
information because we might want to consider having high risk
population, patients with underlying conditions, older population tested
for COVID-19 prior to the vaccination, as this is not currently a
recommendation or a requirement. All is very new and they are all
learning so the reporter wanted to share this information with us. The
patient did not receive any other vaccines within 4 weeks prior to the
COVID vaccine. There are medications the patient received within 2 weeks
of vaccination. Prior to vaccination, the patient was not diagnosed
with COVID-19. Since the vaccination, the patient has been tested for
COVID-19. The outcome of the events was fatal. Information about
Lot/Batch has been requested.; Sender's Comments: The association
between the fatal event lack of effect (pneumonia, respiratory failure
and COVID-19) with BNT162b2 can not be fully excluded. The impact of
this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate
action in response, will be promptly notified to regulatory authorities,
Ethics Committees, and Investigators, as appropriate.; Reported
Cause(s) of Death: Pneumonia, respiratory failure and COVID-19;
Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory
failure and COVID-19; Pneumonia, respiratory failure and COVID-19 No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) he
passed away; not responsive; mind just seemed like it was racing; body
was hyper dried; Restless; not feeling well; ate a bit but not much;
kind of pale; Agitated; Vomiting; trouble in breathing; This is a
spontaneous report from a contactable consumer (brother of the patient).
A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration, on 04Jan2021 (at
the age of 54-years-old) as a single dose for COVID-19 immunization.
Medical history included diabetes and high blood pressure. Concomitant
medications included metformin (MANUFACTURER UNKNOWN) taken for
diabetes, glimepiride (MANUFACTURER UNKNOWN) taken for diabetes,
lisinopril (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER
UNKNOWN). The patient experienced not feeling well, ate a bit but not
much, kind of pale, vomiting, trouble in breathing, and agitated on
04Jan2021; body was hyper dried and restless on 05Jan2021; mind just
seemed like it was racing on 06Jan2021; and not responsive and he passed
away on 06Jan2021 at 10:15 (reported as: around 10:15 AM). The clinical
course was reported as follows: The patient received the vaccine on
04Jan2021, after which he started not feeling well. He went right home
and went to bed. He woke up and ate a bit but not much and then was kind
of pale. The patient then started to vomit, which continued throughout
the night. He was having trouble in breathing. Emergency services were
called, and they took his vitals and said that everything was okay, but
he was very agitated; reported as not like this prior to the vaccine.
The patient was taken to urgent care where they gave him an unspecified
steroid shot and unspecified medication for vomiting. The patient was
told he was probably having a reaction to the vaccine, but he was just
dried up. The patient continued to vomit throughout the day and then he
was very agitated again and would fall asleep for may be 15-20 minutes.
When the patient woke up, he was very restless (reported as: his body
was just amped up and could not calm down). The patient calmed down just
a little bit in the evening. When the patient was awoken at 6:00 AM in
the morning, he was still agitated. The patient stated that he couldn't
breathe, and his mind was racing. The patient's other brother went to
him and he was not responsive, and he passed away on 06Jan2021 around
10:15 AM. It was reported that none of the symptoms occurred until the
patient received the vaccine. Therapeutic measures were taken as a
result of vomiting as aforementioned. The clinical outcome of all of the
events was unknown; not responsive was not recovered, the patient died
on 06Jan2021. The cause of death was unknown (reported as: not known by
reporter). An autopsy was not performed. The batch/lot number for the
vaccine, BNT162B2, was not provided and has been requested during follow
up.; Reported Cause(s) of Death: not responsive and he passed away No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) My mother was given Pfizer vaccine on Thursday and she died 3 days later yesterday on Sunday!!! No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Difficulty breathing, death. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) loss
of consciousness Narrative: Patient received COVID-19 vaccine dose #1
on 1/6/21 w/o complications. Per 1/6/21- 1/9/21 nursing notes, patient
did not experience any injection site reactions, denied pain or
tenderness at injection site, no dizziness, no n/v, remained afebrile.
Around 1/9/21 @1810, patient became acutely nonresponsive after being
helped to the edge of bed. Per nurses, he was previously awake/alert,
talking and asymptomatic. Patient is DNR/DNI but facility rapid response
emergency team called d/t patient's sudden change of condition.
Emergency team helped patient into lying position. Per 1/9/21 ICU
emergency team note, patient appeared comfortable w/ no palpable radial
pulse and had minimal shallow agonal breathing. Pulse ox 94%, HR in 60s
per machine. BP unmeasurably low by BP cuffx3. Resident passed at 18:20
pm. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident was found deceased at approximately 6pm in her apartment No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) unsure
if related to vaccine, but was notified by her next of kin that she
died on 1/4/2021. No reports of side effects or hospitalization were
reported to the facility prior to the notification of death. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) on 1/8/2021 17:30 patient taken to ER, cerebellar hemorrhage, stroke, aneurysm No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Hospice
Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21
resident had decreased appetite noted in am but ate 100% of meal at
dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose
BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take
HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM
nurse noted resident not eating meals but ingesting milkshake and
medications without any problems. Hospice contacted for change in
condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs
to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident
had blood in stool. Resident denies any pain, on 2L of O2 for comfort. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Sudden cardiac death No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Three
hours after receiving COVID 19 vaccination, Patient oxygen level
decreased to a critical level and went into cardiac arrest. Staff
performed full code but was unable to bring back patient from cardiac
arrest. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) patient
passed away after receiving the Covid vaccine; This is a spontaneous
report from a contactable nurse. An 81-year-old male patient received
BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular into
the right arm on 07Jan2021 at 0.3 mL, single for covid-19 immunization.
There was no medical history and no concomitant medications. On
08Jan2021, the patient passed away after receiving the COVID vaccine.
The patient died on 08Jan2021. An autopsy was not performed.
Investigations indicate that unspecified labs were done, but nothing two
weeks prior; no further details were provided. The patient received the
first dose the day prior. The reporting nurse discussed it with the
medical director, and he thought that he potentially passed away from
the COVID vaccine. The relatedness of the event to the suspect vaccine
was reported as related by the reporting nurse per The Agency. The
batch/lot number for the vaccine, BNT162B2, was not provided and will be
requested during follow-up .; Sender's Comments: Based on the limited
information available, it is medically not possible to make meaningful
causality assessment, it is unlikely the vaccine could have contributed
to the death of the patient based on the known safety profile. However
case will be reevaluated when additional information is received during
the follow-up The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety
evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified
to Regulatory Authorities, Ethics Committees and Investigators, as
appropriate.; Reported Cause(s) of Death: Stated that the patient passed
away after receiving the Covid vaccine No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "Heart
attack; This is a spontaneous report from a contactable consumer. An
82-year-old female patient received the first dose of bnt162b2
(PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date:
Unknown), via an unspecified route of administration in the left arm on
05Jan2021 at 13:00 at a single dose for COVID-19 immunization;
administered in doctor's office/urgent care. The patient's medical
history and concomitant medications were not reported. It was unknown if
the patient received any other vaccines within four weeks prior to the
COVID vaccine. Prior to the vaccination, the patient was not diagnosed
with COVID-19. Since the vaccination, the patient had not been tested
for COVID-19. On 05Jan2021, the patient experienced heart attack; which
resulted in death and was assessed as medically significant. The patient
also experienced the associated symptoms of cold sweats, chest pain,
shortness of breath. Therapeutic measures were taken as a result of
heart attack, which included ""life saving measures"" by the paramedics
performed upon arrival with no success. The clinical outcome of the
event, heart attack, was fatal. The patient died on 05Jan2021 due to
heart attack; as ruled by the paramedics. It was unknown if an autopsy
was performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH
COVID-19 MRNA VACCINE, were not provided and will be requested during
follow up.; Reported Cause(s) of Death: Heart attack" No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "Cardiac
Arrest; Patient was found pulseless and breathless 20 minutes following
the vaccine administration.; Patient was found pulseless and breathless
20 minutes following the vaccine administration.; This is a spontaneous
report from a contactable other healthcare professional (HCP). A
66-year-old female patient (pregnant at the time of vaccination: no)
received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,
lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM
at single dose for COVID-19 immunization. Medical history included
diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary
hypertension and COVID-19 (Prior to vaccination, the patient was
diagnosed with COVID-19). The patient received medication within 2 weeks
of vaccination included amiodarone, melatonin, venlafaxine
hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril,
cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine,
furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate
(IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA
[SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The
patient did not receive any other vaccines within 4 weeks prior to the
COVID vaccine. Patient used took Penicillin, propranolol, quetiapine,
topiramate, Lamictal and had allergy to them. Patient used took the
first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right
arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization.
Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2
PCR) via nasal swab on 06Jan2021, covid test result was negative.
Patient was found pulseless and breathless 20 minutes following the
vaccine administration (11Jan2021 12:30 AM). MD found no signs of
anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac
arrest. No treatment received for the events. Outcome of pulseless and
breathless was unknown. the autopsy was performed, and autopsy remarks
was unknown. Autopsy-determined cause of death was unknown. It was
reported as non-serious, not results in death, Life threatening,
caused/prolonged hospitalization, disabling/Incapacitating nor
congenital anomaly/birth defect.; Sender's Comments: Based on the
available information this patient had multiple underlying medical
conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary
hypertension and COVID-19 diagnosed prior to vaccination. All these
conditions more likely contributed to patients cardiac arrest resulting
in death. However, based on a close temporal association (""Patient was
found pulseless and breathless 20 minutes following the second dose of
BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine
to the onset of reported events cannot be completely excluded. The
impact of this report on the benefit/risk profile of the Pfizer product
is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any
appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.;
Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s)
of Death: autopsy remarks was unknown. Autopsy-determined cause of death
was unknown" No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Actual
event and cause of death were unknown; This is a spontaneous report
from a non-contactable consumer. A 90-year-old female patient received
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration on 06Jan2021 at single dose for
COVID Prevention. The relevant medical history included aortic valve
replacement from Nov2019. Concomitant medications were not reported. The
consumer stated that she was taking the reporting responsibilities to
report that a friend of hers, informed that the patient passed away on
Friday, and had received the COVID vaccine on Wednesday. The consumer
stated that it was unknown to her at this time, if the friend had called
to complete a report herself, regarding the incident. Their
conversation was very brief. The patient was 90 years old, and it was
her friend's mother that was the patient. Actual event and cause of
death were unknown. The patient had her vaccine on Wednesday 06Jan2021,
and then the patient collapsed in front of the reporter at Friday night
on 08Jan2021 and passed away that same day. The autopsy was unknown. The
outcome of the event was fatal. No follow-up attempts are possible;
information about lot/batch number cannot be obtained.; Reported
Cause(s) of Death: Actual event and cause of death were unknown No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) little
bit of a reaction light headed after 5 minutes. vitals were low, so
observed for 30 minutes after being light headed. Patient was found
unresponsive and pronounced dead later that day. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Death
occurred 3 days after vaccine receipt; attributed to complications of
her chronic advanced dementia with aspiration at age 87. No evidence of
acute vaccine reaction. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) No
adverse effects from vaccination seen on 1/2/21. On 1/6/21 resident
was seen by Dr and her baclofen pump was refilled with 20 ml Baclofen
4,000mcg/ml. ITB Rate increased by 6% to 455.5 mcg/day simple continuous
rate over 3 days. On 1/8/21 at 0615 resident was shaking, lower
extremities mottled, Sa02 70%, pulse 45. Oxygen started at 2 L/m per NC.
At 0715 her primary physician was notified as well as her daughter.
Oxygen increased to 4 L/min, sats at 83%. SOA noted, reported all over
pain. At 0850 when they attempted to reposition the resident, she was
not responsive. Licensed nurse assessed her and no heartbeat heard or
pulse found. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) 54
y/o M with PMH of HTN, HLD, Alcoholic Cirrhosis, Aortic Valve Stenosis,
and angina BIBA as a Medical Alert for cardiac arrest noted PTA. Per
EMS, the patient called because he was having constant, diffuse
abdominal pain x 1 day that radiated to his chest. On scene, the patient
had a witnessed arrest with EMS starting CPR. He was given 3 rounds of
epi without ROSC. Pt had no associated shockable rhythm. Of note, pt's
wife, had noted pt had received covid vaccine the prior day. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident
received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB,
increased weakness with O2 sats at 91% RA. On 8th resident sustained a
fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with
negative results. Evening of 8th resident was lethargic and diaphoretic
with fever of 99.9. Resident transferred to ER, on 5lt of oxygen.
Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia
and orders for hospice. Continued with fever, crackles and N/V and
loss of appetite from the 9th and 10th of January. Resident expired at
820am on 1/11/2021. Influenza Virus Vaccines - Unknown date/type or brand
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Initial
pain in back of head and extreme headache. Some vomiting. At
emergency, went into coma and was intubated. Hole drilled in skull to
relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead
to death approximately 14 hours after initial symptoms. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) On
day due for 2nd dose, Patient was found unresponsive at work in the
hospital. Patient pupils were fixed and dilated. Full ACLS was
initiated for 55 minutes with multiple rounds of bicarb, calcium
chloride, magnesium, and epinephrine. Patient was intubated. Patient
continued into V. Fib arrest and was shocked multiple times. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) death
2 days after vaccine; 101 fever on day of booster shot; This is a
spontaneous report from a contactable consumer. A 65-year-old male
patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration, on 09Jan2021 (at the age of
65-years-old) as a single dose for COVID-19 immunization. Medical
history included high blood pressure, high cholesterol, enlarged
prostate, and lifelong digestive issues/irritable bowel syndrome (IBS).
Prior to the vaccination, the patient was not diagnosed with COVID-19.
The patient had no allergies to medications, food, or other products.
The patient's concomitant medications were not reported. The patient did
not receive any other vaccines within four weeks prior to the
vaccination. The patient experienced 101 fever on day of booster shot on
09Jan2021 and death 2 days after vaccine on 10Jan2021. The event, death
2 days after vaccine, was reported as fatal. The patient underwent lab
tests and procedures, which included body temperature: 101 on 09Jan2021.
The patient did not receive treatment for the events. The clinical
outcome of 101 fever on day of booster shot was unknown and of death 2
days after vaccine was fatal. The patient died on 10Jan2021. The cause
of death was unknown. It was unknown if an autopsy was done. It was also
reported that since the vaccination, the patient had not been tested
for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not
provided and has been requested during follow up.; Reported Cause(s) of
Death: death 2 days after vaccine No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) resident
coded on 09Jan at 8am and expired; This is a spontaneous report from a
contactable Other Health Professional. A 70-year-old male patient
received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,
Batch/lot number: EL0140), intramuscularly in left arm on 05Jan2021
15:15 at single dose for COVID-19 immunization. Medical history included
DM2(Type two diabetes mellitus), CHF(congestive heart failure), open
wound, wound infection, heart failure. Allergies to medications, food,
or other products: none. Concomitant medications included unspecified
products (List of any other medications the patient received within 2
weeks of vaccination: yes). If the patient received any other vaccines
within 4 weeks prior to the COVID vaccine: Unknown. Facility where the
most recent COVID-19 vaccine was administered: Nursing Home/Senior
Living Facility. The resident coded on 09Jan2021 at 8 AM and expired.
The patient died on 09Jan2021. An autopsy was not performed. AE resulted
in: patient died. Death cause: unknown at this time. Was treatment
received for the adverse event: Unknown. Prior to vaccination, was the
patient diagnosed with COVID-19: No. Since the vaccination, has the
patient been tested for COVID-19: No. Serious: Yes. Seriousness
criteria-Results in death: Yes. Seriousness criteria-Life threatening:
No. Seriousness criteria-Caused/prolonged hospitalization: No.
Seriousness criteria-Disabling/Incapacitating: No. Seriousness
criteria-Congenital anomaly/birth defect: No.; Sender's Comments: The
old patient had diabetes mellitus, congestive heart failure, open wound
complicated by infection, all these pre-existing medical conditions
contribute to the patient death. More information including complete
medical history, concomitant medications and event term details
especially death cause and autopsy results are needed for a full
assessment of the case. The impact of this report on the benefit/risk
profile of the Pfizer product is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly
notified to Regulatory Authorities, Ethics Committees and Investigators,
as appropriate; Reported Cause(s) of Death: resident coded on 09Jan at
8am and expired No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident expired on 12/30/20, dx cardiac arrest. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Resident expired on 1/2/21. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Cardiac
arrest within 1 hour Patient had the second vaccine approximately 2 pm
on Tuesday Jan 12th He works at the extended care community and was
in good health that morning with no complaints. He waited 10-15
minutes at the vaccine admin site and then told them he felt
fine and was ready to get back to work. He then was found
unresponsive at 3 pm within an hour of the 2nd vaccine. EMS called
immediately worked on him 30 minutes in field then 30 minutes at ER
was able to put him on life support yet deemed Brain dead 1-14-21
and pronounced dead an hour or so later No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) On 1/11/21 noted with headache, nausea/vomiting, severe melaise. On 1/12/21 resident expired. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) 71yo
female resident who died after receiving Pfizer BioNTech vaccine. On
1/14/2021, VS taken at 10am, B/P 99/60, O2 sats, 95% (trach w/O2). At
11:30am, Patient showed no s/sx of distress, A&Ox3. At 11:50am, a
nurse went to perform a COVID test and assessment (the facility is
experiencing an outbreak), and found the patient unresponsive on the
bathroom floor. CPR was immediately started; no shock advised per AED;
12:15pm EMS arrived and took over. At 12:38pm, EMT called time of
death. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Has
underlying dementia and often with difficulty eating. 1 week after
immunization she developed a stroke with left sided weakness and
difficulty swallowing. Comfort measures instituted. Not sure if this
is related to the vaccine, but thought I should report No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) "83yo
female resident who died after receiving Pfizer BioNTech vaccine. On
1/14/2021, the patient reportedly got up in the middle of the night with
c/o feeling ""blah"", restlessness, and nausea. VS normal, no other
s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a
nurse and GNA. At 6am, GNA was going to do morning VS and found the
patient unresponsive, no pulse, no respirations. GNA notified the
nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived
and took over. At or around 6:30am, EMT called time of death" No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) No
reactions immediately after vaccine was given. Resident has dementia,
has had multiple hospitalizations related to a renal stone recently. Had
a tooth that was bothering her, went to see her dentist and it was
extracted on 1/6/21. On 1/10 they noted feet and ankles are dark purple
with white splotches appears to be mottling. Minimally responsive to
voice and touch. Not eating. Compassionate visit with family. Family did
not want hospice, did not feel it was needed, said, what more could
they do for her than you're already doing? On 1/11 at 1950 was
determined to be deceased. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) Had
no immediate issues with the vaccine. He had returned from the hospital
on 12/21 and had some concerns about his weight which were shared with
his physician on 1/4/21. On 1/5/21 had a visit with his cardiologist for
a pacemaker check. On 1/8/21 staff were called to his room, he was on
the floor, bluish skin color. No vital signs found, no heart rhythm
heard at 2200. No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) died
3 days after receiving the vaccine/Death cause: Pneumonia per doctor;
This is a spontaneous report from a contactable consumer. An 85-year-old
non-pregnant female patient (reporter's mother) received the first dose
bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route
of administration on 07Jan2021 at single dose for covid-19 immunization.
Medical history included dementia from an unknown date. The patient's
concomitant medications were not reported. The patient died 3 days after
receiving the vaccine on 10Jan2021 11:00, death cause was pneumonia per
doctor. The event was reported as serious as resulted in death. It was
unknown if the patient received treatment for the event. The patient did
not receive any other vaccines within 4 weeks prior to the COVID
vaccine. The patient was not diagnosed with COVID-19 prior to
vaccination, and it was unknow if the patient has been tested for
COVID-19 since the vaccination. The patient died on 10Jan2021. It was
not reported if an autopsy was performed. Information about lot/batch
number has been requested.; Reported Cause(s) of Death: Pneumonia No prior vaccinations for this event.
COVID19 (COVID19 (PFIZER-BIONTECH)) (1200) At
approximately 10:30pm on 1/14/2021, resident was noted to have a rash
on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room
air. applied nasal cannula at 4-L, telephoned Physician orders 6mg
Decadron one time order, a second set of Vitals , reads 99.3, 110, 20,
106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am
on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124,
temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately
2:30am PRN cough syrup and breathing tx. Resident's condition began to
worsen with breathing tx. This LPN updated at 0248 doctor on resident's
condition. Doctor gave permission for resident to go to hospital. At
4:19am the Er called to say resident passed away. No prior vaccinations for this event.