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Case Details |
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: Pt passed away the day after the vaccine was given. | ||||||||||||||||
Administered by: Private Purchased by: ?
Life Threatening? No Write-up: Patient received her first dose of the Moderna COVID-19 Vaccination on Saturday January 16th 2021 at approximately 12pm. She completed all necessary screening forms and was deemed to be at low risk for serious allergic reactions. She tolerated the vaccination well, and no complications or immediate adverse events occurred. She was observed for a full 15 mins per CDPHE/CDC guidelines and left the Clinic in stable condition after her observation period was complete. On the morning of Tuesday, January 19th, 2021, the patient was found unconscious and unresponsive by her husband. She was transferred by Ambulance to Hospital shortly thereafter. She was diagnosed with a brain bleed that was determined to be inoperable. She was transferred to other Hospital for higher level care. She was seen by neurosurgery and diagnosed with a ruptured aneurysm. She was treated in the ICU for 24 hours, at which point her team determined that the severity of her brain bleed would not respond to treatment. Supportive cares were withdrawn on Wednesday Jan 20th, and she passed away shortly thereafter. | ||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: Resident has increase weakness and lethargy with abnormal labs. He was transferred to the ER. He was admitted to the hospital and treated for worsening AKI and hypotension. | ||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: Per Nursing Staff- patient died within 24 hours of receiving the vaccine. patient has hospice. Please contact director of nursing for more details. | ||||||||||||||||
Administered by: Senior Living Purchased by: ?
Life Threatening? No Write-up: per staff at facility patient died 24 hours post vaccination. Please contact Director of Nursing for further details. | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: Narrative: Patient seen in ED 1-17-21 with c/c of "bloated with epigastric pain". Patient with complicated medical history including stage 1B pancreatic cancer (was currently on chemotherapy mFOLFIRINOX), and a leadless permanent pacemaker implantation on 1-11-21 for long episodes of SR with complete heart block following symptoms of syncope (other cardiac history: CAD s/p CABG 2009, PAF, and HTN). Regarding ER visit for epigastric pain, nothing notable was found on workup and patient was to discharge home to rest. There were available doses of COVID-19 Vaccine following a vaccine clinic that same day, and patient was offered and agreed to a dose of vaccine. Patient was monitored for 15 minutes post vaccine with no notable issues. The following day, Monday 1-18-21, patient''s caregiver called facility at 22:30 to report he had a fever of 102.8 degrees and that he had been "feeling kind of bad all day". Patient was advise to seek urgent medical care and reported back to ED on 1-19-21 at 00:55. Patient wasd admitted for SIRS (tachycardia and febrile) -- patient also reported diffuse myalgia. WBC WNL, CXR unremarkable for infection, UA neg for bacteria, LFTs WNL, blood cultures negative. Procalcitonin elevated at 17.8 -- suggesting inflammatory response. Patient initially reported feeling better on the morning of 1-19-21, but around 13:00 began rapidly declining (confusion, unable to walk) and started experiencing EKG changes (9 beats of SVT). Patient then coded and resuscitation was attempted for approximately 30 minutes. Patient did not survive the code. Coroner has been notified and family is considering autopsy at time of this report. | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar death events for 8 patients. This report is for 1st of 8 patient. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender''s Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete 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.,Linked Report(s) : US-PFIZER INC-2021034597 same drug, reporter and event but different patient;US-PFIZER INC-2021034598 same drug, reporter and event but different patient;US-PFIZER INC-2021034599 same drug, reporter and event but different patient;US-PFIZER INC-2021034600 same drug, reporter and event but different patient;US-PFIZER INC-2021034601 same drug, reporter and event but different patient;US-PFIZER INC-2021034603 same drug, reporter and event but different patient;US-PFIZER INC-2021034596 same drug, reporter and event but different patient.; Reported Cause(s) of Death: expired before receiving the second dose | ||||||||||||||||
Administered by: Unknown Purchased by: ?
Life Threatening? No Write-up: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 2nd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender''s Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete 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: expired before receiving the second dose | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 3rd of 8 patients. A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number is requested.; Sender''s Comments: Based on the reasonable temporal association, the Company cannot completely exclude the possible causality between the reported death and the administration of COVID 19 vaccine, bnt162b2. However, more information on the patient''s underlying medical condition, concomitant medications, patient''s age group, clinical course and relevant lab tests would be helpful for the Company to make a more meaningful causality assessment. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: expired before receiving the second dose | ||||||||||||||||
Administered by: Other Purchased by: ?
Life Threatening? No Write-up: expired before receiving the second dose; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 8 patients. This report is for 4th of 8 patient. A patient of unspecified age and gender received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient expired before receiving the second dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information about Lot/Batch number has been requested.; Sender''s Comments: Current information is very limited for full assessment. The patient died following the vaccine use; further information such as patient demographics, complete 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.,Linked Report(s) : US-PFIZER INC-2021034595 same drug, reporter and event but different patient; Reported Cause(s) of Death: expired before receiving the second dose | ||||||||||||||||
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