|
| VAERS ID: |
915682 (history) |
| Form: |
Version 2.0 |
| Age: |
85.0 |
| Sex: |
Female |
| Location: |
Kentucky |
| Vaccinated: | 2020-12-30 |
| Onset: | 2020-12-30 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2020-12-31 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
LA / IM |
Administered by: Senior Living Purchased by: ?
Symptoms: Cardiac arrest,
Death,
Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2020-12-30
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Respiratory Disease, Essential Hypertension, Coronary Artery Disease, History of positive COVID 11/17/20
Allergies: No Known allergies
Diagnostic Lab Data:
CDC Split Type:
Write-up: 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 |
|
| VAERS ID: |
918487 (history) |
| Form: |
Version 2.0 |
| Age: |
94.0 |
| Sex: |
Male |
| Location: |
Michigan |
| Vaccinated: | 2020-01-02 |
| Onset: | 2021-01-04 |
| Days after vaccination: | 368 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-04 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
011L2OA / 1 |
RA / IM |
Administered by: Senior Living Purchased by: ?
Symptoms: Cardiac arrest,
Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-04
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratadine, Plavix, flomax, Lisinopril, atrovastatin, amlodipine, Pentoxifylline, ASA, Donepezil, trazodone, Metoprolol tartrate.
Current Illness: NSTEMI, Dementia, TIA, COVID-19, HTN, CVA, PVD
Preexisting Conditions: HTN, PVD, Dementia
Allergies: Beta Adrenergic Blockers
Diagnostic Lab Data: None
CDC Split Type:
Write-up: Two days post vaccine patient went into cardiac arrest and passed away. |
|
| VAERS ID: |
921768 (history) |
| Form: |
Version 2.0 |
| Age: |
58.0 |
| Sex: |
Female |
| Location: |
Washington |
| Vaccinated: | 2021-01-04 |
| Onset: | 2021-01-04 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-05 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EL0140 / 1 |
UN / IM |
Administered by: Private Purchased by: ?
Symptoms: Cardiac arrest,
Death,
Dizziness,
Dyspnoea,
Fatigue,
Feeling hot,
Hot flush,
Lethargy,
Nausea,
Respiratory rate decreased,
Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-04
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: None Known
Diagnostic Lab Data: Autopsy scheduled for 01/07/2021
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
924464 (history) |
| Form: |
Version 2.0 |
| Age: |
61.0 |
| Sex: |
Female |
| Location: |
Iowa |
| Vaccinated: | 2021-01-05 |
| Onset: | 2021-01-06 |
| Days after vaccination: | 1 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-06 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / UNK |
- / - |
Administered by: Private Purchased by: ?
Symptoms: Cardiac arrest,
Condition aggravated,
Haemoptysis,
Lung neoplasm malignant
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-06
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD, lung cancer
Preexisting Conditions: COPD, lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: coughing up blood, significant hemoptysis -- $g cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer |
|
| VAERS ID: |
927260 (history) |
| Form: |
Version 2.0 |
| Age: |
87.0 |
| Sex: |
Female |
| Location: |
Wisconsin |
| Vaccinated: | 2020-12-28 |
| Onset: | 2021-01-06 |
| Days after vaccination: | 9 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-07 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
037K20A / 1 |
AR / IM |
Administered by: Senior Living Purchased by: ?
Symptoms: Blood lactic acid increased,
Bradycardia,
Cardiac arrest,
Computerised tomogram head normal,
Death,
Heart sounds abnormal,
Pulse absent,
Respiration abnormal,
Resuscitation,
SARS-CoV-2 test negative,
Unresponsive to stimuli,
White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-06
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vit D3, Miralax, Spironolactone, Tramadol, Metoprolol Succinate, MOM, Ferrous Gluconate, Ondansetron, Nitroglycerin Sublingual PRN, PreserVision AREDS, Fluticasone Propionate Suspension, Lisinopril, Clopidogrel Bisulfate, Campor-Methol-Met
Current Illness: Digestive Surgery for bowel obstruction
Preexisting Conditions: HTN, AAA, Chronic Diastolic Heart Failure, Diabetes Type 2, Paroxysmal atrial fibrillation, bradycardia, Hx of STEMI, Hx of CVA, HX of uterine cancer,
Allergies: Codeine, Meperidine, Morphine, Estrogens, Penicillins, Tetanus Toxoids
Diagnostic Lab Data: Brain CT negative WBC and lactic acid increased. COVID 19 on 1/4/21 negative
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
928062 (history) |
| Form: |
Version 2.0 |
| Age: |
85.0 |
| Sex: |
Male |
| Location: |
Massachusetts |
| Vaccinated: | 2021-01-05 |
| Onset: | 2021-01-05 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-08 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
- / 1 |
- / - |
Administered by: Senior Living Purchased by: ?
Symptoms: Blood lactic acid increased,
Cardiac arrest,
Death,
Endotracheal intubation,
Hypotension,
Hypoxia,
Laboratory test,
Lethargy,
Liver function test,
Lung infiltration,
Pancytopenia,
Pulmonary congestion,
Pulmonary imaging procedure abnormal,
Troponin,
Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Myelodysplastic syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-07
Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETAMINOPHEN CARBIDOPA-LEVODOPA CARBIDOPA-LEVODOPA ER CITALOPRAM HBR DONEPEZIL HCL EUCERIN FINASTERIDE FLOMAX LATANOPROST OMEPRAZOLE QUETIAPINE FUMARATE QUETIAPINE FUMARATE SENNA LAX
Current Illness: Parkinson''s Disease with advanced dementia, dysphagia. Alcoholism in remission. HTN. BPH. GERD
Preexisting Conditions: Parkinson''s Disease with advanced dementia, dysphagia. Alcoholism in remission. HTN. BPH. GERD
Allergies: angioedema due to ACE and ARB meds
Diagnostic Lab Data: Pancytopenia, elevated lactate, troponin, LFTs. Left mid lung infiltrate and pulmonary vascular congestion.
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
932898 (history) |
| Form: |
Version 2.0 |
| Age: |
61.0 |
| Sex: |
Male |
| Location: |
Pennsylvania |
| Vaccinated: | 2020-12-17 |
| Onset: | 2020-12-23 |
| Days after vaccination: | 6 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-10 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EK5730 / 1 |
LA / IM |
Administered by: Private Purchased by: ?
Symptoms: Cardiac arrest,
Cardiac disorder,
Intensive care,
Withdrawal of life support
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2020-12-30
Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine, Atorvastatin, Xarelto, Aspirin (These were medications listed with our office in 2019. Unknown if this patient was still taking at time of vaccination).
Current Illness:
Preexisting Conditions: High blood pressure. Congenital unicuspid aortic valve s/p aortic valve replacement 2001 & 2011. Pacemaker placement 2011. Melanoma
Allergies: None known.
Diagnostic Lab Data: Unknown.
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
939845 (history) |
| Form: |
Version 2.0 |
| Age: |
88.0 |
| Sex: |
Male |
| Location: |
Illinois |
| Vaccinated: | 2021-01-11 |
| Onset: | 2021-01-11 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EK9231 / 1 |
RA / SYR |
Administered by: Pharmacy Purchased by: ?
Symptoms: Cardiac arrest,
Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-11
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CHF
Allergies:
Diagnostic Lab Data:
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
940866 (history) |
| Form: |
Version 2.0 |
| Age: |
75.0 |
| Sex: |
Male |
| Location: |
South Carolina |
| Vaccinated: | 2021-01-07 |
| Onset: | 2021-01-09 |
| Days after vaccination: | 2 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA |
011L20A / 1 |
- / IM |
Administered by: Other Purchased by: ?
Symptoms: Abnormal behaviour,
Cardiac arrest,
Cardio-respiratory arrest,
Death,
Pulse absent,
Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-09
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine, ASA, Atorvastatin, Baclofen, Risperidone, Levothyr
Current Illness: None
Preexisting Conditions: Hypothyroidism, Bipolar, Profound ID, HTN, Osteopenia, dysphagia, aphasia, TBI as a young adult,Muscle spasm, Hernia
Allergies: Loxapine, Thioridazine
Diagnostic Lab Data:
CDC Split Type:
Write-up: 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. |
|
| VAERS ID: |
940955 (history) |
| Form: |
Version 2.0 |
| Age: |
66.0 |
| Sex: |
Female |
| Location: |
New York |
| Vaccinated: | 2021-01-11 |
| Onset: | 2021-01-11 |
| Days after vaccination: | 0 |
| Submitted: |
0000-00-00 |
| Entered: |
2021-01-13 |
| Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
| COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH |
EL1284 / 2 |
LA / OT |
Administered by: Other Purchased by: ?
Symptoms: Autopsy,
Cardiac arrest,
Death,
Pulse absent,
Respiratory arrest,
SARS-CoV-2 test negative
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)
Life Threatening? No
Birth Defect? No
Died? Yes
Date died: 2021-01-11
Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ; ; EFFEXOR; ; ABILIFY; ; CRANBERRY; ; TYLENOL; ; LASIX [FUROSEMIDE]; IPRATROPIUM/ALBUTEROL; ; SENNA [SENNA ALEXANDRINA LEAF]; POLYETHYLENE GLYCOL 3350;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19); Diastolic heart failure; Epilepsy; Morbid obesity; Pulmonary hypertension; Spinal stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210111; Test Name: pulseless; Result Unstructured Data: Test Result:pulseless; Test Date: 20210111; Test Name: breathless; Result Unstructured Data: Test Result:breathless; Test Date: 20210106; Test Name: Covid-19 PCR; Result Unstructured Data: Test Result:Negative (Nasal Swab)
CDC Split Type: USPFIZER INC2021018488
Write-up: 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 |
|
