Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
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
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EL1284 | OT | LA |
| RECVDATE: | 01-13-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 01-11-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| 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) |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | ; ; EFFEXOR; ; ABILIFY; ; CRANBERRY; ; TYLENOL; ; LASIX [FUROSEMIDE]; IPRATROPIUM/ALBUTEROL; ; SENNA [SENNA ALEXANDRINA LEAF]; POLYETHYLENE GLYCOL 3350; |
| CUR_ILL: | |
| HISTORY: | 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 |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021018488 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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