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.
Anaphylaxis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128128. The patient was a 15-year and 6-month-old male. Body temperature before vaccination was 36.3 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 18Sep2021 at 15:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY solution of injection 0.3 ml, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration, at 0.3ml, as a single dose, at age of 15-year and 6-month-old of vaccination, for COVID-19 immunization. On 18Sep2021 at 15:08 (8 minutes after the vaccination), the patient experienced anaphylaxis. On 19Sep2021 (1 day after the vaccination), the outcome of the event was recovered. The course of the event was as follows: About 8 minutes after the vaccination, the patient experienced Pallor facial, Loss of consciousness (transient), blood pressure decreased to 70/40. Pulse 37 Spo2 98%. At 15:13 pm, the patient was given epipen, it was seemingly anaphylaxis. After that, blood pressure increased to 115/62, the patient could speak. There was mild redness on right upper arm. The patient had an emergency transport to the hospital from the vaccination venue. The patient was hospitalized in order to watch the progress. The patient took anti-allergic concentrate orally. The symptoms recovered on the next day noon and the patient discharged. The reporting physician classified the event as non-serious. The causality to the vaccine was not provided.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FH0151 |
| RECVDATE: | 10-14-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 1 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20210918; Test Name: blood pressure; Result Unstructured Data: Test Result:70/40; Comments: 15:08; Test Date: 20210918; Test Name: blood pressure; Result Unstructured Data: Test Result:115/62; Comments: 15:13; Test Date: 20210918; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210918; Test Name: pulse; Result Unstructured Data: Test Result:37; Comments: 15:08; Test Date: 20210918; Test Name: SPO2; Test Result: 98 %; Comments: 15:08 |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101289509 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-12-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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