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.
Body weakness; Loss of appetite; Cough; Patient received 4th dose of Pfizer vaccine; Patient received 4th dose of Pfizer vaccine; Patient received 4th dose of Pfizer vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300161243. A 53-year-old male patient received BNT162b2 (COMIRNATY), on 10Feb2022 as dose 4 (booster), single (Lot number: 34300BD) at the age of 53 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: astrazeneca coviD-19 vaccine (Dose 1, Route of administration: Intramuscular, Lot number: A1026), administration date: 28Aug2021, when the patient was 52-year-old, for COVID-19 immunization; astrazeneca coviD-19 vaccine (Dose 2, Route of administration: Intramuscular, Lot number: A1076), administration date: 18Nov2021, when the patient was 52-year-old, for COVID-19 immunization; janssen covid-19 vaccine (Dose 3, Route of administration: Intramuscular, Lot number.:ACB32221), administration date: 07Jan2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (death), INTERCHANGE OF VACCINE PRODUCTS (death), IMMUNISATION (death) all with onset 10Feb2022, outcome "fatal" and all described as "Patient received 4th dose of Pfizer vaccine"; COUGH (death) with onset Nov2022, outcome "fatal"; DECREASED APPETITE (death) with onset Nov2022, outcome "fatal", described as "Loss of appetite"; ASTHENIA (death) with onset 02Jan2023, outcome "fatal", described as "Body weakness". The patient date of death was unknown. Reported cause of death: "Loss of appetite", "Cough", "Body weakness". Clinical information: The patient received 5th dose AstraZeneca on 24Feb2022 (Lot number: A1115, Route: Intramuscular). The patient also received 6th dose AstraZeneca on 01Jun2022 (Lot number: A1140, Route: Intramuscular). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Loss of appetite; Cough; Body weakness
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 4 | COVID19 | PFIZER\BIONTECH | 34300BD | OT |
| RECVDATE: | 01-24-2023 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | PHPFIZER INCPV20230001174 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-23-2023 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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