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.
2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; 2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning; Dose number: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 20Dec2021 at 12:00 (Lot number: FH8027) at the age of 51 years as dose 3 (booster), single for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included: PROTONIX, ADVIL and unspecified MULTIVITAMINS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: EP6955, Administration location: left arm, Route of administration: intramuscular), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction" and Bnt162b2 (DOSE 2, SINGLE, Lot Number: EP6955 ; Administration location: left arm; Route of administration: intramuscular, administration date: 08Apr2021, when the patient was 50 years old, for COVID-19 immunisation, reactions: "No adverse reaction". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021 at 12:00, outcome "unknown", described as "Dose number: 3"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) both with onset 22Dec2021 at 05:00, outcome "recovered" (22Dec2021), and both described as "2 days after vaccine, my left under arm pit was sore and swollen when I woke up in the morning". Therapeutic measures were taken as a result of axillary pain and lymphadenopathy. Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for reported events included advil (patient reported to feel okay after approximately 3 hours after taking advil).
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | FH8027 | OT | LA |
| RECVDATE: | 12-31-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | WRK |
| OTHER_MEDS: | PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ADVIL [IBUPROFEN] |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101845129 |
| FORM_VERS: | |
| TODAYS_DATE: | 12-27-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.