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.
Tingling in left arm and left leg; Headache; Dose number 3; This is a spontaneous report from a non-contactable reporter (consumer or non-HCP). The reporter is the patient. A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 16:30 (Lot number: FD7218) at the age of 33 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEXAPRO; TOPAMAX and AMOXICILLIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: left arm; Lot number: EP7533), administration date: 05Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical location: left arm; Lot number: EW0171), administration date: 26Apr2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 16:30, outcome "unknown", described as "Dose number 3"; PARAESTHESIA (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Tingling in left arm and left leg"; HEADACHE (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Headache". Therapeutic measures were not taken as a result of paraesthesia and headache. Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. No follow-up attempts are possible. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | FD7218 | 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: | U |
| LAB_DATA: | |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | LEXAPRO; TOPAMAX; AMOXICILLIN |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202101845079 |
| FORM_VERS: | |
| TODAYS_DATE: | 12-27-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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