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.
Arm hurt a bit; Potency disturbance; Strength loss of; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2022276312 (RA). Other Case identifier(s): DE-CADRPEI-2022276312 (RA Webportal), DE-PEI-202200078480 (RA). A 61-year-old male patient received BNT162b2 (COMIRNATY), on 19Aug2021 as dose 2, single (Lot number: scrw 2) for covid-19 immunisation. The patient's relevant medical history included: "Hip dysplasia" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "spinal disorder" (unspecified if ongoing); "various operation" (unspecified if ongoing); "Known allergies: House dust allergy" (unspecified if ongoing), notes: House dust allergy was diagnosed over 30 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (MANUFACTURER UNKNOWN)), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 15Sep2021, outcome "recovered with sequelae"; ERECTILE DYSFUNCTION (medically significant) with onset 15Sep2021, outcome "recovered with sequelae", described as "Potency disturbance"; ASTHENIA (non-serious) with onset 15Sep2021, outcome "recovered with sequelae", described as "Strength loss of"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm hurt a bit". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (Jan2022) UNKNOWN RESULTS, notes: I had massive potency problems, spoke several times with my family doctor who then carried out magnetic resonance imaging in Jan2022 which was generally ok. Therapeutic measures were taken as a result of erectile dysfunction, asthenia, headache, pain in extremity. Clinical Information: After the first and second vaccination, his arm hurt a bit and he had a headache for about three days, then there was no break for four weeks. It started with headaches, he was constantly weak and he had massive potency problems, spoke several times with my family doctor who then carried out magnetic resonance imaging in Jan2022 which was generally ok, started taking ibuprofen 1-2 times a day. Event stop date was 15Feb2022 for all the reported events. No follow-up attempts are possible. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||scrw 2||Unknown||Unknown|
|LAB_DATA:||Test Date: 202201; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:UNKNOWN RESULTS; Comments: I had massive potency problems, spoke several times with my family doctor who then carried out magnetic resonance imaging in Jan2022 which was generally ok|
|HISTORY:||Medical History/Concurrent Conditions: Diabetes; Hip dysplasia; House dust allergy (House dust allergy was diagnosed over 30 years); Kidney stones; Operation NOS; Spinal disorder|