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.
have become very tender/sensitive to touch.; I noticed my submandibular, superficial cervical and tonsillar lymph nodes began to swell; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; Severe body, joint and muscle aches/pain; malaise.; This is a spontaneous report from a contactable other hcp (patient). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: ER8734) via intramuscularly, administered in left arm on 19Apr2021 18:30 (age at vaccination 31 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS) and known allergies: Sulfa antibiotics. Concomitant medications in two weeks included levothyroxine, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and metformin taken for unspecified indication from an unknown date. The patient previously received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EN6203) via intramuscularly, administered in left arm on 05Mar2021 15:15 (at the age of 31 years) as DOSE 1, SINGLE for covid-19 immunisation and experienced severe headache 30 minutes after initial injection. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. It was reported that 24 hours after 2nd injection on 20Apr2021 at 18:30 the patient experienced severe body, joint and muscle aches/pain and overall malaise. The patient reported that she was on day 7 after injection and still experiencing those symptoms. On 24Apr2021 on day 5 after injection the patient noticed her submandibular, superficial cervical and tonsillar lymph nodes began to swell and at 18:30 it become very tender/sensitive to touch. It was further reported that on day 7 after injection and still experiencing all of these side effects without relief in sight. The patient was received NSAIDs as a treatment to help with total body discomfort. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | ER8734 | OT | LA |
RECVDATE: | 11-18-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | |
V_ADMINBY: | SCH |
OTHER_MEDS: | LEVOTHYROXINE; ADDERALL; METFORMIN |
CUR_ILL: | |
HISTORY: | Medical History/Concurrent Conditions: Hypothyroidism; Polycystic ovarian syndrome; Sulfonamide allergy |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC2021481613 |
FORM_VERS: | |
TODAYS_DATE: | 11-17-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | Y |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.