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.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SORE ARM ABOUT TWO INCHES BELOW WHERE NEEDLE INSERTED; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 138 pounds, and height was 68 inches. The patient's concurrent conditions included: multiple sclerosis (MS), rheumatoid arthritis (RA), osteoarthritis (OA), emphysema, non- alcoholic, and ex smoker, and other pre-existing medical conditions included: Patient had no known allergies and did not have any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported,1 total, administered on 16-MAR-2021 (in the morning) to right arm for prophylactic vaccination. Concomitant medications included fingolimod hydrochloride, fluconazole, prazosin, prednisone, and sulfasalazine. The patient was taking more medicine but could not remember the name of rest of the medicines. On 17-MAR-2021, the patient experienced sore arm about two inches below where needle was inserted, it started the day after vaccination and lasted either a day or a day and half. On 25-AUG-2021, the patient had protein spike test done and the result came as "zero" antibodies (confirmed immunological vaccine failure). Patient's primary care physician (PCP) ordered the test, so they were aware of the results. Patient was willing to get a copy of the results from the test if required. Patient stated that, no expiration date was written on the vaccination card. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm about two inches below where needle inserted on 18-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191699 This case, from the same reporter is linked to 20210900277.; Sender's Comments: V0: 20210900383-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (JANSSEN)) | 0 | COVID19 | JANSSEN | 1805029 |
| RECVDATE: | 09-03-2021 | 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: | Test Date: 20210825; Test Name: COVID-19 antibody test; Result Unstructured Data: "zero" antibodies |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | GILENYA; SULFASALAZINE; DIFLUCAN; PREDNISONE; PRAZOSIN |
| CUR_ILL: | Abstains from alcohol; Emphysema; Ex-smoker; Multiple sclerosis; Osteoarthritis; Rheumatoid arthritis |
| HISTORY: | Comments: Patient had no known allergies and did not have any drug abuse or illicit drug use. The patient was taking more medicine but could not remember the name of rest medicine. |
| PRIOR_VAX: | |
| SPLTTYPE: | USJNJFOC20210900383 |
| FORM_VERS: | |
| TODAYS_DATE: | 09-02-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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