VAERS ID: 1669585

AGE: 55| SEX: F|State: FL

Description

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

Symptoms

Pain in extremity, SARS-CoV-2 antibody test, Therapy non-responder

Vaccines

VAX DATE: | ONSET DATE: 17 March 2021 | DAYS TO ONSET:
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • JANSSEN
  • COVID19 (COVID19 (JANSSEN))

        RECVDATE:
        03 September 2021
        CAGE_YR:
        CAGE_MO:
        RPT_DATE:
        DIED:
        DATEDIED:
        L_THREAT:
        ER_VISIT:
        HOSPITAL:
        HOSPDAYS:
        X_STAY:
        DISABLE:
        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:
        2
        TODAYS_DATE:
        02 September 2021
        BIRTH_DEFECT:
        OFC_VISIT:
        ER_ED_VISIT:
        ALLERGIES:
        V_FUNDBY: