Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via Pfizer (other manufacturer) concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure (treated), low thyroid function (treated), overweight, seasonal allergies, and drug allergy, and Patient was not pregnant. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: unknown) dose was not reported, 1 total administered in left arm on 09-APR-2021 at 12:00 for prophylactic vaccination. Age at time of vaccination was 50 years. Concomitant medications included atenolol, fluticasone, hydrochlorothiazide, and levothyroxine. The patient additionally received non-company suspect vaccine spikevax (elasomeran) (dose number in series 2) (batch number: 012F21A, expiry: unknown, form of admin, route of admin were not reported) dose was not reported, administered in left arm on 05-NOV-2021 at 14:30 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with spikevax (elasomeran) (dose number in series 2). The patient additionally received non-company suspect vaccine Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 3) (batch number: FK9893 expiry: unknown, form of admin, route of admin, were not reported) dose was not reported, administered in left arm on 09-APR-2022 at 15:00 for prophylactic vaccination. On 10-MAY-2022, the patient experienced cold symptoms in evening (suspected covid-19 infection) (dose number in series 3) and was tested positive for Covid by rapid test on 11-MAY-2022 morning (which led to suspected clinical vaccination failure) (dose number in series 1). The patient took Paxlovid for treatment of Covid-19 (route and form of administration were not reported, batch number: FY6826) from 11-MAY-2022 evening to 16-MAY-2022 morning.  Symptoms improved by 12-MAY-2022 (morning) except for low-grade fever (99.2-99.8 F) which persisted through 23-MAY-2022.  On 20-MAY-2022, rapid test was negative. Cold symptoms (runny nose, cough, fatigue, throat tickle) returned on 22-MAY-2022. Rapid test was positive on 23-MAY-2022 AM (day 13 since initial infection). The action taken with covid-19 vaccine ad26.cov2.s and Pfizer biontech and spikevax (elasomeran) covid-19 vaccine was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000234650.; Sender's Comments: V0: 20220607445 -Covid-19 vaccine ad26.cov2.s -SUSPECTED CLINICAL VACCINATION FAILURE. 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. Therefore, this event(s) is considered not related.