Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included: left kidney removed (The patient reported she had left kidney removed in 2018), and drug allergy (Unspecified), and concurrent conditions included: high blood pressure, and small ground glass opacity in lungs (The patient stated need lung surgery for small ground glass opacity), and the patient stated that she was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 06-MAR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 58 years old. No concomitant medications were reported.  The patient additionally received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2) (batch number: 012H21B expiry: UNKNOWN, form of admin, route of admin were not reported) dose was not reported, administered on 22-DEC-2021 to right arm for prophylactic vaccination. The patient additionally received non-company co-suspect drug Paxlovid (batch number: 00069-1085-30, form of admin, route were not reported, expiry: unknown) dose was not reported, administered from 13-MAY-2022 to 18-MAY-2022 for treatment of COVID-19. On MAY-2022, the patient experienced covid-19 infection (confirmed covid-19 infection) (dose number in series 2). The patient reported that from 13-MAY-2022 for 4 days, she took the morning and evening doses and on day 5 (17-MAY-2022) took morning dose but forgot the evening dose and took dose the next morning. On 18-MAY-2022 (Wednesday) she was covid-19 positive up to Friday (20-MAY-2022) coded as confirmed clinical vaccination failure (dose number in series 1). On 20-MAY-2022 she was tested negative that afternoon (dose number in series 2). On 21-MAY-2022 (Saturday) she was also tested negative. But on 22-MAY-2022 (Sunday) she woke up with a sore throat and tested covid-19 positive (dose number in series 2). On 23-MAY-2022 (Monday) she had typical cold symptoms stuffy nose, sneezing, sore throat, fatigue (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number requested.; Sender's Comments: V0: 20220607882-COVID-19 VACCINE Ad26.COV2.S-  confirmed 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.