Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via other company manufacturer (Pfizer) concerned a 67 year old female. Initial information was processed along with the additional information received on 24-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, morphine allergy and wool allergy. Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total administered to right arm on 13-MAR-2021 16:00 for prophylactic vaccination. Age at time of vaccination 66 years old. Concomitant medications included calcium/cholecalciferol, Vitamin C and lisinopril. The patient additionally received non-company suspect vaccine of Moderna, elasomeran (Spikevax) (dose number in series 2) (form of admin, route of admin not reported, batch number: 050C21A, expiry: unknown) dose was not reported, administered to right arm on 28-OCT-2021 11:00 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Moderna vaccine, elasomeran (Spikevax) (dose number in series 2). The patient received second dose of non-company suspect vaccine of Moderna, elasomeran (Spikevax) (dose number in series 3) (form of admin, route of admin not reported, batch number: 007J21-2A, expiry: unknown) dose was not reported, administered to right arm on 06-APR-2022 13:00 for prophylactic vaccination. On an unspecified date, the patient felt sick (confirmed covid-19 infection, dose number in series 3) and tested positive for Covid-19 on 20-MAY-2022 (confirmed clinical vaccination failure, dose number in series 1). The patient received Paxlovid as prescribed by doctor from 20-MAY-2022 to 25-MAY-2022 for treatment of Covid-19. On 26-MAY-2022, after completion of the 5 day anti-viral treatment, the patient tested negative. Laboratory data included: COVID-19 virus test Negative. On 02-JUN-2022 at 09:00, a week later, the patient had Covid symptoms again and tested positive for another full week until 09-JUN-2022. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose number in series 2) and elasomeran (dose number in series 3) was not applicable. The patient recovered from confirmed covid-19 infection on 09-JUN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000237576.; Sender's Comments: V0-20220650460 -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.