Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 36 year old female. Initial information was processed along with the additional information received on 14-JUL-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: alpha thalassemia (silent carrier), asthma (childhood), overweight, pre-ventricular contraction (PVCs), and allergy, and the patient was not pregnant at time of report. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, and expiry: UNKNOWN) dose was not reported, 1 in total was administered on an unspecified date in MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 35 years old.  The patient received additional booster dose non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (dose number in series 2), (form of admin, route of admin were not reported, batch number: unknown, expiry: UNKNOWN) dose was not reported, administered on an unspecified date in OCT-2021 to left arm for prophylactic vaccination. Concomitant medications included ascorbic acid/betacarotene/calcium carbonate/colecalciferol/docosahexaenoic acid/ferrous fumarate/folic acid/nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine mononitrate/tocopheryl acetate/vitamin b12 nos/zinc oxide (Garden of Life Vitamin Code Raw Prenatal and Nordic Naturals). On 25-JUN-2022, the patient reported that, she was identified as a close contact and tested positive with covid-19 rapid antigen test on 27-JUN-2022. On unspecified date patient experienced confirmed covid-19 infection (dose number in series 2), which led to confirmed clinical vaccine failure (dose number in series 1). The patient was treated with non company co-suspect Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 27-JUN-2022 to 01-JUL-2022 for treatment of COVID-19. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. After completing the treatment of Paxlovid, the patient felt back to normal and tested negative with covid-19 rapid antigen test on 04-JUL-2022 (Day 7). On 06-JUL-2022, the patient developed runny nose and tested positive with covid-19 rapid antigen test on 06-JUL-2022 (Day 9). The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220725482- 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.