Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: RED SPLOTCHES ON THROAT; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 64 year old,  female. The patient's height, and weight were not reported. The patient's past medical history included: cancer (but normal mammograms since), and concurrent conditions included: penicillin allergy. 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 in total was administered to left arm on 09-APR-2021 for covid-19 prophylaxis.  The patient received second dose of non company suspect vaccine tozinameran (Pfizer covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 330268D expiry: unknown) dose was not reported administered on 16-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events after second dose of tozinameran vaccine (dose number in series 2). The patient received third dose of non company suspect vaccine tozinameran (Pfizer covid-19 vaccine) (dose number in series 3) (form of admin, route of admin were not reported, batch number: FJ4989 expiry: UNKNOWN) dose was not reported administered to left arm on 28-APR-2022 for covid-19 prophylaxis. Concomitant medications included alendronate sodium, ascorbic acid/ergocalciferol/folic acid/nicotinamide/panthenol/retinol/riboflavin/thiamine hydrochloride, calcium/colecalciferol, carmellose sodium/glycerol, cyanocobalamin, estradiol, fexofenadine hydrochloride, gabapentin, ibuprofen, lansoprazole, paracetamol, propranolol, and sumatriptan. On an unspecified date in 2022, the patient had sore throat, cough, nasal congestion, fever, body aches and sneezing (covid-19 infection) (dose number in series 3) and tested positive for covid (confirmed clinical vaccination failure) (dose number in series 1). On 05-JUL-2022, the patient was treated with non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: GC0473 and expiry were not reported) dose and frequency were not reported for covid-19 treatment from 05-JUL-2022 to 10-JUL-2022. It was reported that during the time of Paxlovid treatment patient's covid symptoms reduced until they were gone but for an occasional cough. Then 3 or 4 days later on 15-JUL-2022, after the Paxlovid course, the patient suddenly had red splotches on throat (dose number in series 3). 1-2 days after that throat was sore and had cough, as it was when the patient first had covid. These were the two main first symptoms when the patient had first tested positive with Covid. The patient had nasal congestion and sneezing followed, which was worse than the first time. But, the patient did not have fever as before, and also this time, hardly any body aches. It was milder, but it lasted longer, about 10 days. The patient did the home test again, just to be sure it wasn't just a cold this time, but tested positive again, on 20-JUL-2022. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (dose number in series 2), tozinameran (dose number in series 3) and Paxlovid was not applicable. The patient recovered from confirmed covid-19 infection, and red splotches on throat on 25-JUL-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 a product quality complaint: 90000246338.; Sender's Comments: V0: 20220826168-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.