Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: BAD TASTE; THREW UP LIQUID; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 40 year old female. Initial information was processed along with additional information received on 10-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, mold allergy, pet's allergy, becoming lactose intolerant, metabolic syndrome, PCOS (Polycystic ovary syndrome), endometriosis, asthma, and inflammatory disorder (undiagnosed, still seeking diagnosis). The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 06-JAN-2022 for prophylactic vaccination. Age at time of vaccination 39 years old. The batch number was not reported and has been requested. Concomitant medications included cetirizine hydrochloride, famotidine and montelukast sodium were used for unknown indication. On an unspecified date in MAY-2022, the patient experienced covid-19 infection (suspected clinical vaccination failure and suspected covid-19 infection) (Dose number in series 2).  The patient received non company suspect Paxlovid (form of admin, and route of admin were not reported, batch number: FY7026 and expiry: unknown) dose was not reported, administered on 26-MAY-2022 for covid-19 treatment. Patient took her third dose in the Paxlovid series and started noticing bad taste in her mouth, she reported that it was intense after the third dose. Patient was nauseous and unable to eat. Patient stated that she threw up liquid and the liquid had awful taste too (like sour metal). Patient stopped the paxlovid medication and reported that the taste was slowly dissipating and the nausea was going away, and she was able to eat again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with non company suspect (Paxlovid) was drug discontinued. The patient was recovering from suspected covid-19 infection, threw up liquid, and bad taste, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint (PQC): 90000235058; Sender's Comments: V0. 20220610705-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. The event(s) has an unknown/unclear 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.