Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fear, Insomnia, Peripheral coldness
Clinical narrative: AFRAID; HARD TO GET TO SLEEP; FELT OFF BALANCE/GOING TO PASS OUT; COLDNESS IN HER ARMS, HANDS AND FEET; ALTERED TASTE OR A STRANGE TASTE IN HER MOUTH; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) via a company representative concerned a 74 year old female of an unspecified ethnic origin. Initial information was processed along with the additional information received on 28-APR-2022. The patient's weight was 63.96 kilograms, and height was 157 centimeters. The patient was a retired nurse. The patient's past medical history included: fainted, and concurrent conditions included: mild depression, low blood pressure, and cold hands. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 042A21 A, expiry: unknown) dose was not reported, 1 total, first dose administered on 5-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (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: 1822809, expiry: UNKNOWN) dose was not reported, 1 total, second dose administered on 30-NOV-2021 for prophylactic vaccination. Age at time of vaccination for patient was 74 years old. Concomitant medications included paroxetine for mild depression from JUL-2021.  On 13-APR-2022, the patient had confirmed covid-19 infection and confirmed clinical vaccination failure (dose number in series 2). Laboratory data included: COVID-19 virus test (NR: not provided) Positive (dose number in series 2). On 13-APR-2022, the patient was prescribed with non-company suspect drugs Paxlovid (tablet, batch number: FY4445 expiry: JAN-2023, route of admin was not reported) dose and frequency were not reported for covid-19 from her husband. The patient stated experienced nauseating taste in her mouth and has thrown up because of the taste that started since the minute took the first pill of Paxlovid. The patient took treatment with Paxlovid for 3 days. On 15-Apr-2022 the patient experienced altered taste or a strange taste in her mouth, felt off balance and also had coldness in her arms, hands and feet. It was even hard to got to sleep because of the nauseated taste was constant and felt off balance and had that cold sensation.  The patient Took her blood pressure because normally has low blood pressure, but it was okay. The patient was going to pass out, but that subsided in about an hour, it only lasted a little while (dose number in series 2).  The patient stated that talked to her doctor and decided to stop taking Paxlovid, and afraid.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The patient recovered from felt off balance/going to pass out, and coldness in her arms, hands and feet on 15-APR-2022, had not recovered from altered taste or a strange taste in her mouth, and the outcome of confirmed covid-19 infection, confirmed clinical vaccination failure, afraid and hard to get to sleep was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 20220448078 .; Sender's Comments: V0 : 20220448078-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.