Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SHINGLES; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 81 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 08-JUL-2022. The patient's weight, height, and medical history were not reported. The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient received two doses of non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, start therapy date was not reported administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2).  The patient received third dose (boost) of non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 3) (form of administration, route of administration, batch number were not reported, expiry: unknown), dose was not reported, start therapy date was not reported administered for prophylactic vaccination. On an unspecified date, 3 days after the vaccination the patient developed shingles (dose number in series 3).  On 12-JUN-2022, the patient was exposed to covid-19 and three days later, on 15-JUN-2022, she was tested positive for covid (coded as suspected covid-19 infection) (dose number in series 3) which led to suspected clinical vaccination failure (dose number in series 1). On an unspecified date, the patient was treated with non-company suspect drug Paxlovid (form of admin, route of administration, batch number and expiry were not reported) dose and frequency were not reported administered for covid-19 treatment for 5 days and nights as prescribed by doctor. The first day of the medication she had diarrhea but that resolved. She also felt like a head cold and dry throat (dose number in series 3) and had no fever. After finishing the Paxlovid treatment she took a home covid test and it was negative. However, she also had two PCR (polymerase chain reaction) tests done, and both came back as inconclusive. The patient stated that she no longer had symptoms and wanted to know if there were any information on patients getting inconclusive PCR (polymerase chain reaction) results after taking Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure and shingles was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000241600.; Sender's Comments: V0: 20220716430-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.