Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ6369) at the age of 78 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Jan2021 at 10:00 as dose 1, single (Lot number: 041L20A), in right arm, on 26Feb2021 at 10:00 as dose 2, single (Lot number: 011A21A), in right arm and on 26Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 014F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 11May2022, Treatment stop date: 16May2022 lot number: GA1513, indication: Treatment of COVID-19. Other medication in 2 weeks Unknown. The patient had no known allergies. Adverse event: During Paxlovid treatment the bad side effects were bad taste in mouth and loose stool on last day. Last dose taken morning of 16May. Rebound symptoms began again 6 days later. Symptoms are cough, runny nose, body aches, and earache. Adverse events experienced on 22May2022, at 06:00 PM. If patient was not recovered without treatment. Other medical history: Diabetes, congestive heart failure, high blood pressure, high cholesterol, obesity.  Additional Information:This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252.   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FJ6369 (SF: FJ6287). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are needed. No further information is expected.