Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "depression" (unspecified if ongoing); "fatty liver" (unspecified if ongoing); "vit D deficiency" (unspecified if ongoing), notes: other medical history: vit D deficiency. Concomitant medication(s) included in 2weeks: AMLODIPINE; GLUCOPHAGE; PRAVACHOL; SERTRALINE; VASOTEC [ENALAPRILAT]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (21May2022) Negative, notes: testing negative 21May and 22May; (22May2022) Negative, notes: testing negative 21May and 22May; (23May2022) Positive, notes: 23May and COVID test positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Anti viral details: product=COVID 19 Treatment, brand=paxlovid, treatment start date=17May2022, treatment stop date=21May2022, indication=Treatment of COVID-19 and administrator route=Oral. Adverse event: Paxlovid rebound. Finished medication 21May testing negative 21May and 22May. Symptoms recurred with malaise and fever 23May and COVID test positive. Adverse event start date: 23May2022. 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. Refer to the below table for details. Product-description (CR): COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 Lot-# (CR): FD7218. Conclusion of Previously Completed Investigation (FCI/SI/OffCI)*: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FD7218 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FD7218, fill lot FD7213, and the formulated drug product lot FE5063. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.