Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: relapse of Covid infection after full 5-day treatment of Paxlovid Antiviral pills, which brought patient to be negative for 4 days until patient became positive again.; relapse of Covid infection after full 5-day treatment of Paxlovid Antiviral pills, which brought patient to be negative for 4 days until patient became positive again.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Apr2022 as dose 4 (booster), single (Lot number: 065k21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VYVANSE, start date: 01Jan2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "relapse of Covid infection after full 5-day treatment of Paxlovid Antiviral pills, which brought patient to be negative for 4 days until patient became positive again.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) strong positive, notes: patient was strong positive since still today; (12May2022) positive, notes: First time positive for covid on 12May2022; (18May2022) Negative; (21May2022) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Information: Patient had other medication in 2weeks. Other medication in 2weeks product: vyvanse 30mg. Other medication in 2weeks start date: 01Jan2022. The adverse event was a relapse of Covid infection after having taken full 5-day treatment of Paxlovid Antiviral pills, which brought him to be negative for 4 days until patient became positive again. Here was the Timing of events: First time positive for covid on 12May2022, prescribed Antiviral Pfizer on 14May2022, started treatment that evening. Negative on 18May, still negative on 21May2022, then symptoms reappeared on 22May2022 in the evening at 09:00 PM and he was strong positive since still today. Same symptoms level than first time, strong head cold and sinuses congestion, slight cough to none, wake up every 1h30mn in night without reason. Known allergies: bee stings, cat hair.  As of 31May2022 new information received from product quality group providing investigation results. This report included that: Updated Information included: Product Details (Batch and lot tested and found within specifications).   This was 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 Q number and/or Q number.  Product Description (CR): Compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple dose vial 1, Lot- (CR): FH8027 and ER8729, lot EP7534 respectively   Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot FH8027, lot ER8729, lot EP7534 respectively was investigated. The investigation included reviewing manufacturing and packaging batch records, retain samples, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope of this investigation is limited to the reported finished goods lot FH8027 and lot ER8729, lot EP7534 respectively, fill lot FH4340 and lot EP8681, lot EP7532 respectively, and the bulk formulated drug product FH4348 and lot EP8568, lot EP7528 respectively. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.