Age: 42.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 43-year-old patient received BNT162b2 (BNT162B2), on 12Apr2021 as dose 1, single (Lot number: ER8737), in right arm, on 23Apr2021 as dose 2, single (Lot number: EW0151), in right arm and on 03Sep2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 42 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 05Jan2022 as dose 4 (booster), single (Lot number: 032F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: GABAPENTIN, start date: 15Aug2020; AIMOVIG, start date: 24Mar2022; TARO, start date: 06Oct2020; RIBOFLAVIN, start date: Jan2022; SLOW MAG [ASCORBIC ACID; MAGNESIUM CARBONATE], start date: Jan2019; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 25Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "positive on rapid antigen test on days seven, eight (I'm on day eight now)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (01Jun2022) Negative, notes: I started Paxlovid, I tested negative on a rapid antigen test on day four, five and six,; (02Jun2022) Negative, notes: I started Paxlovid, I tested negative on a rapid antigen test on day four, five and six,; (03Jun2022) Negative, notes: I started Paxlovid, I tested negative on a rapid antigen test on day four, five and six,; (04Jun2022) Positive, notes: then positive on rapid antigen test on days seven, eight (I'm on day eight now); (05Jun2022) Positive, notes: then positive on rapid antigen test on days seven, eight (I'm on day eight now). Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: COVID-19 rebound after Paxlovid treatment. With day 0 being the day patient started Paxlovid, patient tested negative on a rapid antigen test on day four, five and six, and then positive on rapid antigen test on days seven, eight (was on day eight now). Initial case was mild, rebound was also mild. Anti viral details: Paxlovid, Treatment start date: 28May2022 and treatment stop date: 01Jun2022. Conclusion: This was a notification generated from the local system. As part of the 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. Product Description (CR): Compound BNT 162 Covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot FC3182 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 was limited to the reported finished goods lot FC3182, fill lot EY0552, and the bulk formulated drug product lot EP8655. 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 needed. No further information expected.