Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Initial COVID infection; positive antigen and PCR tests 25Apr2022.; Initial COVID infection; positive antigen and PCR tests 25Apr2022.; 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 69-year-old male patient received BNT162b2 (BNT162B2), on 23Sep2021 at 13:00 as dose number unknown, single (Lot number: 301458A) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "atopic dermatitis" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Jan2016; DUPIXENT, start date: Sep2018. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 25Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 25Apr2022, outcome "not recovered" and all described as "Initial COVID infection; positive antigen and PCR tests 25Apr2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: Initial COVID infection; positive antigen and PCR tests 25Apr2022; (01May2022) Negative, notes: was symptom free and had a negative antigen test 01May2022; (05May2022) Positive, notes: I have new symptoms and tested Positive with antigen test this date 05May2022; (25Apr2022) Positive, notes: Initial COVID infection; positive antigen and PCR tests 25Apr2022. Therapeutic measures were taken as a result of covid-19. Clinical Course: Patient had Reinfection / rebound infection 5 days after completing Paxlovid 5 day. Initial COVID infection; positive antigen and PCR tests 25Apr2022. (name-withheld) at (name-withheld) Prescribed Paxlovid on that date and Patient had started treatment on that date. Patient was symptom free and had a negative antigen test 01May2022. Patient had new symptoms and tested Positive with antigen test this date 05May2022. Other medication details includes other medication in 2weeks product Atorvastatin 20mg, Zydus Pharmaceu, other medication in 2weeks on Jan2016, Other medication in 2weeks product Dupixent, Sanofi.  Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for a Lack of effect of the Pfizer-biontech covid-19 vaccine lot 30145BA was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled and packaged by Pfizer. The final scope was determined to be lot 30145BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or AQRTs were held as a result of this complaint. The compliant condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to manufacture or vendor processes. The root cause was not determined to be manufacture or vendor related as incoming quality component testing, bulk release testing and certificate of analysis indicates all product testing was determined to be acceptable at time of release. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior any lot being released to the market. No further investigation required.