Age: 61.0
Sex: F
Vaccine: 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 contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 at 13:00 as dose 4 (booster), single (Lot number: 33036BD) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "T2DM" (unspecified if ongoing); "gerd" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; LEXAPRO; LISINOPRIL; XYZAL; METFORMIN; PRAVACHOL. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins"; Cipro, reaction(s): "known allergies: Cipro"; Neosporin oint, reaction(s): "known allergies: Neosporin oint". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive, notes: First positive test 12May. Metallic taste in mouth during treatment; (19May2022) Negative, notes: Tested negative 19May; (24May2022) Positive, notes: returned to work 23May, 24May started sneezing with nasal discharge, tested positive; (28May2022) Positive, notes: 28May, still testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Pfizer Paxlovid; Treatment start date: 12May2022; Treatment stop date: 17May2022; Indication: Treatment of COVID-19. Other medication in 2 weeks product: Nexium, Lexapro, Lisinopril, Zyxal, Metformin, Pravachol. First positive test 12May. Metallic taste in mouth during treatment. Tested negative 19May, returned to work 23May, 24May started sneezing with nasal discharge, tested positive. 28May, still testing positive.  This is a notification generated from the 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 PQSQ1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation: The complaint for a Lack of effect of the pfizer-biontech covid-19 vaccine lot 33036BD 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 was received as preformulated bulk and was manufactured, labeled and packaged by Pfizer (name-withheld). The final scope was determined to be lot 33036BD. No quality issues were identified during the investigation. There was no impact on 6705425 6705085 product quality. An NTM was not issued for the complaint. No regulatory notification were held as a result of this complaint. The complaint 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 and the results of all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. 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.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective/ COVID-19 cannot be ruled out