Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 49 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25May2022 as dose 4 (booster), single (Lot number: FM9992), 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); "Cholesterol" (unspecified if ongoing), notes: both genetic: good diet and lifestyle, BMI 20. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body mass index: 20; Daily tests: antigen band is much stronger than in the original; SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Patient took Paxlovid (Lot number: GF4023) from 07Apr2023 to 11Apr2023 for treatment of COVID-19.  Based on investigation result conclusion: This is a daily notification generated from the RA 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 according to in PQS Q1215 and/or Q1252. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9694. The final scope was determined to be the associated lot(s) of the reported lot FM9992. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300161782 same reporter/patient, different product/event.;US-PFIZER INC-202300161869 Pfizer (Invalid);