Age: 67.0
Sex: F
Vaccine: COVID19, 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 a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 at 17:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in left 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). There were no concomitant medications. Past drug history included: Known allergies: ace inhibitors, reaction(s): "Known allergies: ACE inhibitors". 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: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course- The patient received vaccine. Anti-viral details Product-COVID 19 treatment, Brand-Paxlovid, Treatment start date-30Jun2022, Treatment stop date-05Jul2022, Lot Number-Unknown, Indication-Treatment of COVID-19, Administrator route- Oral. Adverse event: Recurrent cough and nasal discharge. Adverse events start date: 09Jul2022. Adverse events start time: 07:00 PM. Ae resulted in none of the above. If patient recovered it was recovering. If treatment ae was no.  Conclusion-This is 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 Q1215 and/or Q1252. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for Pfizer-Biontech Covid-19 Vaccine was investigated. 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 FK9893. 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. Manufacturing facility 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.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.