Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6207), in left arm and on 08Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 71 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTIN, stop date: 26Apr2022; LISINOPRIL; OXYBUTYNIN CHLORIDE; MUCINEX. Past drug history included: Sulfa, reaction(s): "Known allergies Sulfa". The following information was reported: COVID-19 (medically significant) with onset 04May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, Covid-19. Clinical course: Product= COVID-19, Treatment, brand=Pfizer Paxlovid, treatment start date=26Apr2022, treatment stop date=01May2022, Indication: Treatment of Covid-19. Adverse event: Return of symptoms: fever, congestion, lack of appetite. Adverse event start date: 04May2022. If patient recovering: Not recovered. If treatment AE: No (as reported). Reported Event: Metallic taste in mouth Device Date : 06May2022. Other medication in 2weeks product=Atorvastatin, Lupin, stop date=26Apr2022. This is a notification generated from the local 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 PRIVATE. Conclusion of Previously Completed Investigation: The complaint for a lack of effect in a vial of Pfizer BioNTech Covid-19 vaccine 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 pre formulated bulk, and is manufactured, labeled, and packaged by Pfizer. The final scope Was determined to be lot 30155BA. No quality issues were identified during the investigation. There is no impact on product quality. An RA was not issued for the complaint. No regulatory notification were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and 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 to any lot being released to the market. ID of Previously Completed Inv. PR Link (Previously Investigated CR). No follow-up attempts are possible. No further information is expected.