Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Feb2021 at 14:00 as dose 1, single (Lot number: EN6201), in right arm, on 08Mar2021 at 14:00 as dose 2, single (Lot number: EN6199), in left arm and on 27Oct2021 at 14:00 as dose 3 (booster), single (Lot number: 320308D) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "menopausal symptoms" (unspecified if ongoing). Concomitant medication(s) included: CLARITIN [CLARITHROMYCIN], start date: 03Jan2022, stop date: 09May2022; LEVOTHYROXINE, start date: Jan1982; ESTRADIOL, start date: Sep2010; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL], start date: Jan2010. Other medication in 2weeks brand: Ameal, start date Jan1982, Teva, start date Sep2010, Multivitamin, other medication in 2weeks brand: various. Past drug history included: Fexofenadine, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 18May2022, outcome "unknown", COVID-19 (medically significant) with onset 18May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive. Therapeutic measures were taken as a result of covid-19. It was reported that, COVID symptoms returned 18May2022 and rapid antigen test strong positive.  Conclusion: The complaint for a Lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot 32030BD 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 32030BD. 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 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. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320 and finished goods lot EN6201, fill lot EN5333, and the formulated drug product lot EN5322. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.