Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 at 11:15 as dose 1, single (Lot number: ER8737), in left arm, on 27Apr2021 at 13:15 as dose 2, single (Lot number: ER8735), in left arm and on 23Nov2021 at 14:15 as dose 3 (booster), single (Lot number: 33026BD) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "General Anxiety Disorder" (unspecified if ongoing); "Major Depressive Disorder" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Chronic Bronchitis" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN 40mg, start date: Jan2021; VITAMIN D3 125mcg, start date: Apr2019; VITAMIN B12 1000mcg [CYANOCOBALAMIN], start date: Apr2019; BUPROPION HCL 300mg, start date: Mar2021; FOLIC ACID 1mg, start date: Jan2020; CETIRIZINE HYDROCHLORIDE 10mg, start date: Apr2019; FERROUS SULFATE 325mg, start date: Apr2019. The following information was reported: VACCINATION FAILURE (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: (07Jun2022) negative; (10Jun2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received other medications in two weeks. Patient received paxlovid from 02Jun2022 to 06Jun2022 (lot number: FY565719) for COVID-19 treatment. Adverse event reported as, after completing the full course of treatment on monday, 06Jun, and testing negative on an at-home lateral flow test on tuesday, 07Jun, she developed a sore throat and cough that worsened throughout the afternoon and evening of thursday, 09Jun. She woke up with a persistent sore throat, cough, and congestion on friday, 10Jun, performed another at-home lateral flow test that shows she was positive for Covid-19. Adverse events were recovering and no treatment received for adverse events. Patient had no known allergies.  Product investigation summary conclusion on 13Jun2022 included for LOT#33026BD, 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 was received as preformulated bulk, and was manufactured, labeled, and packaged by Pfizer (withheld). The final scope was determined to be lot 33026BD. No quality issues were identified during the investigation. There was no impact on product quality. An was not issued for the complaint. No regulatory notifications 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 verification of the certificate of compliance with no significant investigations that would have affected product quality and the results of all analytical tests performed at the time of lot release confirmed that the batch met all release 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. PR ID of Previously Completed Inv: 6040511, PR Link (Previously Investigated CR): 6825854.  Conclusion of previously completed investigation for LOT#ER8735: The complaint for lack of effect of the Pfizer BioNTech COVID-19 vaccine lot ER8735 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. Analytical release test results were also reviewed. The final scope included the reported finished goods lot ER8735, fill lot EP8687, and the formulated drug product lot EP8574. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 6040511, PR Link (Previously Investigated CR): 6025183.  Conclusion of previously completed investigation for LOT#ER8737: The complaint for lack of effect of the Pfizer BioNTech COVID-19 vaccine lot ER8737 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 ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/prevent ative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. PR ID of Previously Completed Inv: 5861480, PR Link (Previously Investigated CR): 5857105.