Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive test on 14May; positive test on 14May; 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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: EN6200), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for covid-19 immunisation. The patient's relevant medical history included: "osteoporosis" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing); "childhood bronchial asthma" (unspecified if ongoing); "severe environmental allergies until weekly allergy shots in my twenties" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: IVP dye (anaphylactic)" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL TRANSDERMAL; PROGESTERONE; ALPRAZOLAM; TYLENOL, start date: 09May2022, stop date: 17May2022; VITAMIN C [CALCIUM ASCORBATE]; VITAMIN B COMPLEX; MAGNESIUM; CALCIUM. Past drug history included: Nalidixic acid, reaction(s): "drug allergy"; Hydrocodone, reaction(s): "drug allergy". The following information was reported: COVID-19 (medically significant) with onset 14May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "positive test on 14May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) UNKNOWN RESULT, notes: COVID 19 Treatment; (14May2022) POSITIVE, notes: Rebound Covid after initial bout of Covid with positive test on May 14. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FH8027 was investigated. The investigation included 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 FH8027, fill lot FH4340, and the formulated drug product FH4348. 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. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EN6200 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the bulk formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record.  No follow-up attempts are possible. No further information is expected.