Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, 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 76-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6200, Expiration Date: 30Jun2021) and on 18Mar2021 as dose 2, single (Lot number: EN6207) at the age of 75 years, all intramuscular for covid-19 immunization. The patient's relevant medical history included: "the 1st time she had Covid." (unspecified if ongoing), notes: she had Pfizer vaccines and had zero side effects and was asymptomatic the 1st time she had Covid. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for covid after having Pfizer Covid Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive, notes: Result: positive; Unit: Not Provided; (08Jul2022) Negative, notes: Result: negative; Unit: Not Provided. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient stated that before she took the vaccines, she got Covid too but was asymptomatic. She had gone to her doctor and was told she had covid antibodies, but caller didn't have a clue and had no symptoms. She confirmed this was before getting the vaccines. Patient stated that she was diagnosed with covid after receiving 2 doses of the Pfizer COVID vaccines and she received Paxlovid (NDC number of Paxlovid: 0069-1085-30) for treatment. This most recent time she was diagnosed with Covid was after the two vaccines she received. Patient stated that she was negative this morning (08Jul2022) on her self-test. Her 1st test taken a week ago was positive. She had not required any emergency Room or physician Office visit. No medical history or family medical history. Product investigation results as follows: This was a notification generated from the system. As part of the 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. Refer to the below table for details: AE Ref No. (CC): DRN50ZFO_V2, PR ID (CR): 7421204. Product-Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial x1, Lot-# (CR): EN6200. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6200 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 EN6200, fill lot EN5332, and the formulated drug product lot EN5321. 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. PR ID of Previously Completed Inv: 5706482, PR Link (Previously Investigated CR): 5705159. AE Ref No. (CC): DRN50ZFO_V2, PR ID (CR): 7421206. Product-Description (CR): Compound BNT 162 Covid-19 Vaccine Suspension for Intramuscular 2ml Multiple Dose Vial x1, Lot-# (CR): EN6207. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech Covid-19 Vaccine lot EN6207 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 and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. 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. PR ID of Previously Completed Inv: 5898535, PR Link (Previously Investigated CR): 5898340. No follow-up attempts are possible. No further information is expected.