Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID after Pfizer COVID-19 Vaccine / Only thing she noticed was her taste has not ever returned the same. Her taste is not like the taste used to be and kind of foggy and tastes very bland; Got COVID after Pfizer COVID-19 Vaccine / Only thing she noticed was her taste has not ever returned the same. Her taste is not like the taste used to be and kind of foggy and tastes very bland; 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 received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205) and on 26Mar2021 as dose 2, single (Lot number: ER8727) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Borderline diabetic" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Oct2021, outcome "unknown" and all described as "Got COVID after Pfizer COVID-19 Vaccine / Only thing she noticed was her taste has not ever returned the same. Her taste is not like the taste used to be and kind of foggy and tastes very bland". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Oct2021) Diagnosed with COVID on 28Oct2021, notes: Got COVID after Pfizer COVID-19 Vaccine.  Clinical Course: Patient received her 3rd booster dose Pfizer COVID-19 Vaccine on 26Jan2022 (Lot number: FJ6369) and 4th dose Pfizer COVID-19 Vaccine on 10Sep2022 (Lot number: GH9694). Patient reported she Got COVID after Pfizer COVID-19 Vaccine. She was exposed to COVID on 25Oct2021 and was diagnosed with COVID on 28Oct2021. Only thing she noticed was her taste had not ever returned the same. Her taste was not like the taste used to be and kind of foggy and tasted very bland. She did not have the booster in 04Sep2021 but thought she was sick so did not go in. She did not like the way they changed card on her. She ended up with the 1st booster on 26Jan2022 and her 2nd booster on 10Sep2022. She did not want to provide medication list.  Product quality complaint: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6205 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 EN6205, fill lot EN5337, and the formulated drug product lot EN5326. 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.  Product quality complaint: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 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 ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may have caused a complaint of this nature. No root cause or corrective/preventative actions were 5796893 identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Product quality complaint: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FP FJ6369 (SF: FJ6287). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are needed. No further information is expected.