Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Got COVID in the ER from that hospital visit.; Got COVID in the ER from that hospital visit.; 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 67-year-old female patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3248) and on 19Feb2021 as dose 2, single (Lot number: EL8982) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing), notes: Fibromyalgia Probably diagnosed last year or year before. Not really effected at this time don't take anything for it. Concomitant medication(s) included: PREDNISONE; ELIQUIS; ASPIRIN [ACETYLSALICYLIC ACID] oral; CARVEDILOL oral; WARFARIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered with sequelae" and all described as "Got COVID in the ER from that hospital visit.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: got COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient got COVID and her feet and toes turned purple and were freezing cold in the end of Jul2022. HCP thought it was her circulation but that was not the case. Clarified she was in the ER for her feet and two days later was diagnosed with COVID. Got COVID in the ER from that hospital visit. Was given medicine which cleared it up very fast and felt better. She was given pills she took for 5 days. In two days she felt really better. Pills were 150mg and only for 5 days. Clarified pills to Paxlovid. She got sick, called an ambulance, and then found out about blood clots Aug2022.   Conclusion of Previously Completed Investigation for lot EL8982: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL8982 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 EL8982, fill lot EL8977, and the formulated drug product lot EL8975. 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. Conclusion of Previously Completed Investigation for lot EL3224: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 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 EL3248, fill lot EL3231, and the formulated drug product lot EL3224. 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.