Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dysstasia, Polymerase chain reaction, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Admitted to the hospital with Covid 19; Admitted to the hospital with Covid 19; Has trouble standing now and did not before; thinks Covid 19 affected his muscles.; This is a spontaneous report from a Pfizer sponsored program  via consumer (reporter's husband). A 72-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: EL9267; Expiration Date: 31May2021) as dose 2 , single( Age at time of Vaccination: 72 years old) and dose 1 via an unspecified route of administration on 31Jan2021 (Batch/Lot Number: EL9262; Expiration Date: 31May2021) as dose 1, single (Age at time of Vaccination: 72 years old) both taken for COVID-19 immunisation. Medical history included ongoing diabetes (Diagnosed about 8 years ago), ongoing hypertension (Diagnosed about 5 years ago), ongoing dialysis (Has been on dialysis for about 2-2 and a half years). The patient's concomitant medications were not reported. The vaccination facility type was Hospital, Vaccine was not administered at Facility. The patient did not take Additional Vaccines Administered on Same Date of the Pfizer Suspect, did not had Prior Vaccinations (within 4 weeks). The patient visited Emergency Room and Physician Office. The patient was hospitalized for about 3 weeks. The patient had no adverse event prior vaccinations. The reporter stated that she and her husband both were fully vaccinated and both have tested positive and admitted to the hospital with Covid 19 (on an unspecified date in Mar2021); she was admitted for about 4 days and her husband (patient), who had several symptoms, was in the hospital for about 3 weeks, her husband went to the hospital on 17Jul2021 and was sent home. He went back the next day and was sent home again, he got very sick and went to another hospital, he was there for about a week, went home, had to go back. Then he was there for about a week again, went home, had to go back again. Then he was in the hospital for a few more days (unspecified date). The reporter stated she thought COVID-19 might have affected his muscles because her husband has trouble standing now and he did not before (on an unspecified date in 2021). The patient stated the first one is EL9265, the next one the last one is EN6202." LOT of COVID vaccination for husband, those were LOT for both for them, she further mentioned that Expiration date she did not know that, questioned would it be on her card and stated that she did not see one. The events admitted to the hospital with COVID-19 were considered as serious (Hospitalized) by the reporter.The patient underwent lab test and procedure which included PCR: Positive on 02Mar2021, COVID-19: positive on 30Mar2021. The outcome for all the events was unknown.   New information was received from Product Quality Complaints group. This report included: Details of Suspect products and Product Quality Complaints.This is a complaint for lack of effect of lot EL9262 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate The initial scope of this investigation is limited to EL9262 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9262 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 EL9262, fill lot EL9253, and the formulated drug product lot EL9244. 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 identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.