Sex: U
Vaccine: COVID19
Symptoms: Fungal skin infection, Poor quality product administered, Product administration error
Clinical narrative: 5 Patients Received this Expired Dose: 13Jul2022 NDC: Unknown, Lot: FJ6369 Manufacturer Expiration: 31Aug2022. By Use Date: 07Apr2022; 5 Patients Received this Expired Dose: 13Jul2022 NDC: Unknown, Lot: FJ6369 Manufacturer Expiration: 31Aug2022. By Use Date: 07Apr2022; skin fungus; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 53-year-old patient received BNT162b2 (BNT162B2), on 13Jul2022 at 09:15 as dose 3 (booster), single (Lot number: FJ6369, Expiration Date: 31Aug2022) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD", start date: 06Feb2019 (ongoing); "Bipolar 1 disorder", start date: 06Feb2019 (ongoing); "Schizophrenia", start date: 06Feb2019 (ongoing); "Sleep disorder", start date: 06Feb2019 (ongoing); "Seasonal allergies" (ongoing); "Constipation" (ongoing); "Cardiovascular disease" (ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] oral taken for seasonal allergy, start date: 24May2021 (ongoing); DOCUSATE SODIUM oral taken for constipation, start date: 21Jun2021 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for cardiovascular disorder, start date: 21Jun2021 (ongoing). Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Route of administration: intramuscular), administration date: 08Oct2021, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE; Route of administration: intramuscular), administration date: 17Sep2021, for COVID-19 immunization. The following information was reported: FUNGAL SKIN INFECTION (non-serious) with onset 2022, described as "skin fungus"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 13Jul2022 at 09:15 and all described as "5 Patients Received this Expired Dose: 13Jul2022 NDC: Unknown, Lot: FJ6369 Manufacturer Expiration: 31Aug2022. By Use Date: 07Apr2022". Therapeutic measures were taken as a result of fungal skin infection.  Additional information: It was reported that' HCP called regarding the Pfizer-BioNTech COVID-19 Vaccine, monovalent gray cap formula. She stated one of their health centers "accidently used the wrong expiration date" when administering the vaccines to patients. They "used the manufacturer expiration date of 31Aug2022, instead of the 10-week BUD." Multiple patients were given an expired dose of the vaccine, a total of 41 patients. Lot# FJ6369. The HCP doe does not have information regarding, if the doses were primary series or booster doses that were inadvertently given to patients. The manufacture Expiration Date: 31Aug2022. Lot: FJ6369. Caller clarified there were a total of 15 patients, not 41. Caller stated she misunderstood the document she was given. Caller stated she also realized there were 2 different instances of this that happened close together on two different dates. Caller stated she does not have the patient identifiers or their information with her at that time be she can get that information. Upon follow up on 11Oct2022, it was reported that the patient had no information regarding the reported adverse events with the use of the product. The patient's skin fungus was treated with Lamisil AT/ terbinafine, topically on 10Aug2022. The patient had no prior vaccination within 4 weeks. The patient had no relevant tests nor specific tests for thromboembolic events with thrombocytopenia. The suspect product beyond use date was 07Apr2022.  Follow-up attempts are completed. No further information is expected.  Follow-up (11Oct2022): This is a spontaneous follow up report from a contactable nurse. Updated information included: reporter details (true reporter, nurse), patient's age, relevant medical histories, historical vaccines, suspect product details (dose number, onset date updated, route of administration, description), concomitant medications, reaction data (onset date, new event: skin fungus), and clinical course details.  Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201157433 as same reporter/drug/event, different patients;