Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Obesity, Poor quality product administered, Product administration error
Clinical narrative: Class 2 obesity; Medication was administered after the refrigeration expiration date; Medication was administered after the refrigeration expiration date; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Nurse), Program ID: (Unknown).  An 87-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 at 11:12 as dose 5 (booster), 0.3 ml single (Lot number: GJB5342, Expiration Date: 30Jun2023) at the age of 87 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "hypertension", start date: 17Oct2022 (ongoing); "impaired glucose tolerance" (unspecified if ongoing), notes: impaired glucose tolerance; "type 2 diabetes", start date: 17Oct2022 (ongoing), notes: type 2 diabetes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6201; Anatomical Site of injection: Right deltoid; Route of Administration: intramuscular), administration date: 04Feb2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6199; Anatomical Site of injection: Right deltoid; Route of Administration: intramuscular), administration date: 02Mar2021, when the patient was 85-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3, (BOOSTER) SINGLE; Lot number: FC3184; Anatomical Site of injection: Left arm ; Route of Administration: intramuscular), administration date: 23Sep2021, when the patient was 86-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4, (BOOSTER) SINGLE; Lot number: FJ4989; Anatomical Site of injection: Left deltoid; Route of Administration: intramuscular), administration date: 19Jul2022, when the patient was 87-year-old, for COVID-19 immunization; prevnar 20 (Vaccine Name: Prevnar 20, Manufacturer: Unknown, not given at facility. , Lot Number/Expiry Date: FW6028, Route, Anatomical Location: Unknown, No. of Previous Doses: Unknown, Date: 17Oct2022), administration date: 17Oct2022, when the patient was 87-year-old, for Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 29Nov2022 at 11:12, outcome "unknown" and all described as "Medication was administered after the refrigeration expiration date"; OBESITY (non-serious) with onset 27Mar2023, outcome "not recovered", described as "Class 2 obesity".  Additional information: patient was given vaccine on 29Nov2022, vaccine had expiration date of 23Nov2022. Takes daily medications but nothing that would cause interaction with the vaccine. No additional information provided. Upon follow-up on 03Apr2023: Prior vaccinations were reported. Concomitant drugs were reported as none. Patient medical history was reported. Relevant tests were reported as none. Specific relevant tests for thromboembolic events with thrombocytopenia was reported as none. Patient in clinic on 29Nov2022 for Pfizer BioNTech COVID-19 bivalent vaccine. Patient received Pfizer bivalent booster vaccine - Intramuscular and left deltoid at 11:12 AM. Medication was administered after the refrigeration expiration date. No adverse reactions reported. Patient administered Pfizer BioNTech Bivalent booster after refrigeration expiration date. Medication error occurred when the product was administered to / taken by the patient. Error was not noticed and intercepted before the product was supplied to the patient. Factor considered to be responsible for the medication error was Inadvertent human error. The patient did not experience any adverse(s) as a consequence of the error.  Follow-up (25Jan2023): Follow-up attempts are completed. No further information is expected.  Follow-up (03Apr2023): This is a spontaneous follow-up report from a contactable nurse. This nurse reported for a 87-year-old female patient in response to HCP letter sent via follow-up letter which included that: Updated information included: Reporter details updated (address, city, state, postal code, phone, fax, and email address) added. Onset date for RMH (hypertension, type 2 diabetes) were added. Vaccination facility details was added. suspect details (lot and Expiration date updated), New event (Class 2 obesity) was added. Treatment received was updated as blank for event expired vaccine used and additional information.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346054 same reporter/product/AE, different patient;