Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product administration error
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team, Program ID: Unknown. A 10-year-old female patient received BNT162b2 (BNT162B2), on 27May2022 as dose 1, single (Lot number: FK5618) at the age of 10 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 27May2022 and all described as "10 patients received a dose of the Pfizer Covid 19 vaccine (orange cap, 5-11 years old) after the beyond use date of 10 weeks of the storage in the fridge"; EXPIRED PRODUCT ADMINISTERED (medically significant) with onset 27May2022, described as "received expired vaccines". Clinical course: Term highlighted by the reporter: yes, highlighted by the reporter, serious. Dosage text: first dose, injected into unknown site. It was a report related to a study or programme. Expiry Date of Pfizer COVID-19 vaccine ages 5-11: 31Aug2022. Pfizer COVID-19 vaccine ages 5-11 years past the 10 week expiry mark, and it had expiry of 17May2022 and LOT: FK5618. Agent reports caller also said they had given other doses that has expiry 31May2022. Agent reports caller wanted to know if they need to repeat doses for children who received expired vaccines. Caller said the expiration for the vaccines was from when they received them and removed them from freezer and placed them in the refrigerator, which she believes those were good for 10 weeks once they are in the refrigerator. She said actually they were using same LOT, and apparently there were different shipments so there was one of the same LOT with one vial expiry that was given 01Jun2022 so they are not exactly sure which children were vaccinated with 10 weeks refrigeration expiry of 17May2022 or the 31May2022. Caller says potentially, since the email the nurse sent with dates vaccination were given because were children potentially the 6th one dated 01Jun2022 could have been one with 31 May 2022 expiry date, but she was not sure if it was. She said that the nurse feels most children received the other for the 9 children, the 10 weeks expiry of 17May2022, and the other one with expiry 31May2022. Caller said patient has two middle names. This expired dose was given as a first dose 27May2022, the ten weeks expiry was probably 17May2022, and site injected unknown. Indication: Unknown. Seriousness: Caller says yeah, she would have to say it was significant, they just found out and she thinks they have to inform patients, though she feels the vaccine was pretty safe from all the data. The query was to confirm the total number of patient involved. Whether "3 different patients received a dose 7, 8 and 10 days past the BUD" and "a patient received a dose 1 day past the BUD (01JUN)" was contained in 10 patients or not. The following response was provided: 10 patients received a dose of the vaccine past BUD. Caller didn't mention a number of patients, she stated "for the vial dated 17May2022, they vaccinated on 24May, 25May and 27May, 7, 8 and 10 days past BUD. The last patient was vaccinated on 01Jun, with a vial that had a BUD of 31May. The nurse is sure of that but the other patients may have potentially been vaccinated with the vial of 31May". Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. Linked Report(s): US-PFIZER INC-202200824359 Same reporter/ drug/ event for different patients.