Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error
Clinical narrative: -25 to -15 Centigrade for 21 days/received vaccine after improper storage/for 4 patients, it was a booster dose; -25 to -15 Centigrade for 21 days/received vaccine after improper storage/for 4 patients, it was a booster dose; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 64-year-old patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: FH8027, Expiration Date: 27Jan2022) at the age of 64 years intramuscular, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, Brand: Pfizer/BIONTECH, Date: 11Mar2021, Anatomical site: Unknown, Route of admin: Intramuscular, Lot Number: EN6202), administration date: 11Mar2021, for COVID-19 immunization; BNT162b2 (Dose:2, Brand: Pfizer/BIONTECH, Date: 01Apr2021, Anatomical site: Unknown, Route of admin: Intramuscular, Lot Number: EN6207), administration date: 01Apr2021, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "-25 to -15 Centigrade for 21 days/received vaccine after improper storage/for 4 patients, it was a booster dose".   Additional information: The reporter asked if a patient received a dose of vaccine that had been involved in a temperature excursion (stored in regular freezer at appropriate temperatures for 7 days past the date it should have been moved to the refrigerator), how soon can the dose be repeated. The reporter further stated adult formulation Comirnaty (purple cap) stored in freezer between -25 to -15 Centigrade for 21 days prior to moving to refrigerator. The reporter stated 10 patients received vaccine after improper storage and the vaccines were given over a span of time. The patients did not administer additional vaccines on same date of the Pfizer suspect. The reporter reported the product was stored in the vaccine freezer between -25 and -15 degrees Celsius, for longer than the recommended 21 days. The dates for temperature excursion reported as from 27Dec2021 to 03Jan2022. The vaccine was removed and diluted per the guidelines and administered to 10 patients. The reporter further stated that for 5 patients, the vaccine was a first dose; for 1 patient, it was a second dose and for 4 patients, it was a booster dose. The reporter stated the provider at the office has determined that the patients involved likely do not need revaccination but wanted to offer that as an option to the patients involved and would like to be able to provide an appropriate time frame for revaccination if necessary. It was stated that the patients were monitored during the observation time and there were no issues. Reporter stated she has not spoken to the patients yet. Reporter seriousness for temperature excursion was reported as not serious. Temperature excursion occurred unrelated to a refrigerator or freezer unit failure. Excursion occurred over a holiday were kend when staff failed to realize the vaccine needed to be moved from the freezer to the refrigerator. Vaccine should have been moved from the freezer to the refrigerator on 20Dec2021. Vaccine was not moved to the refrigerator until 27Dec2021. Ten doses of vaccine Lot #FH8027 were administered between 27Dec2021 and 03Jan2022 before staff realized an excursion had occurred. Staff attempted to reach all patients after re-vaccination: 6 opted to not to re-vaccinate, 1 was re-vaccinated, 2 could not be reached, 1 was diagnosed with covid on 08Jan2022. The patient was taking blood thinner.  No follow-up attempts are possible. No further information is expected.  Follow-up (20May2022): This is a spontaneous report from a contactable nurse. Updated information: Patient information (age and age at vaccination), Historical vaccine updated and added (dose 1 information updated and dose 2 added), Dosage regimen (Date of administration, Anatomical site and route of admin added, Dose number), AE onset date added, additional information.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200411772 Same reporter/vaccine/dose/events, different patient