Sex: U
Vaccine: DTAPIPV, HEP, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines were exposed to below freezing temperatures and had been 145 administrations; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Menveo, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Menveo, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, between September 2021 through the date of reporting, there had been 145 administrations of Boostrix, Bexsero, Engerix-B, Menveo, and Kinrix vaccines that were exposed to below freezing temperatures, minimum recorded temperature of 27 degrees Fahrenheit for 5 hours, which led to incorrect storage of drug.  The reporter did not have the patient details, lot number or expiration date, or exact dates of administration available.  The reporter did not know how many administrations there were of each vaccine or how many patients were affected, only that there had been a total of 145 administrations of the affected vaccines.   At the time of reporting, no patients had been re dosed. The reporter consented to follow up. Note- As it was unknown, when the patient received which vaccine between September 2021 till the date of reporting, hence vaccine start date not captured for any vaccine.; Sender's Comments: Administrator reports that between September 2021 thru present day, there have been 145 administrations of Boostrix, Bexsero, Engerix-B, Menveo, and Kinrix vaccines that were exposed to below freezing temperatures (minimum recorded temperature of 27 degrees Fahrenheit for 5 hours). The reporter did not have the patient details, lot number/expiration date, or exact dates of administration available. Reporter did not know how many administrations there were of each vaccine or how many patients were affected, only that there had been a total of 145 administrations of the affected vaccines. At the time of reporting, no patients have been re-dosed. Consented to follow up.Suspect Vaccine Start Date:Sept. 2021 - Present, Suspect Vaccine Start Date:Sept. 2021 - present, Suspect Vaccine Start Date:Sept. 2021 - present, Suspect Vaccine Start Date:Sept. 2021 - present, Suspect Vaccine Start Date:Sept. 2021 - present, Call Notes:HCP gave permission for follow-up