Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HEPAB, RV1, TDAP
Symptoms: Product storage error
Clinical narrative: exposed to freezing conditions; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number N234J, expiry date 21st January 2022), (batch number LM992, expiry date 13th December 2022), (batch number 5295P, expiry date 27th December 2022), (batch number 73H93, expiry date 10th January 2022) and (batch number 2H575, expiry date 12th September 2022) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 3332B, expiry date 5th March 2023) and (batch number 9X3T5, expiry date 5th March 2023) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022), (batch number PX27D, expiry date 17th January 2023), (batch number 7P5J5, expiry date 30th September 2022) and (batch number HB7L7, expiry date 31st August 2002) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 374LB, expiry date 28th June 2022), (batch number X99KA, expiry date 28th October 2022) and (batch number GC5NG, expiry date 1st April 2023) for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number E4447, expiry date 6th July 2022) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022), (batch number G99R4, expiry date 20th May 2022) and (batch number 7J3G3, expiry date 12th June 2022) for prophylaxis, DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) and (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) (batch number 3PP42, expiry date 16th March 2022) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received Pediarix. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Pediarix Pre-Filled Syringe Device and Kinrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Kinrix Pre-Filled Syringe Device and Boostrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device and Havrix. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received Infanrix. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Infanrix Pre-Filled Syringe Device, Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Boostrix, Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Havrix, Infanrix, Infanrix Pre-Filled Syringe Device, Twinrix and Twinrix 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 case details were provided as follows: The age at vaccination was not reported. Health care professional reported several temperature excursions during the last month on which various vaccines were exposed to freezing conditions for different amounts of time which led to incorrect storage of drug. The reporter provided vaccines involved and lot numbers.  Could not confirm if follow-up could be possible since health care professional stated he/she not the supervisor, but I caould ask them later. Health care professional was willing to be contacted at a later time, via email, to confirm follow-up.  No patient information was collected since health care professional would have to review all records for last month to determine which patients received what vaccines and if those vaccines had a prior temperature excursion.