Age: 3.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Rash, Wrong product administered
Clinical narrative: broke out in a general rash on body; a tdap vaccine was accidentally administered to a 4 year old patient; inadvertently administered Boostrix; a 4 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of generalized rash in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F, expiry date 19-JAN-2026) for prophylaxis.   Co-suspect products included benzylpenicillin potassium (Penicillin) for product used for unknown indication.   Previously administered products included Ipv (received 3 doses on an unknown date in past) and Hepatitis b vaccin (received 3 doses on an unknown date in past).   In NOV-2022, the patient received the 4th dose of Boostrix and Penicillin. In NOV-2022, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a tdap vaccine was accidentally administered to a 4 year old patient), wrong vaccine administered (Verbatim: inadvertently administered Boostrix) and accidental underdose (Verbatim: a 4 year old patient). On an unknown date, the patient experienced generalized rash (Verbatim: broke out in a general rash on body). The action taken with Penicillin was unknown. The outcome of the generalized rash was not reported and the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and accidental underdose were unknown.   It was unknown if the reporter considered the generalized rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   It was unknown if the company considered the generalized rash to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-APR-2024 and 16-APR-2024 The pediatric clinic office manager called to report the following was asked to reach out GSK regarding a tdap vaccine was accidentally administered to a 4 year old patient, which led to inappropriate age at vaccine administration and accidental underdose. Here in their clinic, last November and they had notified the mother of the patient and she had asked some further questions most in the way of safety. The healthcare professional had not reported these adverse events before. The vaccine that should be administered was Pediarix. At healthcare professional (HCP's) office reported that they were attempting to administer Pediarix for wound management and inadvertently administered Boostrix, which led to wrong vaccine administered. This dose would had been the patient's 4th dose of DTaP as the patient was off schedule. The caller also reported that the patient had been taking penicillin at the time the patient received Boostrix and broke out in a general rash on body before the error was identified and at that time it was determined that the rash was related to the penicillin. The reporter consented to follow up.