Symptomtext
hives/ on the right deltoid at the injection site; mild edema/ on the right deltoid at the injection site; mild erythema/ on the right deltoid at the injection site; itching/ on the right deltoid at the injection site; This case was reported by a physician via call center representative and described the occurrence of injection site hives in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number F3NL3, expiry date 7th May 2023) for prophylaxis. Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 14th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 15th July 2021, 1 days after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hives, injection site edema, injection site erythema and injection site itching. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site hives, injection site edema, injection site erythema and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site hives, injection site edema, injection site erythema and injection site itching 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 details were reported as follows: The patient received Boostrix on 14th July 2021, in the right deltoid. HCP (healthcare professional ) stated that, the next day on 15th July 2021, the patient began to experiencing itching, mild erythema, mild edema, and hives on the right deltoid at the injection site. The patient had received Benadryl for side effects. The reporter consented to follow up.