Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Urticaria
Clinical narrative: Difficulties swallowing; Product Complaint; Hives all over body not resolved; This case was reported by a nurse via call center representative and described the occurrence of hives in a 44-year-old female patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included egg allergy.   On 15th November 2021, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. On 15th November 2021, less than a day after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the patient experienced swallowing difficult and pharmaceutical product complaint. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the swallowing difficult and pharmaceutical product complaint were unknown.   The reporter considered the hives to be possibly related to Engerix B adult. It was unknown if the reporter considered the swallowing difficult to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. The reporter considered the hives to be related to Engerix B 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 provided are as follows: The patient received a dose of Engerix-B and within 15 hours of vaccination, she developed hives all over her body. The hives resolved but then recurred. The reporter could only guess through the notes that the male patient was the one who experiencing swallowing issues, but really not sure. The reporter believed that the hives are related to this lot number. The reporter reported that neither she nor anyone else has previously reported this complaint to our company. The reporter reported that two patients received Engerix-B of lot 9AX5P, and developed hives. The reporter was uncomfortable using this lot number for any additional patients and product quality complaint was filled, which led to pharmaceutical product complaint. The Engerix-B box had 2 syringes used from it and 8 syringes remain. There was no obvious visual defect noted to the box or syringes.  The reporter ordered additional Engerix-B and received four more boxes of this same suspect lot number. The reporter would retain the vaccine in question until GlaxoSmithKline contacts her. The case was linked with case US2021252041, reported by same reporter. The reporter consented to follow-up. Note: There is discrepancy regarding the event difficult swallowing, during clarification it was not clear which patient had this event only guess was made through the notes that the male patient had, therefore conservatively difficult swallowing was coded in both case.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252041:Same reporter. Pt 2/2.