Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
eyes it is very red in a weird pattern; developed rashes galore after having the first dose of Engerix-B; also swelling around her eyes; food allergy; itch rash; quite warm; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye red in a 2-year-old female patient who received HBV (Engerix B) for prophylaxis. On 12-FEB-2025, the patient received the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced eye red (Verbatim: eyes it is very red in a weird pattern), rash (Verbatim: developed rashes galore after having the first dose of Engerix-B), periorbital swelling (Verbatim: also swelling around her eyes), food allergy (Verbatim: food allergy), itchy rash (Verbatim: itch rash) and skin warm (Verbatim: quite warm). The outcome of the eye red and periorbital swelling were resolving and the outcome of the rash was unknown and the outcome of the food allergy, itchy rash and skin warm were not reported. It was unknown if the reporter considered the eye red, periorbital swelling, food allergy, itchy rash and skin warm to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The reporter considered the rash to be possibly related to Engerix B. It was unknown if the reporter considered the rash to be related to Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the eye red, periorbital swelling, food allergy, itchy rash and skin warm to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The company considered the rash to be possibly related to Engerix B. It was unknown if the company considered the rash 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 Information: GSK Receipt Date:08-APR-2025 A customer called in behalf of her daughter to ask questions related to Engerix-B. The caller (grandmother of the patient) was from one country, the daughter and her granddaughter were from another country. She asked for a list of all ingredients of Engerix-B, what page could they found the list of ingredients in the PI of Engerix-B. The grandchild of the caller could possibly have developed rashes after having the first dose of Engerix-B, the female patient was 2 and a half years old. The first dose of Engerix-B was administered and under the course of the next 3 weeks she has got rashes galore and she has never had any problems before. The grandmother says it could be a coincidence because the family have sensitive skin. The rash comes in certain spots and then heal and goes away. The rash is going away was in different places of her body, they had putted cortisone to treat this rash. The grandchild was also having swelling around her eyes it was very red in a weird pattern but it was getting better. They were getting ready just in case because the patient will need the next doses. They first thought it was an itch rash when it started because it was behind her neck and it was quite warm at touch that day. Now the rash was in her legs. Their Dr said it could be a food allergy. The reporter did not consent to follow-up.