Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (HAVRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | LY35X | — |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U029794 | — |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U039948 | — |
anaphylactic reaction; throwing up; coughing; Lips turned blue; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylactic reaction in a 12-month-old male patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16-FEB-2023) for prophylaxis. Co-suspect products included MMR (MMR vaccine) (batch number U029794) for prophylaxis and Varicella zoster vaccine (Varicella vaccine) (batch number U039948) for prophylaxis. Concurrent medical conditions included meat allergy and food allergy (patient has multiple food allergies). On 22-AUG-2022, the patient received Havrix 720, MMR vaccine and Varicella vaccine. On 22-AUG-2022, 20 min after receiving Havrix 720, MMR vaccine and Varicella vaccine, the patient experienced anaphylactic reaction (Verbatim: anaphylactic reaction) (serious criteria GSK medically significant), vomiting (Verbatim: throwing up), cough (Verbatim: coughing) and lip discoloration (Verbatim: Lips turned blue). The patient was treated with epinephrine. The outcome of the anaphylactic reaction, vomiting, cough and lip discoloration were resolved. It was unknown if the reporter considered the anaphylactic reaction, vomiting, cough and lip discoloration to be related to Havrix 720, MMR vaccine and Varicella vaccine. The company considered the anaphylactic reaction to be unrelated to Havrix 720 and MMR vaccine. It was unknown if the company considered the vomiting, cough and lip discoloration to be related to Havrix 720, MMR vaccine and Varicella vaccine. It was unknown if the company considered the anaphylactic reaction to be related to Varicella vaccine. Additional Information: GSK receipt date: 18-SEP-2025 The mother of a male patient reported that her son, who was 1 year old at the time of the adverse event, experienced an anaphylactic reaction after receiving his first dose of Havrix on 22-AUG-2022. The vaccine was administered into an unknown leg, along with the MMR vaccine and the Varicella vaccine which were given in unknown legs during the same visit. All three vaccines were routine pediatric immunizations. Less than 20 minutes after receiving these vaccines, the patient developed an anaphylactic reaction. He began vomiting, coughing, and his lips turned blue. The pediatrician administered epinephrine, and the patient was transported to the emergency room by ambulance. There was no overnight hospital stay. Following the administration of epinephrine, the patient recovered. The mother reported that the patient, now 4 years old, was under the care of an allergist. Allergy testing revealed that the patient was allergic to pork. In addition to the pork allergy, the patient has multiple food allergies, though no further details were provided. The patient received his second dose of Havrix on 20-MAR-2023 with lot number 9R5LC, Expiry date as November 2024, and no adverse events were reported following the administration of this dose. No additional information regarding these events was provided; Sender's Comments: A case of Dermatitis bullous and Pruritus, 20 min after receiving Shingrix in a 12-month-old male patient. Causal relation is indeterminate considering two vaccines given concomitantly and concurrent meat and food allergy.
Medical History/Concurrent Conditions: Food allergy (patient has multiple food allergies); Meat allergy