Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
infection from the oral surgery; Hives all over her body; Itching; Trouble breathing; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized urticaria in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included oral surgery. Concomitant products included ibuprofen (Motrin). On 25-FEB-2025, the patient received the 1st dose of Shingrix. On 03-MAR-2025, 6 days after receiving Shingrix and 1 days after starting clindamycin, the patient experienced generalized urticaria (Verbatim: Hives all over her body). In MAR-2025, the patient experienced pruritus (Verbatim: Itching) and difficulty breathing (Verbatim: Trouble breathing). On an unknown date, the patient experienced postoperative infection (Verbatim: infection from the oral surgery). The patient was treated with clindamycin and diphenhydramine hydrochloride (Benadryl). The outcome of the generalized urticaria, pruritus, difficulty breathing and postoperative infection were not resolved. It was unknown if the reporter considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix. It was unknown if the company considered the generalized urticaria, pruritus, difficulty breathing and postoperative infection to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 The patient self-reported this case. The patient wanted to get back to the emergency room. The patient's sister was the main reporter, but the patient also took part in the conversation, so the reporter details were that of the patient. The patient had the first dose of Shingrix last Tuesday on 25 February 2025. The patient also had oral surgery the same day. The patient was started on Clindamycin on Sunday on 02 March 2025 due an infection from the oral surgery. It was unclear if the patient was taking another antibiotic prior to the Clindamycin. The patient also had been taking Motrin and an unnamed nausea medication due to the oral surgery. On Monday 03 March 2025 the patient stated to experience hives. At 5:30 am this morning 04 March 2025 the patient went to the emergency room with complaints of severe hives which were all over her body, trouble breathing, and itching. The patient was given steroids and IV Benadryl while in the emergency room. Since being home from the emergency room, the patient was using anti-itch spray and took an epsom salt bath. Since the patient was not getting better, the patient was going back to the emergency room for further evaluation. Reporter consent to contact was not given.
Medical History/Concurrent Conditions: Oral surgery
Motrin