Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 55TH4 | IM / LA |
flu like symptoms; night sweat; shingles in ear; facial herpes zoster; Sore arm; Sore throat; This serious case was reported by a consumer via call center representative and described the occurrence of herpes zoster otitis externa in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4) for prophylaxis. On 18-AUG-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). In AUG-2025, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms), night sweat (Verbatim: night sweat) and sore throat (Verbatim: Sore throat). On 18-AUG-2025, the patient experienced pain in arm (Verbatim: Sore arm). On 29-AUG-2025, the patient experienced herpes zoster otitis externa (Verbatim: shingles in ear) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: facial herpes zoster). The patient was treated with valaciclovir hydrochloride (Valtrex) and doxycycline. In AUG-2025, the outcome of the pain in arm, influenza-like symptoms and night sweat were resolved. The outcome of the herpes zoster otitis externa, facial herpes zoster and sore throat were not resolved. The reporter considered the herpes zoster otitis externa, facial herpes zoster, pain in arm, influenza-like symptoms, night sweat and sore throat to be related to Shingrix. The company considered the herpes zoster otitis externa to be unrelated to Shingrix. The company considered the facial herpes zoster, pain in arm, influenza-like symptoms, night sweat and sore throat to be related to Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 The patient stated that she experienced a sore arm the same evening after receiving the vaccine, and the soreness persisted throughout the following day but had resolved by the time of reporting. Additionally, the patient reported waking up one night wet with sweat, which had since subsided. All these adverse events reportedly lasted for a couple of days and began during the week after receiving the vaccine, although no specific dates were provided. The patient stated that she experienced achiness, which was still ongoing at the time of reporting on 29-AUG-2025. She also reported feeling unwell on that day and described herself as just sitting and doing nothing. Over the weekend (specific dates not provided), the patient stated that she began feeling like pins were sticking in her head and she also reported the appearance of welts and bumps in her hair on the left side of her head, which she described as very sore to touch. According to the patient, there were big lumps on her head that stung when touched, and she was still experiencing these symptoms on 29-AUG-2025. The patient further stated that she developed a rash over the weekend (specific dates not provided), which first appeared on the left side of her neck, then spread to her left jaw and the inside and outside of her left ear. She also reported feeling like she had a stiff neck, which she noted began around the same time as the appearance of the welts on her head. Additionally, the patient reported experiencing an earache and a sore throat, she expressed feeling very upset by these symptoms. On 29-AUG-2025, the patient visited the emergency room and was diagnosed with shingles by the physician there, and she stated that the physician attributed her symptoms to the Shingrix vaccine. The physician also prescribed Gabapentin, although the patient stated that she did not intend to take this medication. Prior to receiving the shingles diagnosis, the patient reported taking one dose of Doxycycline, as she initially suspected her symptoms might have been due to a tick bite.; Sender's Comments: A case of Herpes zoster oticus, 11 days after receiving 1st dose of Shingrix in a 77-year-old female subject. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought.