Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected Vaccination failure; got my whole face hurting my ears; shingles on the side of my face, neck, and top of my head/ it's affecting my whole face; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included electrocution (from a cell phone). Concurrent medical conditions included congestive heart failure (percentage of lungs and heart were working), chronic obstructive pulmonary disease (percentage of lungs and heart were working) and atrial fibrillation (severe atrial fibrillation). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: got my whole face hurting my ears) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on the side of my face, neck, and top of my head/ it's affecting my whole face). The outcome of the vaccination failure, herpes zoster otitis externa and shingles were not reported. It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingrix. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 01-DEC-2025 The patient had severe shingles on the side of his/her face, neck, and top of his/her head. It hurt so badly that he/she was begging God to take his/her life. Tears came from the pain, it affected his/her whole face and hurting ears and he/she even had open, burst sores. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure and Herpes zoster oticus, unknown time after receiving Shingrix, in a patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Atrial fibrillation (severe atrial fibrillation); Chronic obstructive pulmonary disease (percentage of lungs and heart were working); Congestive heart failure (percentage of lungs and heart were working)
Medical History/Concurrent Conditions: Electrocution (from a cell phone)