Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Rash following administration of Shingrix; nerve pain following administration of Shingrix; This serious case was reported by a physician via sales rep and described the occurrence of rash in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash following administration of Shingrix) (serious criteria other: serious as per reporter) and nerve pain (Verbatim: nerve pain following administration of Shingrix) (serious criteria other: serious as per reporter). The outcome of the rash and nerve pain were unknown. The reporter considered the rash and nerve pain to be related to Shingrix. The company considered the rash and nerve pain to be unrelated to Shingrix. Additional Information: GKS receipt date: 13-MAR-2025 The reporter reported that the patient recived Shingrix vaccine the dose number was unknown but, after vaccination patient experienced rash and nerve pain. The expiry date of Shingles vaccine was unknown. The provider sent the patient to several specialist (dermatologist and neurologist) to identify the cause. Their only conclusion was that it was probably Shingrix vaccine. The reporter asked if this was a known side effect. She said she had 2 events but only shared information for one patient.; Sender's Comments: Rash is a listed event which, due to the following criteria (insufficient information regarding medical history, concurrent conditions, concomitant medications, completion of primary vaccination schedule, time to onset) is considered unrelated to GSK vaccine Shingrix. Neuralgia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.