Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; internal shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: internal shingles). The patient was treated with gabapentin, lidocaine, naproxen and tramadol. The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure and zoster sine herpete to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the zoster sine herpete to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was dealing with it now. His/her were considered internal shingles, a few spots on his/her back but no blisters. The pain started with what felt like I was being stabbed in the back. He/she went to urgent aid, and they sent him/her to the Emergency Room checking for heart issues or a pulmonary embolism. After a day in the hospital, he/she ended up on gabapentin, lidocaine patches, antibacterial medications, prescription strength naproxen and tramadol. After 10 days he/she went off everything except the Naproxen and lidocaine patches. The pain was still there but at least after almost 3 weeks it was no longer excruciating. He/she had the vaccine, could not imagine how bad it would have been without it. Get the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete and laboratory confirmation regarding zoster sine herpete were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.