Received Jun 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
Suspected vaccination Failure/lack of drug effect; rash, pain and itch on her left torso/painful with bubbles/diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease (COPD). Concomitant products included oxygen. On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination Failure/lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: rash, pain and itch on her left torso/painful with bubbles/diagnosed with shingles). The patient was treated with gabapentin. The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. Additional Information: GSK Receipt date:18-JUN-2026 The reporter stated that she had received her Shingrix vaccine 2 or 3 years ago. She stated that maybe a year later, she had shingles. She reported that she had been struggling with pain and itching on her torso for almost a year and a half. She stated that it started with very painful with bubbles, rash and pain in the left torso, which drive her at the Emergency Room, and she was diagnosed with shingles. Since then, she had been taking Gabapentin to help manage her pain. She reported that she was feeling little better at the time but still has to deal with it on a daily basis and continued taking Gabapentin. The patient reported that she had never had chickenpox as a child and was surprised to have shingles after receiving the Shingrix vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Vaccination failure, 1 year after receiving Shingrix, in a 83-year-old female 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.
Chronic obstructive pulmonary disease (COPD)
OXYGEN