Received Mar 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; 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. Co-suspect products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox when he/she was little). On an unknown date, the patient received Shingles vaccine and VARICELLA 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 shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles 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 shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had chickenpox when he/she was a child, and in his/her case, it was really bad. Later, he/she got the vaccine but still ended up with shingles, which were very painful. It felt like neither the chickenpox vaccine nor the shingles vaccine made much of a difference for him/her. It was unknown if the reporter considered shingles to be related to varicella vaccine. 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: 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.
Medical History/Concurrent Conditions: Chickenpox (had chickenpox when he/she was little)