Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / LA |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | LA |
Suspected vaccination failure; Enteric Shingles internal/ gut pain and stomach pain; rash was located on the Left side around the waist; the blisters never cracked; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine (intramuscular, left arm) .5 ml and the 1st dose of Shingles vaccine (left arm). On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant and clinically significant/intervention required), zoster sine herpete (Verbatim: Enteric Shingles internal/ gut pain and stomach pain), rash (Verbatim: rash was located on the Left side around the waist) and blister (Verbatim: the blisters never cracked). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was resolving and the outcome of the rash was unknown and the outcome of the blister was resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete, rash and blister to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the zoster sine herpete, rash and blister to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-JUL-2025 The patient mentioned that she had received both doses of vaccine close to the time it was approved around 2018 She had got them as recommended by the product information in a timely manner (2 to 6 months after the 1st dose) and received the doses at a local pharmacy. The patient stated it was a light case and went to urgent care due to gut pain and stomach pain, and it was really tough. She reported she did not know it was shingles until the rash showed. The doctor stated it was enteric shingles (internal), and it was exceedingly unpleasant. The patient stated she got over it faster because the doctor prescribed Valtrex and after 2 days and was better and took Valtrex for 10 days. Further patient mentioned that the blisters never cracked, so she was never contagious. The patient reported about the rash to be located on the left side around the waist. The patient reported having gut pain at the same spot (internally). This case was considered as suspected vaccination failure as details regarding 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's Shingles vaccine (Dose 1 & 2).