Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TTOX | TETANUS TOXOID (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and TETANUS VACCINE for prophylaxis. The patient's past medical history included shingles (she had shingles prior to receiving the vaccine in 2013 or 2014). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix (unknown arm) and TETANUS VACCINE (unknown arm). In APR-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved with sequelae. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 13-MAY-2025 and 14-MAY-2025 The patient reported that she had 2 doses of Shingrix (2 to 6 months apart) back in 2019 and the last month she had nerve sensory discomfort and a rash on left side of back. She went to her health care professional and was diagnosed with shingles and antiviral medication for 10 days. She stated that the rash was gone but she was still having sensory issues in her back. At the beginning she delayed going to the doctor because she was already vaccinated and she thought the 2 doses of Shingrix are enough for lifetime protection. Caller also mentioned she got a Tetanus vaccine (unknown brand, lot number or expiration date) at the same time (but different arm) than the first Shingrix shot, and she forgot to gave that information to the prior agent from GlaxoSmithKline response center. It was unknown if the reporter considered the vaccination failure and shingles to be related to Tetanus vaccine. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2)
Medical History/Concurrent Conditions: Shingles (she had shingles prior to receiving the vaccine in 2013 or 2014)