Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure/ lack of drug effect; internal shingles; currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included mononucleosis (tested positive for mononucleosis). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2025, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ lack of drug effect) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: internal shingles) and flank pain (Verbatim: currently experiencing flank pain/ intense pain/ it's been over 2 weeks of stabbing pain without a rash). The outcome of the vaccination failure and zoster sine herpete were unknown and the outcome of the flank pain was not resolved. It was unknown if the reporter considered the vaccination failure, zoster sine herpete and flank pain 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 zoster sine herpete and flank pain to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 11-JUL-2025 The patient self-reported this case for herself. The consumer (patient) had received the complete series of Shingrix vaccine few years ago but was unsure of the dates and did not have the lot numbers of the medication. The patient stated prior to receiving Shingrix complete vaccine series she was diagnosed with a case of shingles on her spine (date not disclosed). The patient stated she presented to her local emergency department for flank pain and the pain was located on the front and back of her waist. She did not have a rash only intense pain. It had been over 2 weeks of stabbing pain without a rash. The patient stated the emergency department ruled out an issue with her spleen or her pancreas. Patient stated blood work was done, and she was tested positive for mononucleosis. However, the consumer stated she was told by the emergency department physician the flank pain she was experiencing might be an internal case of shingles. The consumer stated she was now in her 3rd week experiencing this flank pain that could not be explained after an ultrasound or a CT of the abdomen. The only explanation was shingles pain without the rash. The consumer stated the emergency room physician did not prescribe an antiviral medication. The consumer stated GlaxoSmithKline could contact the pharmacy that administered the vaccine to obtain that information. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding zoster sine herpete were unknown at the time of reporting. No further information was provided or obtained.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule and regarding laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Mononucleosis (tested positive for mononucleosis)
Medical History/Concurrent Conditions: Shingles
Test Date: 2025; Test Name: Blood test; Result Unstructured Data: (Test Result:mononucleosis positive,Unit:unknown,Normal Low:,Normal High:)