Received Mar 25, 2026
| 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; broke her neck; Shingles; Nightmares; fell; Upset; Drug dose administration interval too short; 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. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, primidone for product used for unknown indication and carbidopa monohydrate;levodopa (Sinemet) for product used for unknown indication. The patient's past medical history included tonsillectomy (in 1943), hysterectomy (in JUN-1970) and elbow fracture (in 28-FEB-1981). On 14-JUL-2021, the patient received the 2nd dose of Shingrix. On 20-MAY-2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient started primidone 50 mg. On 26-MAR-2025, the patient started Sinemet. On 14-JUL-2021, an unknown time after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting primidone and Sinemet, the patient experienced drug dose administration interval too short (Verbatim: Drug dose administration interval too short). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/lack of drug effect) (serious criteria GSK medically significant), cervical vertebral fracture (Verbatim: broke her neck) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), nightmare (Verbatim: Nightmares), fall (Verbatim: fell) and emotional distress (Verbatim: Upset). The patient was treated with aciclovir (Acyclovir). The action taken with primidone was unknown. The action taken with Sinemet was unknown. The outcome of the vaccination failure, shingles, nightmare and fall were unknown and the outcome of the cervical vertebral fracture and emotional distress were not reported and the outcome of the drug dose administration interval too short was not applicable. It was unknown if the reporter considered the vaccination failure, cervical vertebral fracture, shingles, nightmare, fall and emotional distress to be related to Shingrix and Shingrix. The company considered the vaccination failure and cervical vertebral fracture to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles, nightmare, fall and emotional distress to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date:18-MAR-2026 The patient had received both doses of Shingrix. She reported that when she became upset, she experienced a shingles outbreak. She had been prescribed Acyclovir 800 mg, to be taken as one tablet twice daily for 7 days, and she was to start the medication at the first sign of a shingles outbreak. The consumer further stated that she had prescribed Primidone 50 mg and while taking this medication, she fell and sustained a neck fracture. The reason for prescribing Primidone was not disclosed. The consumer also reported that she had been prescribed Sinemet, but she discontinued the medication due to experiencing nightmares. 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. It was unknown if the reporter considered the cervical vertebral fracture, shingles, nightmare, fall and emotional distress to be related to Primidone and Sinemet. The batch number was not provided and the request for the information has been made.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 1st and 2nd doses of Shingrix in an 83-year-old female patient. Based on the available information, a possible causality that the event(s) was caused by the GSK product cannot be ascertained. Further follow up information has been sought. A case of Cervical vertebral fracture, unknown time after receiving 1st and 2nd doses of Shingrix in an 83-year-old female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative etiology (patient fell).
Medical History/Concurrent Conditions: Elbow fracture (in 28-FEB-1981); Hysterectomy (in JUN-1970); Tonsillectomy (in 1943)
PRIMIDONE; SINEMET