Received Jun 17, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Suspected vaccination failure; severe tremors and shaking of my arms and legs like a seizure (but I didn't have seizures it was just severe shaking); Since then, she has developed shingles 2 times/bad case of shingles in 2025; Since then, she has developed shingles 2 times with Shingrix; twice with the shingles vaccine prior to receiving the SHINGRIX vaccine; twice with the shingles vaccine prior to receiving the SHINGRIX vaccine; Painful PHN; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) solution for injection for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) solution for injection for prophylaxis. The patient's past medical history included shingles (had 4 times in adult life). Concurrent medical conditions included blood cholesterol increased. Concomitant products included atorvastatin. On an unknown date, the patient received Shingrix and Shingles vaccine. In JUN-2025, more than 2 years after receiving Shingrix and Shingles vaccine, the patient experienced post herpetic neuralgia (Verbatim: Painful PHN). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), tremor limb (Verbatim: severe tremors and shaking of my arms and legs like a seizure (but I didn't have seizures it was just severe shaking)) (serious criteria clinically significant/intervention required), shingles (Verbatim: Since then, she has developed shingles 2 times/bad case of shingles in 2025), shingles (Verbatim: Since then, she has developed shingles 2 times with Shingrix), shingles (Verbatim: twice with the shingles vaccine prior to receiving the SHINGRIX vaccine) and shingles (Verbatim: twice with the shingles vaccine prior to receiving the SHINGRIX vaccine). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the tremor limb, shingles and post herpetic neuralgia were unknown and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, tremor limb, shingles, shingles and post herpetic neuralgia to be related to Shingrix and Shingles vaccine. It was unknown if the reporter considered the shingles and shingles to be related to Shingles vaccine. The company considered the vaccination failure and tremor limb to be unrelated to Shingrix and Shingles vaccine. Additional Information: GSK Receipt Date: 10-JUN-2026 The consumer who was the reporter and patient called with concerns regarding her experience with the Shingrix vaccine stating that in 2021 she received the Shingrix vaccine and developed a reaction that led her to the hospital where she stayed for 8 hours. The 12 hours after being inoculated, patient was in bed and started having severe tremors and shaking of the arms and legs like a seizure (but did not had seizures it was just severe shaking) so husband took patient to the emergency room and they gave fluids and watched but could not really did much more. Consumer did not have any allergies and was very healthy and leads a healthy lifestyle so was very worried about getting shingles after being vaccinated. The batch number was not provided upon follow up with the reporter. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure on an unknown time after vaccination with unknown dose of Shingrix and unknown dose of Shingles vaccine; Tremor 12 hours after vaccination with unknown dose of Shingrix and unknown time after vaccination with unknown dose of Shingles vaccine, in a elderly female patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.
Blood cholesterol increased
Medical History/Concurrent Conditions: Shingles (had 4 times in adult life)
ATORVASTATIN