Received Mar 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Loss of speech; patient was in hospital for speech swallowing gripping weakness progressive; This serious case was reported by a consumer and described the occurrence of slurred speech in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of dysarthria (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777) and Shingrix with an associated reaction of aphasia (Patient took 1 st dose on 10-APR-2024 case ID :US2025021777). Concurrent medical conditions included miller fisher syndrome. Concomitant products included prednisone. In AUG-2024, the patient received the 2nd dose of Shingrix. On 12-APR-2024, an unknown time after receiving Shingrix, the patient experienced slurred speech (Verbatim: patient was in hospital for speech swallowing gripping weakness progressive) (serious criteria hospitalization). On 02-AUG-2024, the patient experienced speech loss (Verbatim: Loss of speech) (serious criteria hospitalization). Rechallenge with Shingrix was positive. The outcome of the slurred speech and speech loss were not resolved. It was unknown if the reporter considered the slurred speech and speech loss to be related to Shingrix. The company considered the slurred speech and speech loss to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025021777 Additional Information: GSK receipt date: 20-FEB-2025 The reporter reported patient had recived Shingrix vaccine and experienced speech swallowing gripping weakness progressive and loss of speech. The reporter mentioned that dates when patient was in hospital for speech swallowing gripping weakness progressive and loss of speech was unspecified to unspecified. The expiry date of Shingrix was unknown. The reporter reported that other products patient was recived such as prednisone and started in fall 2024 and continues. The reporter mentioned that symptoms started slowly after first immunizations in April 2024 then rapid progression after booster in August 2024 requiring two hospitalizations with ongoing progressive symptoms and now repeating plasmaphoresis and considerdering rituxin infusions.; Sender's Comments: Dysarthria and Aphasia are unlisted events which are considered unrelated to GSK vaccine Shingrix. US-GSK-US2025021777:Same patient. secodn dose case.
Miller Fisher syndrome
PREDNISONE