Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
high fever; shingles infection in left eye which has not resolved in over 7 months; convulsing; had chills; sores in mouth; sore in nose; sleeping for an entire day; This serious case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 13-AUG-2024, the patient received the 2nd dose of Shingrix. In AUG-2024, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: shingles infection in left eye which has not resolved in over 7 months) (serious criteria GSK medically significant), convulsion (Verbatim: convulsing) (serious criteria GSK medically significant and clinically significant/intervention required), fever (Verbatim: high fever), sleepiness (Verbatim: sleeping for an entire day), chills (Verbatim: had chills), mucosal sores (Verbatim: sores in mouth) and nasal ulcer (Verbatim: sore in nose). In AUG-2024, the outcome of the fever was resolved and the outcome of the sleepiness was resolved (duration 1 day). The outcome of the ophthalmic herpes zoster was not resolved and the outcome of the convulsion, chills, mucosal sores and nasal ulcer were resolved. It was unknown if the reporter considered the ophthalmic herpes zoster, convulsion, fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix. The company considered the ophthalmic herpes zoster and convulsion to be unrelated to Shingrix. It was unknown if the company considered the fever, sleepiness, chills, mucosal sores and nasal ulcer to be related to Shingrix. Additional Information: GSK Receipt Date: 24-APR-2025 The patient indicated that she got Shingrix shot 2 at a pharmacy. She said that less than 12 hours after the shot she began experiencing adverse reactions such as she had a high fever 102.6 for two days. She remembers sleeping for an entire day. She had chills and was convulsing such that her husband wanted to take her to hospital. But with extra blankets and changing the house temperature she was able to manage. She got sores inside her mouth and also inside her nose which she said were gross, horrible. She indicated that her left eye was running and that she could not even open her eye, so she went to urgent care. She had a shingles infection in her left eye that has persisted for over 7 months, and this was causing sensitivity to light. She did not had the lot number but she provided the name of the pharmacy and the pharmacy's phone number as the pharmacy should had the lot number on file. She went to the eye doctor twice a week and was prescribed numerous unspecified medications, but none have worked to clear the infection; Sender's Comments: Ophthalmic herpes zoster and Seizure are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Test Name: Body temprature; Result Unstructured Data: (Test Result:102.6,Unit:unknown,Normal Low:,Normal High:)