Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
passed out; Shingles; She had declined to take the second dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included anxiety, macular degeneration, gastroesophageal reflux disease, allergy and cholesterol. Concomitant products included paroxetine, pantoprazole, montelukast, atorvastatin, ascorbic acid;betacarotene;cupric oxide;tocopheryl acetate;zinc oxide (Preservision), colecalciferol (Vitamin D 3), vitamins nos (Multivitamin) and paraffin (Mineral). On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced passed out (Verbatim: passed out) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: She had declined to take the second dose of Shingrix). The outcome of the passed out and shingles were unknown and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the passed out and shingles to be related to Shingrix. The company considered the passed out to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date : 21-APR-2025 She reported that she received one dose of SHINGRIX about 5 or 6 years ago. Two weeks later she noted a severe headache. The following morning she had a swollen right eye. The rash on her face and side of head, into her hair line followed soon after. She stated that she was sick for 2 months. She stated the pain during this time was the worst she had ever experienced. The itching and weird feeling lasted a few months more. She reported that she had a visit with her Ophthalmologist during this time and passed out in the chair due to the close quarters and too many people in the room. She had declined to take the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: Loss of consciousness is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Allergy; Anxiety; Cholesterol; Gastroesophageal reflux disease; Macular degeneration
PAROXETINE; PANTOPRAZOLE; MONTELUKAST; ATORVASTATIN; PRESERVISION; VITAMIN D 3; MULTIVITAMIN; MINERAL