Received Jul 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; shingles got in her eye; shingles in spinal fluid, and the membrane around her brain; blisters started on the left forehead/ it looked like shingles/itching, burning, stinging of the left nostril; Headache; first shot but believes it was one month prior to the second shot; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included glaucoma, celiac sprue, essential tremor, panic attack and fever blister. Concomitant products included levothyroxine, propranolol, primidone, famotidine (Pepcid), clonazepam, imipramine, zinc, lysine and valaciclovir hydrochloride (Valtrex). On 23-FEB-2024, the patient received the 2nd dose of Shingrix (unknown arm). In JAN-2024, the patient received the 1st dose of Shingrix. On 23-FEB-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first shot but believes it was one month prior to the second shot). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria hospitalization and GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles got in her eye) (serious criteria hospitalization and GSK medically significant), herpes zoster meningitis (Verbatim: shingles in spinal fluid, and the membrane around her brain) (serious criteria hospitalization and GSK medically significant), facial herpes zoster (Verbatim: blisters started on the left forehead/ it looked like shingles/itching, burning, stinging of the left nostril) and headache (Verbatim: Headache). The patient was treated with aciclovir (Acyclovir), valaciclovir hydrochloride (Valtrex) and valaciclovir (Valacyclovir). The outcome of the vaccination failure was resolving and the outcome of the ophthalmic herpes zoster, herpes zoster meningitis and facial herpes zoster were not resolved and the outcome of the headache was 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, ophthalmic herpes zoster, herpes zoster meningitis, facial herpes zoster and headache to be related to Shingrix and Shingrix. The company considered the vaccination failure, ophthalmic herpes zoster and herpes zoster meningitis to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and headache to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 26-JUN-2025 The patient had received both shots of Shingrix and does not remember the date of the first shot but she believed that it was one month prior to the second shot which led to drug dose administration interval too short. She cannot recall whether she was injected in the right arm or left arm. She reported that even though she got both shots of Shingrix she now has a bad case of shingles which caused her to be hospitalized for 11 days and was discharged on June 12th. The patient got shingles got in her eye, spinal fluid, and the membrane around her brain. She stated that she went to the emergency room on May 27th because she was having a horrible headache and the shingles blisters had not formed yet. She was given 2 to 3 migraine cocktails. The blisters started showing up and the emergency room, the doctor said it looked like shingles. The blisters started on the left forehead. She was given 27 infusions of acyclovir. Once discharged she was prescribed 5 days of Valtrex and had discarded the Valtrex prescription bottle. The patient mentioned that she was still suffering from shingles her symptoms which were itching, burning, stinging of the left nostril and left eye and currently taking valacyclovir. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2). Ophthalmic herpes zoster and Herpes zoster meningitis are unlisted events which are considered unrelated to GSK vaccine Shingrix (Dose 1 & 2)
Celiac sprue; Essential tremor; Fever blister; Glaucoma; Panic attack
LEVOTHYROXINE; PROPRANOLOL; PRIMIDONE; Pepcid; CLONAZEPAM; IMIPRAMINE; ZINC; LYSINE; VALTREX