Received Feb 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Inappropriate schedule of vaccine administered/ seven months apart 2nd dose of Shingrix; bell's palsy; mouth droop right side; spasmodic dysphonia/dysphonia; inflammation of her right-side vocal cords; trigeminal nerve pain; right ear pain with burning that spread throughout her scalp; right eye is hard to close; slurred speech/difficult to talk; weakness in her right arm; right ear pain; tongue on the right side feels swollen; This serious case was reported by a nurse via call center representative and described the occurrence of bell's palsy in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of ear pain (received 1st dose on FEB-2025, for tolerance of 1st dose of Shingrix, refer case US2026018262). Concurrent medical conditions included ruptured intervertebral disc (ruptured disk L5-S1), asthma, blood cholesterol increased, attention deficit hyperactivity disorder and depression. Concomitant products included salbutamol (Albuterol), lisinopril, evolocumab (Repatha), lisdexamfetamine mesilate (Vyvanse) and desvenlafaxine succinate monohydrate (Pristiq). On 18-SEP-2025, the patient received the 2nd dose of Shingrix. In SEP-2025, less than 2 weeks after receiving Shingrix, the patient experienced bell's palsy (Verbatim: bell's palsy) (serious criteria GSK medically significant), facial droop (Verbatim: mouth droop right side) (serious criteria GSK medically significant), spasmodic dysphonia (Verbatim: spasmodic dysphonia/dysphonia), vocal cord inflammation (Verbatim: inflammation of her right-side vocal cords), trigeminal neuralgia (Verbatim: trigeminal nerve pain), burning sensation (Verbatim: right ear pain with burning that spread throughout her scalp), eye disorder (Verbatim: right eye is hard to close), slurred speech (Verbatim: slurred speech/difficult to talk), weakness of arms (Verbatim: weakness in her right arm), ear pain (Verbatim: right ear pain) and swollen tongue (Verbatim: tongue on the right side feels swollen). On 18-SEP-2025, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered/ seven months apart 2nd dose of Shingrix). Rechallenge with Shingrix was positive. The outcome of the bell's palsy, facial droop, spasmodic dysphonia, vocal cord inflammation, trigeminal neuralgia, burning sensation, eye disorder, slurred speech, weakness of arms, ear pain and swollen tongue were not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the bell's palsy, facial droop, spasmodic dysphonia, vocal cord inflammation, trigeminal neuralgia, burning sensation, eye disorder, slurred speech, weakness of arms, ear pain and swollen tongue to be related to Shingrix. The company considered the bell's palsy and facial droop to be unrelated to Shingrix. It was unknown if the company considered the spasmodic dysphonia, vocal cord inflammation, trigeminal neuralgia, burning sensation, eye disorder, slurred speech, weakness of arms, ear pain and swollen tongue to be related to Shingrix. Linked case(s) involving the same patient: US2026018262 Additional Information: GSK Receipt Date: 06-FEB-2026 The reporter stated that a couple of weeks after the second dose of Shingrix she developed trigeminal nerve pain, right ear pain with burning that spread throughout her scalp. The reporter states she had no blisters at this time, and the symptoms lasted approximately five weeks. The reporter also states after the second dose it looked like she had Bell's palsy. Her right eye was hard to close, and her mouth was drooping on the right side. The reporter stated that her tongue on the right side felt swollen and her speech was slurred. She was diagnosed with spastic dysphonia and inflammation of her right-side vocal cords. The reporter stated that she had a scope evacuation that showed no nodules or bleeding. The reporter states it was very difficult to talk. The reporter stated that she had an upcoming appointment to evaluate the appropriateness of Botox injections to the vocal cords. The reporter also stated that she had weakness in her right arm. All symptoms after the second dose of vaccine persist. The patient also had a myelogram scheduled for 19- Feb-2026. The batch number was not provided upon follow up with the reporter.; Sender's Comments: A case of Bell´s palsy (not meeting BC Criteria) and Facial paralysis, less than 2 weeks after receiving Shingrix, in a 63-year-old female patient. Case lacks further information on medical history, concurrent conditions and relevant laboratory results. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. US-GSK-US2026018262:SAME PATIENT 2nd dose
Asthma; Attention deficit hyperactivity disorder; Blood cholesterol increased; Depression; Ruptured intervertebral disc (ruptured disk L5-S1)
ALBUTEROL; LISINOPRIL; REPATHA; VYVANSE; PRISTIQ
Test Name: Scope evaluation; Result Unstructured Data: (Test Result:no nodules or bleeding,Unit:unknown,Normal Low:,Normal High:)