Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Confusion; Migraine; unable to drive; time gaps with cognitive connections; was determined to be Encephalopathy; Delirium; Headache; Partial visual loss/vision was blocked partially on the left side; This serious case was reported by a consumer via call center representative and described the occurrence of encephalopathy in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included bell's palsy (when the consumer was approximately 20 years old.) and post-traumatic stress disorder. Concurrent medical conditions included disability (medically retired RN and was 100 percent disabled). Concomitant products included INFLUENZA VACCINE. On 10-OCT-2025 15:00, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In OCT-2025, 24 hrs after receiving Shingrix, the patient experienced encephalopathy (Verbatim: was determined to be Encephalopathy) (serious criteria GSK medically significant), delirium (Verbatim: Delirium) (serious criteria GSK medically significant), headache (Verbatim: Headache) and partial visual loss (Verbatim: Partial visual loss/vision was blocked partially on the left side). On an unknown date, the patient experienced confusion (Verbatim: Confusion), migraine (Verbatim: Migraine), driving ability disturbed (Verbatim: unable to drive) and cognitive disorder (Verbatim: time gaps with cognitive connections). The patient was treated with sumatriptan, glucosamine, indometacin (Indomethacin) and paracetamol (Tylenol). The outcome of the encephalopathy, delirium, headache, partial visual loss, confusion, migraine and cognitive disorder were unknown and the outcome of the driving ability disturbed was not resolved. It was unknown if the reporter considered the encephalopathy, delirium, headache, partial visual loss, confusion, migraine, driving ability disturbed and cognitive disorder to be related to Shingrix. The company considered the encephalopathy and delirium to be unrelated to Shingrix. It was unknown if the company considered the headache, partial visual loss, confusion, migraine, driving ability disturbed and cognitive disorder to be related to Shingrix. Additional Information: GSK Receipt Date: 13-JAN-2026 Consumer reported that she received her Shingrix in her left deltoid and within 24 hours had to go to the emergency department. Consumer presented to the emergency room with profound headache and her vision was blocked partially on the left side. Consumer was evaluated and released to home. Consumer complained for the next few weeks, she had headaches off and on. She had a follow up with her primary care physician on 24-OCT-2025. The primary care physician ordered a CT scan which was on 19-NOV-2025 and various blood work was done and sent to labs. The consumer stated she proceeded with daily activities and the headaches would come and go. She was prescribed a prescription for migraines (sumatriptan 50mg tablets to be taken no more than two tablets in 24 hours.) Consumer stated sumatriptan did not help her headaches (lack of effect-manufacturer not disclosed) so she was prescribed. Consumer stated she was prescribed Indomethacin 25mg three times daily along with 1gm of Tylenol at some point for her headaches (date prescribed not disclosed.) Consumer stated that she was seen in the emergency room two more times. Consumer did state that she was in rehab for one and a half weeks. She was in a skilled facility for speech therapy (for cognitive connections,) occupational and physical therapy. Consumer was home now and had in home care for speech, occupation and physical therapy. Consumer was trying her best to provide all information pertaining to care, however, she stated she was a bit confused at times. All information can be obtained from her primary care physician. Consumer stated upon presentation to emergency room (original visit) she was diagnosed with delirium. Her diagnosis after tests and evaluation was determined to be Encephalopathy, however, consumer stated this was not confirmed by MRIs or Pet Scan. Consumer had been referred to Neurology for cognitive testing. Consumer stated she was now unable to drive due to her vision and confusion. Consumer stated prior to vaccination with Shingrix she was in good health and very active and was a runner. The batch number was not provided and request for this information has been made.; Sender's Comments: A case of Encephalopathy and Delirium, 24 hours receiving Shingrix, in a 75-year-old female patient. Causal relation is indeterminate considering two vaccines given concomitantly. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Disability (medically retired RN and was 100 percent disabled)
Medical History/Concurrent Conditions: Bell's palsy (when the consumer was approximately 20 years old.); Post-traumatic stress disorder
INFLUENZA VACCINE
Test Name: blood test; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Date: 20251119; Test Name: Computed tomography; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:)