Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Seizure, Somnolence, Speech disorder, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 79-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included transient ischemic attack (2 different transient ischemic attack in 2017) and slurred speech. Previously administered products included ZOSTAVAX vaccine (10 years ago). Concurrent medical conditions included trigeminal neuralgia. On 22nd March 2019, the patient received the 1st dose of SHINGRIX. On 23rd March 2019, 1 days after receiving SHINGRIX, the patient experienced seizure (serious criteria hospitalization and GSK medically significant), slurred speech (serious criteria hospitalization) and eyes heavy feeling of (serious criteria hospitalization). On 26th March 2019, the patient experienced trigeminal neuralgia (serious criteria hospitalization) and condition aggravated (serious criteria hospitalization). On an unknown date, the patient experienced eating disorder (serious criteria hospitalization). The patient was treated with ibuprofen, PERCOCET, VALTREX, KEPPRA and meprednisone. On 23rd March 2019, the outcome of the eyes heavy feeling of was recovered/resolved. On an unknown date, the outcome of the seizure, slurred speech and trigeminal neuralgia were recovered/resolved and the outcome of the condition aggravated and eating disorder were unknown. It was unknown if the reporter considered the seizure, slurred speech, eyes heavy feeling of, trigeminal neuralgia, condition aggravated and eating disorder to be related to SHINGRIX. Save and rerun narrative: Additional details were provided as follows: This case was reported by the spouse of the patient. The patient had two episodes of minor slurring that were diagnosed as two different transient ischemic attack (TIA) in year 2017. The patient had history of trigeminal neuralgia and got relieved with a gamma knife surgery. The reporter stated he believed SHINGRIX was administered in the left arm. The following day the patient woke up with garbling when talking and she couldn't keep her eyes open for about 3.5 hours when it was time to wake up. She then woke up and was garbling. The reporter took the patient to the emergency room, which was away within 15 minutes. Before the patient reached the emergency room, she was recovered. However, she was kept overnight at the emergency room. She was diagnosed with TIA although she did not have testing showing that she had TIA. She also visited her neurologist and he didn't believe it was TIA and it was seizure. They did all the testings and the conclusions was minor seizures and prescribed KEPPRA. Four days after receiving SHINGRIX, she experienced a trigeminal neuralgia flare, which was described as very painful by the reporter. She couldn't talk or eat. She couldn't do anything because it was painful. It started on that Friday and lasted over the weekend. He contacted the family practice physician because Ibuprofen was not helping. She took some PERCOCET medication and that helped. He spoke with a pain institute and it seems like shingles could trigger trigeminal neuralgia pain so she was prescribed antiviral VALTREX, KEPPRA and a six pack of Metroprednisone. After 2 to 3 days once she started taking this treatment, she was 100 percent recovered. It had been 9 to 10 days that she was normal now. The reporter said that his pharmacist filed the adverse event report with the government. The reporter consented to follow up.