Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
TIA(minor stroke); left lower lobe pneumonia; he was in Afib.; 00he developed shingles on his left chest; He also developed lower leg weakness; developed severe swelling of upper and lower lip; This serious case was reported by a nurse via call center representative and described the occurrence of transient ischemic attack in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. In MAR-2025, the patient received the 1st dose of Shingrix. In JUL-2025, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: 00he developed shingles on his left chest) (serious criteria hospitalization). On an unknown date, the patient experienced transient ischemic attack (Verbatim: TIA(minor stroke)) (serious criteria hospitalization and GSK medically significant), lower lobe pneumonia (Verbatim: left lower lobe pneumonia) (serious criteria hospitalization and GSK medically significant), atrial fibrillation (Verbatim: he was in Afib.) (serious criteria hospitalization and GSK medically significant), lower extremities weakness of (Verbatim: He also developed lower leg weakness) and lip swelling (Verbatim: developed severe swelling of upper and lower lip). The patient was treated with apixaban (Eliquis). The outcome of the transient ischemic attack, lower lobe pneumonia, atrial fibrillation, shingles, lower extremities weakness of and lip swelling were not reported. It was unknown if the reporter considered the transient ischemic attack, lower lobe pneumonia, atrial fibrillation, shingles, lower extremities weakness of and lip swelling to be related to Shingrix. The company considered the transient ischemic attack, lower lobe pneumonia, atrial fibrillation and shingles to be unrelated to Shingrix. It was unknown if the company considered the lower extremities weakness of and lip swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 11-SEP-2025 Retired Nurse reported that her husband in March 2025 received the Shingrix vaccine and within 30 hrs of getting the vaccine he developed severe swelling of upper and lower lip and they both became the size of my thumb, so he was a with, and he was told he cannot take the 2nd Shingrix vaccine. He then 3 months ago he developed shingles on his left chest, the shingles caused believe not only the shingles the rash on the chest, but he was brought to the emergency because he showed signs of having a stoke at home and when called to doctor they came to the home they examined his chest and heart , they did an EKG and he was in Afib. So, he was immediately brought to the emergency room at the hospital in where he stayed for 3.5 days and he had a diagnosis of shingles left lower lobe pneumonia and TIA (minor stroke). He was treated and but on Eliquis, after the viral drug. He was continued at home and Eliquis twice a day. Reporters concern was, he can get shingles again. However, in state, don't know what we do because he can't have shingles but there was a question to what do know because the Zostavax was not available. So, her concern was where do go from here, so he does not get shingles again and worse outcome. He also developed lower leg weakness and doing physical therapy.; Sender's Comments: A case of Transient ischaemic attack, Pneumonia, Atrial fibrillation and Herpes zoster, an unknown time after receiving Shingrix, in a 85-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Further follow up information has been sought.
Test Date: 2025; Test Name: EKG; Result Unstructured Data: (Test Result:he was in Afib,Unit:unknown,Normal Low:,Normal High:)