Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
dizzy and fainted; The fall caused her to bang up her knee and chin; The fall caused her to bang up her knee and chin; The fall caused her to bang up her knee and chin; Angioedema: swelling of the hands, feet and upper lip; fainted; Itchy; broke out in full body hives; uncomfortable; sore injected arm/severe pain at the source (injection site) of the shot; This serious case was reported by a consumer via call center representative and described the occurrence of angioedema in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included chickenpox (as a child). Additional patient notes included She did not have flu-like symptoms, nausea, trouble breathing. On 27-DEC-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 11-JAN-2026, 15 days after receiving Shingrix, the patient experienced generalized urticaria (Verbatim: broke out in full body hives). In JAN-2026, the patient experienced discomfort (Verbatim: uncomfortable). On an unknown date, the patient experienced angioedema (Verbatim: Angioedema: swelling of the hands, feet and upper lip) (serious criteria GSK medically significant), faint (Verbatim: fainted) (serious criteria GSK medically significant), injection site pain (Verbatim: sore injected arm/severe pain at the source (injection site) of the shot), dizziness (Verbatim: dizzy and fainted), fall (Verbatim: The fall caused her to bang up her knee and chin), knee injury (Verbatim: The fall caused her to bang up her knee and chin), jaw injury (Verbatim: The fall caused her to bang up her knee and chin) and pruritus (Verbatim: Itchy). The patient was treated with cetirizine hydrochloride (Zyrtec), famotidine (Pepcid Ac) and methylprednisolone. The outcome of the angioedema, faint, generalized urticaria, dizziness, fall, knee injury, jaw injury and discomfort were resolving and the outcome of the injection site pain was resolved (duration 5 days) and the outcome of the pruritus was not resolved. It was unknown if the reporter considered the angioedema, faint, injection site pain, generalized urticaria, dizziness, fall, knee injury, jaw injury, discomfort and pruritus to be related to Shingrix. The company considered the angioedema and faint to be unrelated to Shingrix. It was unknown if the company considered the injection site pain, generalized urticaria, dizziness, fall, knee injury, jaw injury, discomfort and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JAN-2026 The patient received Shingrix. She did not receive any other vaccines that day). The injected arm was very sore, as if someone had punched, her for 5 days. She noticed this more if she touched the area or if she was lifting something. She described it as significant, severe pain at the source (injection site) of the shot. On 11-JAN-2026, she broke out in full body hives and was very uncomfortable. She also had angioedema, swelling of the hands, feet, and upper lip. She was dizzy and fainted. The fall caused her to bang up her knee and chin. She was treated with oral Zyrtec pills, Pepcid AC, and a 6-day steroid (Methylprednisolone) pack. She noticed that exercising made the hives worse, so she stopped exercising. The steroids would wear off around 3 am and the hives would come back. Patient stated that she was told that did not know the reason for the strong physical reaction if it was due to Shingrix or something else. Her doctor has advised her to get Shingrix shot number 2 but wait until 6 months after the first dose. The patient was not fully resolved. She stated she was still using Zyrtec and Pepcid AC and yet she still was a little itchy this morning. The batch number was not provided and unable to contact the reporter.; Sender's Comments: A case of Angioedema and Syncope, less than a month after receiving Shingrix, in a 50-year-old female patient. Case lacks further information on exact time to onset, 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. Further follow up information has been sought.
Medical History/Concurrent Conditions: Chickenpox (as a child); Comments: She did not have flu-like symptoms, nausea, trouble breathing