Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | PJ353 | IM / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Shoulder pain; Throat pain; Lip swelling; Throat swelling; Neck swelling; itchy palms; This non-serious case was reported by a consumer via call center representative and described the occurrence of throat swelling in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder for asthma. The patient's past medical history included fall (fell off a ladder), shoulder pain (ha d shoulder pain sine fall on the ladde) and esophageal acid reflux. Concurrent medical conditions included asthma and blood cholesterol increased. Concomitant products included atorvastatin and omeprazole. On 27-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid) .5 ml. On an unknown date, the patient started Trelegy Ellipta (inhaled) 1 puff(s) daily (1 puff(s) daily). On 31-MAY-2025, 4 days after receiving Shingrix and an unknown time after starting Trelegy Ellipta, the patient experienced neck swelling (Verbatim: Neck swelling) and itching both hands (Verbatim: itchy palms). On 01-JUN-2025, the patient experienced throat swelling (Verbatim: Throat swelling) and lip swelling (Verbatim: Lip swelling). On 03-JUN-2025, the patient experienced throat pain (Verbatim: Throat pain). On an unknown date, the patient experienced shoulder pain (Verbatim: Shoulder pain). The patient was treated with acetylsalicylic acid, ascorbic acid (Aspirin). Trelegy Ellipta was discontinued on 01-JUN-2025 (Dechallenge was positive). On 02-JUN-2025, the outcome of the throat swelling and neck swelling were resolved and the outcome of the lip swelling was resolved (duration 1 day). The outcome of the itching both hands and shoulder pain were resolving and the outcome of the throat pain was not resolved. It was unknown if the reporter considered the throat swelling, neck swelling, itching both hands, lip swelling, throat pain and shoulder pain to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. It was unknown if the company considered the throat swelling, neck swelling, itching both hands, lip swelling, throat pain and shoulder pain to be related to Shingrix, Trelegy Ellipta and Trelegy Ellipta Dry Powder Inhaler Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 03-JUN-2025 The reporter was the patient, a user of Trelegy Ellipta. He mentioned he fell off a ladder a few months ago and his shoulder has been hurting on and off since then. He received his first Shingrix dose at a pharmacy on Tuesday, 27 May 2025. On Saturday, 31 May 2025, his neck swelled, he had severe pain in both shoulders, and both of his palms were itchy. He went to the emergency department early morning on 1 Jun 2025 (Sunday). The emergency department did blood tests (unknown tests, unknown results), administered a baby aspirin and sent him home. He was not admitted to the hospital. He stopped Trelegy, atorvastatin, and omeprazole due to these events. That evening, 1 Jun 2025, his lips swelled, his throat swelled and his palms started itching again. Early the next morning, 2 Jun 2025, he again went to the emergency room. He was given IV fluids, a steroid injection, an antihistamine and was sent home with an oral prednisone prescription. He plans to begin the oral prednisone today. Today, he has throat pain. His palms are not as itchy today. The shoulder pain has improved. Nothing else was reported.
Asthma; Blood cholesterol increased
Medical History/Concurrent Conditions: Esophageal acid reflux; Fall (fell off a ladder); Shoulder pain (ha d shoulder pain sine fall on the ladde)
Atorvastatin; Omeprazole; TRELEGY ELLIPTA