Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Out of Breath/she gets out of breath when she walks too fast or is rushing; her left arm was sore/left arm tender; she has put on extra weight; she experienced a burning in her left shoulder during the administration of the vaccine; she had swelling for about three days after receiving the first dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of exertional dyspnea in a 72-year-old female patient who received fluticasone propionate, salmeterol xinafoate (Advair Diskus) inhalation powder (batch number PX4U, expiry date 31-OCT-2025) for asthma. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Additional patient notes included Other Conditions: No. On an unknown date, the patient started Advair Diskus. On 25-JUL-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 25-JUL-2025, an unknown time after starting Advair Diskus and immediately after receiving Shingrix, the patient experienced burning sensation (Verbatim: she experienced a burning in her left shoulder during the administration of the vaccine). On an unknown date, the patient experienced exertional dyspnea (Verbatim: Out of Breath/she gets out of breath when she walks too fast or is rushing), swelling arm (Verbatim: she had swelling for about three days after receiving the first dose of Shingrix), pain in arm (Verbatim: her left arm was sore/left arm tender) and weight gain (Verbatim: she has put on extra weight). Advair Diskus was continued with no change. The outcome of the exertional dyspnea, pain in arm, burning sensation and weight gain were unknown and the outcome of the swelling arm was resolved (duration 3 days). It was unknown if the reporter considered the exertional dyspnea, swelling arm, pain in arm, burning sensation and weight gain to be related to Advair Diskus, Advair Diskus Dry Powder Inhaler Device and Shingrix. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. GSK receipt date: 25-AUG-2025 The reporter/patient with Asthma that reported that she gets out of breath when she walks too fast or is rushing, and this started (most recently, but no specific dates provided) while she was on Advair Diskus. The patient has been on Advair Diskus for 20 plus years (no specific dates provided). The patient stated she has put on extra weight, which she is trying to lose. The patient also reported that she received the first dose of Shingrix 25-JUL-2025 in her left arm, and that she experienced a burning in her left shoulder during the administration of the vaccine. The patient also reported that she was already having this burning in her left shoulder four days before receiving the first dose of the Shingrix vaccine. The patient reported that this burning still comes and goes, (is not continuous), like before she received Shingrix. The patient reported that her left arm was sore, tender, and she had swelling for about three days after receiving the first dose of Shingrix. The patient reported that she used ice cubes on this area to relieve the swelling. I have reported all that was provided about these adverse events. Conmed product included Vitamins.
Comments: Other Conditions: No
Advair diskus