Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Discomfort; Pain; Mucus/she is having mucus that is olive green in color currently; real bad allergic reaction to the shingles vaccine first dose; Knot on Arm/she had a knot the size of a medium sized egg where her shoulder comes down into her arm, around the injection site; did not know she needed to prime her new device before/also does not wait for 1 minute between inhalations for two puffs; she did not know she had to clean her Ventolin, has never cleaned one in the past/ran the device under hot water; This non-serious case was reported by a consumer via call center representative and described the occurrence of discomfort in a female patient who received salbutamol sulfate (Ventolin Hfa) inhaler (batch number 622W, expiry date 30-SEP-2026) for chronic obstructive asthma (with obstructive pulmonary disease) and wheezing. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concomitant products included ipratropium bromide, salbutamol sulfate (Ipratropium Bromide/Albuterol Sulfate). On an unknown date, the patient started Ventolin Hfa (inhaled) 2 puff(s) and the 1st dose of Shingrix. On an unknown date, an unknown time after starting Ventolin Hfa and an unknown time after receiving Shingrix, the patient experienced discomfort (Verbatim: Discomfort), pain (Verbatim: Pain), mucosal discolouration (Verbatim: Mucus/she is having mucus that is olive green in color currently), allergic reaction (Verbatim: real bad allergic reaction to the shingles vaccine first dose), injection site swelling (Verbatim: Knot on Arm/she had a knot the size of a medium sized egg where her shoulder comes down into her arm, around the injection site), wrong technique in device usage process (Verbatim: did not know she needed to prime her new device before/also does not wait for 1 minute between inhalations for two puffs) and wrong technique by user in product cleaning (Verbatim: she did not know she had to clean her Ventolin, has never cleaned one in the past/ran the device under hot water). The patient was treated with naproxen sodium (Aleve). Ventolin Hfa was continued with no change. The outcome of the discomfort, pain and mucosal discolouration were unknown and the outcome of the allergic reaction and injection site swelling were resolved and the outcome of the wrong technique in device usage process and wrong technique by user in product cleaning were not applicable. It was unknown if the reporter considered the discomfort, pain, mucosal discolouration and wrong technique in device usage process to be related to Ventolin Hfa, Ventolin Hfa Metered Dose Inhaler Device and Shingrix. The reporter considered the allergic reaction and injection site swelling to be unrelated to Ventolin Hfa and Ventolin Hfa Metered Dose Inhaler Device. It was unknown if the reporter considered the allergic reaction and injection site swelling to be related to Shingrix. The company considered the allergic reaction and injection site swelling to be unrelated to Ventolin Hfa and Ventolin Hfa Metered Dose Inhaler Device.. 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: 31-MAR-2025 and 31-MAR-2025: The reporter is a female. Patient with Asthma and COPD that states that she did not know she had to clean her Ventolin HFA device, and has never cleaned one in the past. The patient did try to clean her current device per her pharmacist's instructions, and the patient ran the device under hot water, with the metal canister in the plastic actuator, and took the metal canister out and also ran the white tip of the metal canister under hot water. The patient also did not know she needed to prime her new device before using it, and has not been doing this. The patient also does not wait for 1 minute between inhalations for two doses. The patient also mentioned that she had a "real bad allergic reaction to the shingles vaccine first dose" (AE Filed) that she received in her left arm in the afternoon two weeks ago (no specific date provided). The patient reports that in the evening after she received the first dose of the shingles vaccine, she had a knot the size of a medium sized egg where her shoulder comes down into her arm, around the injection site (AE Filed). The patient reported the injection site area was swollen and stayed swollen for two days (AE Filed). The patient reports that same evening after receiving the first shingles vaccine, all her muscles and joints felt like she had the flu, and she took an Aleve Gelcap (Unknown Product Information) that evening that did not help the discomfort or the pain (AE's Filed). The patient reports that she went to the ER on 26-MAR-2025 for these adverse events, but did not stay overnight and the physician tested her for the Flu, which was negative, and made her nose bleed during the flu test (AE Filed). The patient did not have any Lot Expiry/NDC/ Route of administration for the shingles vaccine (Product Not Verified). The patient also mentioned that she is having mucus that is olive green in color currently (AE Filed). The patient also states she uses Ipratropium Bromide/Albuterol Sulfate Nebulizer Solution (DuoNeb) (Limited Product Information) every four to six hours in her nebulizer and has to use it more often when she does not have Ventolin HFA available. She had reported all that was provided about these adverse events.
IPRATROPIUM BROMIDE/ALBUTEROL SULFATE; VENTOLIN HFA