Received May 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 93KK4 | IM / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Fatigue; lot of discomfort; Headache; pain in the arm; Pain injection site since vaccination date; she had not have a night sleep, the pain wake her up every night; Increased symptoms for asthma; Increased symptoms for Chronic obstructive airways disease exacerbated; Increased symptoms for cellulitis; Increased symptoms for tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthma aggravated in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included cellulitis, asthma, tinnitus and chronic obstructive airways disease exacerbated. On 11-APR-2025, the patient received the 1st dose of Shingrix. On 11-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site since vaccination date). In APR-2025, the patient experienced asthma aggravated (Verbatim: Increased symptoms for asthma), chronic obstructive airways disease exacerbated (Verbatim: Increased symptoms for Chronic obstructive airways disease exacerbated), cellulitis aggravated (Verbatim: Increased symptoms for cellulitis), tinnitus aggravated (Verbatim: Increased symptoms for tinnitus) and difficulty sleeping (Verbatim: she had not have a night sleep, the pain wake her up every night). On an unknown date, the patient experienced fatigue (Verbatim: Fatigue), discomfort (Verbatim: lot of discomfort), headache (Verbatim: Headache) and pain in arm (Verbatim: pain in the arm). The outcome of the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, difficulty sleeping, fatigue and headache were unknown and the outcome of the injection site pain, discomfort and pain in arm were not resolved. It was unknown if the reporter considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix. It was unknown if the company considered the asthma aggravated, chronic obstructive airways disease exacerbated, cellulitis aggravated, tinnitus aggravated, injection site pain, difficulty sleeping, fatigue, discomfort, headache and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 01-MAY-2025 The patient had vaccine on 11 Apr 2025, they said that the pain in the arm will disappear and was still experiencing a lot of things. The patient was still in a lot of discomfort. The patient mentioned that since the vaccination until today 01 May 2025, had a lot of pain in the injection site, and due to this, she had not had a night sleep, the pain wakes her up every night. She also mentioned that since the vaccination, all her illness (cellulitis, asthma, Chronic obstructive airways disease exacerbated and tinnitus) gets on and on and also mentioned that she would not get the 2nd dose.
Asthma; Cellulitis; Chronic obstructive airways disease exacerbated; Tinnitus