Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
Joint pain/Elbow pain; pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.; had soreness at injection site/Injection site pain; Injection site warmth; unable to bring her arm up; unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included hypothyroidism, diabetes, blood cholesterol increased (Cholesterol high), gastroesophageal reflux (gastric reflux), energy decreased, anxiety and depression. Concomitant products included levothyroxine sodium (Euthyrox), tirzepatide (Mounjaro), rosuvastatin, omeprazole, magnesium oxide, clonazepam, duloxetine hydrochloride (Cymbalta), citric acid, inositol, magnesium citrate, musa x paradisiaca, pyridoxine hydrochloride (Kidney Cop) and aspirin. On 15-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, right deltoid). On 15-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: had soreness at injection site/Injection site pain) and injection site warmth (Verbatim: Injection site warmth). In APR-2025, the patient experienced mobility decreased (Verbatim: unable to bring her arm up) and activities of daily living impaired (Verbatim: unable to bring her arm up far enough to don a pair of earrings or come hair due to the pain). On 20-APR-2025, the patient experienced arthralgia (Verbatim: Joint pain/Elbow pain) and pain in arm (Verbatim: pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow.). The outcome of the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired were resolving. It was unknown if the reporter considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, arthralgia, pain in arm, mobility decreased and activities of daily living impaired to be related to Shingrix. Additional Information: GSK Receipt Date: 21-APR-2025 The patient self-reported this case for herself. The reporter received her first Shingrix in her right deltoid. She reported that the same day, she had soreness and warmth at the injection site, which still persists but was improving. At beginning 20th April 2025 she noted pain in her entire upper right arm, radiating all the way from the top of her arm into her elbow. She stated that she was unable to bring her arm up far enough to done a pair of earrings or come hair due to the pain. She stated that it may be a little better on the day of reporting.
Anxiety; Blood cholesterol increased (Cholesterol high); Depression; Diabetes; Energy decreased; Gastroesophageal reflux (gastric reflux); Hypothyroidism
Euthyrox; Mounjaro; Rosuvastatin; Omeprazole; Magnesium oxide; Clonazepam; Cymbalta; Aspirin; KIDNEY COP