Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: redness had spread down to elbow; Redness just below the injection site of the left arm; swollen just below the injection site of the left arm; warm just below the injection site of the left arm; usual soreness/ body aches; Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number TS525, expiry date 10-MAR-2027) for prophylaxis.   The patient's past medical history included polycythemia vera (had been controlled for 6-7 months). Previously administered products included Zostavax (received Zostavax about 10 years ago). Concurrent medical conditions included hypertension, cholesterol, osteoporosis and sleep disorder. Concomitant products included alprazolam (Xanax), ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (Vitamins) and abaloparatide (Tymlos).   On 21-MAR-2025, the patient received Shingrix (left arm). On 21-MAR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). On 22-MAR-2025, the patient experienced general body pain (Verbatim: usual soreness/ body aches). On 23-MAR-2025, the patient experienced injection site erythema (Verbatim: Redness just below the injection site of the left arm), injection site swelling (Verbatim: swollen just below the injection site of the left arm) and injection site warmth (Verbatim: warm just below the injection site of the left arm). On 24-MAR-2025, the patient experienced erythema of extremities (Verbatim: redness had spread down to elbow). The action taken with Shingrix was unknown. On 22-MAR-2025, the outcome of the general body pain was resolved. The outcome of the injection site erythema, injection site swelling, injection site warmth, pain in arm and erythema of extremities were resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain, pain in arm and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site warmth, general body pain, pain in arm and erythema of extremities to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 and 26-MAR-2025 The patient was the reporter. The patient took medications for hypertension, Osteoporosis, and high cholesterol. The patient received the first dose of Shingrix on Friday afternoon on 21st march 2025. The next day, the patient experienced usual soreness and body aches. On Sunday, 23rd Match 2025, the patient noticed redness just below the injection site of the left arm, it was also swollen and warm, swelling had subsided but the redness remained although not as severe. Yesterday on Monday, 24th March 2025, the redness had spread down to her elbow, still a little sore. Today on 25th March 2025) the redness was barely visible. The patient received Zostavax about 10 years ago.