Age: 71.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Headache, Incorrect route of product administration, Injection site erythema, Injection site pain
Clinical narrative: 2 inch diameter red swollen area below the deltoid extending to the bicep of the injected arm; 2 inch diameter red swollen area below the deltoid extending to the bicep of the injected arm; Anorexia; Felt nauseated; Headache; Muscle ache; Fatigue; the vaccine was given subcutaneously; Flare up fibromyalgia; Unable to perform usual daily activities; This non-serious case was reported by a consumer via call center representative and described the occurrence of anorexia in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 34MK3, expiry date 08-JUL-2024) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On 11-SEP-2023, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). On 11-SEP-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: the vaccine was given subcutaneously). On 12-SEP-2023, the patient experienced anorexia (Verbatim: Anorexia), nausea (Verbatim: Felt nauseated), headache (Verbatim: Headache), muscle pain (Verbatim: Muscle ache) and fatigue (Verbatim: Fatigue). On 13-SEP-2023, the patient experienced local swelling (Verbatim: 2 inch diameter red swollen area below the deltoid extending to the bicep of the injected arm) and erythema (Verbatim: 2 inch diameter red swollen area below the deltoid extending to the bicep of the injected arm). In SEP-2023, the patient experienced activities of daily living impaired (Verbatim: Unable to perform usual daily activities) and fibromyalgia worsened (Verbatim: Flare up fibromyalgia).  The patient was treated with ibuprofen. The outcome of the anorexia, nausea, headache, muscle pain, fatigue, activities of daily living impaired and intramuscular formulation administered by other route were unknown and the outcome of the local swelling and erythema were not resolved and the outcome of the fibromyalgia worsened was not reported.   It was unknown if the reporter considered the anorexia, nausea, headache, muscle pain, fatigue, activities of daily living impaired, local swelling, erythema and fibromyalgia worsened to be related to Shingrix.     It was unknown if the company considered the anorexia, nausea, headache, muscle pain, fatigue, activities of daily living impaired, local swelling, erythema and fibromyalgia worsened to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-SEP-2023 The patient was self-reported this case. The patient received the first dose of Shingrix on Monday. The reporter reported that the patient received vaccine subcutaneously and not Intramuscular, which led to Intramuscular formulation administered by other route. The patient received the vaccine in the anterior lower aspect of the deltoid of the left arm.   On 12th September 2023, the patient experienced anorexia, felt nauseated, headache,, muscle ache, and fatigue.   The patient was unable to perform usual daily activities.  The patient felt like she was having a flare up of fibromyalgia.    The patient took ibuprofen which helped with the muscle ache and headache. Patient had a 2 inch diameter red swollen area below the deltoid extending to the bicep of the injected arm.   The reporter or patient is also a retired nurse who was an Immunization nurse. The reporter or patient also plans on reporting these event on VAERS. The reporter consented to follow up.