Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Hand Swelling/Puffy Hand; Tightness in Hand; limited range of motion/hard to move; Pain in right arm; Upper arm/ shoulder pain; fatigue; injection site as Itching; injection site as Redness; injection site as Rash; injection site as Hot; injection site as Burning/Pain at injection site/Sore arm/ sorness and pain; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 455KD, expiry date 31st October 2019) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th April 2019, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site erythema, injection site rash, injection site warmth, injection site pain and fatigue. On 30th April 2019, the patient experienced hand swelling, muscle tightness, injected limb mobility decreased, pain in arm and musculoskeletal pain. The patient was treated with ibuprofen (Advil) and antihistamine. On 30th April 2019, the outcome of the hand swelling and muscle tightness were recovered/resolved. On 1st May 2019, the outcome of the musculoskeletal pain was recovered/resolved. On 3rd May 2019, the outcome of the injection site erythema, injection site warmth and pain in arm were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. On an unknown date, the outcome of the injection site itching and injection site rash were not recovered/not resolved and the outcome of the injected limb mobility decreased and fatigue were unknown.   It was unknown if the reporter considered the injection site itching, injection site erythema, injection site rash, injection site warmth, injection site pain, hand swelling, muscle tightness, injected limb mobility decreased, fatigue, pain in arm and musculoskeletal pain to be related to Shingrix.  Additional details were reported as follows: The patient received the Shingrix vaccine on in her right arm and complains of soreness and pain within 15 to 30 minutes.  Within a few hours caller reported fatigue, and injection site as itchy, red, rash (2 to 3 inches by 1 to 1.5 inches wide), hot, and 15 minutes after vaccination experienced burning.  The next day caller reported pain in right arm going up to shoulder, and that was relieved by Wednesday.  Also on the next day caller reported her right hand started to swell, puffy, hard to move, and tightness, that event lasted approximately an hour. The patient reported taking Advil for 1 to 2 days. On Thursday caller reported remaining symptoms going away and by Friday symptoms were gone.  However, the day before reporting, on monday 6th May 2019, caller reported itchy, burning rash came back, and also reported taking 1 or 2 dose of an antihistamine which The reporter consented to follow up. The outcome reported for in the structured field of XML is recovering for Itching, Rash, Burning and (recovered/resolved with sequel) for Tightness in Hand, Puffy Hand, Hand Swelling, Upper arm/ shoulder pain, Pain at injection site, Sore arm, Hot and(recovering/resolving) for rash" instead of " Itching, Rash, Burning,  (Not Recovered/Not Resolved), Redness, Hot, Sore arm, Pain at injection site , Puffy Hand, Tightness in Hand , limited range of motion , (Recovered), " (outcome uploaded in Argus).