Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Fatigue, Hypersensitivity, Injection site pain
Clinical narrative: burning / her legs were on fire; the skin on her legs and it turned bright red; her hands turned dark blue; fingernails were black; tongue was swollen; throat is raspy / throat started itching; allergic reaction / severe allergic reaction; hives; my throat started to close.; face is still swollen /facestarted swelling; Major itching; left arm still hurts at the injection site; very tired; This case was reported by a consumer and described the occurrence of pruritus in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number XN443, expiry date unknown) for prophylaxis.   Concurrent medical conditions included penicillin allergy and sulfonamide allergy.   On 25th September 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and tiredness. On 25th September 2020, the patient experienced pruritus, hives, throat constriction and facial swelling. On 25th September 2020 11:30, the patient experienced throat irritation and allergic reaction. On 25th September 2020 16:30, the patient experienced burning sensation, redness of legs, skin discoloration, nail discoloration and swollen tongue. The patient was treated with steroids nos (Steroids), benadryl (nos) (Benadryl) and ambiguous medication nos (Epipen (Nos)). On an unknown date, the outcome of the pruritus, throat irritation, allergic reaction, facial swelling, injection site pain and tiredness were not recovered/not resolved and the outcome of the burning sensation, hives, throat constriction, redness of legs, skin discoloration, nail discoloration and swollen tongue were unknown.   It was unknown if the reporter considered the pruritus, burning sensation, hives, throat constriction, throat irritation, allergic reaction, redness of legs, skin discoloration, nail discoloration, swollen tongue, facial swelling, injection site pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had a number of allergies including allergies to penicillin and sulfa drugs. The patient had an allergic reaction to Shingrix that required the patient going to the emergency room. The patient had major itching, burning and hives and the patient's throat started to close. The patient was given steroids, benadryl intravenously and an epipen. The patient enquired about the ingredients. The patient wanted to see if they can identify what caused the reaction. The patient was beyond the critical part but the patient's face was still swollen, was itchy and throat was raspy at the time of reporting. Follow up was received from patient on 28th September 2020. The patient reported 1st dose of Shingrix administered Friday 25th September 2020 at 09:30 in left arm. At 11:30 of 25th September 2020, the patient's throat started itching.  At 4:30 pm the patient felt like her legs were on fire, she rubbed the skin on her legs and it turned bright red, her hands turned dark blue, her fingernails were black, and her tongue was swollen.  The patient was directed to the emergency room, where her face started swelling. The patient stated that she was treated and released from the ER for a severe allergic reaction. The patient stated that her left arm hurts at the injection site and she was very tired till the time of reporting. The reporter consented to follow up with her health care professional.