Sex: F
Vaccine: VARZOS
Symptoms: Depression, Dry skin, Feeling abnormal, Pain, Paraesthesia
Clinical narrative: rash in between the legs; arms were tingling / like little needle pricks from the shoulder to the wrist; depressed; miserable; pink, red dots in her arms; dry skin; pink, red dots in her arms; pain at injection site; itchy like the classic hives/arm were itching but were not hives (itchy arm, both arms are itchy); Body aches; 1st dose in October or November 2019. Customer reports that she got her 2nd dose 2 weeks ago; hives everywhere/stomach area, front and back of the middle body, and legs. Hives changes areas, and it shows on legs, back; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (after 1st dose in October or November 2019 experienced cold, tremor and bedridden). Concurrent medical conditions included urticaria (she has had 10 years of post-menopausal urticaria) and migraine.   On 16-SEP-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 16-SEP-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in October or November 2019. Customer reports that she got her 2nd dose 2 weeks ago). On 17-SEP-2023, the patient experienced general body pain (Verbatim: Body aches). On 18-SEP-2023, the patient experienced hives (Verbatim: hives everywhere/stomach area, front and back of the middle body, and legs. Hives changes areas, and it shows on legs, back). On an unknown date, the patient experienced injection site pain (Verbatim: pain at injection site), itchy upper limbs (Verbatim: itchy like the classic hives/arm were itching but were not hives (itchy arm, both arms are itchy)), rash (Verbatim: rash in between the legs), tingling of extremity (Verbatim: arms were tingling / like little needle pricks from the shoulder to the wrist), depression (Verbatim: depressed), feeling miserable (Verbatim: miserable), red spotty rash (Verbatim: pink, red dots in her arms), dry skin (Verbatim: dry skin) and skin discoloration (Verbatim: pink, red dots in her arms).  The patient was treated with benadryl (nos) (Benadryl), cetirizine hydrochloride (Zyrtec), rizatriptan benzoate (Maxalt) and prednisone. The outcome of the injection site pain, general body pain and rash were resolved and the outcome of the itchy upper limbs, red spotty rash and skin discoloration were not resolved and the outcome of the hives was resolved (duration 2 weeks) and the outcome of the tingling of extremity, depression, feeling miserable and drug dose administration interval too long were unknown and the outcome of the dry skin was not reported.   It was unknown if the reporter considered the injection site pain, general body pain, itchy upper limbs, hives, rash, tingling of extremity, depression, feeling miserable, red spotty rash, dry skin and skin discoloration to be related to Shingrix.     It was unknown if the company considered the injection site pain, general body pain, itchy upper limbs, hives, rash, tingling of extremity, depression, feeling miserable, red spotty rash, dry skin and skin discoloration to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR136229   Additional Information: GSK Receipt Date: 03-OCT-2023 The pharmacist was a patient who administered both doses of Shingrix in left arm. The patient received first dose in October or November 2019 and two weeks ago on 16th September 2023 received the second dose of Shingrix, which led to lengthening of vaccination schedule. The patient reported her second dose was very painful at injection site. Next day of vaccination patient had body aches. She also had 10 years of post-menopausal urticaria which she don't know if it was coincidence or something different. On 18th September 2023 she had hives everywhere on stomach area, front and back of the middle body, and legs.  She reported it was itchy like the classic hives (Itchiness), her arms were itchy but she stated it was not hives. On 19th September she took 2 tablets of Zyrtec for itchiness. She did have pink, red dots in her arms. On Friday 22 September 2023 her hives stopped for about two days and then came back with a vengeance. On 02nd October patient went to doctor and her hives and itching lasted. According to doctor it lasts for 2 weeks so doctor prescribed her prednisone. She stated that her hives changes areas, and it showed on her legs, back.  She took 2 50 mg Benadryl every 6 hours in addition to the 2 tablets of Zyrtec in the morning. She stated she never had dry skin either in past and her skin was very good. During the day her arm were tingling like little needle pricks from the shoulder to the wrist. She reported it was so new to her that it made her miserable and depressed like when she had the migraines and she must have to take the Maxalt. She was afraid to take the Prednisone but on 02 October 2023 she took it. Not all information was available. The reporter consented to follow up with her and her Health care profession.; Sender's Comments:  US-GSK-US2023AMR136229:Same patient, 1st dose