Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Electric shock sensation, Herpes zoster reactivation, Inappropriate schedule of product administration
Clinical narrative: "Reactivation" of this virus; Vesicles with clear fluid like chickenpox; Vesicles with clear fluid/looks to me like chickenpox; Reddish bumps on my left wrist at first with itching/ along my waistline then from trunk to left arm and under both breasts; Reddish bumps on back of neck; Intense electric-like pinpricks; Burning; Burning with continued severe itching/ pain coupled with itching/ intolerable; 1st dose on 10th June 2020 and 2nd dose on 8th October 2021; Itching remains intense at times; Pain became really severe, intolerable/the pain came back with a vengeance; This case was reported by a nurse and described the occurrence of herpes zoster reactivation in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 75XA2, expiry date unknown) and (batch number 3N3GH, expiry date unknown) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valtrex) tablet for prophylaxis.   The patient's past medical history included chickenpox (had severe chickenpox in 1956) and shingles (had 2 episodes of shingles in the late 1980, those were very typical with along nerve path clustering ( waistline area)). Previously administered products included Shingrix with an associated reaction of no adverse event (patient received first Shingrix dose on 10th June 2020). Concurrent medical conditions included fibromyalgia (had long term history), ulcerative colitis (had long term history), arthritis (had long term history) and breast cancer (had long term history). Concomitant products included fentanyl (Fentanyl Patch).   On 8th October 2021, the patient received Shingrix .5 ml. On an unknown date, the dose was .5 ml. On 13th October 2021, the patient started Valtrex (oral) 500 mg 3 times daily (1500 mg daily). On 8th October 2021, unknown after receiving Shingrix and not applicable after starting Valtrex, the patient experienced drug dose administration interval too long. On 10th October 2021, the patient experienced herpes zoster reactivation, vesicles, varicella-like rash, itchy rash, erythropapular rash, tingling, burning sensation and pruritus. In October 2021, the patient experienced pain and lack of drug effect. The patient was treated with calamine + pramocaine hydrochloride (Caladryl Lotion), non-drug therapy (Ice Pack (No Medication)) and paracetamol (Tylenol). The action taken with Valtrex was unknown. On an unknown date, the outcome of the herpes zoster reactivation, varicella-like rash, itchy rash, erythropapular rash, tingling, burning sensation, lack of drug effect and drug dose administration interval too long were unknown and the outcome of the vesicles was recovering/resolving and the outcome of the pain and pruritus were not recovered/not resolved.   The reporter considered the herpes zoster reactivation, vesicles, varicella-like rash, itchy rash, erythropapular rash, pain, tingling, burning sensation and pruritus to be related to Shingrix. It was unknown if the reporter considered the pruritus to be related to Valtrex.  Additional details were provided as follows: The reporter was the patient herself. The reporter was a retired nurse. The patient received Shingrix in the left deltoid and about 10th October 2021, she found 1 then 2 reddish bumps on her left wrist at first with itching. Over the course of the next 24 hours, many more appeared along the waistline then from trunk to left arm and back of neck; also under both breasts. Concurrently, pain had started and became really severe, intense electric-like pinpricks and burning with continued severe itching. There were no eruptions on face, hands or feet. There was no reaction at the injection site; also no fever , shortness of breath or allergy-like other symptoms. The patient described that she had vesicles with clear fluid ( which looked like chickenpox to her) The patient took Caladryl lotion and then ice packs that helped control the pain somewhat. There was no effect on the pain with twice medication of Tylenol. This went on for the next 24 hours and the patient was able to get an appointment for evaluation on 13th October 2021 with an MD. The patient was evaluated and Rx for Valtrex tablets of 500mg thrice a day for 7 days was provided, which led to off label dosing frequency. The patient refused pain medication as she had a chronic condition controlled with a Fentanyl 12mcg patch and she was sure that it also helped controlling the pain of the outbreak to some extent. The patient received the first Shingrix dose on 10 June 2020, more than a year ago, which led to drug dose administration interval too long for the second dose. The patient did not experience any reaction and no unexpected untoward reaction to any other vaccines for the 1st dose. The patient did not have further pain at the time of reporting but the itching remained intense at times, which led to lack of drug effect for Valtrex. Several vesicles had dried and no new outbreak was noted over last 12 hours from the time of reporting. The patient had attached 3 pictures which she took for documentation. The patient was reporting it as she did not find any documentation listing such reaction as a possibility (common or uncommon). The patient further provided information that the pain came back with a vengeance and coupled with the itching, making it quite intolerable. The reporter stated that, based on her life in science, she was baffled that a vaccine which was aimed at preventing, was evidently causing a reactivation of the virus. The reporter was asking if there was any scientist in the organization who could answer this puzzling question.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR214491:Same reporter, same patient, same suspect, different dose