Age: 63.0
Sex: F
Vaccine: VARZOS, UNK, UNK, VARZOS
Symptoms: Malaise, Nausea, Pruritus, Pyrexia, Rash
Clinical narrative: itching, whole body; skin was crawling; spot on back, dime size, rash; shingles; fever; chills; sick (malaise); nausea; dry heaves (Retching that does not cause vomiting); Pain from rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included hydrocortisone (Hydrocortisone Cream) for rash and diphenhydramine (Benadryl (Diphenhydramine)) for rash.   The patient's past medical history included shingles (13 years ago). Previously administered products included Zostavax (approximately 13 years ago) and Shingrix with an associated reaction of pyrexia (received 1st dose on an unknown date, for tolerance refer case US2021202251).   On 20th September 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 22nd September 2021, the patient started Hydrocortisone Cream at an unknown dose and frequency and Benadryl (Diphenhydramine) at an unknown dose and frequency. In September 2021, less than a week after receiving Shingrix, the patient experienced pain. On 20th September 2021, the patient experienced shingles, fever, chills, malaise, nausea and dry heaves. On 21st September 2021, the patient experienced rash. On 22nd September 2021, the patient experienced generalized pruritus and crawling sensation. Rechallenge with Shingrix was positive. The action taken with Hydrocortisone Cream was unknown. The action taken with Benadryl (Diphenhydramine) was unknown. On an unknown date, the outcome of the shingles, rash, generalized pruritus, crawling sensation and pain were not recovered/not resolved and the outcome of the fever, chills, malaise, nausea and dry heaves were recovered/resolved.   The reporter considered the shingles, rash, generalized pruritus, crawling sensation and pain to be related to Shingrix. It was unknown if the reporter considered the fever, chills, malaise, nausea and dry heaves to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient was diagnosed with Shingles 13 years ago and when the rash went away, she received the Zostavax vaccine (approximately 13 years ago). The concomitant medication includes blood pressure lowering medicine and cholesterol lowering medicine. The patient received 2nd dose of Shingrix on an unknown deltoid. Starting hours after the second dose, the patient had fever, chills, and had been sick all week, had nausea, dry heaves and on Tuesday night when she took off her bra, on her back below neck there was the first spot, kind of dime size. The patient went back to primary care on Wednesday (22nd September2021) and she started itching her whole body, felt like skin was crawling, and the spot on her back had turned into a rash. The patient was told to take some Benadryl and put hydrocortisone cream on it, Benadryl did not help, Hydrocortisone cream made it worse, Wednesday was horrible, Thursday the rash was worse, she went back to the physician and was diagnosed with Shingles. The physician told her to take Lyrica for the pain from the Shingles rash, but she did not take Lyrica. The patient would like for it to be recorded that she was furious that a vaccine caused her Shingles outbreak. It was unknown if reporter consider shingles, pain and rash to be related Benadryl and Hydrocortisone cream. The call center representative referred her to speak with her doctor about her medical concerns. The patient said she might seek legal representation. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202251:Same reporter