Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Scratch, Skin ulcer
Clinical narrative: Pruritus on right side on back across to buttock extending almost to front on right side/itching on leg; Halfway up right leg, caller describes an area that feels hot; multiple sores that burn on his head; reports underneath skin it feels like sandpaper; difficulty sleeping at night; very small bumps underneath the skin; Skin reportedly can become red; scratch; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number not known, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose in left deltoid approximately 4-5 months ago, refer case US2019AMR224850).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pruritus, feeling hot, skin ulcer, skin rough, difficulty sleeping, contusion, skin red and scratch. The patient was treated with benadryl (nos) (Benadryl). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pruritus, feeling hot, skin ulcer, skin rough and difficulty sleeping were not recovered/not resolved and the outcome of the contusion, skin red and scratch were unknown.   It was unknown if the reporter considered the pruritus, feeling hot, skin ulcer, skin rough, difficulty sleeping, contusion, skin red and scratch to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left deltoid approximately 2 months after receiving the first dose. Following the second dose, caller reports the itching became severe. Severe itching following 2nd dose reported on right side on back across to buttock extending almost to front on right side. The consumer reported itching on left leg near ankle. Halfway up right leg, caller describes an area that feels hot and itchy.  The caller reported the left side on his head or his side did not itch. Severe itching on head caused consumer to scratch and as a result he developed multiple sores that burn on his head.  The caller reported a prescription from his dermatologist that he puts in his head after showering which helps subside itching for approximately 1 hour but then itching returns. Skin on right side of forehead reportedly has not broken out, but the caller reported underneath skin it feels like sandpaper or very small bumps underneath.  The Skin reportedly can become red but no large bumps have appeared. The caller reported seeing his family doctor and specialist several times and was prescribed undisclosed anti-itch medication although severe itching still occurs resulting in difficulty sleeping at night. The caller reported taking Benadryl with some relief but it did not completely resolve itching.  He stated that due to taking other unspecified medication he cannot take Benadryl. The caller would like an acknowledgement letter sent to his personal address as well as to the physicians.