Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain in extremity, Pain of skin, Paraesthesia, Tenderness, Urinary retention
Clinical narrative: unable to urinate; burning sensation on his thighs and torso /on and off burning sensation; weak; hard time walking; muscle pain; tingling in his thighs traveled up up his back and around his ribs.; leg buckle; TENDERNESS; Shooting pain; Skin painful to touch; Skin painful to touch; Sore in both thighs / sore arm; Fatigue for 2-3 days; Slight headache; This case was reported by a consumer via call center representative and described the occurrence of unable to urinate in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 12th January 2021) for prophylaxis.   On 25th January 2020, the patient received the 1st dose of Shingrix. On 2nd February 2020, 8 days after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced touch sensitivity increased, stinging skin, tenderness and shooting pain. On 3rd February 2020, the patient experienced limb discomfort. On 4th February 2020, the patient experienced muscle pain and tingling. On 6th February 2020, the patient experienced unable to urinate (serious criteria GSK medically significant), burning sensation, weakness and walking difficulty. In February 2020, the patient experienced pain in extremity, fatigue and headache. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin and tramadol. On 7th February 2020, the outcome of the unable to urinate was recovered/resolved. On an unknown date, the outcome of the pain in extremity, touch sensitivity increased, muscle pain, tingling, weakness, walking difficulty, tenderness and shooting pain were unknown and the outcome of the fatigue, headache and limb discomfort were recovered/resolved and the outcome of the stinging skin was recovering/resolving and the outcome of the burning sensation was not recovered/not resolved.   It was unknown if the reporter considered the unable to urinate, pain in extremity, fatigue, touch sensitivity increased, stinging skin, headache, muscle pain, tingling, burning sensation, weakness, walking difficulty, limb discomfort, tenderness and shooting pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 2nd February 2020, the patient experienced pain presented on both thighs.The front, inner and outer area of both thighs is painful to touch and the skin stings. On 3rd February 2020, the reporter stated that, after vaccination the patient had sore arm and fatigue for 2 to 3 days and slight headache presented on and off for 1 to 2 days. The muscle pain and tingling in his thighs has traveled up up his back and around his ribs.  The patient had a shooting pain on the outer side of his right thigh that made his leg buckle, then it resolved. The patient stated that, the stinging pain was little better than yesterday. The patient received valtrex, gabapentin and tramadol as a treatment medication. The patient did not provide many details for the adverse event report because he was angry and wanted an answer.