Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, VARZOS, VARZOS
Symptoms: Back pain, Biopsy, Burning sensation, Contusion, Decreased immune responsiveness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, COVID-19 MRNA-1273 VACCINE (COVID-19 VACCINE MODERNA) (batch number 040B21A, expiry date unknown) for prophylaxis and COVID-19 VACCINE MODERNA (batch number 002B21A, expiry date unknown) for prophylaxis.   Concurrent medical conditions included ulcerative colitis. Concomitant products included azathioprine.   On 11th June 2019, the patient received the 2nd dose of Shingrix. On 9th April 2019, the patient received the 1st dose of Shingrix. On 9th April 2021, the patient received the 2nd dose of COVID-19 VACCINE MODERNA. On 11th March 2021, the patient received the 1st dose of COVID-19 VACCINE MODERNA. In May 2021, between 1 and 2 years after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced shingles, feeling abnormal, back pain (with radiation), leg pain, generalized raised red spots limbs, red spotty rash, touch sensitivity increased, stinging, pain in thigh, buttock pain, burning sensation and bruising of leg. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), feeling unwell and decreased immune responsiveness. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, feeling unwell, feeling abnormal, back pain (with radiation), leg pain, touch sensitivity increased, decreased immune responsiveness, stinging, pain in thigh, buttock pain, burning sensation and bruising of leg were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the generalized raised red spots limbs and red spotty rash were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, feeling unwell, feeling abnormal, back pain (with radiation), leg pain, generalized raised red spots limbs, red spotty rash, touch sensitivity increased, decreased immune responsiveness, stinging, pain in thigh, buttock pain, burning sensation and bruising of leg to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self reported the case. On an unknown date, less than 3 months after the 1st dose and less than 2 months after the 2nd dose the patient experienced shingles, feeling unwell, feeling abnormal, back pain (with radiation), leg pain, generalized raised red spots limbs, red spotty rash, touch sensitivity increased, decreased immune responsiveness, stinging, pain in thigh, buttock pain, burning sensation and bruising of leg. The patient had not felt good for a few weeks and then in the last week before the reporting date he started to get symptoms.  The patient felt crappy and had shooting pain in his back on the left side and the pain shot down his leg and then he had a rash on his left leg later. His torso, back, butt, and upper thighs were stingy, burning, and he was sensitive to the touch on his skin before the rash appeared. He described it as aches and pains and a stingy, needle feeling.  The patient had a history of ulcerative colitis and he took Azathioprine during the past few years so he was unsure if his rash was related to his weak immune system or the COVID vaccine.  The patient had sent pictures of his left leg rash to his physician and they recommended him to see a dermatologist who diagnosed him with shingles after a biopsy and tests. They immediately put him on Valtrex and he claimed that things started to calm down and the rash was started to dry up.  The patient described the rash as starting off as red spots that were raised up that looked like a target with a red circle around it that would get bigger. The raised spot looked like there was fluid inside. The dot in the middle looked dark in color and the red part that had spread looked like a bruise that was resolving with the color of yellow and brown.  The patient had a few clusters of the rash on the inside and outside of his left leg and back on his calf.  It was unknown if the reporter considered the shingles, feeling unwell, feeling abnormal, back pain (with radiation), leg pain, generalized raised red spots limbs, red spotty rash, touch sensitivity increased, decreased immune responsiveness, stinging, pain in thigh, buttock pain, burning sensation and bruising of leg to be related to COVID-19 VACCINE MODERNA and COVID-19 VACCINE MODERNA. The reporter consented to follow up.