Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Insomnia, Miliaria, Muscle strain, Pain
Clinical narrative: strained muscle; shingles hurts/pain/in pain; little bumps; little bumps that look like heat rash; little bumps that look like heat rash and discolored.; can't sleep; received the second dose of Shingrix in the summer 2018 / last Thursday, 9/3/2020 he was diagnosed with shingles/ Suspected vacination failure; shingles/shingles again; This case was reported by a consumer via call center representative and described the occurrence of suspected  vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced shingles in 2013, for 5 to 6 months with nerve pain) and nerve pain. Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. In August 2020, unknown after receiving Shingrix and less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness were recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the muscle strain, pain, swelling, heat rash, skin discoloration and sleeplessness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received the second dose of Shingrix in the summer 2018, in left arm.  He thought that he had a strained muscle on his side from playing golf so he saw his physician on 3rd September 2020.  The patient was diagnosed with shingles which started 8 days ago on his right side. He reported that the shingles hurts a lot with a few little bumps that look like heat rash and were discolored. The patient could not sleep at night and the area affected was from his right side going from his sternum under his right breast along his side and spine and back. He claimed that it was around his torso. In 2013, patient had a horrible case of shingles for 5 to 6 months with nerve pain on his left side. The patient reported that he did get the Zostavax vaccine after his shingles experience in 2013. This shingles experienced was not as bad as his first case of shingles. He believed that he received the Shingrix in his left arm and his condition was improving a little from last week and his pain has lessened 20 percent at the time of reporting. The patient stated that he was just frustrated. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.