Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge, X-ray limb abnormal
Clinical narrative: Shingrix shot #2 on 08-June-2021 / Now has shingles/ suspected vaccination failure; Now has shingles around her torso / nose / right leg /spots "here and there"; Shingles are painful; After each vaccine patient had swelling; Same effects after both / vaccine / Blood pressure was raised; Same effects after both / vaccine / Retained water; Has a blister on the side of her breast / contagious shingles blister; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip surgery, back surgery, corona virus infection (was sick for 3 weeks), foot operation (the surgery was done where bone was taken off from the foot) and blood pressure high. Previously administered products included Levaquin. Concurrent medical conditions included plantar fasciitis (had been getting steroid shots in her feet, which cuased anxiety for her) and hereditary disorder. Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE (MANUFACTURER UNKNOWN)) and COVID-19 VACCINE (COVID 19 VACCINE (MANUFACTURER UNKNOWN)).   On 8th June 2021, the patient received the 2nd dose of Shingrix. In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, swelling, increased blood pressure, water retention and blister. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vaccination failure, shingles, pain, swelling, increased blood pressure, water retention and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, swelling, increased blood pressure, water retention and blister to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, pain and blister to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient herself. The patient's mother was in a memory care center. The diagnosed with Coronavirus treated with Levaquin was sick for 3 weeks then got 1st dose of Covid shot on 8th April 2021 then got 2nd dose of Covid shot sometime before her foot operation around on 29th April 2021. she said she thought she had plantar fasciitis and had been getting steroid shots in her feet (which caused anxiety for her). The patient said that one of her feet never got better and they took an X-ray of the foot and there was a pocket which was causing excoriating pain and the surgery was done where bone was taken off from the foot. The patient said the foot problem was due to the genetic hereditary deformity and was taking Levaquin at the time. After 2nd dose of Shingrix vaccine patient had swelling, blood pressure was raised which caused her to retainer water and she had a ring cut off. The patient had shingles around her torso and had blister on the side of her breast. The patient was scared to death because she had confusion. The patient stated that she was feeling better at the time of reporting, though she currently still had shingles across the bridge on her nose and on right leg and a couple other shingle spots here and there on her body. The patient was given an antibiotic because she developed a contagious shingles blister. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory confirmation were unknown at the time of reporting The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021160837:Same reporter, same patient, same suspect, different dose (1st)