Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis
Clinical narrative: Inability to move; Jaundice; Extremely elevated liver enzymes; bright orange urine; Arthritis in knees, ankles and shoulders; exausted; Flu-like symptoms; Chills; Nausea; Inability to stand; "Feeling like I was going to pass out"; Hardness in arm; redness in arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number PN454, expiry date 25th April 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020 with no adverse event).   On 12th March 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (serious criteria hospitalization and clinically significant/intervention required), chills (serious criteria hospitalization and clinically significant/intervention required), nausea (serious criteria hospitalization and clinically significant/intervention required), difficulty in standing (serious criteria hospitalization and clinically significant/intervention required), dizziness (serious criteria hospitalization and clinically significant/intervention required), induration (serious criteria hospitalization and clinically significant/intervention required) and erythema (serious criteria hospitalization and clinically significant/intervention required). On 19th March 2020, the patient experienced jaundice (serious criteria hospitalization and clinically significant/intervention required) and elevated liver enzymes (serious criteria hospitalization and clinically significant/intervention required). On 26th March 2020, the patient experienced urine coloring orange (serious criteria hospitalization and clinically significant/intervention required), arthritis (serious criteria hospitalization and clinically significant/intervention required), immobile (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and exhaustion (serious criteria hospitalization). On 6th August 2020, the outcome of the influenza-like symptoms, chills, nausea, difficulty in standing, dizziness, induration, erythema, urine coloring orange, arthritis, jaundice, elevated liver enzymes, immobile and exhaustion were recovered/resolved.   The reporter considered the influenza-like symptoms, chills, nausea, difficulty in standing, dizziness, induration, erythema, urine coloring orange, arthritis, jaundice, elevated liver enzymes, immobile and exhaustion to be related to Shingrix.  Additional details were provided as follows: The patient stated that she received the 2nd vaccination of Shingrix and within 3 hours of receiving the shot, she began to experience flu-like symptoms, chills, nausea, inability to stand up, feeling like she was going to pass out, hardness and redness in the arm she received the vaccine in. Two weeks later the patient started to experience more severe symptoms. The patient reported that she had bright orange urine, arthritis in her ankles, knees and shoulders, jaundice, extremely elevated liver enzymes and inability to move. She went to the emergency room and was then hospitalized for a week. The patient stated after having a liver biopsy, her doctor confirmed these reactions were from the Shingrix vaccine. The patient reported that all of her symptoms have finally resolved. The reporter consented to follow up. The case has been linked with the US2020AMR153870 and US2020AMR153873 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR153870:same reporter US-GLAXOSMITHKLINE-US2020AMR153873:same reporter