Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Fatigue, Gait inability, Immediate post-injection reaction, Incomplete course of vaccination
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 72-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included osteoporosis and pain in elbow. On 14th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 14th June 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced pain in extremity. On an unknown date, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), unable to walk, tiredness, influenza-like symptoms, muscle inflammation and incomplete course of vaccination. In July 2018, the outcome of the pain in extremity was recovered/resolved. On an unknown date, the outcome of the polymyalgia rheumatica, unable to walk, tiredness, influenza-like symptoms and muscle inflammation were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the polymyalgia rheumatica, unable to walk, tiredness, influenza-like symptoms and muscle inflammation to be related to SHINGRIX. It was unknown if the reporter considered the pain in extremity to be related to SHINGRIX. Additional details were provided as follows: The patient got a sore arm right away after vaccination with SHINGRIX. Her sore arm lasted 3 weeks. On the other hand, the patient had a steroid shot about a week later of having the vaccine. She has those shots routinely for her joints in her elbow. She only has them on her elbow. The patient did not have new elbow pain; patient said she had these problems prior to getting SHINGRIX. However, the effects of the steroid have worn off now and she was having pain in her arms, back of legs. Less than a year after receiving SHINGRIX, the patient said that she could not move around. She also felt tired and felt like coming down with the flu. The patient felt that she could have had these symptoms as side effects of SHINGRIX but she did not notice those until six weeks ago before the date of reporting because of the effects of the steroid shots that she took soon after getting the vaccine. The patient has been to the physician and has had blood test. Less than a year after receiving SHINGRIX, the patient was diagnosed with PMR. Her blood test shows high inflammation on her muscles. The patient could not remember the numbers but her number for one test was over 60 and the normal was 30 or below. Another test showed 30 and it was supposed to be 5 or below. She was on her fourth day of taking steroids orally as a treatment. The patient was upset because she felt like the SHINGRIX activated this. The patient was late in receiving the second dose of the SHINGRIX. She said that she would not get the 2nd dose until it has been confirmed that SHINGRIX might not have caused these symptoms. The reporter did not consent to follow-up. The reporter did not give permission to follow up yet. She asked the company to send her a letter in the mail and she might give permission to contact her physician then. This case has been linked to the case US2019004822 (reporter's husband), reported by same reporter. Lab Comments: Lab test was done on an unknown date.