Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Loss of personal independence in daily activities, Myalgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, immediately after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy. On an unknown date, the outcome of the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy were recovering/resolving and the outcome of the skin bleeding was unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling, muscle pain, arthralgia, pain in arm, skin bleeding, general body pain, tiredness, bruising of arm, activities of daily living impaired and loss of energy to be related to SHINGRIX. Additional information was reported as follows: The patient stated that, right after the vaccination, she experienced sore muscles and joints, injection site redness and swelling and this continued following the first week after the vaccination. The patient stated that, the soreness and muscle pain in the injected arm was so bad that she could not turn the keys to even start her car, lift up a cup of coffee or even vacuum her floors. The patient was unable to do the tasks which she usually could do. The soreness and pain traveled down to her right hip to the left hip and further followed up her left arm. She said it was like the soreness and pain was traveling across her body. The patient's daughter noticed that she saw bruising on patient's arm. The bruises looked more like blood running under the skin. It looked like streaks running down her arms and legs. The patient also stated that, the weird thing was that the bruising was down her right arm and left calf on her leg. Less than a month after the vaccination the patient experienced streaks running down her arms and legs, soreness across the body, tiredness, bruising on arm, unable to do tasks the patient usually could do and no energy to do anything. She could not make sense of what was happening to her. She was still experiencing the adverse effects till the time of reporting; however, they had started resolving at the time of reporting. At the time of reporting, the soreness and bruising were almost gone in her right arm and the left arm was getting better and the side effects in her right hip were not as bad as the left hip. The patient also stated that, all this went for a period of about 3 weeks. At the time of reporting, she still felt tired and had no energy to do anything. She had not contacted her physician. The patient could not remember the exact dates of vaccination and the event onset dates. The patient stated that she would not be getting the second dose of SHINGRIX.