Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gait disturbance, Headache, Injection site discolouration, Injection site erythema
Clinical narrative: night sweats; arthritis; Ice pick headache; fatigue/ loss of stamina; limp; loss strength/loss of stamina; Hip pain/knee pain/wrist pain; back pain; Neck pain; Activities of daily living impaired; Mobility difficult; autoinmune response; chronic pain; injection site reaction; Injection site redness; injection site swelling; Injection site discoloration; This case was reported by a consumer via call center representative and described the occurrence of autoimmune disorder in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received Shingrix. In September 2018, less than a day after receiving Shingrix, the patient experienced injection site reaction, injection site erythema, injection site swelling, injection site discoloration and chronic pain. On an unknown date, the patient experienced autoimmune disorder (serious criteria GSK medically significant), night sweat, arthritis, ice pick headache, fatigue, limping, strength loss of, pain in hip, back pain, neck pain, activities of daily living impaired and mobility decreased. The patient was treated with diclofenac sodium and naproxen (Naprosyn). In September 2018, the outcome of the injection site reaction, injection site erythema, injection site swelling and injection site discoloration were recovered/resolved. On an unknown date, the outcome of the autoimmune disorder, night sweat, ice pick headache, fatigue, limping, activities of daily living impaired and mobility decreased were unknown and the outcome of the chronic pain, arthritis, strength loss of, pain in hip, back pain and neck pain were not recovered/not resolved.   It was unknown if the reporter considered the autoimmune disorder, injection site reaction, injection site erythema, injection site swelling, injection site discoloration, chronic pain, night sweat, arthritis, ice pick headache, fatigue, limping, strength loss of, pain in hip, back pain, neck pain, activities of daily living impaired and mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received a Shingrix vaccine and within 24 hours experienced an injection site reaction. The injection site had a large, dark, red and painful swelling and resolved 24 hours later.  The patient had been in chronic pain since receiving the injection, the chronic pain occurred within a week or two after receiving the injection. The pain started out gradually in her right knee and then spread to her left knee, right wrist, both hips, back and neck. She had an X-ray of her right wrist and showed some arthritis. It had come to a point that she cannot lift or open jars and has lost strength in her right wrist. The chronic pain has made her mobility difficult, affects her daily functions and has now developed a limp due to the pain in the left knee being worse than the right knee. She also experienced night sweats, ice pick headaches, fatigue or loss of stamina. The patient's physician advised her that she had suffered an autoimmune response.  At the time of report, her chronic pain has not resolved. The reporter declined to provide her treating physician's contact information at this time, would like to inform the physician that she has spoken with GlaxoSmithKline before providing the information.  Lot number and expiry date was not provided.      Lab Comments: On an unknown date, the patient had X-ray right wrist which showed some arthritis.