Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza, Insomnia, Musculoskeletal stiffness
Clinical narrative: muscle aches; nerve pain; sore arm/ left arm very tender; could not sleep; feeling stiff and sore all over; fatigue; sore all over; nausea; joint pain; flu; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluconazole (Fluzone (Fluconazole)) for product used for unknown indication.   The patient's past medical history included head and neck cancer and stroke. Concurrent medical conditions included blindness, automobile accident (- soft tissue injuries, broken sernum, Nov 2018, still recovering from injuries), thyroid disorder, vestibular disorder (caused by head and neck cancer treatment), gastroesophageal reflux disease, soft tissue injury (still recovering from injuries) and fractured sternum (still recovering from injuries). Concomitant products included omeprazole, paracetamol (Tylenol), thyroid hormones (Thyroid Hormone) and medication unknown (Blood Pressure Medication).   On 18th September 2019 16:30, the patient received the 1st dose of Shingrix. On 18th September 2019, the patient started Fluzone (Fluconazole) at an unknown dose and frequency. In September 2019, 9 hrs 30 min after receiving Shingrix, the patient experienced muscle pain, nerve pain, pain in arm, insomnia, stiffness, fatigue, general body pain, nausea, joint pain and influenza. On an unknown date, the outcome of the muscle pain, nerve pain, pain in arm, nausea, joint pain and influenza were recovered/resolved and the outcome of the insomnia, stiffness, fatigue and general body pain were unknown.   It was unknown if the reporter considered the muscle pain, nerve pain, pain in arm, insomnia, stiffness, fatigue, general body pain, nausea, joint pain and influenza to be related to Shingrix.  Additional details were provided as follows: On 18th September 2019, The reporter stated that the patient got the first dose of Shingrix, as well as Fluzone, , around 4:30 PM. Prior to getting the vaccines the patient had physical therapy for previous car crash injuries and also did some shopping. The patient went to bed around 8:30 PM exhausted from a busy day. On 19th September 2019, at 2 am around, the patient woke up with severe muscle pains, her left arm very tender, and the sheet moving against her body causing nerve pain. The patient felt like she did right after her car accident. The patient got up feeling stiff and sore all over and took some Tylenol.  The patient could not sleep the rest of the night. That morning she had two previously scheduled appointments with her physician and ophthalmologist. The patient got home from her appointments around 2 PM and was so fatigued she fell asleep as soon as she got home. The patient woke up about 4 PM and drank a lot of water. The patient spent the rest of the day treating herself like she had the flu. The symptoms resolved after about 24 hours. During this period she had these symptoms she had a little bit of nausea, which was solved by eating food. The patient thinks she was hungry and also had flashes of joint pain like her knees were getting electric shots. The patient noted that she was often stiff and sore after physical therapy, so she was not sure how much of the symptoms were due to the vaccine versus her previous activities. She does not think any of it was caused by Fluzone. She has never had problems with flu vaccines in the past.