Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Spinal X-ray, Swelling, X-ray limb normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of generalized muscle aches in a 70-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 28th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 29th May 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, injection site pain, headache, thinking slow and condition aggravated. On an unknown date, the outcome of the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, headache, thinking slow and condition aggravated were unknown and the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, injection site pain, headache, thinking slow and condition aggravated to be related to SHINGRIX. It was unknown if the reporter considered the generalized muscle aches, weakness, tiredness, tingling sensation, sleepiness, difficulty sleeping, generalized joint pain, hand swelling, swelling, hot flashes, stomach pain, difficulty breathing, headache, thinking slow and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st and 2nd dose of SHINGRIX in the left arm. The patient stated that less than a year after the 1st dose of SHINGRIX, she experienced muscle pain all over the body, headache, weakness, tiredness, tingling in the muscle, sleepiness, fogginess in thinking, joint pain all over the body, swelling of hands and body, hot flashes all day and night, stomach pain and difficulty breathing. The patient was also having trouble laying on the back and sides. After the second shot of the SHINGRIX all the symptoms experienced previously with the first dose had gotten worse. The patient also experienced pain at the injection site with the 2nd dose of SHINGRIX, which lasted for total of 5 days. The patient visited her doctor after the second shot of the vaccine and was then referred to an orthopedic and neuro-surgeon. She had MRI for the lumbar region, along with right side hip and knee. She also went through x ray for lumbar spine and right side knee. All results were negative. The patient was currently undergoing physical therapy. The patient was referred to her health care provider. The patient gave permission to contact her healthcare provider and provided his contact details. No further details were provided.