Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Restlessness
Clinical narrative: Dizziness; felt like I was being pushed against the wall /  I couldn't walk straight and had to cling to something / my balance was off/ falling over to left side; didn't get a lot of sleep; arm felt sore / hurt to lift it up; hurt to lift it up; tight muscles in the upper shoulder area; didn't get a lot of sleep, got up and didn't feel real good; couldn't walk straight; didn't feel real good; had fever; This case was reported by a consumer and described the occurrence of dizziness in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number J454X, expiry date 4th October 2022) for prophylaxis.   The patient's past medical history included back pain and muscle tightness. Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in November 2020, for tolerance refer case US2021AMR025675).   On 28th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced fever, muscle tightness, sleeplessness, walking difficulty and malaise. On 28th January 2021, the patient experienced restlessness, pain in arm and pain upon movement. On 30th January 2021, the patient experienced dizziness and balance disorder. On an unknown date, the outcome of the dizziness, balance disorder, restlessness, fever, pain in arm and malaise were recovered/resolved and the outcome of the pain upon movement, muscle tightness, sleeplessness and walking difficulty were unknown.   The reporter considered the dizziness, balance disorder, restlessness, fever, pain in arm, pain upon movement, muscle tightness, sleeplessness, walking difficulty and malaise to be possibly related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient did not have a history of reaction to any previous vaccines. The patient received 2nd dose of Shingrix and a day after she experienced dizziness, and falling over to left side. The patient had to support or she would have gone down. On the night of vaccination, the patient's arm felt sore, hurt to lift it up but otherwise felt fine. She had restless night that night, had fever and it was 0.9 degrees over normal. She was up for a while, did not get a lot of sleep, got up and did not feel very good. She felt like, she needed more sleep. She felt fine after sitting down on toilet but when she looked out and things did not look right, so she stood up and just went to her left up against the wall. She managed to walk over, hung on to door and managed to walk to the sink. It just felt like she was being pushed against the wall. She had no history of this happening before. One time she had dizzy spell from a new blood pressure medication, but that was totally different, that felt like room was spinning. With this the patient could not walk straight and had to cling to something, like her balance was off. The patient had a history of issues with back and tight muscles but now she felt like she had tight muscles in the upper shoulder area. She stated she sat on bed for 10 minutes or so, walked out to the family room with husband supporting her on the left, husband used a massager to work on muscles of neck and shoulder and after another 20 minutes or so, she was able to walk around with support. Then within an hour the symptoms were resolved. The reporter thought it was possible that these reactions related to the vaccination since the patient just had the shot the day before it could have something to do with it. The reporter consented to follow up with her as well as with her pharmacist who administered the vaccine. The patient had not yet discussed symptoms with her physician and was referred to her physician for further evaluation and discussion. This case had been linked with US2021025187 and US202102517, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021025187:same reporter US-GLAXOSMITHKLINE-US2021AMR025675:same reporter