Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Limb discomfort, Mobility decreased, Musculoskeletal discomfort
Clinical narrative: pain at the injection site; unable to move arm, Cannot move arm, cannot lift his arm, he cannot move it up; Problem with shoulder, went to ER; squeezing of the left arm; disrupted sleep; Frozen Shoulder Syndrome, physical therapy; pain in both arms; unable to sleep; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-NOV-2022, the patient received the 1st dose of Shingrix (left arm). On 05-FEB-2023, 74 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: pain in both arms) and sleeplessness (Verbatim: unable to sleep). On 07-FEB-2023, the patient experienced frozen shoulder (Verbatim: Frozen Shoulder Syndrome, physical therapy). On an unknown date, the patient experienced injection site pain (Verbatim: pain at the injection site), mobility decreased (Verbatim: unable to move arm, Cannot move arm, cannot lift his arm, he cannot move it up), shoulder discomfort (Verbatim: Problem with shoulder, went to ER), pressure in limbs (Verbatim: squeezing of the left arm) and sleep disorder (Verbatim: disrupted sleep). The patient was treated with KETOROLAC and non-drug therapy (Physical Therapy). The outcome of the injection site pain, mobility decreased, shoulder discomfort, pain in arm and pressure in limbs were unknown and the outcome of the frozen shoulder and sleep disorder were not recovered/not resolved and the outcome of the sleeplessness was recovered/resolved (duration 10 days).   It was unknown if the reporter considered the injection site pain, mobility decreased, shoulder discomfort, pain in arm, frozen shoulder, pressure in limbs, sleep disorder and sleeplessness to be related to Shingrix.     It was unknown if the company considered the injection site pain, mobility decreased, shoulder discomfort, pain in arm, frozen shoulder, pressure in limbs, sleep disorder and sleeplessness to be related to Shingrix.   Additional Information: GSK receipt date: 1-May-2023 and 2-May-2023 The patient previously worked for a piano company (moving, lifting piano's) for 14 years but retired before this event. The patient had his dose of Shingrix vaccine and started having excruciating pain in both arms. On 6th February 2023, the patient went to the emergency department because he had a side effect of a problem with his shoulder. He was given Ketorolac by injection for the pain and was treated, released (with a prescription for Ketorolac pills for pain) and referred to a neurologist for follow up. On 7th February 2023, the patient went to a neurologist who diagnosed him with frozen shoulder syndrome that was caused by Shingrix vaccination.  He was referred to physical therapy 3 times weekly and was told that after 1 to 1 and 1/2 years his condition could be significantly improved with therapy.  On the day of reporting, the patient reported that his pain, which was initially at 10 (on a scale of 1-10 with 10 being the worst pain) was at a 1 or 2.  The sensation he feels in his arm was as if he was having his blood pressure taken, a constant squeezing of the left arm. The patient was not taking pain medication.  The patient still endures disrupted sleep due to pain and the need to reposition his arm when lying down.  The patient reported that this was in stark contrast to when he first started experiencing pain in his arms, at that time he was unable to sleep for 10 days straight.  The patient's wife helped to dress and bathe him.  The patient cannot lift his arm above his head and the arm stays near his ribs, he cannot move it up and also reported that sometimes he feels pain at the injection site.  The patient reported that he has not had his second vaccination of Shingrix due to this adverse event.  The reporter consented to follow-up.