Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Pain, Red blood cell sedimentation rate increased, Wrong technique in product usage process
Clinical narrative: the Shingrix and Tdap (Sanofi) in her left deltoid; Pain all over, systemic pain, ER visit required; Hip pain, acute bilateral shoulder pain; Myalgia; This case was reported by a other health professional and described the occurrence of general body pain in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 577BF, expiry date 30th September 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number 4L5YX, expiry date 30th June 2023) for prophylaxis, flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (TDAP) for prophylaxis.   On 9th December 2022, the patient received the 1st dose of Shingrix (intramuscular), the 1st dose of Fluarix Tetra 2022-2023 season (intramuscular), Fluarix Tetra Pre-Filled Syringe Device and TDAP. On 9th December 2022, unknown after receiving Shingrix and not applicable after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced wrong technique in drug usage process. In December 2022, the patient experienced general body pain, arthralgia and myalgia. On 26th January 2023, the outcome of the arthralgia was not recovered/not resolved. On an unknown date, the outcome of the general body pain and myalgia were not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the general body pain, arthralgia and myalgia to be related to Shingrix, Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-JAN-2023  Reporter's Comment: The reporter was medical assistant calling to report adverse events with Shingrix and Fluarix.  The patient received 3 vaccines at the same time and were Fluarix, Shingrix, and a TDAP (Sanofi). The patient complained of pain all over with an emphasis on bilateral shoulder pain beginning soon after she received the vaccines (within 12 hours).  The patient received the Shingrix and Tdap (Sanofi) in her left deltoid and Fluarix in the right deltoid.  The patient returned to the physician's office on 6th January 2023, complaining of systemic pain, hip pain and shoulder pain.  At that time, the following labs were done , C-reactive protein 1.3, Sedimentation rate 77.  The patient returned again to the physician's office on 16th January 2023, and repeated the C-reactive protein 0.7, sedimentation rate 53.  She was still complaining of myalgia and now shoulder pain was acute bilaterally.  The pain had not resolved.  ER (emergency room) visit was required. The reporter consented to follow up. It was unknown if the reporter considered the general body pain, arthralgia and myalgia to be related to Tdap (Sanofi) vaccine. Additional Supportive Information: The patient received the Shingrix and Tdap (Sanofi) in her left deltoid, which led to wrong technique in drug usage process .