Symptomtext
Fever; Arm pain/arm hurt; nausea; vomiting; Visual changes; Labored breathing; almost hypopnea RR: 9; Arm pain that shoots down arm interfering with daily activities and sleep; Arm pain that shoots down arm interfering with daily activities and sleep; Stridor; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN) for prophylaxis. In JUN-2023, the patient received the 1st dose of Bexsero (left deltoid). In JUN-2023, 1 hr after receiving Bexsero, the patient experienced fever (Verbatim: Fever), pain in arm (Verbatim: Arm pain/arm hurt), nausea (Verbatim: nausea), vomiting (Verbatim: vomiting), visual disturbance (Verbatim: Visual changes), labored breathing (Verbatim: Labored breathing), hypopnea (Verbatim: almost hypopnea RR: 9), activities of daily living impaired (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep), sleep disturbance (Verbatim: Arm pain that shoots down arm interfering with daily activities and sleep) and stridor (Verbatim: Stridor). The outcome of the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor were not reported. It was unknown if the reporter considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the fever, pain in arm, nausea, vomiting, visual disturbance, labored breathing, hypopnea, activities of daily living impaired, sleep disturbance and stridor to be related to Bexsero and Bexsero 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: 09-AUG-2023 A physician reported that patient received 1st dose of Bexsero and immediately following dose, patient complained that arm hurt and went home and slept. Within an hour patient experienced nausea, vomiting, fever, visual changes (saw rings in field of vision) Stridor, labored breathing, almost hypopnea RR: 9. No rash or tongue swelling, patient says she just felt "out of it", lasted about 6 hours, did not need to go to ER. Arm pain that shoots down arm interfering with daily activities and sleep. Revisit with physician 6 days later due to persistent arm pain, patient had full range of motion, no redness, swelling or erythemia, Physician and patient agree to not receive Dose 2. The reporter agrees to follow up.