Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: hurts when he uses it, such as if he raises his arm, similar to how one might feel if they have pulled a muscle; could not get comfortable; hurts when he uses it, such as if he raises his arm, similar to how one might feel if they have pulled a muscle; first shot was given on 01-Nov-2018 / second shot was given 08-Mar-2021; caused him to not be able to sleep the first night; arm was sore and painful / felt he had broken his arm / arm  was in constant pain; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pain in extremity (received 1st dose on 1st November 2018, batch no ABX657AA, for tolerance refer case US2021069895).   On 8th March 2021, the patient received the 2nd dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. In March 2021, less than 3 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injected limb mobility decreased, pain in arm, arm discomfort, sleeplessness, pulled muscle and drug dose administration interval too long. Rechallenge with Bexsero was positive. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm and pulled muscle were recovering/resolving and the outcome of the arm discomfort and drug dose administration interval too long were unknown and the outcome of the sleeplessness was recovered/resolved.   The reporter considered the injected limb mobility decreased, pain in arm, arm discomfort, sleeplessness and pulled muscle 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 details were provided as follows: The case was reported by the patient's mother. The patient was now vaccinated with second dose of Bexsero in unknown arm. After the shot, the arm was clear visually, had no redness and no hotness but the arm was sore and painful and he could not get comfortable which caused him to not be able to sleep the first night. The patient said, it felt like he had broken his arm. The patients arm was in constant pain until around day 4. Since then it only hurt when he used it, such as if he raised his arm, similar to how one might feel if they have pulled a muscle. The pain was getting better but was not fully resolved. The reporter was concerned since the patient received first dose in 2018 and second dose in 2021, it led to drug dose administration interval too long. She said her doctor's office did not set them up with an appointment for the second shot. Later it was discovered (at a routine physical, by a different doctor) that he was due for it. She though that perhaps the doctors office thought that Bexsero was a one shot series. The reporter consented to follow up.  GSK note- as per narrative, it seems that, the patient had all these events on the vaccinated arm and therefore injected limb mobility decreased added as events for the term, had pain when raised the arm, considering worst case approach.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021069895:Same patient