Sex: U
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Huge painful lump in arm vaccination site; Arm swelled up vaccination site; Huge painful lump in arm vaccination site; Redness vaccination site; Colds; Legs are still not working well; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included diarrhea, mood disorder, energy decreased, lower extremities weakness of, hair loss, weakness of arms, myasthenia gravis, systemic lupus erythematosus, autoimmune disorder (had 5 autoimmune disease) and allergy (had allergies but were not reported). Concomitant products included MENVEO, MENVEO, MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO), pyridostigmine bromide (Mestinon) and RAVULIZUMAB (ULTOMIRIS).   On 03-MAY-2023, the patient received the 2nd dose of Bexsero (left deltoid). On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: Huge painful lump in arm vaccination site), injection site swelling (Verbatim: Arm swelled up vaccination site), injection site mass (Verbatim: Huge painful lump in arm vaccination site), injection site erythema (Verbatim: Redness vaccination site), cold (Verbatim: Colds) and mobility decreased (Verbatim: Legs are still not working well). The outcome of the injection site pain was resolved and the outcome of the injection site swelling, injection site mass, injection site erythema and cold were not reported and the outcome of the mobility decreased was not resolved.   The reporter considered the injection site pain, injection site swelling, injection site mass and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the reporter considered the cold and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the injection site pain, injection site swelling, injection site mass and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the cold and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: Receipt date: 2-Aug-2023 The patient had 5 auto-immune disease but only mentioned lupus and generalized myasthenia gravis.  The patient did admit to significant improvement in her arm weakness and reported being able to do activities and she had not been able to do in years. The patient had a lot of hair loss but it started before the infusions and had not gotten worse (thought it was related to her lupus) and also took high-dose steroids (unspecified). She was hoping to reduce both pyridostigmine bromide and steroids (unspecified) when she see her neurologist next on 1st June 2023, as she had great results on the ravulizumab. The patient received the first set of vaccines, Bexsero and Menveo. On 3rd May 2023, the patient received the second set of vaccines, Bexsero and Menveo and she reacted to the meningococcal vaccine Bexsero (dose, route, and frequency not reported), unsure if it was A or B but it happened with each dose.  The reaction was in her left arm and stated her arm swelled up (vaccination site swelling) with a huge painful lump (vaccination site mass vaccination site pain). The patient had no reaction either time to Menveo.  The patient did admit to continued leg weakness still using a wheelchair and would be starting physical therapy and also shared, that she always gets little cold and stuff like that she was seeing pulmonary, and they thought it was interstitial lung disease. Her legs were still not working at all (limb discomfort). Her neurologist was aware of this. She did not share any additional details than reported above. She was doing well with ravulizumab, next dose was planned for 28th June 2023 and had improvement in her arms and hands. The third Menveo vaccine was scheduled to be given on 5th September 2023. The follow-up could not be possible as no contact details were available.