Age: 12.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness, Generalised oedema, Headache, Peripheral swelling, Swelling
Clinical narrative: generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back; progressively worse during the month after administration; headaches; having periods of dizziness; fainting which began within the month after receiving the meningococcal vaccination; Initial information received on 12-Aug-2024 regarding an unsolicited valid  serious case received from a consumer/Non-Healthcare Professional.  This case involves a 12 years old female patient who had fainting which began within the month after receiving the meningococcal vaccination, generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back, headaches and having periods of dizziness.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Immunisation.  On 26-Jan-2018, the patient received a dose 1 TOTAL of suspect Meningococcal Vaccine produced by unknown manufacturer lot A17013 via unknown route in unknown administration site for Immunization (strength, dose, and expiry date unknown).  On 26-Jan-2018 the patient developed generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back (generalised oedema) (latency same day). On an unknown date in 2018 the patient developed fainting which began within the month after receiving the meningococcal vaccination (syncope), headaches (headache), periods of dizziness (dizziness) and progressively worse during the month after administration (condition aggravated) (latency within months).  Action taken:not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Not Recovered / Not Resolved for all the events  Seriousness criteria-Medically significant for syncope; Sender's Comments: Sanofi Company Comment dated 14-Aug-2024: This case involves a 12 years old female patient who had fainting which began within the month after receiving the meningococcal vaccination, generalized swelling that started almost immediately after receiving vaccination that got progressively worse during the month after administration, swelling on the back of the neck, arms, legs, chest and back, headaches and having periods of dizziness. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed