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Write-up: expanded subdural haematoma; expanded cerebral haematoma; vomited three times; pallor; 4 fingertip-size haematomas on the chest; somnolence; This case was reported by a physician via regulatory authority and described the occurrence of subdural haematoma in a 3-month-old female patient who received Men B NVS (Bexsero) (batch number ABXA40AB, expiry date unknown) for meningococcal immunization. Co-suspect products included PENTAXIM (batch number ROB 851, expiry date unknown) for prophylaxis and MENINGOCOCCAL GROUP C CONJUGATE VACCINE (NEISVAC-C) (batch number ARO6561, expiry date unknown) for prophylaxis. The patient''s past medical history included upper respiratory tract infection (on 11th October 2019). On 15th October 2019, the patient received Bexsero (intramuscular) .5 ml. On 1st October 2019, the patient received PENTAXIM (intramuscular) .5 ml and NEISVAC-C (intramuscular) .5 ml. On 29th October 2019, 14 days after receiving Bexsero and 28 Day after receiving PENTAXIM and NEISVAC-C, the patient experienced vomiting (serious criteria death), pallor (serious criteria death), haematoma (serious criteria death) and somnolence (serious criteria death). On 30th October 2019, the patient experienced subdural haematoma (serious criteria death and GSK medically significant) and cerebral haematoma (serious criteria death and GSK medically significant). On 31st October 2019, the outcome of the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence were fatal. The patient died on 31st October 2019. The reported cause of death was vomiting, pallor, subdural haematoma, cerebral hematoma, hematoma and somnolence. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Bexsero. Additional details: The age at vaccination was not reported, however the patient was 2 or 3-month-old at the time of vaccination. It was unknown if the reporter considered the subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence to be related to Neisvac-C and Pentaxim. On 30th October 2019, CT brain scan showed expanded subdural and cerebral haematoma. On 29th October 2019, Body temperature was normal. Initial information was reported by a physician via regulatory authority on 11th December 2019: Vomited three times, subdural haematoma, cerebral haematoma, vomiting, pallor, haematoma and somnolence. Sender''s comments : According to the SmPCs, vomitus and somnolence are expected adverse events of BEXSERO, PENTAXIM and NEISVAC-C. Pallor is expected for BEXSERO. Cutaneous haematoma is rare adverse event of NEISVAC-C, listed in the product information. Subdural and cerebral haematomas are considered unexpected events. The events occured around the same time, which is suggestive of a common etiology, vomitus, somnolence and pallor is presumably related symptoms of haematomas. Chest subduraland cerebral haematomas are suggestive of an excessive bleeding by the patient. Time to onset was 14 days for BEXSERO and 28 days for PENTAXIM and NEISVAC-C. Due to lack of close temporality and fatal symptoms that are not typical for adverse reactions after vaccination, causal relationship between BEXSERO, PENTAXIM, NEISVAC-C and the reported adverse events (vomitus, pallor, somnolence, chest-, subdural- and cerebral haematomas) is assessed unlikely. The case is considered serious due to fatal outcome. Further information is expected from the national competent authority for vaccines.; Reported Cause(s) of Death: Vomiting; Pallor; Subdural haematoma; Cerebral haematoma; Haematoma; Somnolence
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