fever 37.5 after 6/12 hours, diarrea day 4; fever 37.5 after 6/12 hours, diarrea day 4; this case was reported by a physician via regulatory authority and described the occurrence of fever in a 4-month-old male patient who received men b nvs (bexsero) (batch number abxb13aa, expiry date unknown) for prophylaxis. co-suspect products included meningococcal b recom vaccine + aloh + omv pre-filled syringe device (meningococcal b vaccine pre-filled syringe device) injection syringe for prophylaxis. on 3rd september 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 3rd september 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced fever (serious criteria other: serious as per reporter) and diarrhea (serious criteria other: serious as per reporter). on 8th september 2021, the outcome of the fever and diarrhea were recovered/resolved. it was unknown if the reporter considered the fever and diarrhea to be related to bexsero and meningococcal b vaccine 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 reported as follows: on 3rd september 2021, the body temperature of patient was recorded as 37.5 degree celsius. the duration for events fever and diarrhea was 5 days. the time to onset was reported as fever after 6/12 hours and diarrhea on day 4 however time to onset was captured as less than a day as per the event onset date. initial information was received from a physician via regulatory authority on 28th february 2022: fever 37.5 after 6/12 hours, diarrhea day 4

test date: 20210903; test name: body temperature; result unstructured data: (test result:37.5,unit:degree c,normal low:,normal high:)

na

na