redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours; this case was reported by a physician via regulatory authority and described the occurrence of injection site induration in a 3-month-old female 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 20th july 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 20th july 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced injection site induration (serious criteria other: serious as per reporter), injection site redness (serious criteria other: serious as per reporter), injection site swelling (serious criteria other: serious as per reporter), irritability (serious criteria other: serious as per reporter), drowsiness (serious criteria other: serious as per reporter), crying abnormal (serious criteria other: serious as per reporter) and tissue puffing (serious criteria other: serious as per reporter). on 23rd july 2021, the outcome of the injection site induration, injection site redness, injection site swelling, irritability, drowsiness, crying abnormal and tissue puffing were recovered/resolved. it was unknown if the reporter considered the injection site induration, injection site redness, injection site swelling, irritability, drowsiness, crying abnormal and tissue puffing 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: duration of events injection site induration, injection site redness, injection site swelling, irritability, drowsiness, crying abnormal and tissue puffing were 3 days. note: in event verbatim redness, swelling and hardening in the injection site was mentioned hence additional event injection site swelling was updated as the event tissue puffing was reported for which preferred term was swelling. as per event verbatim injection site induration, injection site redness, injection site swelling and tissue puffing lasted until day 2 and irritability, drowsiness, crying abnormal were up to 6/12 hours however duration was captured as per dates. initial information received from physician via regulatory authority on 25th february 2022: redness, swelling and hardening in the injection site until day 2, sleeping, abnormal crying and irritability up to 6/12 hours