Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Wheezing
Clinical narrative: The customer reported that the patient received Vaxelis at 2 months, 4 months, and 6 months of age. The patient was wheezing for around 4 to 7 days after each dose of Vaxelis.; This serious spontaneous safety report with MSD  was received by a partner on 18-APR-2023 from an administrator and forwarded to Agency on 19-APR-2023.   A patient of unknown gender, unknown age, with no reported relevant medical history, had been vaccinated with Vaxelis (unknown route of administration, dose numbers 1, 2 and 3) on an unspecified date (unknown batch number) for prophylaxis.   No concomitant vaccinations were reported.  On an unknown date, after receiving the Vaxelis vaccination, it was reported that the patient was wheezing for around 4 to 7 days. On unspecified date, the patient was admitted to the hospital for 5 days. Previously, the patient received Vaxelis at 2 months and 4 months of age, and experienced wheezing for 4 to 7 days after Vaxelis administration.  The outcome of the event wheezing for around 4 to 7 days after each dose was reported as resolved.  The reporter did not assess the causal relationship between Vaxelis and the event, "the customer reported that the patient received Vaxelis at 2 months, 4 months, and 6 months of age. The patient was wheezing for around 4 to 7 days after each dose of Vaxelis". The hospital doctor did not think that these symptoms were related to Vaxelis.   Further information is expected.   For reference purposes, the case is linked to MCM-004731 and MCM-004736.  COMPANY COMMENT: Wheezing was assessed as serious due to hospitalization.   Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).   Despite the medical history of similar adverse events following the previous doses of Vaxelis and no confounding factor (co-suspect vaccine), due to the lack of information in this case (time to onset, medical history), the causal relationship between Vaxelis and the event Wheezing was excluded and assessed as not related following the hospital physician's assessment.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.; Sender's Comments: Wheezing was assessed as serious due to hospitalization.   Wheezing is unlisted for Vaxelis as per the Reference Safety Information (CCDS).   Despite the medical history of similar adverse events following the previous doses of Vaxelis and no confounding factor (co-suspect vaccine), due to the lack of information in this case (time to onset, medical history), the causal relationship between Vaxelis and the event Wheezing was excluded and assessed as not related following the hospital physician's assessment.   This single individual case safety report does not modify the benefit/risk balance of this product. Therefore, no change in the label or other measures is recommended at this time. However, the company will continue to monitor all respective reports received and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.