Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Weight gain poor
Clinical narrative: Failure to thrive; Not gaining weight appropriately/ Unable to gain weight; HCP called to report that a 2-month-old infant has tested positive for the Rota Virus today, 10/19/2023/ Admin Rotateq on 09/21/23/ Tested positive for Rotavirus on 18-OCT-2023.; This serious spontaneous safety report with reference # (Interaction#) was received by a partner on 02-NOV-2023 and forwarded to agency on 28-NOV-2023 from a Health Care Professional. A male patient, with medical history of failure to thrive and a birth weight of 7 pounds 0.4 ounces, had been vaccinated with Vaxelis primary dose 1 on 21-SEP-2023 at the age of 2 months old (intramuscular route, Batch # U7374AA). Co-suspect vaccinations included RotaTeq (Batch# 1933912) and Vaxneuvance (Batch # V004289).  No concomitant vaccinations or medications were reported.   On 18-OCT-2023, the infant was hospitalized for being unable to gain weight.   On 18-OCT-2023 (also reported as 19-OCT-2023), the patient tested positive for Rotavirus. The baby's stool was tested, with a PCR test, as part of routine testing related to the infant not gaining weight appropriately.   On 19-OCT-2023, the infant also tested positive to adenovirus. It was reported that the infant had no other signs or symptoms and was not premature. On the same day, the infant was started on iron supplementation, he was not taking any other medications, or supplements.  At time of this report, the outcome of the events "failure to thrive and not gaining weight appropriately/ unable to gain weight was unknown/not reported and that of event rotavirus infection was reported as resolved on an unknown date.  The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events: Rotavirus infection, failure to thrive and not gaining weight appropriately/ unable to gain weight.  FOLLOW UP information was received by agency on 28-Nov-2023 from the local affiliate.  The correct day zero(0) for MCM-005491 is 02-NOV-2023, Initially it was incorrectly reported as 03-NOV-2023 by the local affiliate, hence the case MCM-005491 will be deactivated after submission, and the case MCM-005561 was created with a correct day 0(02-NOV-2023).   Further information is expected.  COMPANY COMMENT:  Rotavirus infection, Failure to thrive and Weight gain poor were assessed as serious due to causing hospitalization.   Rotavirus infection, Failure to thrive and Weight gain poor are unlisted for Vaxelis as per the Reference Safety Information.   Considering the current knowledge on the vaccine, the co-suspect vaccines (RotaTeq, Vaxneuvance), the long onset latency (28 days after vaccination) and different etiology of events, the causal relationship between Vaxelis and Rotavirus infection, Failure to thrive and Weight gain poor is excluded and assessed as not related.  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: Rotavirus infection, Failure to thrive and Weight gain poor were assessed as serious due to causing hospitalization.   Rotavirus infection, Failure to thrive and Weight gain poor are unlisted for Vaxelis as per the Reference Safety Information   Considering the current knowledge on the vaccine, the co-suspect vaccines (RotaTeq, Vaxneuvance), the long onset latency (28 days after vaccination) and different etiology of events, the causal relationship between Vaxelis and Rotavirus infection, Failure to thrive and Weight gain poor is excluded and assessed as not related.  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.