Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Hypersomnia, Hypophagia, Infantile diarrhoea, Infantile vomiting, Otitis media
Clinical narrative: Gastroenteritis; Dehydration; This 10-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 14-SEP-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 14-SEP-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-JUL-2023, for prophylaxis.   On 05-JAN-2024, 113 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 179 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 gastroenteritis (Verbatim: Gastroenteritis). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 dehydration (Verbatim: Dehydration) on 05-JAN-2024 with serious criteria of hospitalization. The subject was treated with sodium chloride, ondansetron, ibuprofen, glucose (Dextrose) and ranitidine hydrochloride (Mylanta). The action taken with Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation was no change. The outcome of gastroenteritis was resolved on 15-JAN-2024. The outcome(s) of the additional event(s) included dehydration (resolved on 09-JAN-2024).   Relevant Tests: Due to low bicarb and decreased glucose, patient was admitted for IV fluids.   On an unknown date in Jan 2024 X-ray Impression showed, Nonobstructive bowel gas pattern.  Small amount of stool in the colon.  Couple of scattered air-fluid levels in a nonspecific pattern are noted on the decubitus view. No pneumoperitoneum, No pneumatosis, No portal venous gas. No calcifications. Lung bases are clear. Osseous structures are unremarkable.   The investigator considered that there was no reasonable possibility that the gastroenteritis and dehydration may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation.   The company considered that there was no reasonable possibility that the gastroenteritis and dehydration may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation.   GSK receipt date: 09-JAN-2024, 10-JAN-2024 and 15-JAN-2024.  Parent reported onset of vomiting and diarrhea on 05Jan2024. Subject presented to the ER (Emergency room) on 08Jan2024 and was subsequently admitted for gastroenteritis and dehydration. Subject was admitted on 08Jan2024 and was discharged on 09Jan2024. Per the hospital record, subject presented with diarrhea and vomiting and one wet diaper that day. Subject had been pulling at right ear. Subject had persistent OM in the right ear and received Ceftriaxone on 12/31 and Jan. 1. Crying at home like he was in pain. Diarrhea and vomiting since 1/5. Other family members have had it. Decreased activity, increased sleep and decreased PO on 08Jan2024. History of persistent otitis media, no chronic illness, never hospitalized. PE noted Frequent crying at home today. Dull TM left ear. Decreased bowel sounds. Erythematous diaper area, liquid yellow stool. Remainder of exam normal.  Follow up information received on 21-MAR-2024 Summary of changes: Dose updated as unknown for Mylanta  Follow up information received on 08-JUL-2024 Summary of changes: General narrative comment updated.  Follow up information received on 23-OCT-2024 Summary of changes: Outcome of event was updated from Not Recovered/ Not Resolved to Recovered/Resolved for Gastroenteritis and Dehydration Event end date updated for Gastroenteritis was 15-Jan-2024 and for Dehydration was 5-Jan-2024, Narrative was updated  Follow up information received on 06-NOV-2024, 11-NOV-2024  Summary of changes: General narrative comments updated.  Follow up information received on 06-JAN-2025 Summary of changes: Treatment drug name updated Dextrose to Dextrose 5%.  Upon internal review the case was updated on: 08-Jan-2025 : The suspect product mmR and virvax removed.; Sender's Comments: A case of Gastroenteritis and Dehydration, 113 days after receiving 3rd dose of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV  and Hiberix, 179 days after receiving 2nd dose of Rotarix lyophilized formulation,  in a 10-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.