Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Gastroenteritis; This 14-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 10-OCT-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 10-OCT-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 10-AUG-2023, for prophylaxis. On 11-JUN-2024 14:00, 245 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 306 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 gastroenteritis (Verbatim: Gastroenteritis). Serious criteria included hospitalization. The subject was treated with famotidine (Pepcid). Bexsero vs Placebo was interrupted. The outcome of gastroenteritis was resolved on 15-JUN-2024. The investigator considered that there was no reasonable possibility that the gastroenteritis 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 may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Linked case(s) involving the same subject: US2024075244 GSK Receipt Date:17-JUN-2024, 18-JUN-2024, 20-JUN-2024, 24-JUN-2024 On 11 JUN 2024 subject had vomiting and was taken to the ER (emergency room), subject was diagnosed with dehydration and hospitalized for observation and IV (intravenous) fluids. Subject was discharged 12 JUN 2024. On 14 JUN 2024 subject had 4-6 loose stools and was taken to the ER, subject was diagnosed with viral gastroenteritis and hospitalized for observation with IV fluids and Pepcid for GI (gastrointestinal) protection. Subject was discharged on 15 JUN 2024. The subject received treatment medication IV Fluids start date 11/Jun/2024 End date 12/Jun/2024 Route of administration was Intravenous Medical indication was Hydration. The subject received treatment medication IV Fluids start date 14/Jun/2024 End date 15/Jun/2024 Route of administration was Intravenous Medical indication was Hydration. On 21-Jun-2024 GSK case ID US2024075244 was identified as duplicate of US2024075241. All future correspondence will be submitted to US2024075241. Follow up information received 29-AUG-2024, 03-SEP-2024 Summary of changes: Treatment medication Pepcid route of administration updated. Follow up information received 23-Oct-2024. Summary of changes: Event Dehydration deleted. Follow up information received on 27Dec2024 Summary of changes : Event onset date updated from, 14Jun2024 to 11Jun2024, TTO updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed. Upon internal review the case was updated on 18-Mar-2025. Study drug's device updated.; Sender's Comments: A case of Gastroenteritis, 245 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV, 3rd dose of Hiberix and 2nd dose of Rotarix lyophilized formulation in a 14-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (viral). US-GSK-US2024075244: