Received Feb 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPHEPBIP | DTAP + HEPB + IPV (PEDIARIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | IM / LL |
| HIBV | HIB (HIBERIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 4 | UNK | IM / LL |
| RV1 | ROTAVIRUS (ROTARIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | IM / RL |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Acute Gastroenteritis; This 14-month-old female subject was enrolled in a study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 13-APR-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 13-SEP-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-JUL-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 13-APR-2023, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 13-APR-2023, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. On 15-JUN-2023 08:00, 63 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 275 days after receiving Hiberix and DTPa-HBV-IPV and 343 days after receiving Rotarix lyophilized formulation, the subject developed mild - grade 1 acute gastroenteritis (Verbatim: Acute Gastroenteritis). Serious criteria included hospitalization. The subject was treated with saline and famotidine (Pepcid). The outcome of acute gastroenteritis was resolved on 19-JUN-2023 09:00. Relevant Tests: The subject underwent to the following: On 15JUN2023, Stool Culture was Negative On 15JUN2023, Blood Culture was Negative On 15JUN2023, Sars-Cov-2AG was Nonreactive On 15JUN2023, Flu A was Negative On 15JUN2023, Flu B was Negative.. The investigator considered that there was no reasonable possibility that the acute gastroenteritis may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the acute gastroenteritis may have been caused by Bexsero vs Placebo, Hiberix, Rotarix lyophilized formulation, DTPa-HBV-IPV, M-M-R II and Varivax. Linked case(s) involving the same subject: US2023065422, US2023148628 GSK receipt date: 29-AUG-2023, 01-SEP-2023 SAE 15JUN2023: The SAE started on 15 Jun 2023. The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to Acute Gastroenteritis. The subject was administered with Probiotics, Pepcid and saline solution. 19JUN2023: The subject was discharge on 19JUN2023 with a good prognosis. Subject recovered without sequelae. The SAE is not related to the study vaccine. The subject received treatment medication Probiotics from 15-JUN-2023 to 19-JUN-2023, unknown dose and frequency for the Indication of Acute Gastroenteritis orally. Follow-up information received on 11-SEP-2023 Summary of changes: Type of drug updated from concomitant to treatment. Upon internal review the case was updated on 07-FEB-2025. Authorization Number updated for Products Hiberix from 125347 to World-INV, Rotarix lyophilized formulation from 125265 to World-INV, DTPa-HBV-IPV updated to World-INV, Prevenar 13 updated to World-INV. Device causality of DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE was updated from no to unknown. Start date, dose number and time to onset for suspect vaccines Bexsero vs Placebo, Prevenar 13 and DTPa-HBV-IPV were updated, Suspect vaccines M-M-R II and Varivax were updated.; Sender's Comments: A case of Gastroenteritis, 63 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 275 days after receiving Hiberix and DTPa-HBV-IPV and 343 days after receiving Rotarix lyophilized formulation, in a 14-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility. US-GSK-US2023148628: US-GSK-US2023065422:
Comments: The subject underwent to the following: On 15JUN2023, Stool Culture was Negative On 15JUN2023, Blood Culture was Negative On 15JUN2023, Sars-Cov-2AG was Nonreactive On 15JUN2023, Flu A was Negative On 15JUN2023, Flu B was Negative.