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 | 4 | 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 |
| 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 |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Coxsackie A16 virus; Influenza B virus; This 18-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 13-APR-2023. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, 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 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. Concomitant products included famotidine (Pepcid) and ceftriaxone sodium (Rocephin). On 15-OCT-2023 08:50, 185 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 397 days after receiving DTPa-HBV-IPV and Hiberix and 465 days after receiving Rotarix lyophilized formulation, the subject developed mild - grade 1 coxsackie viral infection (Verbatim: Coxsackie A16 virus). Serious criteria included hospitalization. Additional event(s) included mild - grade 1 influenza b virus infection (Verbatim: Influenza B virus) on 15-OCT-2023 08:50 with serious criteria of hospitalization. The subject was treated with oseltamivir phosphate (Tamiflu), budesonide (Pulmicort) and salbutamol (Albuterol). The outcome of coxsackie viral infection was resolved on 24-OCT-2023 08:00. The outcome(s) of the additional event(s) included influenza b virus infection (resolved on 24-OCT-2023 08:00). Relevant Tests: On Unk-Oct-2023 X Rays Chest bilateral Findings/Impressions was Abnormal On Unk-Oct-2023 Influenza B virus was positive. The investigator considered that there was no reasonable possibility that the coxsackie viral infection and influenza b virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. The company considered that there was no reasonable possibility that the coxsackie viral infection and influenza b virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation, M-M-R II and Varivax. Linked case(s) involving the same subject: US2023065422, US2023118007 GSK Receipt Date: 26-OCT-2023, 27-OCT-2023, 30-OCT-2023 SAE 15OCT2023: The SAE started on 15 OCT 2023. The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to Influenza B virus positive. During hospitalization, the subject was also diagnosed with coxsackie A16 virus. 06MAY2023: The subject was discharge on 19OCT2023 with a good prognosis. 24OCT2023: Subject recovered without sequelae. The SAE is not related to the study vaccine. Follow up information received on 02-Nov-2023. Summary of changes: Concomitant and treatment medications added. Relevant test and narrative updated. Follow up information received on 12-JUL-2024 Summary of changes: Treatment drug (Rocephin) route updated. Upon internal review the case was update don 07-Feb-2025. Authrization number of Rotarix lyophilized formulation was updated from World-MKT 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. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Coxsackie viral infection and Influenza, 185 days after receiving 4th dose of Bexsero vs Placebo, 4th dose of Prevnar 13, 1st dose of M-M-R II, and 1st dose of Varivax, 397 days after receiving 3rd dose of DTPa-HBV-IPV, 397 days after receiving 3rd dose of Hiberix, and 465 days after receiving 2nd dose of Rotarix lyophilized formulation, in a 18-month-old female infant. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset. US-GSK-US2023065422: US-GSK-US2023118007:
Pepcid; ROCEPHIN
Comments: On Unk-Oct-2023 X Rays Chest bilateral Findings/Impressions was Abnormal On Unk-Oct-2023 Influenza B virus was positive