Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Respiratory Syncytial Virus; This 6-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 01-NOV-2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 01-NOV-2018, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for an unknown indication. On 05-JAN-2019, 65 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix, the subject developed moderate - grade 2 respiratory syncytial virus infection (Verbatim: Respiratory Syncytial Virus). Serious criteria included hospitalization. The subject was treated with sodium chloride and glucose;potassium chloride (Dextrose;Potassium Chloride). Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus infection was resolved on 11-JAN-2019. Relevant Tests: On an unknown date in Jan2019 Normal Chest x-ray while in hospital; RSV(Respiratory syncytial virus) TEST POSTITVE. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation and Hiberix. GSK Receipt Date : 08-Jan-2019 Subject was seen in ER(emergency room) on 06Jan2019 and diagnosed with RSV(respiratory syncytial virus). Subject got worse overnight and came to Clinic and was given a breathing treatment with little improvement so mom was told to watch subject and return if she got any worse. Subject was not improving that afternoon so Mom was told to take her to the the ER and she was admitted. While in hospital subject was given updrafts and IV Fluids. Subject was discharged from Hospital on 09Jan2019. Follow up information received on 10-Feb-2025, 11-Feb-2025 Medication name as reported was Sodium chloride updraft, Little Noses (Sodium Chloride Summary of changes: Lab data updated, Causality of device updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 65 days after receiving the 2nd doses of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV Hiberix and Rotarix lyophilized formulation, in a 6-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering the implausible time to onset , absence of biological plausibility and alternative etiology (Respiratory syncytial virus test positive).
Comments: On an unknown date in Jan2019 Normal Chest x-ray while in hospital; RSV(Respiratory syncytial virus) TEST POSTITVE