Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (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 / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Respiratory Syncytial Virus Infection; This 5-month-old male subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 31st October 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 31st October 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 11th December 2018, 41 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus infection. Serious criteria included hospitalization. The subject was treated with sodium chloride. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. DTPa-HBV-IPV was continued with no change. Hiberix was continued with no change. The outcome of respiratory syncytial virus infection was recovered/resolved on 9th January 2019. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus infection may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Diagnostic results (unless otherwise stated, normal values were not provided): On 13th December 2018, Respiratory syncytial virus test result was positive. GSK Receipt Date: 17-DEC-2018 Patient presented to clinic on 12/13/18 with complaints of fever, congestion, and cough. Congestion for a week and cough for two days and fever started over night. Subject was tested for RSV and test results were positive. Subject returned to the clinic on 12/15/18 with worsening of fever, cough and congestion and now had wheezing. Was diagnosed with still having RSV and Bilateral Acute Otitis Media. Due to symptoms being worse patient was sent to ED for admission for RSV. While in hospital patient received Rocephin, iv fluids, and sodium chloride updraft. Patient was discharged on 12/17/18 and came to clinic on 12/18/18 for a follow up visit and patient is improving. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus infection, 41 days after receiving 2nd dose of Bexsero vs Placebo, 2nd dose of Prevnar 13, 2nd dose of DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe, 2nd dose of Hiberix, 2nd dose of Rotarix lyophilized formulation (Rotarix Oral Applicator Device) co-administered with PCV and routine vaccines in a 5-month-old male subject . Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Test Date: 20181213; Test Name: Respiratory Syncytial Virus; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:)