Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 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 |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 4 | UNK | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Viral Syndrome; Reactive Airway Disease Exacerbation; Reactive Airway Disease Exacerbation; This 15-month-old female subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 18-OCT-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 26-APR-2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 26-APR-2019, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 18-OCT-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 15-FEB-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 18-OCT-2019, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. The subject's past medical history included influenza a virus infection. Concurrent medical conditions included reactive airways disease. On 02-FEB-2020, 107 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 282 days after receiving DTPa-HBV-IPV and Hiberix and 352 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 viral syndrome (Verbatim: Viral Syndrome). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 reactive airways disease (Verbatim: Reactive Airway Disease Exacerbation) on 02-FEB-2020 with serious criteria of hospitalization and severe - grade 3 condition aggravated (Verbatim: Reactive Airway Disease Exacerbation) on 02-FEB-2020 with serious criteria of hospitalization. The subject was treated with dexamethasone, ibuprofen, salbutamol (Albuterol), budesonide, ipratropium and dexamethasone sodium succinate (Dexamethasone Sodium). The outcome of viral syndrome was resolved on 06-FEB-2020. The outcome(s) of the additional event(s) included reactive airways disease (resolved on 16-FEB-2020) and condition aggravated (resolved on 16-FEB-2020). The investigator considered that there was no reasonable possibility that the viral syndrome, reactive airways disease and condition aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II, Rotarix lyophilized formulation and Varivax. The company considered that there was no reasonable possibility that the viral syndrome, reactive airways disease and condition aggravated may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, M-M-R II, Rotarix lyophilized formulation and Varivax. Linked case(s) involving the same subject: US2020029361 GSK Receipt Date:18-FEB-2020 15 Month girl with history of reactive airway disease, admitted for wheezing and rapid onset of respiratory distress in setting of a viral upper respiratory infection. Family had been giving 1 dose of budesonide and albuterol and bedtime. Day of admission, she had increasing work of breathing and so was given multiple doses of albuterol nebs and puffs, then went to ED (emergency department). Received dexamethasone, albuterol b x2, ipratropium x1, and was placed on continuous albuterol at 5mg/hr. Swas quickly weaned overnight to 3 puffs every 4 hours with normalized work of breathing and no wheezes. Was also recently hospitalized from 13JAN2020 to 15JAN2020 for complex febrile convulsions and Influenza A. Subject admitted to hospital on 02FEB2020 and discharged on 03FEB2020 Follow-up information received on 23-Mar-2022. This follow-up was considered significant. Summary of Changes: added suspect drugs, subject linked case and updated narrative Follow-up information received on 03-JUN-2022. This follow-up was considered non-significant. Summary of Changes: Concomitant product updated. Follow-up information received on 2nd August 2022. This follow-up was considered significant. Summary of changes: Suspect and Medical condition updated. Follow-up information received on 17-AUG-2023 Summary of changes: new treatment drug Dexamethasone added and narrative updated. Follow up information received on 25-OCT-2024 Summary of changes: Treatment medication Albuterol 0.5% Nebulizer 5mg/mL End date updated, Additional Event condition aggravated updated. Follow up information received on 14-JAN-2025 Reported medication name Budesonide 0.25mL/2mL Nebulizer, Albuterol 0.5% Nebulizer 5mg/mL, Albuterol 90 mcg/actuation HPA MDI, Ipratropium 0.02% Nebulizer Summary of changes: Treatment medication Albuterol 0.5% Nebulizer 5mg/mL unit updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of viral infection, bronchial hyperreactivity and Condition aggravated 107 days after receiving 4th dose of Bexsero vs Placebo, Prevnar 13, M-M-R II and Varivax, 282 days after receiving DTPa-HBV-IPV and Hiberix and 352 days after receiving Rotarix lyophilized formulation in a 15-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility for the event viral infection and considering alternate etiology (reactive airways disease and underlying infection) based on the medical history for the event bronchial hyperreactivity. US-GLAXOSMITHKLINE-US2020029361:
Reactive airways disease
Medical History/Concurrent Conditions: Influenza A virus infection