Received Mar 18, 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 |
Bronchiolitis; This 16-month-old male subject was enrolled in a blinded study. The subject received the 4th dose of Bexsero vs Placebo (intramuscular, right thigh) on 16-JUL-2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 21-DEC-2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 17-OCT-2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 21-DEC-2018, for prophylaxis. The subject received the 1st dose of M-M-R II (subcutaneous, right arm) on 16-JUL-2019, for prophylaxis. The subject received the 1st dose of Varivax (subcutaneous, left arm) on 16-JUL-2019, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) on 16-JUL-2019, for prophylaxis. Concurrent medical conditions included bronchiolitis (Multiple episodes) and otitis media chronic. Concomitant products included ofloxacin and amoxicillin. On 30-OCT-2019, 106 days after receiving Bexsero vs Placebo, M-M-R II, Varivax and Prevnar 13, 313 days after receiving DTPa-HBV-IPV and Hiberix and 378 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol). The outcome of bronchiolitis was resolved on 07-NOV-2019. Relevant Tests: On 31Oct2019 Chest x-ray, showed atelectasis (no pneumonia). On 01Nov2019, Renal function panel performed unremarkable. The investigator considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. The company considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and Prevnar 13. Linked case(s) involving the same subject: US2020047884 GSK Receipt Date: 04-NOV-2019 Subject presented with one day cough, congestion and increased work of breathing. Went to OSH (outside hospital) first, chest x-ray with possible pneumonia was referred to emergency department for further care. In the ED,subject required vapotherm support to 14L and was admitted to the PICU for further care. Admitted for approximately 1 day with diagnosis of Bronchiolitis. Max respiratory support was 14L high flow. He improved with nasal suction and albuterol treatments. Respiratory support was weaned and he was able to be transferred to the hospital floor. Remained hospitalized for additional 2 days, able to wean down oxygen support to room air and remained stable on room air overnight prior to discharge. Subject was admitted 31Oct2019 and was discharged 03Nov2019. Follow up information received on 31-JUL-2024 Summary of changes: Concomitant medications updated. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of bronchiolitis, 106 days after receiving the 4th dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, 1st dose of M-M-R II, Varivax, Prevnar 13, 313 days after receiving 3rd dose of DTPa-HBV-IPV with DTPa-HBV-IPV vaccine pre-filled syringe device, Hiberix and 378 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix vaccine Oral Applicator Device, in a 16-month-old male subject. Report is inconsistent with causal relation to the vaccine products, considering implausible time to onset, absence of biological plausibility and alternate etiology of concurrent medical condition bronchiolitis (Multiple episodes) based on medical history. US-GLAXOSMITHKLINE-US2020047884:
Bronchiolitis (Multiple episodes); Otitis media chronic
OFLOXACIN; AMOXICILLIN
Comments: On 31Oct2019 Chest x-ray, showed atelectasis (no pneumonia). On 01Nov2019, Renal function panel performed unremarkable