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 / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
| VARCEL | VARICELLA (VARIVAX) | MERCK & CO. INC. | 1 | UNK | SC / LA |
Bronchiolitis; This 13-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, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 07-JUL-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 13-SEP-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. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 13-SEP-2022, for prophylaxis. Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis. Concomitant products included famotidine (Pepcid). On 02-MAY-2023 16:00, 19 days after receiving Bexsero vs Placebo, M-M-R II and Varivax, 299 days after receiving Rotarix lyophilized formulation and 231 days after receiving Hiberix and DTPa-HBV-IPV, the subject developed mild - grade 1 bronchiolitis (Verbatim: Bronchiolitis). Serious criteria included hospitalization. The subject was treated with paracetamol (Acetaminophen), budesonide and salbutamol (Albuterol). The outcome of bronchiolitis was resolved on 13-MAY-2023 12:00. Relevant Tests: On unknown date in MAY 2023 X Rays: Chest and lateral Findings/Impressions: There is a normal cardiothymic silhourtte. There are prominent perihilar interstitial markings, as seen with bronchiolitis in the appropriate clinical setting. No consolidation or pulmonary edema. No pleural effusion. On unknown date in MAY 2023 Culture Blood Pediatric On unknown date in MAY 2023 Culture Blood Observations: No growth in 2 days. Diagnostic results (reference ranges are provided in parenthesis if available): X-ray-In MAY-2023 confirmed the Bronchiolitis diagnosis.. The investigator considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and DTPa-HBV-IPV. The company considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, Rotarix lyophilized formulation, Hiberix, M-M-R II, Varivax and DTPa-HBV-IPV. Linked case(s) involving the same subject: US2023118007, US2023148628 GSK Receipt Date: 05-MAY-2023, 10-MAY-2023 Serious adverse event 02MAY2023: The Serious adverse event started on 02 May 2023. 03MAY2023: The subject's mother took the subject to the hospital and the subject was hospitalized. Admitted due to fever and acute bronchospasm. 06MAY2023: The subject was discharge on 06MAY2023 with a good prognosis. 13MAY2023: Subject recovered without sequelae. The Serious adverse event was not related to the study vaccine. Follow-up information received on 26-MAY-2023, 30-MAY-2023, 31-MAY-2023. Concomitant medication reported as S-Budesonide and Albuterol 0.042 percent Summary of changes: Narrative updated , Concomitant medication added, Lab data updated. Follow-up information received on 07-JUN-2023. Summary of changes: Concomitant drugs updated to Treatment. Follow up information received on 12-Jun-2024 Summary of change : New concomitant medication Pepcid was added , lab data and narrative updated. Follow up information received on 22-NOV-2024 Summary of change: Concomitant medication Pepcid end date updated. Upon internal review the case was updated on 07-Feb-2025. Authorization number of Hiberix was updated from 125347 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 bronchiolitis,19 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, 299 days after receiving 2nd dose of Rotarix lyophilized formulation and 231 days after receiving 3rd dose of Hiberix and 3rd dose of DTPa-HBV-IPV in a 13-month-old female subject. Report is inconsistent with causal relation to the vaccine products considering absence of biological plausibility. US-GSK-US2023148628: US-GSK-US2023118007:
Pepcid
Test Date: 202305; Test Name: X-rays; Result Unstructured Data: (Test Result:confirmed the Bronchiolitis diagnosis.,Unit:unknown,Normal Low:,Normal High:); Comments: On unknown date in MAY 2023 X Rays: Chest and lateral Findings/Impressions: There is a normal cardiothymic silhourtte. There are prominent perihilar interstitial markings, as seen with bronchiolitis in the appropriate clinical setting. No consolidation or pulmonary edema. No pleural effusion. On unknown date in MAY 2023 Culture Blood Pediatric On unknown date in MAY 2023 Culture Blood Observations: No growth in 2 days