Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | 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 | 3 | UNK | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
RSV Bronchiolitis; This 10-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 25-JUL-2023, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 25-JUL-2023, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 19-MAY-2023, for prophylaxis. Concomitant products included paracetamol (Tylenol) and ibuprofen (Motrin). On 16-DEC-2023 11:44, 144 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV and Hiberix and 211 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 respiratory syncytial virus bronchiolitis (Verbatim: RSV Bronchiolitis). Serious criteria included hospitalization. The subject was treated with dexamethasone (Decadron) and salbutamol (Albuterol). Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was resolved on 21-DEC-2023. Diagnostic results (reference ranges are provided in parenthesis if available): Influenza virus test- 10-DEC-2023 negative. Oxygen saturation- 18-DEC-2023 88 %, (95.00-100.00). Respiratory syncytial virus test- 18-DEC-2023 positive. SARS-CoV-2 test- 10-DEC-2023 negative. X-ray- 18-DEC-2023 shows changes consistent with a bronchiolitis. The investigator considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. The company considered that there was no reasonable possibility that the respiratory syncytial virus bronchiolitis may have been caused by Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. GSK Receipt Date: 20-MAR-2024 Subject came into clinic after hours with symptoms of URI (Upper respiratory infection) and fever for 1-2 days on 12/18/2023. Mom was worried because cough was getting worse and difficulty breathing. Clinic gave a nebulizer treatment stats mostly 90-91 percent even after treatments. A Decadron shot was also given in clinic with but did not seem to help. Stats were mid 80 percent and was sent to the ER. The ER checked O2 (oxygen) and it was low 90's with an increased work of breathing. ER (Emergency Room) admitted to the peds floor of the hospital for observation and from there was admitted an albuterol treatment was given on 12/18 and 12/19 with no change in stats. Subject was then put on oxygen via nasal cannula on 12/19/23 child was given acetaminophen and ibuprofen on 12/19/23 to help with fever and pain. on 12/21/23 subject was discharged from hospital where oxygen levels were in the upper 90's with no trouble breathing and symptoms getting better. Follow up information received on 03-APR-2024 Summary of changes: Concomitant, treatment, action taken and lab data were updated. Follow up information received on : 01-JUL-2024 The investigator confirmed that Hypoxemia was deleted due to it being a symptom of RSV Summary of change : Event Hypoxemia was deleted , Lab data and narrative updated. Follow up information received on 16-DEC-2024 Summary of changes: oxygen saturation lab data unit and range was updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Respiratory syncytial virus bronchiolitis, 144 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV, 3rd dose of Hiberix and 211 days after receiving the 2nd dose of Rotarix lyophilized formulation in a 10-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility, alternative etiology (Respiratory syncytial virus) and alternate risk factor (Age) based on medical history.
TYLENOL; Motrin
Test Date: 20231210; Test Name: Flu test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231218; Test Name: Oxygen saturation; Test Result: 88 %; Test Date: 20231218; Test Name: RSV test; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231210; Test Name: Covid test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 20231218; Test Name: X-ray; Result Unstructured Data: (Test Result:shows changes consistent with a bronchiolitis,Unit:unknown,Normal Low:,Normal High:)