Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Oxygen saturation decreased, Pneumonia bacterial, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Bacterial Pneumonia; This 12-month-old female subject was enrolled in a study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 24-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 24-OCT-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 24-OCT-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 21-JUL-2022, for prophylaxis.   Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis.   The subject's past medical history included upper respiratory tract infection, respiratory syncytial virus infection and viral upper respiratory tract infection (with cough). Concurrent medical conditions included upper respiratory tract infection.   On 31-MAR-2023, 158 days after receiving Bexsero vs Placebo, Hiberix and DTPa-HBV-IPV and 253 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 pneumonia bacterial (Verbatim: Bacterial Pneumonia). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol), amoxicillin, ceftriaxone sodium (Rocephin) and oxygen. Bexsero vs Placebo was continued with no change. The outcome of pneumonia bacterial was resolved on 13-APR-2023.   Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray-In APR-2023 with viral appearance, no focal infiltrate.                                                                                                     The investigator considered that there was no reasonable possibility that the pneumonia bacterial may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation.    The company considered that there was no reasonable possibility that the pneumonia bacterial may have been caused by Bexsero vs Placebo, Hiberix, DTPa-HBV-IPV and Rotarix lyophilized formulation.   GSK Receipt Date: 17-APR-2023.  Subject was a 1 year old female with history of recurrent viral illnesses this past year including Respiratory Syncytial Virtus but no prior hospitalization. They presented with a 2 day history of cough and fever preceded by runny nose for a few days prior to onset of cough. Treated with tylenol for fevers. Subject was nursing frequently, but otherwise with decrease appetite, emesis couple times with coughing. Mom noted some increased work of breathing and checked sats with owlette at home with sats in the low 80's prompting visit to the Emergency room (ER) on 4/2/23. In the ER, was initially noted to be setting fine on room air, but upon falling asleep dropped to mid 80's. Albuterol nebulizer was administered but no significant response as no wheezing was noted. Subject was admitted to pediatrics for observation. Event clinical details noted above. Event diagnosis was hypoxia. Concurrent conditions viral upper respiratory infection and bacterial pneumonia. Concomitant medications included oxygen, rocephin, and amoxicillin. Subject was admitted to hospital on 4/2/23 and discharged on 4/3/23  Follow-up information received on 24-Apr-2023 and 01-May-2023. Summary of changes: Narrative updated.  Follow-up information received on 10-MAY-2023 and 16-MAY-2023. Summary of changes: Treatment medications (Oxygen, Rocephin, Amoxicillin), narrative, hospitalization dates were updated.  Follow-up information received on 17-MAY-2023. Summary of changes: Treatment medication (Albuterol) was updated.  Follow-up information received on 20-JUN-2023. Summary of changes: Event term was updated from "hypoxia" to "Pneumonia", Emergency Room Visit ticked.  Follow-up information received on 11-jul-2023. Summary of changes: past medical history added.  Follow-up information received on 23-AUG-2023. Summary of changes: Treatment medication end date was updated (Rocephin).  Follow up information received on 13Sep2023. Summary of changes: Indication updated for Amoxicillin hypoxia to pneumonia.  Follow up information received on 30-Oct-2023. Summary of changes: Historical condition of viral upper respiratory tract infection (with cough) added.  Follow up information received on 13-FEB-2024. Summary of changes: general narrative updated.  Follow-up information received on 22-AUG-2024 Summary of changes: Dose, unit for treatment drug Amoxicillin was updated.  Follow up information received on: 20-NOV-2024 Summary of changes: Dose and unit for treatment drug Albuterol was updated.  Follow up information received on: 06-JAN-2025 Summary of changes: Dose for treatment drug Albuterol was updated from 0.0 to Unknown  Upon internal review the case was updated on 08-JAN-2025, The action taken with Prevnar vaccine was changes from not applicable to no change.  Follow up information received on: 14-JAN-2025  Summary of changes: General narrative comments updated, Event start date updated, Relevant medical condition Viral Upper Respiratory Infection with cough start date updated, Event term updated from Pneumonia to Bacterial pneumonia, TTO updated.; Sender's Comments: A case of Pneumonia bacterial, 158 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of Prevnar 13, 3rd dose of DTPa-HBV-IPV ,the 3rd dose of Hiberix, and 253 days after receiving 2nd dose of Rotarix lyophilized formulation, in 12-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility and alternative risk factor (h/o upper respiratory tract infection, respiratory syncytial virus infection ).