Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Pyrexia, Respiratory distress, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Viral Bronchiolitis; This 9-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 08-JUL-2020, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 08-JUL-2020, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 08-JUL-2020, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 11-MAY-2020, for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis.   On 14-OCT-2020, 98 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV and Hiberix and 156 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 bronchiolitis (Verbatim: Viral Bronchiolitis). Serious criteria included hospitalization. The subject was treated with salbutamol (Albuterol), fluticasone, sodium chloride, ipratropium, calcium chloride;potassium chloride;sodium lactate (Lactated Ringers) and dexamethasone. Bexsero vs Placebo was continued with no change. The outcome of bronchiolitis was resolved on 19-NOV-2020.   Relevant Tests: On 28OCT2020 Chest x-ray shows right mild-lung opacity may represent focus on infection On 28-OCT-2020 C-Reactive protein showed 0.1 mg/dL On 28-OCT-2020 Influenza virus A and Influenza virus B results were not detected On 28-OCT-2020 respiratory syncytial virus results were not detected. On 28-OCT-2020 normal Covid-19 showed negative On 28-OCT-2020 white blood count showed 13.2 K/uL (not elevated, no fever).   The investigator considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation. Other possible cause(s) of the bronchiolitis included DTPa-HBV-IPV vaccine PRE-FILLED SYRINGE DEVICE and Rotavirus vaccine ORAL APPLICATOR DEVICE.   The company considered that there was no reasonable possibility that the bronchiolitis may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation.   9-month male who presents with 2weeks of intermittent dry cough and increased wheezing an fussiness on 10/28/20. His symptoms started 2 weeks ago, when he had a 101F fever at home, for which he was given Tylenol. Since then, he hasn't had any fevers. He has had on and off cough, up to 2days without cough. He had been going to daycare throughout this time and the playground starting a week ago. On 10/28/20, during daycare, he had sudden onset of wheezing and fussiness. He was saturating high 80 percent to low 90 percent on arrival to ED (Emergency Department), with audible wheezing, retraction, tachypnea. He was placed on IV fluids and given duo nebs, which improved his work of breathing for 1hr but worsened again. He was given Decadron PO x1. Started on 5mg/hr continuous albuterol and supplemental O2. Admitted for respiratory support and IV hydration. Chest x-ray has questionable infiltrate but no elevated WBC, fever or C-reactive protein elevation. Consider less likely. Back infections seem possible and is often seen at this age group. Subject responded well to albuterol and improved overnight on continuous Albuterol and High flow humidified nasal cannula of 6L. Early morning on 10/29/20, rapid response called for tachypnea of 50-60s, tachycardia to 201, still on continuous nebulizers but was well appearing. Albuterol changed to every 4 hours to reduce tachycardia. Subject given one more dose of Decadron on 10/29/20. Subject was discharged on albuterol nebulizer on 10/30/20.   Follow-up information received on 20-SEP-2022. This follow-up was considered non-significant. Summary of changes: Treatment medication updated.  Follow-up information received on 07-NOV-2022. Summary of changes: Frequency updated for treatment medication ALBUTEROL 2.5 MG/0.5ML NEBULIZER 1.25MG, SODIUM CHLORIDE 0.9 percent 3mL FLUSH  Follow-up information received on 13-Apr-2023, Summary of change: Treatment medications are updated.  Follow-up information received on 08-JUN-2023  Summary of changes: Treatment medication ALBUTEROL 2.5MG/ML NEBULIZER 1.25 MG frequency updated.  Follow-up information received on 20-DEC-2024 Subject received treatment medication D5-NACL 0.9 percent IV PREMIX from 28/Oct/2020 to 28/Oct/2020 in dose of 40 ml/hr Continuous infusion by route intravenous for medical indication Respiratory Distress Summary of changes: Event Respiratory distress of child was deleted and narrative were updated.; Sender's Comments: A case of bronchiolitis, 98 days after receiving 3rd dose of Bexsero vs Placebo, 3rd dose of DTPa-HBV-IPV with DTPa-HBV-IPV vaccine pre-filled syringe device injection syringe , Prevnar 13 and 1st dose of Hiberix and 156 days after receiving 2nd dose of Rotarix lyophilized formulation with Rotarix vaccine Oral Applicator Device, in a 9-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.