Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
Respiratory Syncytial Virus bronchiolitis; This 4-month-old female subject was enrolled in a blinded study. The subject received the 2nd dose of Bexsero vs Placebo (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Prevnar 13 (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of DTPa-HBV-IPV (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Hiberix (intramuscular) on 4th December 2018, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 4th December 2018, for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis. On 30th December 2018, 26 days after receiving Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed moderate - grade 2 respiratory syncytial virus bronchiolitis. Serious criteria included hospitalization. The subject was treated with electrolytes nos + glucose (Pedialyte), 5% dextrose + potassium chloride + 0.9% sodium chloride iv, phenylephrine, ondansetron, albuterol and sodium chloride. Bexsero vs Placebo was continued with no change. The outcome of respiratory syncytial virus bronchiolitis was recovered/resolved on 10th January 2019. 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. Diagnostic results (unless otherwise stated, normal values were not provided): On 1st January 2019, Respiratory syncytial virus test result was Positive for RSV (normal high: negative). On 2nd January 2019, Blood calcium result was 9.3 mg/dL (normal low: 8.00, normal high: 10.50), Blood chloride result was 106 mmol/L (normal low: 97.00, normal high: 108.00), Blood creatine result was 0.3 mg/dL (normal low: 0.10, normal high: 0.40), Blood potassium result was 4.9 mmol/L (normal low: 3.50, normal high: 5.80), Blood sodium result was 137 mmol/L (normal low: 130.00, normal high: 145.00), Blood urea result was 10 mg/dL (normal low: 6.00, normal high: 17.00) and Carbon dioxide result was 25.0 mmol/L (normal low: 15.00, normal high: 28.00). In January 2019, Blood glucose result was 93 mg/dL (normal low: 54, normal high: 117). GSK Receipt Date: 02-JAN-2019 Subject presented to emergency room on 01Jan2019 with complaint of nasal congestion, cough, poor oral intake and less wet diapers starting 30Dec2018. Complaint of wheezing with start date of 01Jan2019. Mom states vomiting as well after cough. Subject positive for RSV. Subject received deep suctioning, Zofran, and Pedialyte in emergency room. Subject received albuterol treatment with no improvement. Subject admitted for observation, suctioning, and IV hydration. Subject was discharged from hospital on 02Jan2019. Subject is still ill per parent report on 03Jan2019 continuing Pedialyte and phenylephrine nose drops at home. 01Feb2019 mom reports all symptoms resolved as of 10Jan2019. On 07 Mar 2019, investigator confirmed that 'Respiratory Syncytial Virus bronchiolitis' is not an AESI. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of respiratory syncytial virus bronchiolitis, 26 days after receiving 2nd dose of Bexsero vs Placebo co-administered with PCV and routine vaccines, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device injection syringe, Hiberix and Rotarix lyophilized formulation with rotavirus vaccine oral applicator device in a 4-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Test Date: 20190102; Test Name: Calcium; Test Result: 9.3 mg/dl; Test Date: 20190102; Test Name: Chloride; Result Unstructured Data: (Test Result:106,Unit:mmol/L,Normal Low:97.00,Normal High:108.00); Test Date: 20190102; Test Name: Creatine; Test Result: 0.3 mg/dl; Test Date: 201901; Test Name: random glucose; Test Result: 93 mg/dl; Test Date: 20190102; Test Name: Potassium; Result Unstructured Data: (Test Result:4.9,Unit:mmol/L,Normal Low:3.50,Normal High:5.80); Test Date: 20190102; Test Name: Sodium; Result Unstructured Data: (Test Result:137,Unit:mmol/L,Normal Low:130.00,Normal High:145.00); Test Date: 20190102; Test Name: Blood urea nitrogen; Test Result: 10 mg/dl; Test Date: 20190102; Test Name: Carbon dioxide; Result Unstructured Data: (Test Result:25.0,Unit:mmol/L,Normal Low:15.00,Normal High:28.00); Test Date: 20190101; Test Name: RSV EIA; Result Unstructured Data: (Test Result:Positive for RSV,Unit:unknown,Normal Low:,Normal High:negative)