Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LL |
fever; Rhinovirus; This 2-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo co-administered with PCV and routine vaccines (intramuscular) on 24th September 2018, for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix), Hib (Hiberix), Rota (Rotarix) and PNEUMOCOCCAL VACCINE (PREVNAR 13) for prophylaxis. The subject's past medical history included acute upper respiratory tract infection. On 26th September 2018, 2 days after receiving Bexsero vs Placebo co-administered with PCV and routine vaccines, the subject developed mild - grade 1 fever. Serious criteria included hospitalization. Additional event(s) included mild - grade 1 rhinovirus infection on 26th September 2018 with serious criteria of hospitalization. The subject was treated with PARACETAMOL (TYLENOL). Bexsero vs Placebo co-administered with PCV and routine vaccines was continued with no change. The outcome of fever was recovered/resolved on 27th September 2018. The outcome(s) of the additional event(s) included rhinovirus infection (recovered/resolved on 9th October 2018). The investigator considered that there was a reasonable possibility that the fever may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. The investigator considered that there was no reasonable possibility that the rhinovirus infection may have been caused by Bexsero vs Placebo co-administered with PCV and routine vaccines. Other possible causes of the fever included pediarix and hiberix. Relevant Tests: On 27Sep2018, Respiratory Panel collected and result was positive for Rhinovirus On 27Sep2018, Chemistry panel collected and result was normal On an unknown date in Sep2018 nasal swab result was positive for rhinovirus. Diagnostic results (unless otherwise stated, normal values were not provided): In September 2018, Body temperature result was 102 degree F and Body temperature result was 99 degree F. Investigator Text: Developed fever of 102 given Tylenol and came down to 99, Emergency room with labs, failed attempt at lumbar puncture, nasal swab positive for rhinovirus. Elected observation overnight. No further fever and no medication given. Admission: 9/27/18 00:38 Discharge: 9/27/18 15:12. Additional information received on 01Oct2018: Fever in 66 day old was principal reason for the admission and may have been from vaccine or from rhinovirus which was positive on testing. Additional details: On 26 Sep 2018, 2 days after receiving 1st dose of Pediarix (GSK product, taken as prophylaxis), Hiberix (GSK product, taken as prophylaxis), Rotarix (GSK product, taken as prophylaxis), and PREVNAR 13 (non GSK product, taken as prophylaxis), the subject experienced Fever. The investigator considered that there was a reasonable possibility that the fever may also have been caused by Pediarix and Hiberix. The investigator considered that there was no reasonable possibility that the fever may have been caused by Rotarix and Prevenar 13. Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of Pyrexia and Rhinovirus infection , 2 days after receiving 1st dose of Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Rotarix lyophilized formulation and Prevnar 13 in a 2-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility for Rhinovirus infection and alternative risk factors (Age, h/o acute upper respiratory tract infection, multiple concomitant vaccines).
Medical History/Concurrent Conditions: Acute upper respiratory tract infection
Test Date: 201809; Test Name: Body temperature; Result Unstructured Data: (Test Result:102,Unit:degree F,Normal Low:,Normal High:); Test Date: 201809; Test Name: Body temperature; Result Unstructured Data: (Test Result:99,Unit:degree F,Normal Low:,Normal High:); Comments: On 27Sep2018, Respiratory Panel collected and result was positive for Rhinovirus On 27Sep2018, Chemistry panel collected and result was normal On an unknown date in Sep2018 nasal swab result was positive for rhinovirus.