Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, RV1, UNK, VARCEL
Symptoms: Chest X-ray normal, Cough, Croup infectious, Dyspnoea, Full blood count normal
Clinical narrative: Influenza A; This 20-month-old male subject was enrolled in a Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine when Administered Concomitantly with Routine Vaccines to Healthy Infants. The subject received the 4th dose of Bexsero vs Placebo (intramuscular) on 16-JUL-2019, for prophylaxis. The subject received the 4th dose of DTPa-HBV-IPV (intramuscular) on 16-JUL-2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (intramuscular) on 17-OCT-2018, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 21-DEC-2018, for prophylaxis. The subject received the 1st dose of M-M-R II (intramuscular) on 16-JUL-2019, for prophylaxis. The subject received the 1st dose of Varivax (intramuscular) on 16-JUL-2019, for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylaxis.   Concomitant products included montelukast sodium (Singulair).   On 07-MAR-2020, 235 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, M-M-R II and Varivax, 507 days after receiving Rotarix lyophilized formulation and 442 days after receiving Hiberix, the subject developed severe - grade 3 influenza a virus infection (Verbatim: Influenza A). Serious criteria included hospitalization. The subject was treated with cetirizine hydrochloride (Zyrtec), amoxicillin, salbutamol (Albuterol), prednisolone, oseltamivir phosphate (Tamiflu) and paracetamol (Tylenol). The outcome of influenza a virus infection was resolved on 20-MAR-2020.   Relevant Tests: On 07-MAR-2020 RSV test performed result showed negative. On 11-MAR-2020 RSV test performed result showed negative. On 15-MAR-2020 Chest x-ray showed negative. On 15-MAR-2020 CBC showed negative. On 15-MAR-2020 Flu A showed Positive..   The investigator considered that there was no reasonable possibility that the influenza a virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax. Other possible cause(s) of the influenza a virus infection 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 influenza a virus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix, M-M-R II and Varivax.   Linked case(s) involving the same subject:  US2019200424   GSK Receipt Date: 17-MAR-2020, 24-MAR-2020, 30-MAR-2020, 02-APR-2020, 08-APR-2020, 24-APR-2020, 27-APR-2020, 28-OCT-2020, 12-NOV-2020, 14-DEC-2020, 08-APR-2021, 22-APR-2021, 26-APR-2021, 04-MAY-2021.  Subject admitted for Respiratory Failure. Mom stated the subject began having shortness of breath on 15Mar2020 at 9:00 a.m. She treated with Albuterol.  subject did not improve so she took him to the hospital.  The subject was admitted that night. subject was positive for Flu A.  subject was discharged 19Mar2020. Prior to admission, the subject was seen by the Primary care physician on 07Mar2020 and diagnosed with acute obstructive laryngitis (croup) and cough.  Also complained of fever, vomiting and difficulty breathing.  subject was prescribed Prednisolone and Amoxicillin.  subject was seen by Primary care physician on 11Mar2020 for cough, fever, nasal congestion, shortness of breath and wheezing. subject was continuing the Amoxicillin. The PI reviewed the medical record and determined that the SAE term should be Influenza A and not respiratory distress.  The respiratory distress was caused by the Influenza A.   Follow-up information received on 30-DEC-2024, 31-DEC-2024 Summary of changes: Dose, unit, frequency for medication Singulair, Zyrtec were updated, drug name for Albuterol 0.083 percent was updated and narrative updated.; Sender's Comments: A case of influenza, 235 days after receiving the 4th dose of Bexsero vs Placebo, the 4th dose of DTPa-HBV-IPV, 1st dose of M-M-R II and the 1st dose of Varivax, 442 days after receiving the 3rd dose of Hiberix and 507 days after receiving the 2nd dose of Rotarix lyophilized formulation , in a 20-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology (On 15-MAR-2020 Flu A showed Positive). US-GLAXOSMITHKLINE-US2019200424: