Age: 0.33
Sex: M
Vaccine: HIBV, MEN, PNC13, UNK, UNK
Symptoms: Fall, Near drowning, Pulmonary oedema, Small airways disease, Vomiting
Clinical narrative: Near Drowning; This 11-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 12th March 2019, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular) on 14th May 2019, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular) on 14th May 2019, 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 11th October 2019, 150 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Prevnar 13 and 213 days after receiving Rotarix lyophilized formulation, the subject developed severe - grade 3 near drowning. Serious criteria included hospitalization. Bexsero vs Placebo was continued with no change. Prevnar 13 was continued with no change. The outcome of near drowning was recovered/resolved on 11th October 2019.   The investigator considered that there was no reasonable possibility that the near drowning may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Rotarix lyophilized formulation, Hiberix and Prevnar 13.   Relevant Tests: On 11 Oct 2019, Chest X-ray (poster anterior and lateral) done, results showed Hilar and Perihilar changes suggest edema versus small airways disease. No Focal airspace opacities identified.   Diagnostic results (unless otherwise stated, normal values were not provided):  On 11th October 2019, Chest X-ray result was see text.  GSK Receipt Date - 07-NOV-2019  Patient was taking bath with mom and throwing a temper tantrum with crying when she wouldn't give him a cup. He took a deep breath in to cry but at the same time fell forward and inhaled water. Immediately took him out and he seemed not to be able to take a breath. Started drooling water, no cyanosis. Stood him up then put him against her on side and ultimately called 911 but by then was crying. They recommended he still come in to be checked. Vomiting X1. Otherwise usual self but seems like he needs to burp. This occurred at 7pm because on phone with 911 by 7:03 per mom. 12Nov2019-Follow-up response regarding query. Date of hospital admission is 11Oct2019. Date of hospital discharge is 12Oct2019.  Follow up information received on 11-Mar-2025 End of study Unblinding completed.; Sender's Comments: A case of near drowning, 150 days after receiving 3rd doses of Bexsero vs Placebo, Prevnar 13, DTPa-HBV-IPV with dtpa-hbv-ipv vaccine pre-filled syringe device, Hiberix and  213 days after receiving the 2nd dose of Rotarix lyophilized formulation with Rotarix Oral Applicator Device, in a 11-month-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.