Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, UNK
Symptoms: Livedo reticularis, Lower respiratory tract infection, Nasal congestion, Otitis media, Pneumonia
Clinical narrative: Pneumonia; This 3-month-old male subject was enrolled in a blinded study. The subject received the 1st dose of Bexsero vs Placebo (intramuscular, right thigh) on 27-NOV-2018, for prophylaxis. The subject received the 1st dose of DTPa-HBV-IPV (intramuscular, left thigh) on 27-NOV-2018, for prophylaxis. The subject received the 1st dose of Hiberix (intramuscular, right thigh) on 27-NOV-2018, for prophylaxis. The subject received the 1st dose of Rotarix lyophilized formulation (oral) on 27-NOV-2018, for prophylaxis.   Co-suspect products included Prevenar 13 (Non-GSK Comparator) (Prevenar 13) for prophylaxis.   On 28-DEC-2018, 31 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, the subject developed severe - grade 3 pneumonia (Verbatim: Pneumonia). Serious criteria included hospitalization. The subject was treated with lactobacillus reuteri, amoxicillin, paracetamol (Tylenol), ceftriaxone sodium (Rocephin), salbutamol (Albuterol), paracetamol (Acetaminophen) and sodium chloride. The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix, Prevenar 13 and Rotarix lyophilized formulation was no change. The outcome of pneumonia was resolved on 06-JAN-2019.   Relevant Tests: On 31-Dec-2018 Chest X-Ray suspect multifocal infection consider atypical organisms. On 31-Dec-2018 Human Meta Pneumovius virus RNA PCR was positive.  on 31-Dec-2018 Procalcitonin 1.67 mg/ml normal greater than equal to 0.07. c-reactive protein 18.0 mg/dL normal greater than equal to 0.9.Bands 30 percent normal 0-5..   Diagnostic results (reference ranges are provided in parenthesis if available): Blood culture-In DEC-2018 negative. Heart rate- 31-DEC-2018 180s. Oxygen saturation- 31-DEC-2018 89 percent. Respiratory rate- 31-DEC-2018 50s.                                                                                                     The investigator considered that there was no reasonable possibility that the pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix,Prevenar 13 and Rotarix lyophilized formulation.   The company considered that there was no reasonable possibility that the pneumonia may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix ,Prevenar 13 and Rotarix lyophilized formulation.   GSK Receipt date: 07-JAN-2019 Subject with upper respiratory illness symptoms and fever since 28Dec2018. Went to the clinic on 31-Dec-2018, febrile and with oxygen saturation at 89 percent , HR in the 180s, respiratory rate 50s and retracting, was sent to the Emergency Department, started on 1-2L of nasal cannula for respiratory distress.Admitted with multifocal pneumonia and dehydration and hypoxemia. On admission, he appeared moderately dehydrated with prolonged capillary refill and cool mottled extremities but with normal venous blood gas and lactate reassuring against sepsis. He was rehydrated with Pedialyte via nasogastric tube initially due to difficult access, then after intravenous successfully placed was on intravenous fluid. He was started on intravenous ceftriaxone for pneumonia and transitioned to oral amoxicillin. He was weaned down to room air over 2 days and was stable on it by 01-Jan-2019 afternoon.  He was discharged on 02-Jan-2019, afebrile and oxygen saturation on room air greater or equal to 95 percent, capillary refill less than 2 seconds. He was weaned off IV fluids and showed adequate oral intake. He remained congested. On follow-up appointment on 04-Jan-2019 remained afebrile, back to normal temperament, continued with nasal congestion, currently  was with rhonchi and rales at posterior lung field and with right otitis media. Amoxicillin completed on 06-Jan-2019  Follow-up information received on 07-AUG-2024 Medication name was reported as Acetaminophen 98mg in diluent. Subject received Sodium Chloride 0.9% flush from 1/Jan/2019 to 1/Jan/2019 of dose 3 ml once only via intravenous route for indication prophylactic . The subject received D5-NaCl 0.45 percent with KCL 20 meq/L on 31-Dec-2018 to 31-Dec-2018 25.0 ml/hr Continuous infusion intravenous for dehydration. The subject received D5NaCl 0.9 percent  with KCL 20 meq/L 1/Jan/2019 to 2/Jan/2019 5.0 ml Continuous infusion intravenous  for pneumonia. The subject received D5 NaCl 0.9 percent  with KCL 20meq/L 31/Dec/2018 to 1/Jan/2019 25.0 ml/hr Continuous infusion intravenous for pneumonia. Summary of changes: treatment drug (Albuterol Nebulizer, Rocephin, Tylenol) mg/ml to mg, frequency updated, General narrative comment updated.  Follow-up  information received on 22-AUG-2024 Summary of changes: Events Dehydration and Hypoxemia were deleted.  Follow-up information received on 08-NOV-2024 Summary of changes: The indication for the drug  Sodium Chloride 0.9% was updated from pneumonia  to dehydration. The indication for D5 NaCl 0.9% with KCL 20meq/L of dose 25 ml/hr was updated from dehydration to pneumonia.  Follow up information received on 19-DEC-2024 Summary of changes :- The route of administration for Albuterol Nebulizer was updated from other to Inhaled route.  Upon internal review case was updated on 26-DEC-2024 The study drug Hiberix was added in product tab. Action taken for suspect products was updated from not applicable to dose not changed. Indication for medication D5-NaCl 0.45 percent with KCL 20 meq/L was updated from pneumonia to dehydration. Indication for medication D5NaCl 0.9 percent  with KCL 20 meq/L was updated from dehydration to pneumonia. Medication Sodium Chloride 0.9% flush was added in narrative. Follow up liner for 08-NOV-2024 was updated.; Sender's Comments: A case of Pneumonia, 31 days after receiving 1st dose of Bexsero vs Placebo, DTPa-HBV-IPV, Hiberix and Rotarix lyophilized formulation, in a 3-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 (Human Meta Pneumovius virus RNA PCR positive).