Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RL |
| MMR | MEASLES + MUMPS + RUBELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / RA |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 1 | UNK | IM / LL |
| VARCEL | VARICELLA (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | SC / LA |
acute bronchiolitis due to other specified organisms; community acquired pneumonia of left upper lobe of lung; acute respiratory failure due to bronchiolits; This 11-month-old female subject was enrolled in a blinded study titled A Phase 3a, observer-blind, randomized, controlled study to evaluate the safety of an investigational varicella vaccine compared with Varivax, administered as a first dose to healthy children 12 to 15 months of age. The subject received the 1st dose of Varicella VNS vs Varivax (subcutaneous, left deltoid) on 23-APR-2025 11:52, for prophylaxis. The subject received the 1st dose of MMR vaccine (subcutaneous, right deltoid) .5 ml on 23-APR-2025 11:52, for prophylaxis. The subject received the 1st dose of Hepatitis A vaccine (intramuscular, right thigh) .5 ml on 23-APR-2025 11:52, for prophylaxis. The subject received the 1st dose of Prevnar 13 (intramuscular, left thigh) .5 ml on 23-APR-2025 11:52, for prophylaxis. On 13-JUN-2025, 51 days after receiving Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13, the subject developed severe - grade 3 acute bronchiolitis (Verbatim: acute bronchiolitis due to other specified organisms). Serious criteria included hospitalization. Additional event(s) included severe - grade 3 community acquired pneumonia (Verbatim: community acquired pneumonia of left upper lobe of lung) on 13-JUN-2025 with serious criteria of hospitalization and moderate - grade 2 acute respiratory failure (Verbatim: acute respiratory failure due to bronchiolits) on 13-JUN-2025 with serious criteria of hospitalization. The subject was treated with salbutamol (Albuterol Hfa), amoxicillin, ceftriaxone and paracetamol (Acetaminophen). The outcome of acute bronchiolitis was resolved on 15-JUN-2025. The outcome(s) of the additional event(s) included community acquired pneumonia (resolved on 15-JUN-2025) and acute respiratory failure (resolved on 15-JUN-2025). Relevant Tests: On an unknown date, Chest x-ray showed findings consistent with small airways disease/viral infection or reactive airways disease On an unknown date, Id- rp2 (Biofire Respiratory Panel 2.1) was negative On an unknown date, Chest x-ray showed left suprahilar opacity versus atelectasis. Diagnostic results (reference ranges are provided in parenthesis if available): Body temperature-In JUN-2025 101 F. C-reactive protein-In JUN-2025 0.7. Chest X-ray-In JUN-2025 showed l suprahilar opacity vs atelectasis. Haemoglobin-In JUN-2025 12.6. The investigator considered that there was no reasonable possibility that the acute bronchiolitis, community acquired pneumonia and acute respiratory failure may have been caused by Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. The company considered that there was no reasonable possibility that the acute bronchiolitis, community acquired pneumonia and acute respiratory failure may have been caused by Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13. Additional Information: GSK receipt date: 13-MAR-2026 Subject was ex term, with an unremarkable past medical history, and presented with cough, congestion, and tachypnea for 2 days. Symptoms had started with fever, fussiness, and cough. Yesterday, the subject had developed tachypnea with intercostal retractions and belly breathing. The subject had been using bulb suction with good output. Attempts at per oral Tylenol/Motrin at home yesterday were followed by 2 episodes of emesis. The subject had had decreased per oral intake, with no intake that day and no urine output since the previous evening. There had been no diarrhea, rash, malodorous urine, or hematuria. There had been no apnea, cyanosis, coughing fits, or post tussive emesis. The additional streaky left suprahilar opacity likely represented atelectasis, although pneumonia was not excluded radiographically. Hospital course at discharge: Cardiovascular The subject had remained hemodynamically stable and had not required any intravenous pressor support. Resp. The subject was initially started on nasal CPAP pressure support upon admission to the pediatric intensive care unit and was weaned to room air on 6/15. The subject was treated with albuterol and hypertonic saline to assist in pulmonary clearance. The subject did not require steroids. The subject was discharged to continue albuterol for 24 hours, then as needed. The subject had no atopy. Renal. The subject had maintained adequate urine output throughout the hospitalization and had received intravenous hydration. Fluids, Electrolytes, Nutrition. The subject was initially made NPO on intravenous fluids and was subsequently advanced to a regular diet as tolerated. The subject tolerated a regular diet at the time of discharge and did not have any significant electrolyte abnormalities. Hematology and Oncology. The subject did not require any blood transfusions. The subject was started on CRO antibiotics to cover any concern for bacterial pneumonia. She was discharged on high dose amoxicillin to complete a 5 day total course. Neuro/Pain/MSK. The subject had required intravenous sedation with Precedex while on positive pressure ventilation, which was weaned off on 14 Jun 2025. Mom reported her being back at baseline neurological status at discharge running in the room and smiling.; Sender's Comments: A case of Bronchiolitis, Pneumonia, Acute respiratory failure, 51 days after receiving 1st dose of Varicella VNS vs Varivax, MMR vaccine, Hepatitis A vaccine and Prevnar 13 in a 11-month-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative risk factors (age, infectious diseases).
Test Date: 202506; Test Name: FEVER; Result Unstructured Data: (Test Result:101 F,Unit:unknown,Normal Low:,Normal High:); Test Date: 202506; Test Name: Chest X-Ray; Result Unstructured Data: (Test Result:showed l suprahilar opacity vs atelectasis,Unit:unknown,Normal Low:,Normal High:); Test Date: 202506; Test Name: crp; Result Unstructured Data: (Test Result:0.7,Unit:unknown,Normal Low:,Normal High:); Test Date: 202506; Test Name: hgb; Result Unstructured Data: (Test Result:12.6,Unit:unknown,Normal Low:,Normal High:); Comments: On an unknown date, Chest x-ray showed findings consistent with small airways disease/viral infection or reactive airways disease On an unknown date, Id- rp2 (Biofire Respiratory Panel 2.1) was negative On an unknown date, Chest x-ray showed left suprahilar opacity versus atelectasis