Received Sep 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | OT |
rapidly progressing acute epiglottitis despite being fully vaccinated; rapidly progressing acute epiglottitis despite being fully vaccinated; This spontaneous report was received from the authors above and refers to a(n) 3-year-old patient of unknown gender. On an unknown date, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Oral liquid administered by Oral route (lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient was evaluated in the emergency department (ED) for fever, diarrhea and emesis for 2 days. They were discharged with the diagnosis of gastroenteritis 12 hours later the patient re-presented to the ED with new bilateral neck swelling. On evaluation by ear nose and throat (ENT) the patient was stable on blow by oxygen with mild tachypnea. However, over the next 20 minutes stridor developed. racemic epinephrine was started and beside laryngoscopy was performed which revealed diffuse airway swelling of the uvula, epiglottis and supraglottic structures with near occlusion of the airway (rapidly progressing acute epiglottitis and vaccination failure). The patient was transferred to the operation room (OR) for intubation. A Complete blood count was performed which reveal severe pancytopenia. The patient entered in the OR on a stretcher on 10 liters of oxygen via facemask, sitting in a tripod position. At this time oxygen saturation was 95% with increased breathing, stridor and drooling. At intubation the ENT surgeon encountered a sever swollen epiglottis with complete obstruction of the glottic opening. The patient was paralyzed, mechanically ventilated and transported to UCI. At the reporting time the outcome of the events was not provided. The events were considered to be related with suspect therapy. Upon internal review, the event(s) of rapidly progressing acute epiglottitis despite being fully vaccinated was/were determined to be medically significant.
Gastroenteritis
Test Name: laryngoscopy; Result Unstructured Data: diffuse airway swelling of the uvula, epiglottis, and supraglottic structures with near occlusion of the airway.; Test Name: CBC; Result Unstructured Data: severe pancytopenia; Test Name: Oxygen saturation; Test Result: 95 %