Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, DTAPHEPBIP, MMR
Symptoms: Lethargy, Rash erythematous, Stridor
Clinical narrative: Widespread red rash; Stridor; hives; Lethargic with pulse ox 95%; congestion; This spontaneous report was received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with sterile diluent (both strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis.  On an unknown date, the patient had reactions of hives and congestion (ill-defined disorder) after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered. The patient was treated with unspecified medication. The outcome of hives and ill-defined disorder was unknown.  The causality assessment between the events and the suspect vaccine was unknown.  Follow up information has been received from vaccine provider on 26-OCT-2021.  The patient was a 4-year-old female. Concomitant medications, pre-existing allergies, birth defects or medical conditions were reported; however, source document was illegible. She weighed 3.44 kg at the time of birth.  On 21-SEP-2021, she was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (dosage regimen was not provided) lot# S039312, expiration date 04-DEC-2021, administered subcutaneously (SQ); and with the third dose of diphtheria vaccine toxoid (+) hepatitis B vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) (dosage regimen not provided) lot# TP243, expiration date 08-APR-2023, administered intramuscularly (IM) as prophylaxis. Both vaccines were given as single use vaccines per healthcare professional according to the instruction leaflet and who was reported as trained; however, vaccines were not available for return as were discarded after usage. The vaccines did not experience any temperature excursion resulted of a digital data logger reading.  On that day, she presented with widespread red rash, stridor with pulse oximetry at 95% and lethargic after vaccinated with aforementioned suspect vaccines. Therefore, she was given epinephrine (EPIPEN) 0.15 mg, IM; albuterol sulfate 3mL via nebulizer; diphenhydramine hydrochloride 5mL via G-tube; and dexamethasone 7mL via G-tube. Later that day, she recovered from the events of stridor, hives, and lethargic. Moreover, she was taken by emergency medical services (EMS) to the hospital and was hospitalized on an unknown date in September 2021, due to the events. Other treatment administered to the patient included the following: sodium chloride, acetaminophen, budesonide, cetyl alcohol (+) propylene glycol (+) sodium lauryl sulfate (+) stearic acid (+) tocopheryl acetate (CETAPHIL MOISTURIZING CREAM), ibuprofen, ipratropium bromide, melatonin, nystatin, milk (+) iron (+) DHA (ENFAGROW TODDLER NEXT STEP), and saccharomyces boulardii (FLORASTOR KIDS). At the time of the report, the outcome of rash erythematous was unknown.  The causal relationship between all reported events and the suspect vaccines was unknown.  Upon internal review, the events of stridor, hives, lethargy and rash erythematous were considered as medically significant because all were treated with medications administered by G-tube.