Sex: F
Vaccine: MMR
Symptoms: Administration site erythema, Administration site swelling, Drooling, Dyspnoea, Grunting
Clinical narrative: following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; following the intramuscular administration, the infant was immediately fussy, having labored breathing, grunting, breathing fast, mild drooling and lower lip swelling about double the size; Redness and swelling at the site of administration; Redness and swelling at the site of administration; This spontaneous report was received from a healthcare business professional (HBP) and refers to an 18-month-old female patient.  Information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was not provided.  On 28-FEB-2024, the child was vaccinated with measles (+) mumps (+) rubella (WISTAR RA 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection administered intramuscularly with lot # X014243 and expiration date 16-MAY-2025 as prophylaxis (strength, dose, and vaccination scheme frequency were not provided).  Following the intramuscular administration of measles (+) mumps (+) rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) on that day, the infant was immediately fussy (irritability), having labored breathing (dyspnoea), grunting, breathing fast (tachypnoea), mild drooling (drooling), and lower lip swelling about double the size (lip swelling). The HBP stated that the child's lungs were clear at all times, and that there was redness and swelling at the site of administration (vaccination site swelling, vaccination site joint erythema). As a result, epinephrine was administered intramuscularly, and 5 milliliters of dyphenydramine (BENADRYL) was given orally in the office as treatment; and within 3 to 4 minutes the swelling went down, grunting stopped, the infant became calm, and the administration site reaction improved. Then, she was taken via rescue to the emergency room, and was discharged later that evening. The plan of care was for this patient to be followed up with an immunologist. At the time of this report, the outcome of all the adverse events was unknown.   The causal relationship between all the events was considered as related to measles (+) mumps (+) rubella (WISTAR RA 27-3) virus vaccine, live (M-M-R II) (also reported as an 18 month-old had an adverse reaction to measles [+] mumps [+] rubella [WISTAR RA 27-3] virus vaccine, live [M-M-R II]).  Upon internal review, the adverse events of labored breathing (dyspnea) and lower lip swelling about double the size (Lip swelling) were considered medically significant.