Age: 4.0
Sex: M
Vaccine: FLUN4, MMR, UNK, VARCEL
Symptoms: Cough, Crying, Heart rate increased, Influenza A virus test positive, Influenza B virus test positive
Clinical narrative: PATIENT WAS TESTED AND IT CAME BACK POSITIVE FOR BOTH INFLUENZA A; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; PATIENT WAS TESTED AND IT CAME BACK POSITIVE FOR BOTH INFLUENZA B; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; CRYING; PULSE 170; A spontaneous report has been received from a health professional concerning a 4-year-old male patient ethnic origin (height 104 cm, weight 16 kg).    No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown. No concomitant products were reported.    On 07-Nov-2022 the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number: PJ3267) (expiration date: 26-Dec-2022) 0.2 ml once/single administration, via nasal route. The patient started treatment with Mmr (measles vaccine, mumps vaccine, rubella vaccine) 0.5 mL once/single administration, subcutaneous, with Varicella Vaccine (varicella zoster vaccine) 0.5 mL once/single administration, subcutaneous, and with Dtap/ipv (diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid) 0.5 mL.    A Health Professional administered Flumist Quadrivalent. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. Patient was tested and it came back positive for both influenza a (preferred term: Influenza A virus test positive) and for influenza b (preferred term: Influenza B virus test positive). On an unknown date, the patient experienced sore throat, a fever, crying (preferred term: Crying) and pulse 170 (preferred term: Heart rate increased).    The outcome of the events of patient was tested and it came back positive for both influenza a, patient was tested and it came back positive for both influenza b, crying and pulse 170 was unknown.    The company physician suggested not to capture sore throat, a fever and a cough as events.     The company physician suggested to updated the events verbatims patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a and positive for influenza b to be patient was tested and it came back positive for both influenza a and b and split the event as patient was tested and it came back positive for both influenza a and patient was tested and it came back positive for both influenza b.    The events of patient was tested and it came back positive for both influenza a and patient was tested and it came back positive for both influenza b were upgraded by the company physician from non-serious to serious due to important medical event criterion.     The company physician assessed the events crying and pulse 170 as non-serious.     The company physician suggested to upgrade the product role of MMR, Varicella vaccine and DTAP/IPV to suspect.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Follow-up information received by AstraZeneca/MedImmune 14-Dec-2022 upgraded this case to expeditable from Health professional via spontaneous source: New non-serious events Crying and Pulse 170. The events verbatims patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a and positive for influenza b were updated as patient was tested and it came back positive for both influenza a and b and split the event as patient was tested and it came back positive for both influenza a and patient was tested and it came back positive for both influenza b and seriousness criteria of important medical event was added for both events. Case seriousness upgraded. Flumist start and stop date added. Lot number and expiration date added. New suspect vaccines added. Patient demographics added. New lab data added. HCP ID added. Narrative updated. Minor correction on 19-Dec-2022: Parent reporter added. Narrative amended.; Sender's Comments: Influenza A virus test positive and Influenza B virus test positive are not listed in the company core data sheet of Q/LAIV. Due to limited information on the onset date and outcome of the events, underlying co-morbidities, past medical history, concomitant medications, risk factors (exposure to cold, humid, crowded environment), pulmonary work up, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the events and Q/LAIV.