Age: 5.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Condition aggravated, Seasonal allergy, Urticaria
Clinical narrative: urticaria on his arms; hives turned and got much worse on his face, trunk, arms and legs; seasonal allergic rhinitis due to pollen and drug allergies; Initial information received on 02-Dec-2021 regarding an unsolicited valid serious case received from an other health professional.  This case involves a 7 years old male patient (height: 127 cm and weight: 23 kg) who had hives and urticaria on his arms (urticaria), hives turned and got much worse on his face, trunk, arms and legs (condition aggravated) and seasonal allergic rhinitis due to pollen and drug allergies (seasonal allergy) after receiving INFLUENZA VACCINE and COVID-19 VACCINE MRNA.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included SALBUTAMOL (PROVENTIL [SALBUTAMOL]).  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.   At the time of the event, the patient had ongoing Reactive airways disease on 06-NOV-2019 and Drug allergy with amoxicillin and cefdinir. the amoxicillin says serum sickness and the reaction is hives and the reaction to cefdinir is a rash.  The patient is using inhalers and it is originally reported that he has asthma because she sees that there is an asthma action plan in his chart. He is using the ProAir Proventil inhaler. Caller later clarifies that the patient does not have asthma, he has reactive airway disease. Inquired for the ProAir Proventil Inhaler start date and dosage and caller did not provide these when requested. During the vaccine supplemental form caller provided that the patients mother reported that his arm was sore from the COVID vaccine.  On 06-Nov-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot UT7336NA and expiration date not provided) via unknown route in the left deltoid and On 05-Nov-2021, he also received a dose of the same vaccine with same lot via unknown route in the left deltoid for prophylactic vaccination.  On 26-Nov-2021, the patient received a first dose of suspect COVID-19 VACCINE MRNA not produced by Sanofi Pasteur (lot FK5127 and expiration date 31-Jan-2022) via unknown route in unknown administration site for prophylactic vaccination.  On 26-Nov-2021, the patient developed a serious hives, urticaria on his arms (urticaria), hives turned and got much worse on his face, trunk, arms and legs (condition aggravated) and seasonal allergic rhinitis due to pollen and drug allergies (seasonal allergy), 2 years 20 from the first dose and 21 days from the last dose following the administration of INFLUENZA VACCINE and on the same day following the administration of COVID-19 VACCINE MRNA.   This events were assessed as medically significant.  It was unknown if the patient experienced any additional symptoms/events.  It was reported that, at the time of administration (Covid 19 vaccine) the liquid leaked outside of the syringe and onto his arm and then onto the floor. They are not sure if the patient received the full dose of the vaccine or not. The transfer agent has already gave the information that the caller needed in regard to revaccination.  No laboratory data reported.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives. turned and got much worse on his face, trunk, arms and legs then the mother gave him antihistamines and took him to the emergency room at that time. It all improved with antihistamines and there were no systemic issues present. 11. He has multiple aero.  At time of reporting, the outcome was not resolved for the event urticaria, resolving for the event condition aggravated and unknown for the event seasonal allergy.; Sender's Comments: This case concerns a 07-year-old male patient who had urticaria, condition aggravated and seasonal allergy after vaccination with INFLUENZA VACCINE and COVID-19 VACCINE MRNA. Concomitant medications included SALBUTAMOL (PROVENTIL [SALBUTAMOL]). At the time of the event, the patient had ongoing Reactive airways disease on 06-NOV-2019 and Drug allergy with amoxicillin and cefdinir. the amoxicillin says serum sickness and the reaction is hives and the reaction to cefdinir is a rash. The time to onset is compatible. However, relevant laboratory data were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.