Age: 7.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Device connection issue, Seasonal allergy, Underdose, Urticaria
Clinical narrative: hives and urticaria on his arms (urticaria); seasonal allergic rhinitis due to pollen and drug allergies; hives turned and got much worse on his face, trunk, arms and legs; 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; e 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; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives and urticaria on his arms (urticaria)), SEASONAL ALLERGY (seasonal allergic rhinitis due to pollen and drug allergies) and CONDITION AGGRAVATED (hives turned and got much worse on his face, trunk, arms and legs) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. FK5127) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic.    Previously administered products included for Drug use for unknown indication: cefdinir and amoxicillin allergy (and the reaction is hives). Past adverse reactions to the above products included Rash with cefdinir; and Serum sickness with amoxicillin allergy. Concurrent medical conditions included Bronchial hyperreactivity since 06-Nov-2019, Reactive airways disease since 06-Nov-2019 and Asthma (He is using the ProAir Proventil inhaler). Concomitant products included SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.   On 06-Nov-2019, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 05-Nov-2021, received dose of INFLUENZA VACCINE (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives and urticaria on his arms (urticaria)), SEASONAL ALLERGY (seasonal allergic rhinitis due to pollen and drug allergies) (seriousness criterion medically significant), CONDITION AGGRAVATED (hives turned and got much worse on his face, trunk, arms and legs) (seriousness criterion medically significant), DEVICE CONNECTION ISSUE (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) and UNDERDOSE (e 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 patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives and urticaria on his arms (urticaria)) had not resolved, SEASONAL ALLERGY (seasonal allergic rhinitis due to pollen and drug allergies), DEVICE CONNECTION ISSUE (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) and UNDERDOSE (e 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) outcome was unknown and CONDITION AGGRAVATED (hives turned and got much worse on his face, trunk, arms and legs) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in  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. Company comment  This spontaneous case reported by a Health Care Professional, concerns a 7 year old male child, , with relevant concurrent illness of Bronchial hyperreactivity, Reactive airways disease and Asthma, who  experienced the unexpected, serious (medically significant) events of URTICARIA (hives and urticaria on his arms (urticaria)), SEASONAL ALLERGY (seasonal allergic rhinitis due to pollen and drug allergies) and CONDITION AGGRAVATED (hives turned and got much worse on his face, trunk, arms and legs)  unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. It was reported that the vaccine liquid leaked outside of the syringe and onto his arm and then onto the floor. They were not sure if the patient received the full dose of the vaccine or not. Previous adverse reactions of the patient included Rash with cefdinir; and Serum sickness with amoxicillin. Patient had previously received 2 doses with Influenza vaccines with the last dose given about 20 days prior to receiving Moderna vaccine, which are all confounders to the events.  The patient was treated with Diphenhydramine hydrochloride for Hives. No further clinical information on other comorbidities, labs, diagnostics, were reported. The event urticaria had not resolved, condition aggravated was resolving and outcome of Seasonal allergy was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a Health Care Professional, concerns a 7 year old male child, , with relevant concurrent illness of Bronchial hyperreactivity, Reactive airways disease and Asthma, who  experienced the unexpected, serious (medically significant) events of URTICARIA (hives and urticaria on his arms (urticaria)), SEASONAL ALLERGY (seasonal allergic rhinitis due to pollen and drug allergies) and CONDITION AGGRAVATED (hives turned and got much worse on his face, trunk, arms and legs)  unknown days after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events. It was reported that the vaccine liquid leaked outside of the syringe and onto his arm and then onto the floor. They were not sure if the patient received the full dose of the vaccine or not. Previous adverse reactions of the patient included Rash with cefdinir; and Serum sickness with amoxicillin. Patient had previously received 2 doses with Influenza vaccines with the last dose given about 20 days prior to receiving Moderna vaccine, which are all confounders to the events.  The patient was treated with Diphenhydramine hydrochloride for Hives. No further clinical information on other comorbidities, labs, diagnostics, were reported. The event urticaria had not resolved, condition aggravated was resolving and outcome of Seasonal allergy was unknown. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.