Age: 1.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Anaphylactic reaction, Inappropriate schedule of product administration, Vaccination site rash
Clinical narrative: Anaphylaxis; Inappropriate schedule of vaccine administered; Light rash in the site of the injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 1-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included Hemangioma, Eczema and COVID-19 (Patient got COVID-19 when he was 3 months old at the end of Apr2022.) in April 2022. Previously administered products included for Hemangioma: Timolol (Hemangioma treated with Timolol (beta blocker).); for Eczema: Topical Hydrocortisone (Eczema treated with topical Hydrocortisone as needed.). Past adverse reactions to the above products included No adverse effect with Timolol and Topical Hydrocortisone.   On 18-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced VACCINATION SITE RASH (Light rash in the site of the injection). On 16-Nov-2022, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 19-Aug-2022 at a dose of UNK, Frequency After; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) on 16-Nov-2022 at an unspecified dose and frequency and EPINEPHRINE (EPIPEN [EPINEPHRINE]) on 16-Nov-2022 at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) and VACCINATION SITE RASH (Light rash in the site of the injection) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient's caregiver stated that her son received 3 other vaccines on the same day of 1st dose of Moderna but she did not remembered the names. Patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was assessed if it should be appropriate to go to ER but it was not needed since there was no rebound.   Company Comment:  This spontaneous case concerns a 1-year-old male patient, with medical history of Hemangioma, Eczema and COVID-19 (Patient got COVID-19 when he was 3 months old at the end of Apr2022) and Co-suspect product INFLUENZA VACCINE who experienced the medically significant expected event of anaphylactic reaction, the unexpected event of Inappropriate schedule of product administration event in the context of 2nd.  dose of  mRNA- 1273 vaccine.As the SD information, there were more than 35 days between first two doses, then Inappropriate schedule of vaccine administration was noted in this case. The expected event occurred after the 1st. dose, and the serious event the same day of the second dose.  The patient was treated with BENADRYL and EPINEPHRINE and the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.