Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Ear infection, Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Revaccination with different COVID-19 vaccine; interchange of vaccine products; Ear infection; Ear drainage; COVID-19; Patient received dose 1 on 15-Apr-2020 and dose 2 on 15-Jun-2020; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection), OTORRHOEA (Ear drainage), COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 15-Apr-2020 and dose 2 on 15-Jun-2020) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    No Medical History information was reported.   On 15-Apr-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient received third dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate free. On 15-Jun-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 15-Apr-2020 and dose 2 on 15-Jun-2020). In July 2022, the patient experienced EAR INFECTION (Ear infection), OTORRHOEA (Ear drainage) and COVID-19 (COVID-19). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, EAR INFECTION (Ear infection), OTORRHOEA (Ear drainage) and COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 15-Apr-2020 and dose 2 on 15-Jun-2020), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            No concomitant medications was reported.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of COVID-19, Ear infection and Ear drainage with Humira was not provided and with Janssen COVID-19 vaccine was reported as probable.  No treatment medications was reported. Company Comment:    This is an spontaneous case concerning a 20-years-old male patient with medical history of Co-suspect products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis who experienced the unexpected AESI of COVID-19, and the unexpected events of Ear infection and otorrhoea  unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received a dose of Janssen covid-19 vaccine, and the 2 first doses of Moderna one in an inappropriate schedule, Revaccination with different COVID-19 vaccine,  interchange of vaccine products and inappropriate schedule of product administration events were noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment:    This is an spontaneous case concerning a 20-years-old male patient with medical history of Co-suspect products ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis who experienced the unexpected AESI of COVID-19, and the unexpected events of Ear infection and otorrhoea  unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received a dose of Janssen covid-19 vaccine, and the 2 first doses of Moderna one in an inappropriate schedule, Revaccination with different COVID-19 vaccine,  interchange of vaccine products and inappropriate schedule of product administration events were noted in the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.