Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Tested positive for COVID-19 at home test/minor congestion/light cough; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 at home test/minor congestion/light cough), DRUG INEFFECTIVE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: Janssen COVID-19 Vaccine(COVID-19 vaccine AD26.COV2.S)(suspension for injection (Janssen COVID-19 Vaccine(COVID-19 vaccine AD26.COV2.S)(suspension for injection)batch number201A21A) on 08-Apr-2021. Past adverse reactions to the above products included Pain in arm with Janssen COVID-19 Vaccine(COVID-19 vaccine AD26.COV2.S)(suspension for injection.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19 at home test/minor congestion/light cough) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Tested positive for COVID-19 at home test/minor congestion/light cough), DRUG INEFFECTIVE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive and positive (Positive) Positive.         No concomitant medication information was provided. On 17-Jan-2022, the patient experienced minor congestion and light cough and tested positive for COVID-19 at home test. Then patient went to the doctor's office and took a saliva PCR test and received positive result on 19-Jan-2022. No treatment medication was provided.  Company comment-This spontaneous case concerns a 37-year-old male patient with no relevant medical history who experienced the unexpected, non serious AESI event of COVID-19 (SARS-CoV-2 test positive and with clinical symptoms of light cough and mild congestion) approximately 40 days after the booster dose of mRNA-1273. The patient had received initial schedule of vaccination with Janssen COVID-19 Vaccine (interchange of vaccine products) approximately 9 months before the event. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37-year-old male patient with no relevant medical history who experienced the unexpected, non serious AESI event of COVID-19 (SARS-CoV-2 test positive and with clinical symptoms of light cough and mild congestion) approximately 40 days after the booster dose of mRNA-1273. The patient had received initial schedule of vaccination with Janssen COVID-19 Vaccine (interchange of vaccine products) approximately 9 months before the event. The current pandemic situation of COVID 19 may remain as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.