Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Cough, Product quality issue, Pyrexia, SARS-CoV-2 test
Clinical narrative: event product quality complaint; fever; cough; revaccination with different Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), COUGH (cough), COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine) and PRODUCT QUALITY ISSUE (event product quality complaint) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine). On 14-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever) and COUGH (cough). On an unknown date, the patient experienced PRODUCT QUALITY ISSUE (event product quality complaint). On 15-Mar-2022, COUGH (cough) had resolved. On 17-Mar-2022, PYREXIA (fever) had resolved. At the time of the report, COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine) and PRODUCT QUALITY ISSUE (event product quality complaint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2022, SARS-CoV-2 test: positive (Positive) Positive.         Patient had no known allergies.  No concomitant medication was reported. Patient had suspected covid-19 infection. No treatment information was reported.  Company comment: This is a spontaneous case concerning a 43-year-old, male patient with no reported medical history and with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected non-serious event of cough and the expected non-serious event of pyrexia. Unspecified product quality issue was also reported. The events occurred 110 days after the second dose of mRNA-1273 vaccine administration in Covid-19 vaccination in series. The event cough has an approximate duration of 1 day while the event fever has an approximate of 3 days duration. The patient was tested positive with Covid-19 rapid antigen test (Binax now) approximately 1 day after the onset of the events. No other information surrounding the events was reported. The outcome of the events was reported as resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 43-year-old, male patient with no reported medical history and with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine Janssen) as the first dose of Covid-19 vaccine in Covid-19 vaccination in series, who experienced the unexpected non-serious event of cough and the expected non-serious event of pyrexia. Unspecified product quality issue was also reported. The events occurred 110 days after the second dose of mRNA-1273 vaccine administration in Covid-19 vaccination in series. The event cough has an approximate duration of 1 day while the event fever has an approximate of 3 days duration. The patient was tested positive with Covid-19 rapid antigen test (Binax now) approximately 1 day after the onset of the events. No other information surrounding the events was reported. The outcome of the events was reported as resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.