Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Pyrexia
Clinical narrative: sneezing; cough; fever; headache; chills; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), SNEEZING (sneezing), COUGH (cough), PYREXIA (fever) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    No Medical History information was reported.   On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 03-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On 13-May-2022, the patient experienced SNEEZING (sneezing), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). On 09-May-2022, COVID-19 (COVID-19) had resolved. At the time of the report, SNEEZING (sneezing), COUGH (cough), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2022, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  It was reported that, patient took 4 days of Paxlovid treatment from day 2 to 5 of infection. Later, patient was recovered and tested negative on day 6 of infection (09-May-2022). On 13-May-2022 (day 10 of infection), the patient began re-experiencing symptoms including fever, headache, cough, sneezing and chills.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient had COVID-19 on 03-MAY-2022 and was treated with co-suspect, non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) the next day for four days, noted with improvement and COVID-19 test was negative on day 6 of infection, however on day 10 of infection, the patient began re-experiencing symptoms including fever, headache, cough, sneezing and chills, no further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the first dose of mRNA-1273 Vaccine. As reported, the patient had COVID-19 on 03-MAY-2022 and was treated with co-suspect, non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) the next day for four days, noted with improvement and COVID-19 test was negative on day 6 of infection, however on day 10 of infection, the patient began re-experiencing symptoms including fever, headache, cough, sneezing and chills, no further clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.