Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: First onset of Covid symptoms (fever, congestion, headache, musculoskeletal pain) was on May 13, 2022.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (First onset of Covid symptoms (fever, congestion, headache, musculoskeletal pain) was on May 13, 2022.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048221A, 059E21A, 025C21A and 025321A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Methotrexate. Past adverse reactions to the above products included Allergy with Methotrexate. Concurrent medical conditions included Psoriatic arthritis and Hypertension. Concomitant products included ETANERCEPT (ENBREL), LISINOPRIL, METOPROLOL and PIROXICAM from 01-Dec-2019 to an unknown date for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced COVID-19 (First onset of Covid symptoms (fever, congestion, headache, musculoskeletal pain) was on May 13, 2022.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 27-May-2022, COVID-19 (First onset of Covid symptoms (fever, congestion, headache, musculoskeletal pain) was on May 13, 2022.) had resolved.            Patient had allergic reaction to Sulfa drugs. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine. Patient experienced symptoms on 13-May-2022 and were resolved completely by 19-May-2022. Symptoms returned on 22-May-2022 with equal severity and lasted through 27-May-2022. Patient did not receive a second round of Paxlovid.  Device Date :27-May-2022 Company Comment: This spontaneous case concerns a 55 year old male patient  with relevant medical history of Psoriatic arthritis , hypertension and concomitant medication of Etanercept ( Enbrel) , who experienced non-serious , unexpected . AESI of Covid 19 which occurred 1 month , 13 days post vaccination with the 4th dose of mRNA-1273 vaccine. The dose 1, 2 ,3 Covid 19 vaccine of this patient were also mRNA-1273 vaccine given on 21-04-2021. 19-05-2021. 20-08-2021 respectively . This patient reported  that the first onset of Covid symptoms (fever, congestion, headache, musculoskeletal pain) was on May 13, 2022. His  provider, MIT Medical, immediately prescribed Paxlovid at an unspecified dose and frequency which he obtained from a pharmacy that night. His  Paxlovid course lasted from the evening of May 13 to the morning of May 17(Day5).Symptoms resolved completely by May 19.Symptoms returned on May 22 (Day 9) with equal severity and lasted through May 27 (Day 14). He did not receive a second round of Paxlovid.   Other details of the event such as other treatment medications, results of laboratories/diagnostic procedures were not reported. Outcome of the event was reported as resolved. The concurrent medical history of Psoriatic arthritis, hypertension and the concomitant mediation Etanercept are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55 year old male patient  with relevant medical history of Psoriatic arthritis , hypertension and concomitant medication of Etanercept ( Enbrel) , who experienced non-serious , unexpected . AESI of Covid 19 which occurred 1 month , 13 days post vaccination with the 4th dose of mRNA-1273 vaccine. The dose 1, 2 ,3 Covid 19 vaccine of this patient were also mRNA-1273 vaccine given on 21-04-2021. 19-05-2021. 20-08-2021 respectively . This patient reported  that the first onset of Covid symptoms (fever,congestion, headache, musculoskeletal pain) was on May 13, 2022. His  provider, MIT Medical, immediately prescribed Paxlovid at an unspecified dose and frequency which he obtained from a pharmacy that night. His  Paxlovid course lasted from the evening of May 13 to the morning of May 17(Day5).Symptoms resolved completely by May 19.Symptoms returned on May 22 (Day 9) with equal severity and lasted through May 27 (Day 14). He did not receive a second round of Paxlovid.   Other details of the event such as other treatment medications, results of laboratories/diagnostic procedures were not reported. Outcome of the event was reported as resolved. The concurrent medical history of Psoriatic arthritis, hypertension and the concomitant mediation Etanercept are considered as confounders for the event Covid 19 . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.