Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; On 22-May-2022 symptoms returned, runny nose, sore throat headache, without fever and patient tested positive for SARS-Cov-2 again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On 22-May-2022 symptoms returned, runny nose, sore throat headache, without fever and patient tested positive for SARS-Cov-2 again) and COVID-19 (COVID 19) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: PENICILLIN NOS. Past adverse reactions to the above products included Allergy with PENICILLIN NOS. Concurrent medical conditions included Bicuspid aortic valve. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) from 01-May-2022 to 11-May-2022, CELECOXIB (CELEXA [CELECOXIB]) from 01-May-2022 to 22-May-2022 and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) from 01-May-2022 to 10-May-2022 for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022, the patient experienced COVID-19 (On 22-May-2022 symptoms returned, runny nose, sore throat headache, without fever and patient tested positive for SARS-Cov-2 again). On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (On 22-May-2022 symptoms returned, runny nose, sore throat headache, without fever and patient tested positive for SARS-Cov-2 again) had not resolved and COVID-19 (COVID 19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient was tested negative for SARS-Cov-2 on 19 May 2022. On 22 May 2022 the symptoms returned which included runny nose, sore throat headache, without fever and tested positive for SARS-Cov-2 again.  Company comment: This spontaneous case concerns a 45-year-old male patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 12-May to 16-May. Patient tested negative for COVID 19 on 19-May. 3 days later the symptoms returned, runny nose, sore throat headache, without fever, and patient again tested positive for COVID 19 on 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old male patient with no relevant medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 5 days as treatment for COVID 19 from 12-May to 16-May. Patient tested negative for COVID 19 on 19-May. 3 days later the symptoms returned, runny nose, sore throat headache, without fever, and patient again tested positive for COVID 19 on 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.