Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Home test positive again/still mild rhinorrhea; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Home test positive again/still mild rhinorrhea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung cancer. Concomitant products included CAPECITABINE (CAPECIT) from 05-Nov-2021 to an unknown date, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) from 06-Feb-2021 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 13-Jul-2021 to an unknown date for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-May-2022, the patient experienced COVID-19 (Home test positive again/still mild rhinorrhea). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 20-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Home test positive again/still mild rhinorrhea) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2022, SARS-CoV-2 test: negative (Negative) negative home test. On 01-Jun-2022, SARS-CoV-2 test: positive (Positive) home test positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had allergy from some medication.  The patient had received some medications/products within 2 weeks of starting COVID-19 treatment. The COVID symptoms started on 19-May-2022 and patient started Paxlovid symptoms resolved with a negative home test on26-May-2022. On 29-Ma,y-2022 patient had recurrence rhinorrhea and retested. On 01-Jun-2022 patient had home positive test, still. The device date was reported as 01-Jun-2022.  Company comment: This spontaneous case concerns a 67-year-old, male patient with medical history of Lung cancer, who experienced the unexpected, non-serious of COVID-19. The event COVID-19 occurred 57 days after administration of second dose of mRNA-1273, the interval between the two initial doses of mRNA-1273 is 28 days, the third dose of mRNA-1273 was given 4 months later. On May 26, 2022, SARS-CoV-2 test was done which revealed a negative result. It has been reported that the patient experienced COVID symptoms on May 19, 2022, and was started on Paxlovid treatment regimen, to which he tested negative after the medication course, on May 29, 2022, patient experienced rhinorrhea, SARS-CoV-2 test was done which revealed a positive result. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 67-year-old, male patient with medical history of Lung cancer, who experienced the unexpected, non-serious of COVID-19. The event COVID-19 occurred 57 days after administration of second dose of mRNA-1273, the interval between the two initial doses of mRNA-1273 is 28 days, the third dose of mRNA-1273 was given 4 months later. On May 26, 2022, SARS-CoV-2 test was done which revealed a negative result. It has been reported that the patient experienced COVID symptoms on May 19, 2022, and was started on Paxlovid treatment regimen, to which he tested negative after the medication course, on May 29, 2022, patient experienced rhinorrhea, SARS-CoV-2 test was done which revealed a positive result. The benefit-risk relationship of mRNA-1273 is not affected by this report.