Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (COVID-19 virus test positive after 2nd dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Sulfonamide allergy (Sulpha), Multiple sclerosis, Breast cancer and Ulcerative colitis. Concomitant products included GLATIRAMER ACETATE (COPAXONE) for Multiple sclerosis, MESALAMINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (COVID-19 virus test positive after 2nd dose). At the time of the report, COVID-19 (COVID-19 virus test positive) and DRUG INEFFECTIVE (COVID-19 virus test positive after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient visited her dentist. The patient started having problem with the multiple sclerosis medication that she had been taking for 18 years.  Patient stated that she did not get the vaccine because in Nov 2021 her HCP said she had COVID immunity to wait 90 days to get the shot.  Treatment medication was not provided by the reporter.  Company Comment:  This spontaneous case concerns a a 63-year-old female patient with concurrent Breast cancer and concomitant use of Glatiramer acetate (Copaxone) for Multiple sclerosis, who experienced the unexpected non-serious adverse event of special interest COVID-19 (COVID-19 virus test positive) approximately 6 months after receiving 2nd dose of mRNA-1273 vaccine.  Additionally, Drug ineffective (COVID-19 virus test positive after 2nd dose) was also noted. Patient previously received mRNA-1273 vaccine given as first dose 28 days prior to current mRNA-1273 vaccine which falls within the recommended vaccination interval.  Concurrent Breast cancer and concomitant use of Glatiramer acetate (Copaxone) could be considered as predisposing risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-592955 (Patient Link).; Sender's Comments: This spontaneous case concerns a a 63-year-old female patient with concurrent Breast cancer and concomitant use of Glatiramer acetate (Copaxone) for Multiple sclerosis, who experienced the unexpected non-serious adverse event of special interest COVID-19 (COVID-19 virus test positive) approximately 6 months after receiving 2nd dose of mRNA-1273 vaccine.  Additionally, Drug ineffective (COVID-19 virus test positive after 2nd dose) was also noted. Patient previously received mRNA-1273 vaccine given as first dose 28 days prior to current mRNA-1273 vaccine which falls within the recommended vaccination interval.  Concurrent Breast cancer and concomitant use of Glatiramer acetate (Copaxone) could be considered as predisposing risk factors. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.