Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold; they got COVID in August. They tested positive; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they got COVID in August. They tested positive), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (Cold) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (they got COVID in August. They tested positive) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold). At the time of the report, COVID-19 (they got COVID in August. They tested positive), DRUG INEFFECTIVE (Lack of drug effect) and NASOPHARYNGITIS (Cold) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant use were reported. No Treatment were reported. The patient states that she also had a breakthrough case.  Company comment: This case concerns a 54-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-415883 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow-up received and patient demographics, events and batch number details were added.; Sender's Comments: This case concerns a 54-years-old female patient, with no medical history reported in this case, who experienced the non-serious AESI of COVID-19. Additionally, Drug ineffective was also reported. The events were reported to occur approximately 4 months after the administration of the second dose of a proper schedule of vaccination with the mRNA-1273 vaccine (29 days between doses).  Further information received states that the patient had cold symptoms and no hospitalization was required.  No further information was disclosed.  The rechallenge is not applicable as the events occurred after the administration of the second dose of the mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.