Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Headache, Illness, Intentional product use issue
Clinical narrative: Deathly sick/sick from both ends; Diagnosed with COVID - home test kit (late January/February); Only one dose received; Real dizzy; Severe headaches and thought she was going to pass out/since she had the shot she has headaches practically everyday; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Deathly sick/sick from both ends), COVID-19 (Diagnosed with COVID - home test kit (late January/February)), INTENTIONAL PRODUCT USE ISSUE (Only one dose received), DIZZINESS (Real dizzy) and HEADACHE (Severe headaches and thought she was going to pass out/since she had the shot she has headaches practically everyday) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Deathly sick/sick from both ends), COVID-19 (Diagnosed with COVID - home test kit (late January/February)), INTENTIONAL PRODUCT USE ISSUE (Only one dose received), DIZZINESS (Real dizzy) and HEADACHE (Severe headaches and thought she was going to pass out/since she had the shot she has headaches practically everyday). At the time of the report, ILLNESS (Deathly sick/sick from both ends), COVID-19 (Diagnosed with COVID - home test kit (late January/February)), INTENTIONAL PRODUCT USE ISSUE (Only one dose received) and DIZZINESS (Real dizzy) outcome was unknown and HEADACHE (Severe headaches and thought she was going to pass out/since she had the shot she has headaches practically everyday) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) (Positive) Diagnosed with COVID - home test kit (late January/February).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. It was reported that patient was kept in pharmacy for quite a while (after shot) then brought home. Patient thought as was going to pass out.Took 3-4 days to get stabilized. Patient was diagnosed with COVID using home test kit in late January/February and was down for 3-4 days with bad flu like symptoms. No treatment medications were reported.  Company comment: This case concerns a 74-year-old female patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. An assessment for lack of drug effect cannot be concluded since the patient only received 1 dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-562864 (Patient Link).; Sender's Comments: This case concerns a 74-year-old female patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after the first dose of mRNA-1273. An assessment for lack of drug effect cannot be concluded since the patient only received 1 dose of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.