Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired quality of life
Clinical narrative: affected her life; headache which won't go away; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache which won't go away) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (headache which won't go away) (seriousness criterion disability). On an unknown date, the patient experienced IMPAIRED QUALITY OF LIFE (affected her life). At the time of the report, HEADACHE (headache which won't go away) and IMPAIRED QUALITY OF LIFE (affected her life) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HEADACHE (headache which won't go away) and IMPAIRED QUALITY OF LIFE (affected her life) to be related.    Patient reports that after the second dose has been experiencing headaches. She's been to several doctors and was given many medications with no improvement, which has been affecting her life. She mentions to have had headaches after the first dose that resolved. Patient states she's not getting the booster dose.  Company comment: This is a spontaneous case concerning a 70-year-old, female patient with no medical history reported, who's been experiencing headache since 2nd dose was administered, 11 months prior this report. Patient sought medical assistance with multiple doctors and none of the treatments prescribed improved her symptom and says it has been affecting her life. Rechallenge is positive as she refers she also had headache after taking the 1st dose, but it was mild in intensity and resolved quickly. Event assessed as serious, disability criterion, due to the persistent duration of the event and its impact in patient's quality of life. Further information has been requested to get a better characterization of the event and treatments performed. The benefit-risk relationship of mRNA-1273 in not affected by this report.   This case was linked to MOD-2022-440564 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 70-year-old, female patient with no medical history reported, who's been experiencing headache since 2nd dose was administered, 11 months prior this report. Patient sought medical assistance with multiple doctors and none of the treatments prescribed improved her symptom and says it has been affecting her life. Rechallenge is positive as she refers she also had headache after taking the 1st dose, but it was mild in intensity and resolved quickly. Event assessed as serious, disability criterion, due to the persistent duration of the event and its impact in patient's quality of life. Further information has been requested to get a better characterization of the event and treatments performed. The benefit-risk relationship of mRNA-1273 in not affected by this report.