Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Loss of personal independence in daily activities, Malaise, Myalgia
Clinical narrative: were in bed for 2 days; very low energy; hard to eat; felt they were going to faint but did not, it was quite frequently.,; bizarre thing in the brain; pretty knocked out; rushing or pressure, a weird sensation from the back of the head to the top; severe reaction; general malaise/did not feel great; very sick; chills; achy body/body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (pretty knocked out), HEAD DISCOMFORT (rushing or pressure, a weird sensation from the back of the head to the top), VACCINATION COMPLICATION (severe reaction), MALAISE (general malaise/did not feel great) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (were in bed for 2 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hormone replacement therapy (low dose bioidentical hormone replacement, since their late 40s.).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (severe reaction), MALAISE (general malaise/did not feel great), ILLNESS (very sick), CHILLS (chills), MYALGIA (achy body/body aches), HEADACHE (headache) and PYREXIA (fever). On an unknown date, the patient experienced FEELING ABNORMAL (pretty knocked out), HEAD DISCOMFORT (rushing or pressure, a weird sensation from the back of the head to the top), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (were in bed for 2 days), ASTHENIA (very low energy), FEEDING DISORDER (hard to eat), PRESYNCOPE (felt they were going to faint but did not, it was quite frequently.,) and FEELING ABNORMAL (bizarre thing in the brain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (pretty knocked out), HEAD DISCOMFORT (rushing or pressure, a weird sensation from the back of the head to the top), VACCINATION COMPLICATION (severe reaction), MALAISE (general malaise/did not feel great), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (were in bed for 2 days), ASTHENIA (very low energy), FEEDING DISORDER (hard to eat), PRESYNCOPE (felt they were going to faint but did not, it was quite frequently.,), FEELING ABNORMAL (bizarre thing in the brain), ILLNESS (very sick), CHILLS (chills), MYALGIA (achy body/body aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            Patient 1 states they had pre ventricular contractions before.  Company Comment: This is a spontaneous case concerning a 66-year-old, female patient with a history of pre-ventricular contractions and hormone replacement therapy, who experienced the unexpected NON-serious events of vaccination complication, malaise, head discomfort, feeling abnormal, asthenia feeding disorder, personal independece in daily activities, presyncope and ilness; and expected events of headache, myalgia, chills and pyrexia. The expected events occurred on the same day after the 2nd dose of mRNA-1273 Moderna vaccine, the exact date of unexpected events was not provided, but occured after the 2nd dose of vaccine. The rechallenge was not applicable. very limited information regarding medical history was provided but could be potentially confounders.  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-362400, MOD-2021-361534 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, female patient with a history of pre-ventricular contractions and hormone replacement therapy, who experienced the unexpected NON-serious events of vaccination complication, malaise, head discomfort, feeling abnormal, asthenia feeding disorder, personal independece in daily activities, presyncope and ilness; and expected events of headache, myalgia, chills and pyrexia. The expected events occurred on the same day after the 2nd dose of mRNA-1273 Moderna vaccine, the exact date of unexpected events was not provided, but occured after the 2nd dose of vaccine. The rechallenge was not applicable. very limited information regarding medical history was provided but could be potentially confounders.  The benefit-risk relationship of Spikevax is not affected by this report.