Sex: F
Vaccine: COVID19
Symptoms: Pain, Product dose omission issue, Pruritus, Pyrexia, Urticaria
Clinical narrative: 36 days have passed since the 1st dose; hives all over her body; itchy; heart was heavy; chest was heavy; heart was heavy; felt tired / so tired; high blood pressure over 200 mm hg; had chest pain; very low fever (99°F); pain; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (high blood pressure over 200 mm hg), CHEST DISCOMFORT (heart was heavy), CARDIAC DISCOMFORT (heart was heavy) and CHEST DISCOMFORT (chest was heavy) in a 65-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.     The patient's past medical history included No adverse event (no adverse event history reported) since an unknown date.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-Mar-2021, the patient experienced PAIN (pain).   On 04-Mar-2021, the patient experienced CHEST PAIN (had chest pain) and PYREXIA (very low fever (99°F)).   On 05-Mar-2021, the patient experienced FATIGUE (felt tired / so tired), HYPERTENSION (high blood pressure over 200 mm hg) (seriousness criterion medically significant) and CARDIAC DISCOMFORT (heart was heavy) (seriousness criterion medically significant).   On 10-Mar-2021, the patient experienced CHEST DISCOMFORT (heart was heavy) (seriousness criterion medically significant) and CHEST DISCOMFORT (chest was heavy) (seriousness criterion medically significant). On 11-Apr-2021, the patient experienced URTICARIA (hives all over her body) and PRURITUS (itchy).   On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (36 days have passed since the 1st dose).   At the time of the report, CHEST PAIN (had chest pain), PYREXIA (very low fever (99°F)), FATIGUE (felt tired / so tired), HYPERTENSION (high blood pressure over 200 mm hg), CHEST DISCOMFORT (heart was heavy), URTICARIA (hives all over her body), PRURITUS (itchy), PRODUCT DOSE OMISSION ISSUE (36 days have passed since the 1st dose), CARDIAC DISCOMFORT (heart was heavy), CHEST DISCOMFORT (chest was heavy) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. The event of product omission is assessed as not applicable; Sender's Comments: This is a case of a 65-year-old female who missed due date for second week as it was 6 weeks since first dose in addition to the events (product dose omission). Based on the available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, causal relationship cannot be excluded. The event of product dose omission is assessed as not applicable