Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension, Hypotension, Illness, Inappropriate schedule of product administration
Clinical narrative: scleroderma; 1st Moderna dose 27Mar2021 and her 2nd dose 1May2021; high blood pressure  of 175/106; extremely exhausted; the worst headache ever in her life.; very low blood pressure; extremely ill from 3May2021 to 7May2021; diarrhea; had the  shakes really bad for 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (extremely ill from 3May2021 to 7May2021), DIARRHOEA (diarrhea), HEADACHE (the worst headache ever in her life.), HYPOTENSION (very low blood pressure), FATIGUE (extremely exhausted), TREMOR (had the  shakes really bad for 15 minutes), HYPERTENSION (high blood pressure  of 175/106), SCLERODERMA (scleroderma) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose 27Mar2021 and her 2nd dose 1May2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced ILLNESS (extremely ill from 3May2021 to 7May2021) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea) (seriousness criterion hospitalization). On 04-May-2021, the patient experienced HEADACHE (the worst headache ever in her life.) (seriousness criterion hospitalization) and HYPOTENSION (very low blood pressure) (seriousness criterion hospitalization). On 05-May-2021, the patient experienced FATIGUE (extremely exhausted) (seriousness criterion hospitalization). On 07-May-2021, the patient experienced HYPERTENSION (high blood pressure  of 175/106) (seriousness criterion hospitalization). In May 2021, the patient experienced TREMOR (had the  shakes really bad for 15 minutes) (seriousness criterion hospitalization). On an unknown date, the patient experienced SCLERODERMA (scleroderma) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose 27Mar2021 and her 2nd dose 1May2021) (seriousness criterion hospitalization). The patient was hospitalized from 07-May-2021 to 08-May-2021 due to DIARRHOEA, FATIGUE, HEADACHE, HYPERTENSION, HYPOTENSION, ILLNESS, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION, SCLERODERMA and TREMOR. On 07-May-2021, ILLNESS (extremely ill from 3May2021 to 7May2021) had resolved. At the time of the report, DIARRHOEA (diarrhea), HEADACHE (the worst headache ever in her life.), HYPOTENSION (very low blood pressure), FATIGUE (extremely exhausted), TREMOR (had the  shakes really bad for 15 minutes), HYPERTENSION (high blood pressure  of 175/106), SCLERODERMA (scleroderma) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Moderna dose 27Mar2021 and her 2nd dose 1May2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Heart rate increased: high (High) very high pulse rate. On 07-May-2021, Blood pressure measurement: 175/106 (High) high blood pressure  of 175/106. On 07-May-2021, Heart rate: abnormal (abnormal) heart rate was 108 to 130..         She went  into the hospital from 7May-8May with high blood pressure  of 175/106 and her heart rate was 108 to 130.   While in hospital, she had the  shakes really bad for 15 minutes. All tests came back normal.  She also has scleroderma. Her doctors recommended vaccine. Concomitant medication use was not provided by reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.