Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypertension, Insomnia
Clinical narrative: High Blood Pressure 200/110 mmHg; Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head; Pain in the Right Side of the Neck and Right Shoulder; No Energy,Not myself; Not Myself" (After Second Shot); she is not able to sleep at night from the Pain; Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colon cancer stage II (last chemo was 6 years ago.). Concomitant products included LOSARTAN, METOPROLOL and AMLODIPINE for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HYPERTENSION (High Blood Pressure 200/110 mmHg) (seriousness criterion hospitalization), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head) (seriousness criteria hospitalization and medically significant) and ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder) (seriousness criterion hospitalization). On 27-Apr-2021, the patient experienced ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough). The patient was hospitalized on 06-Apr-2021 due to ARTHRALGIA, HEADACHE and HYPERTENSION. At the time of the report, HYPERTENSION (High Blood Pressure 200/110 mmHg), HEADACHE (Excruciating Severe Headache (After Second Shot)/Excruciating Pain on the Right Side of Head), ARTHRALGIA (Pain in the Right Side of the Neck and Right Shoulder), ASTHENIA (No Energy,Not myself), FEELING ABNORMAL (Not Myself" (After Second Shot)), INSOMNIA (she is not able to sleep at night from the Pain) and COUGH (Excruciating Pain on the Right Side of Head when CoughExcruciating Pain on the Right Side of Head when Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 200/110 (abnormal) 200/110 mmHg. On an unknown date, Computerised tomogram: normal (normal) normal.         Treatment with IV pain medications and was held in dark room in the Emergency room for several hours and discharged.  This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-092739 (E2B Linked Report).; Sender's Comments: This case concerns a 62-year-old female hospitalized with serious unexpected events of hypertension, headache, arthralgia, and nonserious unexpected asthenia, feeling abnormal, insomnia, and cough. Event onset the same day as second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-092739:Case for dose 1