Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: Severe stomach pain; Intense headache/intense pain at the back of her head (almost like migraine); Blood pressure was very high/Blood pressure was 195/122; Whole body was shaking (uncontrollable shaking)/Shaking was more severe; Heart was beating very fast; Could not breath; she also had nausea; Soreness at the injection site; Intense itchy at the injection site; hives at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pain), HEADACHE (Intense headache/intense pain at the back of her head (almost like migraine)), BLOOD PRESSURE INCREASED (Blood pressure was very high/Blood pressure was 195/122), TREMOR (Whole body was shaking (uncontrollable shaking)/Shaking was more severe), HEART RATE INCREASED (Heart was beating very fast), DYSPNOEA (Could not breath) and NAUSEA (she also had nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 091B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain) (seriousness criterion medically significant), HEADACHE (Intense headache/intense pain at the back of her head (almost like migraine)) (seriousness criterion medically significant), BLOOD PRESSURE INCREASED (Blood pressure was very high/Blood pressure was 195/122) (seriousness criterion medically significant), TREMOR (Whole body was shaking (uncontrollable shaking)/Shaking was more severe) (seriousness criterion medically significant), HEART RATE INCREASED (Heart was beating very fast) (seriousness criterion medically significant), DYSPNOEA (Could not breath) (seriousness criterion medically significant), NAUSEA (she also had nausea) (seriousness criterion medically significant), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Intense itchy at the injection site) and VACCINATION SITE URTICARIA (hives at the injection site). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain), HEADACHE (Intense headache/intense pain at the back of her head (almost like migraine)), BLOOD PRESSURE INCREASED (Blood pressure was very high/Blood pressure was 195/122), TREMOR (Whole body was shaking (uncontrollable shaking)/Shaking was more severe), HEART RATE INCREASED (Heart was beating very fast), DYSPNOEA (Could not breath), NAUSEA (she also had nausea), VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE PRURITUS (Intense itchy at the injection site) and VACCINATION SITE URTICARIA (hives at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 195/122 (abnormal) 195/122. On an unknown date, Heart rate: increased (High) increased.         Concomitant and Treatment medications were not reported. After the 2nd dose, within 24 hours patient developed symptoms of hives at the injection site, intense itchy and soreness. After 3 days, Patient went to the ER because she had severe stomach pain. About a week after the ER visit, patient started having intense headache, her blood pressure was very high, her whole body was shaking (uncontrollable shaking), heart was beating very fast, she could not breath and she was having intense pain at the back of her head (almost like migraine). A week after that they had to go back in again for exactly the same thing. A week after that, the shaking was more severe, her blood pressure was 195/122 but it seems to be fluctuating, she also had nausea. They had to go in again back to the ER again yesterday because the symptoms were worse. She was young, full of life but what ever it was, was wiping her out.  Company comment: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Abdominal pain upper, Headache, Blood pressure increased, Tremor, Heart rate increased, Dyspnoea and Nausea. The events of headache and nausea are unexpected as they are retained as serious per the source document authority reporting. The events occurred within 2 weeks after the second dose of Moderna COVID-19 Vaccine. After 3 days of vaccination, patient visited emergency room (ER) with stomach pain and about after 10 days of vaccination, visited ER again with intense headache, high blood pressure, uncontrollable shaking, very fast heart beating and difficulty in breathing. Labs/diagnostic results, neurological and cardiologist assessment, treatment and outcome were not reported. The rechallenge was not applicable as the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Abdominal pain upper, Headache, Blood pressure increased, Tremor, Heart rate increased, Dyspnoea and Nausea. The events of headache and nausea are unexpected as they are retained as serious per the source document authority reporting. The events occurred within 2 weeks after the second dose of Moderna COVID-19 Vaccine. After 3 days of vaccination, patient visited emergency room (ER) with stomach pain and about after 10 days of vaccination, visited ER again with intense headache, high blood pressure, uncontrollable shaking, very fast heart beating and difficulty in breathing. Labs/diagnostic results, neurological and cardiologist assessment, treatment and outcome were not reported. The rechallenge was not applicable as the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.