Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular autonomic function test, Postural orthostatic tachycardia syndrome
Clinical narrative: dysautonomia called Postural Orthostatic Tachycardia Syndrome (POTS); This spontaneous case was reported by a patient and describes the occurrence of POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (dysautonomia called Postural Orthostatic Tachycardia Syndrome (POTS)) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 046A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (dysautonomia called Postural Orthostatic Tachycardia Syndrome (POTS)) (seriousness criterion disability). The patient was treated with ARIPIPRAZOLE (ABILIFY) at a dose of .5 milligram once a day; NALTREXONE at an unspecified dose and frequency; MIDODRINE at a dose of UNK, tid and IVABRADINE at a dose of 5mg in morning and 2.5mg at night. At the time of the report, POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (dysautonomia called Postural Orthostatic Tachycardia Syndrome (POTS)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cardiovascular autonomic function test: developed form of dysautonomia called Postural Orthostatic Tachycardia Syndrome (POTS).         No concomitant medication was reported. After 2nd dose on April,2021, patient started developing heart issues, heart was working too hard at rest, eventually over course of summer, developed tremors in hands, developed severe headaches, was no longer able to tolerate certain foods or alcohol and started developing eyes issues.  The patient stated that she was not hospitalized but was basically bed bound and unable to take care of herself for 5 months and was operating at maybe 50% of normal. In the fall of 2021, got lot worse, felt like hungover every day, felt like she had a bad hangover and had a woozy lightheaded feeling. The patient stated that she was trying to get help through medical establishment and stated that it ended up being sent for autonomic test. The patient stated that she was a runner, in shape, active and now she could not do that stuff anymore and said it was like taking life away from her and cannot work full time. The patient stated that she was limited, this had been taken away from her. Patient received lot of stuff. Company comment: This is a spontaneous case concerning a 42-year-old female patient with no reported medical history, who experienced the unexpected, serious (disability) adverse event of special interest of Postural orthostatic tachycardia syndrome, on unknown date after receiving the second dose of mRNA-1273 vaccine. The patient started to develop heart issues (heart was working too hard at rest), tremors in hands, severe headaches, unable to tolerate certain foods and alcohol and eyes issues. The symptoms worsened that the patient felt like she had bad hangover every day with woozy lightheaded feeling. The patient underwent autonomic test and stated that she developed Postural orthostatic tachycardia syndrome. The patient was not hospitalized but was bed bound and unable to take care of herself for 5 months and was only able to operate at 50% of normal. The patient was treated with Aripiprazole, Naltrexone, Midodrine and Ivabradine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 42-year-old female patient with no reported medical history, who experienced the unexpected, serious (disability) adverse event of special interest of Postural orthostatic tachycardia syndrome, on unknown date after receiving the second dose of mRNA-1273 vaccine. The patient started to develop heart issues (heart was working too hard at rest), tremors in hands, severe headaches, unable to tolerate certain foods and alcohol and eyes issues. The symptoms worsened that the patient felt like she had bad hangover every day with woozy lightheaded feeling. The patient underwent autonomic test and stated that she developed Postural orthostatic tachycardia syndrome. The patient was not hospitalized but was bed bound and unable to take care of herself for 5 months and was only able to operate at 50% of normal. The patient was treated with Aripiprazole, Naltrexone, Midodrine and Ivabradine. The benefit-risk relationship of mRNA-1273 is not affected by this report.