Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Laboratory test, Malaise, Mechanical urticaria, Muscle twitching
Clinical narrative: Dermatographia; Her heart rate is ok when sitting but abnormal when she stands up.; Legs would look purple and blotchy and it has progressed to the arms; Rash came back after 2nd dose; legs and arms ache/She can't do anything because pain gets worse with activity/Palms and feet sting; skin change colors, Legs would look purple and blotchy and it has progressed to the arms; Patient had ribcage pain; she still has burning sensation; She also had bruising flares are often; Small muscle twitches; She felt the blood going to her feet when standing up; she doesn't feel dizzy but she feels like rocking on a boat; Fatigue comes and goes; petechiae; Chest pain/ even though she had chest pain the cardiology tests came back normal; She was diagnosed with Postural orthostatic syndrome in mid October.; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechiae), CHEST PAIN (Chest pain/ even though she had chest pain the cardiology tests came back normal), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (She was diagnosed with Postural orthostatic syndrome in mid October.), MECHANICAL URTICARIA (Dermatographia), HEART RATE ABNORMAL (Her heart rate is ok when sitting but abnormal when she stands up.), RASH MACULAR (Legs would look purple and blotchy and it has progressed to the arms), RASH (Rash came back after 2nd dose), PAIN (legs and arms ache/She can't do anything because pain gets worse with activity/Palms and feet sting) and SKIN DISCOLOURATION (skin change colors, Legs would look purple and blotchy and it has progressed to the arms) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Insomnia and Fatigue. Concurrent medical conditions included Penicillin allergy.    On 16-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (She was diagnosed with Postural orthostatic syndrome in mid October.) (seriousness criterion medically significant). On an unknown date, the patient experienced PETECHIAE (petechiae) (seriousness criterion medically significant), CHEST PAIN (Chest pain/ even though she had chest pain the cardiology tests came back normal) (seriousness criterion medically significant), MECHANICAL URTICARIA (Dermatographia) (seriousness criterion medically significant), HEART RATE ABNORMAL (Her heart rate is ok when sitting but abnormal when she stands up.) (seriousness criterion medically significant), RASH MACULAR (Legs would look purple and blotchy and it has progressed to the arms) (seriousness criterion medically significant), RASH (Rash came back after 2nd dose) (seriousness criterion medically significant), PAIN (legs and arms ache/She can't do anything because pain gets worse with activity/Palms and feet sting) (seriousness criterion medically significant), SKIN DISCOLOURATION (skin change colors, Legs would look purple and blotchy and it has progressed to the arms) (seriousness criterion medically significant), MUSCULOSKELETAL CHEST PAIN (Patient had ribcage pain), BURNING SENSATION (she still has burning sensation), CONTUSION (She also had bruising flares are often), MUSCLE TWITCHING (Small muscle twitches), SENSATION OF BLOOD FLOW (She felt the blood going to her feet when standing up), MALAISE (she doesn't feel dizzy but she feels like rocking on a boat) and FATIGUE (Fatigue comes and goes). The patient was treated with PROPRANOLOL for Postural orthostatic tachycardia syndrome and Tachycardia, at an unspecified dose and frequency. At the time of the report, PETECHIAE (petechiae), CHEST PAIN (Chest pain/ even though she had chest pain the cardiology tests came back normal), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (She was diagnosed with Postural orthostatic syndrome in mid October.), MECHANICAL URTICARIA (Dermatographia), HEART RATE ABNORMAL (Her heart rate is ok when sitting but abnormal when she stands up.), RASH MACULAR (Legs would look purple and blotchy and it has progressed to the arms), RASH (Rash came back after 2nd dose), SKIN DISCOLOURATION (skin change colors, Legs would look purple and blotchy and it has progressed to the arms), MUSCLE TWITCHING (Small muscle twitches), SENSATION OF BLOOD FLOW (She felt the blood going to her feet when standing up) and MALAISE (she doesn't feel dizzy but she feels like rocking on a boat) outcome was unknown, PAIN (legs and arms ache/She can't do anything because pain gets worse with activity/Palms and feet sting), CONTUSION (She also had bruising flares are often) and FATIGUE (Fatigue comes and goes) had not resolved and MUSCULOSKELETAL CHEST PAIN (Patient had ribcage pain) and BURNING SENSATION (she still has burning sensation) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) abnormal. On an unknown date, Laboratory test: normal (normal) Normal. On an unknown date, Platelet count: normal (normal) platelet levels were fine.         Patient had seen a great number of specialists but the lab work was normal. The patient never had COVID + test or diagnosis. Patient had taken a T cell test, a nucleocapsid and PCR test to rule out COVID. The patient the aching of legs and arms, skin changes colors, legs would look purple and blotchy and it has progressed in the arms, that was not there initially. The patient had to go to Urgent care, for the first symptoms and the petechia, she followed up with primary care doctor, and was referred to a neurologist, cardiologist and dermatologist but no one has helped her and the tests have come out normal. The patient did receive other vaccines within 1 month prior to Moderna Covid-19 vaccine. The AE cause patient to seek urgent care and patient had been referred to several specialists (Cardiologist, Neurologist, Dermatologist). The AE outcome some are ongoing some have improved.  Concomitant medications were not reported.  Company comment:This spontaneous case concerns a 34 year old female  patient with no relevant medical history reported, who experienced the Serious ( Medically significant ) , unexpected, AESI event of Postural Otthostatic tachycardia syndrome  which she occurred  approximately 1.5 months post vaccination with the 2nd dose of mRNA -1273 vaccine On an unknown date this patient experienced,  Serious , unexpected events of petechiae , pain,  chest pain, mechanical urticaria , heart rate abnormal , rash macular, skin discoloration  and rash . This case was  accomapanied by other non-serious unexpected events of malaise , musculo-skeletal chest pain , burning sensation , contusion muscle twitiching , sensation of blood flow and non-serious expected event of fatigue. The patient had  pain  of legs and arms, skin changes colors, legs would look purple and blotchy and it has progressed in the arms.  The patient had to go to Urgent care, for the first symptoms and also because of the petechiae , she followed up with primary care doctor, and was referred to a neurologist, cardiologist and dermatologist but there was no improvement  and the tests have all  come out normal. The patient never had COVID + test or diagnosis. Patient had taken a T cell test, a nucleocapsid and PCR test to rule out COVID.Treatment information was  not reported ( but in the product tab  included Propanolol was specified as treatment drug  for tachycardia and POTS)  including the specific laboratories/diagnostic procedures and the results .It was mentioned that the rash recurred after the 2nd dose of mRNA-1273 which was initially experienced  after the 1st dose hence for this event it may be assessed as a positive re-challenge.   At the time  of this report the events  of burning sensation and musculo-skeletal  chest  pain are resolving while the other reported events are unresolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-493999 (Patient Link).; Sender's Comments: This spontaneous case concerns a 34 year old female  patient with no relevant medical history reported, who experienced the Serious ( Medically significant ) , unexpected, AESI event of Postural Otthostatic tachycardia syndrome  which she occurred  approximately 1.5 months post vaccination with the 2nd dose of mRNA -1273 vaccine On an unknown date this patient experienced,  Serious , unexpected events of petechiae , pain,  chest pain, mechanical urticaria , heart rate abnormal , rash macular, skin discoloration  and rash . This case was  accomapanied by other non-serious unexpected events of malaise , musculo-skeletal chest pain , burning sensation , contusion muscle twitiching , sensation of blood flow and non-serious expected event of fatigue. The patient had  pain  of legs and arms, skin changes colors, legs would look purple and blotchy and it has progressed in the arms.  The patient had to go to Urgent care, for the first symptoms and also because of the petechiae , she followed up with primary care doctor, and was referred to a neurologist, cardiologist and dermatologist but there was no improvement  and the tests have all  come out normal. The patient never had COVID + test or diagnosis. Patient had taken a T cell test, a nucleocapsid and PCR test to rule out COVID.Treatment information was  not reported ( but in the product tab  included Propanolol was specified as treatment drug  for tachycardia and POTS)  including the specific laboratories/diagnostic procedures and the results .It was mentioned that the rash recurred after the 2nd dose of mRNA-1273 which was initially experienced  after the 1st dose hence for this event it may be assessed as a positive re-challenge.   At the time  of this report the events  of burning sensation and musculo-skeletal  chest  pain are resolving while the other reported events are unresolved. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.