chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parasite stool test negative, Respiratory viral panel, Ultrasound liver abnormal, Vomiting
Clinical narrative: Patient presented with severe fatigue, nausea, lightheadedness, and palpitations. Started 1 day after 2nd dose of vaccine. Called off work day after 2nd vaccine. Went to ER with palpitations and lightheadedness 3 days after her 2nd dose. Was given fluids and nausea medication and sent home. 8 days after her 2nd dose, she was admitted to the hospital with worsening nausea, fatigue, lightheaded, and palpitations. Her heart rate would elevate into the 140's with minimal exertion. She works as a nurse at night, normally does not have any medical problems or fatigue or palpitations. Very fatigued and painful with abdominal pain, nauseated and vomiting. Required IV narcotics and IV benzos for pain control and nausea control. Palpitations uncontrolled with lopressor, fatigue and nausea difficult to control. palpitations did not improve with improvement of oral intake or with fluid resuscitation.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Dyspnoea, Headache, Hypoaesthesia
Clinical narrative: Numbness in arms and legs Difficulty breathing Severe body weakness and fatigue Dizziness
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: Numbness in arms and legs Difficulty breathing Severe body weakness and fatigue Dizziness
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, CSF test abnormal, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Numbness in arms and legs Difficulty breathing Severe body weakness and fatigue Dizziness
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Inflammatory marker increased, Lumbar puncture, Magnetic resonance imaging normal
Clinical narrative: Numbness in arms and legs Difficulty breathing Severe body weakness and fatigue Dizziness
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fall, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: I received the Moderna vaccine. The pharmacist administering commented on the odd response I had to the shot in my arm and within 1 minute, I said, "I don't feel so good" and began to have my first seizure. I fell out of my chair and hit my head on one of the pharmacy shelves. My wife was with me and the pharmacist called emergency services. The nurse came from the back and propped my legs up as I laid on the floor. Within minutes, the fire department and EMS arrived. They took my blood pressure, blood sugar and vitals which all were normal. I then began to have another seizure in which the EMS team assisted. They loaded me onto a stretcher and took me to the hospital in an ambulance. This entire course of events occurred within approximately 6 minutes of receiving my first COVID-19 vaccine. At the hospital, I received a chest X-ray, EKG and blood and vitals tests which all were normal. They concluded that it was an unexplainable reaction to the vaccine. I have no history of seizures and am a healthy 27 year old male. I take no prescription drugs, walk daily, work out regularly, eat a healthy diet and drink a gallon of water a day. Since receiving the vaccine, I have soreness on my head from hitting it on the shelf and a bite mark on my tongue from the seizures. I have been sleeping 12+ hours a day for the last two days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Electrocardiogram normal, Fall, Head injury
Clinical narrative: I received the Moderna vaccine. The pharmacist administering commented on the odd response I had to the shot in my arm and within 1 minute, I said, "I don't feel so good" and began to have my first seizure. I fell out of my chair and hit my head on one of the pharmacy shelves. My wife was with me and the pharmacist called emergency services. The nurse came from the back and propped my legs up as I laid on the floor. Within minutes, the fire department and EMS arrived. They took my blood pressure, blood sugar and vitals which all were normal. I then began to have another seizure in which the EMS team assisted. They loaded me onto a stretcher and took me to the hospital in an ambulance. This entire course of events occurred within approximately 6 minutes of receiving my first COVID-19 vaccine. At the hospital, I received a chest X-ray, EKG and blood and vitals tests which all were normal. They concluded that it was an unexplainable reaction to the vaccine. I have no history of seizures and am a healthy 27 year old male. I take no prescription drugs, walk daily, work out regularly, eat a healthy diet and drink a gallon of water a day. Since receiving the vaccine, I have soreness on my head from hitting it on the shelf and a bite mark on my tongue from the seizures. I have been sleeping 12+ hours a day for the last two days.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypersomnia, Malaise, Seizure, Tongue biting
Clinical narrative: I received the Moderna vaccine. The pharmacist administering commented on the odd response I had to the shot in my arm and within 1 minute, I said, "I don't feel so good" and began to have my first seizure. I fell out of my chair and hit my head on one of the pharmacy shelves. My wife was with me and the pharmacist called emergency services. The nurse came from the back and propped my legs up as I laid on the floor. Within minutes, the fire department and EMS arrived. They took my blood pressure, blood sugar and vitals which all were normal. I then began to have another seizure in which the EMS team assisted. They loaded me onto a stretcher and took me to the hospital in an ambulance. This entire course of events occurred within approximately 6 minutes of receiving my first COVID-19 vaccine. At the hospital, I received a chest X-ray, EKG and blood and vitals tests which all were normal. They concluded that it was an unexplainable reaction to the vaccine. I have no history of seizures and am a healthy 27 year old male. I take no prescription drugs, walk daily, work out regularly, eat a healthy diet and drink a gallon of water a day. Since receiving the vaccine, I have soreness on my head from hitting it on the shelf and a bite mark on my tongue from the seizures. I have been sleeping 12+ hours a day for the last two days.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus arrhythmia, Ventricular extrasystoles, Ventricular tachycardia
Clinical narrative: ventricular tachycardia; sinus arrythmia; premature ventricular contractions; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (ventricular tachycardia) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 2008, Benign prostatic hyperplasia and Erectile dysfunction. Concomitant products included FINASTERIDE for Benign prostatic hyperplasia, ACETYLSALICYLIC ACID (ASPIRIN ACTAVIS) for Cardiac disorder NOS, TADALAFIL (CIALIS) for Erectile dysfunction, LISINOPRIL for Hypertension, FISH OIL and VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VENTRICULAR TACHYCARDIA (ventricular tachycardia) (seriousness criterion medically significant), SINUS ARRHYTHMIA (sinus arrythmia) and VENTRICULAR EXTRASYSTOLES (premature ventricular contractions). The patient was treated with METOPROLOL SUCCINATE (TOPROL XL) ongoing since an unknown date for Cardiac disorder, at a dose of 12.5 milligram/ 1X. At the time of the report, VENTRICULAR TACHYCARDIA (ventricular tachycardia), SINUS ARRHYTHMIA (sinus arrythmia) and VENTRICULAR EXTRASYSTOLES (premature ventricular contractions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   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. GS   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Patient demographics were added. Concomitant medication were added. Second dose of moderna drug was added. Current condition, hypertension and sinus were added.  Outcome of the event was changed. On 07-Jul-2021: Event terms were updated to the final diagnoses and treatment medication was added.; 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. GS
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Magnetic resonance imaging, Myalgia, Tinnitus, Vaccination site pain
Clinical narrative: loss of hearing in my left ear; muscle aches,pain,pain sore arm; Sore arm; really loud noises in my ears like tinnitus,annoying tinnitus/both tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus), EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears), PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus) and EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, TINNITUS (really loud noises in my ears like tinnitus,annoying tinnitus) and EAR DISORDER (sound like high pitched vacuum cleaner in my ears, background noise which is light, noise still bothers me in my ears) had not resolved and PAIN IN EXTREMITY (typical sore arm), PAIN (ache and pain) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient's  lab data, current condition and contact information updated.; 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.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Appendicitis, Asthenia, Decreased appetite, Fall
Clinical narrative: anorexia; severe abdominal pain; severe weakness; Fall; fever; vomiting; appendicitis; Mild facial swellling; This spontaneous case was reported by a non-health professional and describes the occurrence of APPENDICITIS (appendicitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JQ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Food allergy (Allergies to foods). Concomitant products included FEXOFENADINE for an unknown indication.    On 26-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SWELLING FACE (Mild facial swellling). On 29-Jan-2021, the patient experienced APPENDICITIS (appendicitis) (seriousness criterion medically significant), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting). The patient was treated with LORATADINE ongoing since an unknown date for Adverse event, at a dose of 1 UNK. At the time of the report, APPENDICITIS (appendicitis), SWELLING FACE (Mild facial swellling), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow-up with serious and non-serious events added and email added; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Vomiting
Clinical narrative: anorexia; severe abdominal pain; severe weakness; Fall; fever; vomiting; appendicitis; Mild facial swellling; This spontaneous case was reported by a non-health professional and describes the occurrence of APPENDICITIS (appendicitis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011JQ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Food allergy (Allergies to foods). Concomitant products included FEXOFENADINE for an unknown indication.    On 26-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SWELLING FACE (Mild facial swellling). On 29-Jan-2021, the patient experienced APPENDICITIS (appendicitis) (seriousness criterion medically significant), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting). The patient was treated with LORATADINE ongoing since an unknown date for Adverse event, at a dose of 1 UNK. At the time of the report, APPENDICITIS (appendicitis), SWELLING FACE (Mild facial swellling), DECREASED APPETITE (anorexia), ABDOMINAL PAIN (severe abdominal pain), ASTHENIA (severe weakness), FALL (Fall), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Significant follow-up with serious and non-serious events added and email added; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. The Company believes the events of Decreased appetite, Pyrexia, Vomiting Abdominal pain were due to the event of Appendicitis and not to the product. Further, the Company believes the event of Appendicitis is unlikely related to the product.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement
Clinical narrative: Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.  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. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from  follow up document.; 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. However, more information is required for further assessment.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate, Heart rate increased
Clinical narrative: Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.  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. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from  follow up document.; 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. However, more information is required for further assessment.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Limb discomfort, Nausea, Oropharyngeal pain
Clinical narrative: Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.  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. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from  follow up document.; 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. However, more information is required for further assessment.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: Vertigo; Sore throat; Increased heart rate; Dizziness; Nausea; Fatigue; Severe headache; Right shoulder pain; High BP of 294/224; High blood sugar of 750; Severe allergic reaction; Tingling in the right arm; Numbness; Heaviness in both arms; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High BP of 294/224) and BLOOD GLUCOSE INCREASED (High blood sugar of 750) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (High BP of 294/224) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (High blood sugar of 750) (seriousness criterion medically significant), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), HEADACHE (Severe headache) and ARTHRALGIA (Right shoulder pain). On 28-Feb-2021, the patient experienced VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, BLOOD PRESSURE INCREASED (High BP of 294/224), BLOOD GLUCOSE INCREASED (High blood sugar of 750), HYPERSENSITIVITY (Severe allergic reaction), PARAESTHESIA (Tingling in the right arm), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Heaviness in both arms), VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Sore throat), HEART RATE INCREASED (Increased heart rate), DIZZINESS (Dizziness), HEADACHE (Severe headache), ARTHRALGIA (Right shoulder pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Blood glucose: 750 High. On 26-Feb-2021, Blood pressure measurement: 294/224 High. On 26-Feb-2021, Heart rate: High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment were reported.  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. However, more information is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 04-Mar-2021: No new information was updated from  follow up document.; 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. However, more information is required for further assessment.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oral pain, Pulmonary embolism, Pyrexia
Clinical narrative: Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive.         No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. 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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyskinesia, Fatigue, Headache
Clinical narrative: mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side  jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication detail was reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Memory impairment, Pain, Pain in jaw, Transient ischaemic attack
Clinical narrative: mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side  jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication detail was reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; 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.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: mini stroke; high blood pressure; difficulty recalling word; dizziness; no control over body; Shaking Arms; weakness; right side  jaw pain; soreness; exhaustion; throbbing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021. The most recent information was received on 12-Jul-2021 and was forwarded to Moderna on 12-Jul-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke) and HYPERTENSION (high blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016ZMOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced HYPERTENSION (high blood pressure) (seriousness criterion medically significant), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke) (seriousness criterion medically significant). The patient was treated with ALPRAZOLAM (XANAX) at a dose of UNK, qd. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke), HYPERTENSION (high blood pressure), MEMORY IMPAIRMENT (difficulty recalling word), DIZZINESS (dizziness), DYSKINESIA (no control over body), TREMOR (Shaking Arms), ASTHENIA (weakness), PAIN IN JAW (right side  jaw pain), PAIN (soreness), FATIGUE (exhaustion) and HEADACHE (throbbing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication detail was reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: follow up received and Updated reporter contact information. On 01-Jul-2021: The follow up document contain no new information. On 12-Jul-2021: Added newserious event (transient ischaemic attack).; 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.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID-19; Sore throat; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient tested positive for COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever). On 21-Feb-2021, the patient experienced COVID-19 (Patient tested positive for COVID-19). At the time of the report, COVID-19 (Patient tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.  The patient was scheduled to receive his second dose on 13 March 2021.  The patient received an antibody infusion on 23 February 2021.  Company Comment : 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. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.; 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. Additionaly, based on the mechanism of action of mRNA-1273 the event COVID 19 is unlikely related to the vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Urticaria
Clinical narrative: hives; Sore arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021. The most recent information was received on 07-Jul-2021 and was forwarded to Moderna on 07-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hay fever and Heartburn. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) and CALCIUM for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm). At the time of the report, URTICARIA (hives) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.2 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included medication for heart burn. No treatment products information was 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. Further information has been requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-058213 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up document received on 07-JUL-2021 contains significant information and updated patient demographics and Type of Vaccination facility and Clinic name. Added events Hypertension and Hypothyroid.; 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. Further information has been requested. US-MODERNATX, INC.-MOD-2021-058213:Case for second dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hypertension, Hypothyroidism, Injection site urticaria, Menstrual disorder
Clinical narrative: Hypothyroid; thyroiditis; Hypertension; Missed her menstrual cycle; Vaccination site pain; urticaria; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOTHYROIDISM (Hypothyroid) and THYROIDITIS (thyroiditis) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heartburn since an unknown date. Concomitant products included VITAMIN D NOS and CALCIUM for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced HYPOTHYROIDISM (Hypothyroid) (seriousness criterion medically significant) and MENSTRUAL DISORDER (Missed her menstrual cycle). 23-Mar-2021, the patient experienced THYROIDITIS (thyroiditis) (seriousness criterion medically significant), HYPERTENSION (Hypertension), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria). At the time of the report, HYPOTHYROIDISM (Hypothyroid), THYROIDITIS (thyroiditis), HYPERTENSION (Hypertension), MENSTRUAL DISORDER (Missed her menstrual cycle), VACCINATION SITE PAIN (Vaccination site pain) and INJECTION SITE URTICARIA (urticaria) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 98.2 98.2. On 23-Mar-2021, Thyroid function test: positive (Positive) Thyroiditis confirmed.         Concomitant medications include treatment for heartburn. The patient was started on medication to treat hypothyroid and hypertension.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-058198 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant follow up received on 7-JUL-2021. New events added(Hypertension, Hypothyroid) Race information added, pregnancy information added.; 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. US-MODERNATX, INC.-MOD-2021-058198:Case for first dose