chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Cerebrovascular accident, Cognitive disorder, Erythema, Facial discomfort
Clinical narrative: Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient had presented these reactions a month after their second dose of the vaccine.  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.; 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: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Peroneal nerve palsy, Pruritus, Rash
Clinical narrative: Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient had presented these reactions a month after their second dose of the vaccine.  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.; 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Headache, body ache, joint pain, fatigue and loss of appetite. Symptoms started about 2 hours after waking up. Symptoms ended by the next morning. No medication was taken during the symptoms. Regular vegetarian meals and water intake when able. Slept about 3 hours during the day and rested early night.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Myalgia, Neck pain
Clinical narrative: Extreme Debilitating Dizziness for 4 days so far as well as fatigue. Muscle pain that comes and goes in left arm, neck , upper back and both legs.  Wheezing on days 1-3.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Wheezing
Clinical narrative: Extreme Debilitating Dizziness for 4 days so far as well as fatigue. Muscle pain that comes and goes in left arm, neck , upper back and both legs.  Wheezing on days 1-3.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Biopsy bone marrow abnormal, Capsule endoscopy, Clamping of blood vessel, Colon operation
Clinical narrative: Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Colonoscopy, Death, Dizziness, Fatigue, Gastrointestinal arteriovenous malformation
Clinical narrative: Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal haemorrhage, Haematochezia, Haemoglobin decreased, Internal haemorrhage, Intestinal resection
Clinical narrative: Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Large intestinal haemorrhage, Melaena, Myelodysplastic syndrome, Occult blood positive, Platelet count decreased
Clinical narrative: Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count decreased, Transfusion
Clinical narrative: Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor.  From the date of 02/13/2021,the first COVID-19 vaccine shot,  Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection:  1) 2/25/2021 NP, received lab results which she had ordered earlier.  Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report.  Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the  ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions.  Diagnosis: Arteriouvenous Malformation in descending colon. Treatment:  4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match.   10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon.  Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days.   14) 4/14/2021 My dad died.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Musculoskeletal stiffness, Paraesthesia, Skin discolouration
Clinical narrative: I had a twinge in my neck as I sat down to wait my 30 minutes and it felt stiff.  I noticed my index and middle fingers tingling while I grocery shopped (the pharmacy is in a grocery) about 40 minutes later.  When I got to my car I saw that the tips of my index, middle and thumbs on both of my hands were turning yellowish.  I drove 5 minutes to my next destination and they were turning almost white and were very tingly/numb.  By 3:07 all of these fingers were pinking back up except the right index which was starting to turn pink again (I took a photo so that's how I have the time stamp). I also realized that my next was no longer stiff.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient died 72 hours after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died 72 hours after receiving the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 26-Apr-2021 The patient died on 26-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medication was not provided, Treatment medication was not reported.  A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported.  Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported.  Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Died 72 hours after receiving the vaccine.
Age: 68.0
Sex: F
Vaccine: SMALL
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: SIRVA -- Shoulder Injury Resulting from Vaccine Administration
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Dyskinesia, Dyspnoea, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: Immediately after administration, patient became pale diaphoretic, lost consciousness, had jerking body movements, maintained pulse and airway. Once regained consciousness, vomited 3 times. Pt was given pepcid with fathers consent. After about 10 minutes started to complain of tightness of chest, short of breath. With consent from father administered 25 mg of benadryl. Monitored for 30 minutes. Patient status returned to baseline at the end of the 30 minutes observation. encouraged to follow up with pc prior to next vaccination to weigh the risk and benefits. Afterwards, dad said patient had reactions like this in past with vaccination. Asked multiple times if wanted EMS called or transport to medical facility. Declined by father.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, Vomiting
Clinical narrative: Immediately after administration, patient became pale diaphoretic, lost consciousness, had jerking body movements, maintained pulse and airway. Once regained consciousness, vomited 3 times. Pt was given pepcid with fathers consent. After about 10 minutes started to complain of tightness of chest, short of breath. With consent from father administered 25 mg of benadryl. Monitored for 30 minutes. Patient status returned to baseline at the end of the 30 minutes observation. encouraged to follow up with pc prior to next vaccination to weigh the risk and benefits. Afterwards, dad said patient had reactions like this in past with vaccination. Asked multiple times if wanted EMS called or transport to medical facility. Declined by father.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PATIENT WAS NOT 18 YEARS OLD WHEN VACCINATED. MODERNA AGE INDICATION IS 18 YEARS OLD AND OLDER.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient fainted while doing IM COVID injection. RN called another staff to assist lowering patient to ground and elevating feet. Patient felt better after laying down. Nursing staff took vitals (supine), which were BP - 118/84, SPO2 - 97%, pulse - 48. Patient rested for a while, taking some deep breaths and putting an ice pack on the back of her neck. After approx. five minutes staff helped patient to a seated position and re-took vitals which were 122/80, SPO2 - 99%, pulse - 57. Patient drank some water and was observed for approx. 30 minutes following injection, stating she "felt better".
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and Slight Fever
Sex: F
Vaccine: COVID19
Symptoms: Encephalopathy, Seizure
Clinical narrative: encephalopathy; seizures; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALOPATHY (encephalopathy) and SEIZURE (seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C01A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Systemic lupus erythematosus since an unknown date.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced SEIZURE (seizures) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ENCEPHALOPATHY (encephalopathy) (seriousness criteria hospitalization and medically significant). At the time of the report, ENCEPHALOPATHY (encephalopathy) and SEIZURE (seizures) outcome was unknown.            Treatment information not provided. Concomitant medications were not 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.; 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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram
Clinical narrative: 1610 c/o dizziness. VSS  HR 52 regular, BP 147/91, oxygen saturation 100%. She Reports history of hypertension and Dizziness. She takes metoprolol 100mg daily. Refused offer to be transported to the ER for evaluation. 12 lead EKG done by EMT.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Day 5 after first injection my injection shit is red, swollen, hot and extremely sore and itchy.     These symptoms are now on day 4
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Ultrasound scan
Clinical narrative: I experienced a Miscarriage 03/22/2021 at five weeks pregnancy. I had gotten the second dose of the vaccine eight weeks before that.  I was unaware that I was pregnant when I miscarried. I only found out I was pregnant four days before it happened.  Due Date-09/18/2021 Pregnancy-Third
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient was instructed to wait 15 minutes before leaving the pharmacy.  During the 15 minutes, a team member on the store floor witnessed the patient faint and hit the floor.  Within 30 seconds, the patient regained consciousness and got up and sat back in the chair.  911 was called and EMS arrived within 10 minutes to evaluate the patient.  EMS determined that all his vitals were normal and allowed the patient to leave the pharmacy.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Patient has a cough that has persisted since getting the vaccine on 5/12/21
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Haemorrhage, Sleep disorder, Transfusion, Uterine contractions during pregnancy
Clinical narrative: May 4th - Therapeutic rest  - had been having contractions for a couple of days and hadn't had sleep- admitted to hospital. May 6 baby was born.  I was full term - 40 weeks and six days. I was in labor and admitted for labor and delivery. Baby was born with a vacuum assist and had some risk for jaundice but didn't get a jaundice diagnosis. Small for gestation age - Baby's size - 6 lbs and 9 oz.  I had some blood loss and did have a blood transfusion after deliver.   It was my first pregnancy.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vacuum extractor delivery
Clinical narrative: May 4th - Therapeutic rest  - had been having contractions for a couple of days and hadn't had sleep- admitted to hospital. May 6 baby was born.  I was full term - 40 weeks and six days. I was in labor and admitted for labor and delivery. Baby was born with a vacuum assist and had some risk for jaundice but didn't get a jaundice diagnosis. Small for gestation age - Baby's size - 6 lbs and 9 oz.  I had some blood loss and did have a blood transfusion after deliver.   It was my first pregnancy.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head abnormal, Encephalopathy, Generalised tonic-clonic seizure, Magnetic resonance imaging head abnormal
Clinical narrative: Grand mal seizure; encephalopathy
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Back pain, Dyspnoea, Headache, Myalgia
Clinical narrative: headache, shortness of breath, back pain, nausea, vomiting, hair loss, myalgia
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache, shortness of breath, back pain, nausea, vomiting, hair loss, myalgia
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hot flush, Neurological examination, Night sweats, Pain
Clinical narrative: Dull head pain located at the front of the head to the temples, almost like when you have a fever but without a temperature.  Severe night sweats, and have had hot flashes around the ears a few times. This has been going on since the evening of  my vaccine. The head pain is constant and the night sweats have occurred almost every night. On night one the head pain was moderate.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dull head pain located at the front of the head to the temples, almost like when you have a fever but without a temperature.  Severe night sweats, and have had hot flashes around the ears a few times. This has been going on since the evening of  my vaccine. The head pain is constant and the night sweats have occurred almost every night. On night one the head pain was moderate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Collagen-vascular disease, Seizure
Clinical narrative: Patient husband said that he found her convulsing on the kitchen floor about 4 hours after her 2nd Moderna Covid Shot.  Patient has or suspected of a hereditary collagen disease  that runs in her first line relatives and it's prone to seizure but she had never suffered of a seizure episode of before.  Paramedics were called to scene but per husband she refused to go to hospital. Paramedics instructed her to follow-up with PCP if she continues with episodes.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Swelling face
Clinical narrative: Patient reported swelling in his face as well as fever blisters on his body approximately 4 days after his vaccination. Patient reported he went to the ER  and received treatment there with steroids and antihistamines, as well as was given a prescription for the same thing to take for a few days after. Event was reported by the ER to the CDC when they were aware, and patient informed us at the site he was vaccinated on 5/20/21 of this reaction
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain
Clinical narrative: Chills, Migraine, aches, Feels like I have a fever, but don't.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperaesthesia, Influenza like illness, Pain
Clinical narrative: Feels like I have the flu. Body aches and hurts to the touch, huge headache
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia, Haemophagocytic lymphohistiocytosis, Inflammatory marker test, Lymphadenopathy, Serum ferritin increased
Clinical narrative: Anemia, Elevated Ferritin, Inflammatory markers, Transaminitis, Splenomegaly, Lymphadenopathy, HLH syndrome
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Splenomegaly, Transaminases increased
Clinical narrative: Anemia, Elevated Ferritin, Inflammatory markers, Transaminitis, Splenomegaly, Lymphadenopathy, HLH syndrome
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No adverse event.  patient was only 17 years old not 18.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Vasovagal reaction. Was observed by EMS and her symptoms resolved. She left under her own ambulation and was symptom free.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chest pain, Diarrhoea, Headache
Clinical narrative: at around 3:30 on the 18th i began to experience a bad headache, in the middle of night my joints started to ache. after eating a light protein dinner i had diarreha. the morning of the 19th headache still with me, back of neck and burning under arm area, at about 5:30 i began to run 102.3 fever took some tylenol. at 1:35 i woke to burning across my chest into breast (had sensation like you get when you breastfeed a baby) the very tender and hurt closer down towards ribs. Woke up drenched in sweat and body aches the morning of 20th still have same symptoms as day before constantly sweating and nausea.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Neck pain, Pain, Pyrexia
Clinical narrative: at around 3:30 on the 18th i began to experience a bad headache, in the middle of night my joints started to ache. after eating a light protein dinner i had diarreha. the morning of the 19th headache still with me, back of neck and burning under arm area, at about 5:30 i began to run 102.3 fever took some tylenol. at 1:35 i woke to burning across my chest into breast (had sensation like you get when you breastfeed a baby) the very tender and hurt closer down towards ribs. Woke up drenched in sweat and body aches the morning of 20th still have same symptoms as day before constantly sweating and nausea.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Fall
Clinical narrative: Patient received the vaccine and proceeded to walk to the front of the store.  He describes the experience as his ears stopped hearing and he fell to his knees (passed out).  Patient did not report that he had been hurt in any way.  He came back to the pharmacy where we had him sit with his legs up.  He already had a bottle of water and was drinking.  Patient's blood pressure was a bit elevated 139/104.  He declined a second blood pressure check.  He stayed waiting for approximately 15 minutes then felt well enough to leave.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Patient has cough that has persisted since getting the vaccination on 05/12/21
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear congestion, Hyperacusis, Tinnitus
Clinical narrative: 05/14/2021  Sudden hearing loss in left ear.  Pressure in ear.   Sound amplified in right ear.  In evening schirping starts in left ear.  Progresses to constant static and sound of trickling water by next morning.  As of 05/20/2021 conditions have remained stable: hearing loss and tinnitus the same.   No history of hearing related issues.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Patient DOB: 11/25/2001. Received his first dose Pfizer (LOT#: EW0185 EXP: 8/2021) at 0920on 5/18/21. Patient alerted EMT. Patient stated that he felt light headed and also felt anxious. Patient stated that he had not had not eaten in the morning. EMT took patients vital signs at 0928. BP: 138/82 pulse: 75, O2: 98%. Patient was given water, juice and food. Patient was placed in zero gravity chair. Patient was asked to stay an extra 30 minutes for further observation. EMT reassessed and re-took vital signs at 0945. BP: 132/74, pulse: 76, O2: 98%. Patient stated he was feeling better and only slightly felt the symptoms. Patient was educated on worsening signs and symptoms of vaccine and when to seek EMS or urgent care. Patient verbalized understanding of education. Patient left vaccination site at 0947 before the 30 minute observation was completed. PHN educated patient that he was leaving AMA. Patient insisted on leaving and was feeling better. Patient left vaccination site unassisted and with a steady gait.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Malaise
Clinical narrative: Patient felt warm and did not feel well.   The pharmacy staff gave the patient a bottle water and ice pack.  After 30 min, the symptoms significantly decreased and the patient felt fine.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure like phenomena
Clinical narrative: Siezure like activity.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Disorientation, Electrocardiogram normal, Hypersomnia, Palpitations
Clinical narrative: Fever of 103.5. Disoriented. Slept 20 hours. Heart palpitations lasting several days. Extreme thirst lasting several weeks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Thirst
Clinical narrative: Fever of 103.5. Disoriented. Slept 20 hours. Heart palpitations lasting several days. Extreme thirst lasting several weeks.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dysgeusia, Fatigue, Injection site pain
Clinical narrative: unfamiliar taste in mouth accompanied by excessive salivation within approx 5 minutes of shot, severe muscle weakness at injection site within approx 4 hours followed by severe muscle soreness/pain that gradually recovered over 2.5 days, fatigue/tiredness for 2 days, gastrointestinal upset and diarrhea starting within approximately 5 hours of shot and lasting approximately 5 days
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Muscular weakness
Clinical narrative: unfamiliar taste in mouth accompanied by excessive salivation within approx 5 minutes of shot, severe muscle weakness at injection site within approx 4 hours followed by severe muscle soreness/pain that gradually recovered over 2.5 days, fatigue/tiredness for 2 days, gastrointestinal upset and diarrhea starting within approximately 5 hours of shot and lasting approximately 5 days
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Computerised tomogram, Ecchymosis, Electrocardiogram, Fall
Clinical narrative: After Pfizer vaccination patient was being observed for 15 minutes for  adverse reaction. Patient passed out and fell face first to the floor. Patients nose  was bleeding. A rapid response was called. Patient was placed in a wheelchair and taken to  the ER.Patient  normal vitals on presentation. Not acutely toxic appearing.  Exam with mild ecchymoses along the left maxilla and along the left neck  concerning for possible head injury. EKG shows sinus bradycardia. Head CT shows  no evidence of acute intracranial hemorrhage. It does note a posterior left  orbital floor fracture with blood in the left maxillary sinus. He has no evidence  of visual acuity changes or visual complaints. No signs of entrapment. Feel he is  stable for discharge at this time. I spoke with on-call ophthalmology, doctor. He states that the patient walk-in tomorrow for follow-up.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nasal injury
Clinical narrative: After Pfizer vaccination patient was being observed for 15 minutes for  adverse reaction. Patient passed out and fell face first to the floor. Patients nose  was bleeding. A rapid response was called. Patient was placed in a wheelchair and taken to  the ER.Patient  normal vitals on presentation. Not acutely toxic appearing.  Exam with mild ecchymoses along the left maxilla and along the left neck  concerning for possible head injury. EKG shows sinus bradycardia. Head CT shows  no evidence of acute intracranial hemorrhage. It does note a posterior left  orbital floor fracture with blood in the left maxillary sinus. He has no evidence  of visual acuity changes or visual complaints. No signs of entrapment. Feel he is  stable for discharge at this time. I spoke with on-call ophthalmology, doctor. He states that the patient walk-in tomorrow for follow-up.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fear of injection, Headache, Hyperhidrosis, Loss of consciousness
Clinical narrative: Roughly 5 minutes after vaccination patient said he started to feel lightheaded, patient started to pass out but we got him to a laying flat position fast enough that I'm not sure if he fully passed out. Patient immediately could verify his name, DOB, what just happened etc. Declined any symptoms that would indicate any form of allergic reaction. Said he felt dizzy/lightheaded/sweaty. Sat patient up after a couple minutes and took a blood pressure. It read 103/52. Patient then informed me he does pass out after shots. He says he doesn't get vaccines because of his fear of needles but in the past when he had a shot for a medication he has passed out. Took another blood pressure about 10 minutes later which read 126/86. Patient also informed me he hadn't ate/drank anything all day and did work all day prior. Got patient a pop to help with any low blood sugar. Patient had a friend pick him up, didn't want an ambulance, said he felt fine after 30ish minutes passed by besides a minor headache.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Pt had itchiness all over the body but more on the upper part of the body including chest, arms, ears, and face.  These symptoms lasted for 2 days.  She says it was mild and she did not break out. There were no hives or shortness of breath.  Patient used claritin on day 2 and it went away after 1 dose.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Injection site pain, Mobility decreased, Pyrexia, Somnolence
Clinical narrative: High fever approximately 12 hours after injection of second shot and drowsiness approximately 4 hours after injection. During the fever, had significant trouble walking and moving any part of body. Significant arm soreness at site of injection.  All symptoms resolved themselves within 24 hours of receiving the vaccine aside from the arm soreness which resolved itself within 72 hours.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash
Clinical narrative: 15 minutes after shot, rash on torso (front and back) and neck, red flush on face.  Seen at County site by EMT for 1 hour.  No SOB, alert.  Rash lessened after 1 hour, dissipated entirely after 3 hours.  Patient advised to contact PCP and not to have second dose.  PCP notified 2/24/2021,  reiterated not to take second dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: 15 minutes after shot, rash on torso (front and back) and neck, red flush on face.  Seen at County site by EMT for 1 hour.  No SOB, alert.  Rash lessened after 1 hour, dissipated entirely after 3 hours.  Patient advised to contact PCP and not to have second dose.  PCP notified 2/24/2021,  reiterated not to take second dose.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash morbilliform
Clinical narrative: 15 minutes after shot, rash on torso (front and back) and neck, red flush on face.  Seen at County site by EMT for 1 hour.  No SOB, alert.  Rash lessened after 1 hour, dissipated entirely after 3 hours.  Patient advised to contact PCP and not to have second dose.  PCP notified 2/24/2021,  reiterated not to take second dose.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Paraesthesia oral, Swollen tongue
Clinical narrative: After my 30 minute observation period, I left the facility. Shortly after leaving the Campus, I felt my lips begin to tingle and noticed my face was hot and turning red. As I was pulling over to the side of the road to pull medication from my purse, my symptoms increased and my tongue began to swell.  I took two Benadryl gel-caps and waited to see if my symptoms would calm or if I would need my epi pen . The Benadryl calmed the response and I continued home. This was approximately 40 minutes after my vaccination. When I have an anaphylactic reaction to pork, tuna, or shell fish, the reaction time is typically much closer to the event, but the reaction sequence is similar.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Mixed series. PT received a dose of Moderna on 4/22/2021 and a dose of Pfizer 5/20/2021
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypotension, Syncope
Clinical narrative: Patient experienced fainting symptoms immediately after administration of vaccine. Further investigation showed patient had low blood pressure 73/57 mm Hg.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Vaccination site pruritus
Clinical narrative: I have been feeling itchy at the injection site; My menstrual cycle was off this month. I was three weeks late; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 07Apr2021 at 08:45 (at age of 45 years old, no pregnant at time of vaccination, Lot Number: EP7533) as a single dose for covid-19 immunization. Medical history included cholesterol high. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not had been tested for COVID-19. Concomitant medication included fenofibrate. The patient had been feeling itchy at the injection site on 08Apr2021. It comes and goes and was not that serious. Also she think it was worth mentioning that her menstrual cycle was off this month in Apr2021. She was three weeks late. No treatment received for the events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gout, Pain in extremity, Peripheral swelling
Clinical narrative: developed gout; left toe joint pain; left toe joint pain; a swollen foot; This is a spontaneous report from a contactable consumer. This consumer reported that a 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 15Apr2021 as single dose for COVID-19 immunization. Medical history included he had an episode of gout last year but it only lasted one day. Concomitant medications were not reported. The patient received bnt162b2 and the next day he developed gout including left toe joint pain and a swollen foot. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip swelling, Muscle spasms, Palpitations, Throat tightness
Clinical narrative: immediately felt her heart race; her throat got really tight; lips were swollen the next day; one leg (left leg) felt numb or asleep for 4 days; tiny muscle jumps; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route in right arm single dose for COVID-19 immunisation on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. After the first vaccine dose to right arm, the patient immediately felt her heart race. She reported that they watched her for a while (around for 1 hour) her heart was pounding. The patient reported that she took a diphenhydramine hydrochloride (BENADRYL) prior to going on the advice of her doctor. She reported that it got better but then once she got home, 3 hours later her throat got really tight and stayed that way for "quite a while". She reported that when that finally resolved she went to bed but when she woke up her "lips were swollen the next day". The patient reported that one leg (left leg) felt numb or asleep for 4 days and both legs had "tiny muscle jumps". Outcome of the event heart race was resolving, outcome of the event throat got really tight was resolved, outcome of the other events was unknown.  No Follow-up attempts are needed. No further information is expected.