chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess.   09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now.   The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration.   Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home.  Allergy added to patient chart.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Inflammation
Clinical narrative: Patient reports a skin rash on right arm, feels burning. I took Benadryl however still had symptoms, Saturday the 19th I went to the emergency room at the clinic and they prescribed Dexamethasone  and a Lotrisone cream. She felt no improvement because of what happened on Sunday and they injected Benadryl and Solumedrol in addition to a medication for headache. As a home treatment they gave her a Medrol dose pack
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Rash
Clinical narrative: Patient reports a skin rash on right arm, feels burning. I took Benadryl however still had symptoms, Saturday the 19th I went to the emergency room at the clinic and they prescribed Dexamethasone  and a Lotrisone cream. She felt no improvement because of what happened on Sunday and they injected Benadryl and Solumedrol in addition to a medication for headache. As a home treatment they gave her a Medrol dose pack
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: DOSE ADMINISTERED TO MINOR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced dose administered to minor. On 21-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered to minor and off label use was not reported. This report was non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: DOSE ADMINISTERED TO MINOR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287, and expiry: UNKNOWN) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced dose administered to minor. On 21-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose administered to minor and off label use was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Energy increased
Clinical narrative: pt. had good results from vax , had super energy , cleaned and  felt like she had extreme energy .  After about 05;00 pm her energy  dissipated  when pt laid down heart felt like it was beating hard., only adverse event is left arm has a tingle  that feels like electrical pulse that last seconds..
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Energy increased, Palpitations, Paraesthesia
Clinical narrative: pt. had good results from vax , had super energy , cleaned and  felt like she had extreme energy .  After about 05;00 pm her energy  dissipated  when pt laid down heart felt like it was beating hard., only adverse event is left arm has a tingle  that feels like electrical pulse that last seconds..
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Received 1st injection on lunch break around noon.   Went back to work and a few hours later I felt light pressure on left side beneath left breast.  The pressure became worse and felt tight.  It became hard to breathe. I kept trying to take breaths but could not get enough air. It was frightening so I went and told one of the doctors I work with what I was feeling.  He told another doctor.  They both told me I may be experiencing anxiety as I wouldn?t be able to feel reactions from the vaccination so soon.   I can?t tell you exactly how long this tight/pressure hard-to-breathe feeling lasted but it was enough to make me lightheaded.  It was enough to make me call the number on the Pfizer booklet they gave me but the number took me to a hotline and it was confusing and there wasn?t a clear option to talk to someone to tell them what I was experiencing.  I also had to continue working.    I was so happy when my chest started to gradually feel less pressure.  Then breathing became easier.   I was tired after I went home and experienced soreness at the site of injection after approXimately 5 pm.  This was serious and now that I had a abnormal EKG and am scheduled for an echocardiogram, makes me wonder if what I felt was due to the vaccination.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Received 1st injection on lunch break around noon.   Went back to work and a few hours later I felt light pressure on left side beneath left breast.  The pressure became worse and felt tight.  It became hard to breathe. I kept trying to take breaths but could not get enough air. It was frightening so I went and told one of the doctors I work with what I was feeling.  He told another doctor.  They both told me I may be experiencing anxiety as I wouldn?t be able to feel reactions from the vaccination so soon.   I can?t tell you exactly how long this tight/pressure hard-to-breathe feeling lasted but it was enough to make me lightheaded.  It was enough to make me call the number on the Pfizer booklet they gave me but the number took me to a hotline and it was confusing and there wasn?t a clear option to talk to someone to tell them what I was experiencing.  I also had to continue working.    I was so happy when my chest started to gradually feel less pressure.  Then breathing became easier.   I was tired after I went home and experienced soreness at the site of injection after approXimately 5 pm.  This was serious and now that I had a abnormal EKG and am scheduled for an echocardiogram, makes me wonder if what I felt was due to the vaccination.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Nausea
Clinical narrative: Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sickness
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain at injection site and entire leg, Nausea, severe exhaustion, chills, general feeling of sickness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus: loud static with occasional ringing. Static 24/7. Louder at night. Is subsiding but still there.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Dyspnoea, Electrocardiogram abnormal, Insomnia
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Troponin increased
Clinical narrative: chest pain. myocarditis. elevated troponin
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I have been having mild fever for a week after my vaccination
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin decreased, Heavy menstrual bleeding, Immune thrombocytopenia
Clinical narrative: The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Platelet count decreased, Platelet transfusion
Clinical narrative: The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Transfusion, White blood cell count decreased
Clinical narrative: The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune neutropenia, Biopsy bone marrow normal, Dizziness, Haemoglobin decreased, Heavy menstrual bleeding
Clinical narrative: The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia, Neutrophil count decreased, Platelet count decreased, Vaccination complication
Clinical narrative: The week after vaccination I was admitted into the hospital for severe menstrual bleeding. My CBC result shows a platelet count of 17 10*3/uL, accompanied by low white blood cell and red blood cells count. I received multiple transfusions (2 units of whole blood and one unit of platelets), and was diagnosed with ITP.  I then received steroid treatment (Dexamethasone, 40mg/day,  4days), after which my blood counts are restored.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Adenovirus test, Alanine aminotransferase normal, Anion gap decreased, Aspartate aminotransferase increased, Basophil count decreased
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Basophil percentage, Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood glucose normal
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood phosphorus normal, Blood potassium normal, Blood sodium normal, Blood urea normal, Brain natriuretic peptide increased
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, C-reactive protein increased, Carbon dioxide normal, Cardiac telemetry normal, Chest pain
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chlamydia test negative, Coronavirus test negative, Differential white blood cell count, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram PR interval, Electrocardiogram QT interval, Electrocardiogram RR interval, Electrocardiogram ST segment elevation
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Enterovirus test, Eosinophil count decreased, Eosinophil percentage, Full blood count
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Human metapneumovirus test, Human rhinovirus test, Influenza A virus test negative
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza B virus test, Influenza virus test negative, Injection site pain, Intensive care, Lymphocyte count normal
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphocyte percentage increased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Mean platelet volume normal
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Monocyte count decreased, Monocyte percentage increased, Mycoplasma test negative, Neutrophil count normal
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Neutrophil percentage decreased, Platelet count normal, Polymerase chain reaction, Protein total normal, Pyrexia
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: QRS axis, Red blood cell count normal, Red blood cell nucleated morphology, Red cell distribution width normal, Respiratory syncytial virus test negative
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel, Respirovirus test, Sinus arrhythmia, Sinus rhythm, Troponin I increased
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Viral test negative, White blood cell count normal
Clinical narrative: Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report  on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital,  initially monitored with telemetry, troponin levels every 6 hours and started on scheduled ibuprofen.  Troponin peaked at 22.82 first hospital night on 6/18, then down-trending. Telemetry was without any ectopy. Symptoms improved and hemodynamically stable throughout his PICU course.  Transferred to the pediatric floor on 6/19, continued to do well. Discharged on 6/20 with troponin of 5.92 ng/mL and EF of 55-60% on ECHO.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chills, Gait inability, Headache, Hyperventilation
Clinical narrative: Approx 12 hours after second dose of Pfizer COVID vaccine, my son experienced severe chills (teeth chattering so bad he couldn?t talk) , heart palpitations, said his heart hurt so bad he was crying, rapid uncontrollable breathing, fever, headache (said his head felt like it was going to pop), aches and pains to the point he couldn?t walk.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: Approx 12 hours after second dose of Pfizer COVID vaccine, my son experienced severe chills (teeth chattering so bad he couldn?t talk) , heart palpitations, said his heart hurt so bad he was crying, rapid uncontrollable breathing, fever, headache (said his head felt like it was going to pop), aches and pains to the point he couldn?t walk.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test, Chest X-ray normal, Chest discomfort, Electrocardiogram normal
Clinical narrative: heavy feeling on left side of chest. Went to care facility, they did a chest xray and EKG and gave me an aspirin then sent me to the ER. At the ER they did and EKG and blood work, did not find anything of concern. They sent me for a stress test, no problems found.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: I did end up getting Covid in May. I had a stuffy nose, which was easily kept at bay with mucinex and nasal spray. Nausea and vomiting and malaise. I?m assuming this is the the reaction the message on my phone was about.Otherwise, I don?t know what the message was talking about, and no one ever answers the phone there.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Heart rate increased
Clinical narrative: Headache, chest tightness and discomfort, elevated heart rate (resting heart rate bpm in the high 90s as measured by a home pulse oximeter). Resolved  the following day, resting heart rate back to low 80s.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: Fainted in the car, went to urgent care with chest pains, shortness of breath, trouble breathing (needed oxygen)  elevated and rapid heart rate, ringing in ears, numbness in left hand, arm and feet, blotches on arms and legs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Laboratory test abnormal, Platelet count decreased, Rash macular
Clinical narrative: Fainted in the car, went to urgent care with chest pains, shortness of breath, trouble breathing (needed oxygen)  elevated and rapid heart rate, ringing in ears, numbness in left hand, arm and feet, blotches on arms and legs.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tinnitus
Clinical narrative: Fainted in the car, went to urgent care with chest pains, shortness of breath, trouble breathing (needed oxygen)  elevated and rapid heart rate, ringing in ears, numbness in left hand, arm and feet, blotches on arms and legs.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rhinorrhoea, Vomiting
Clinical narrative: Runny nose, tiredness and vomiting
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Extrasystoles, Heart rate irregular
Clinical narrative: Irregular heartbeat. Skip heartbeats.  Went to 180/mins for a few mins while sitting still. It happened several times.  I went to the hospital and ER but no cause can be found.  I scheduled the cardiologist and nothing found.  I wore the Zio heart monitor for two weeks from June 3rd to June 17th. The device was sent to the doctor and no result yet. I still feel the skip and irregular beats every day.  Hope I can get some results this time.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdomen scan, Blood test, Herpes zoster
Clinical narrative: Shingles
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Myalgia, Pain, Pyrexia
Clinical narrative: Had fever after first shot. Body ache, headache and muscle pain after 2nd shot. No period since then . Last period was on January 18th, 2021. Period abruptly stopped
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Swelling
Clinical narrative: I am having swelling  and discomfort on left side of my body  since getting the Pfizer vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cough, Heart rate increased
Clinical narrative: Severe cough, chest pain, rapid heart rate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Tachycardia
Clinical narrative: Next day: tachycardia, short of breath, fatigue exerrtonal fatigue
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Redness, swelling, and itchiness surrounding area of the vaccination shot roughly an hour or so after injection (continuing as of the present time, 11:41 PM 6/22/2021)
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles diagnosis 4 weeks after receiving the second shot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Dizziness, Headache, Heart rate irregular
Clinical narrative: 102 fever-2 days Intense lower center abdominal pain-7 days Body ache-3 days Diarrhea-7 days Headache-5 days Low blood pressure-3 days Irregular hearbeat-7 days Light-headed-5 days "Covid arm" extending elbow to shoulder-back of arm to front of arm-3 days
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Pain, Pyrexia
Clinical narrative: 102 fever-2 days Intense lower center abdominal pain-7 days Body ache-3 days Diarrhea-7 days Headache-5 days Low blood pressure-3 days Irregular hearbeat-7 days Light-headed-5 days "Covid arm" extending elbow to shoulder-back of arm to front of arm-3 days
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, SARS-CoV-2 test
Clinical narrative: Excessive , uncontrollable bleeding; This is a spontaneous report from a contactable consumer (patient).    A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date not provided), 2nd dose via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Lot Number: EW0151) at age of 34 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. Medical history included anxiety. Concomitant medication included paroxetine hydrochloride (PAXIL).  The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, date as a single dose for covid-19 immunisation and No reaction on previous exposure to drug. The patient experienced excessive, uncontrollable bleeding on 27May2021 18:15 with outcome of recovering.  The patient was hospitalized for the event for 3 days. The patient underwent lab tests and procedures which included Nasal swab: negative on an unknown date. The patient received Blood transfusion and Premarin as treatment for the event. The event was resulted to visit Emergency room/department or urgent care. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine.  Information on the lot/batch was available, further information has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Blood pressure decreased, Blood pressure measurement
Clinical narrative: Appendicitis; Drop in Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 29-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.     Concurrent medical conditions included Irritable bowel syndrome, Anxiety and Blood pressure high.   On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced BLOOD PRESSURE DECREASED (Drop in Blood Pressure). On 03-Jun-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in June 2021 due to APPENDICITIS. The patient was treated with Surgery for Appendicitis. On 09-May-2021, BLOOD PRESSURE DECREASED (Drop in Blood Pressure) had resolved. On 04-Jun-2021, APPENDICITIS (Appendicitis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: drop (Low) Drop in Blood Pressure.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  The patient stated that abdomen started hurting really bad. The patient went to the emergency room and diagnosed it as appendicitis. The patient had emergency surgery to remove appendix and recovering well. The patient was not sure if the appendicitis was because of the first 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.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: The follow up document was received from the initial reporter: New event blood pressure drop and lab data were 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.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP reporting a temperature excursion for PROQUAD and reports a dose of PROQUAD was administered to a patient; Caller reported no additional AE/PQC at time of call; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage regimen was not reported), lot # T005401 (rHA) and expiration date 12-AUG-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 80 degree fahrenheit (°F) for 23 hours; no previous temperature excursions were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Incorrect dose administered by device, No adverse event, Syringe issue
Clinical narrative: No additional adverse events reported; patient received a partial dose of PEDVAX HIB and a repeat dose was administered; patient received a partial dose of PEDVAX HIB and a repeat dose was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 17-JUN-2021, a nurse had a malfunction with a non-Merck syringe, so the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T026067, expiration date 01-APR-2023; strength, dose and anatomical location were not reported) intramuscularly for prophylaxis which was not given in its entirety (incorrect dose administered by device). It could not confirm exact issue with syringe and reports it could have been user error. On the same day, the patient was vaccinated with a repeat dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 ml, lot# T026067, expiration date 01-APR-2023; strength and anatomical location were not reported) intramuscularly for prophylaxis (extra dose administered). Agent confirmed no product quality complaint with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). No further information provided. No additional adverse events reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details are available.; a dose which expired on 6/10/2021 was administered to a patient on 6/17/2021; This spontaneous report has been received from an administrator referring to a 6 years old patient of unknown gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 17-JUN-2021, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 mL, lot # S029542 has been verified to be a valid lot number, expiration date: 10-JUN-2021; strength and route were not provided) for prophylaxis (expired product administered). The reporter denied any temperature excursions for the product. No additional adverse event (AE) details are available. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional information; VAQTA was administered 4 days after its expiration date; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 08-JUN-2021, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) (expiration date 04-JUN-2021; strength, dose, route of administration, anatomical location and lot# were not reported) for prophylaxis, which was administered 4 days after its expiration date (expired product administered). No product quality complaint (PQC) was involved. No additional information (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine snd has gotten shingles every year since/suspected vaccination failure; has gotten shingles every year since / badly; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that his/her friend got the vaccine and has gotten shingles every year since badly. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: Got 1st / shot May 15th, got shingles June 3rd / in & around eye; Got 1st / shot May 15th, got shingles June 3rd / scalp, & side of head & face; This case was reported by a consumer via media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th May 2021, the patient received the 1st dose of Shingrix. On 3rd June 2021, 19 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient got Shingles in and around left eye, scalp, and side of head and face 2 weeks later after Shingrix vaccination.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colitis ulcerative, Crohn's disease, Feeling abnormal, Influenza, Lactose intolerance
Clinical narrative: Colitis ulcerative aggravated; Crohn's disease aggravated; Lactose intolerance; FELT TERRIBLE/SO BAD; ACHES AND PAINS; LIKE A BAD FLU; This case was reported by a consumer via other manufacturer and described the occurrence of colitis ulcerative aggravated in a 68-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Previously administered products included Humira (received Humira on unknown date in 2005). Concurrent medical conditions included lactose intolerance, crohn's disease and ulcerative colitis.   On an unknown date, the patient received Hz/su + AS01B and COVID-19 VACCINE (intramuscular). On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced colitis ulcerative aggravated (serious criteria GSK medically significant), crohn's disease aggravated (serious criteria GSK medically significant), lactose intolerance, feels awful, pain and influenza. On an unknown date, the outcome of the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, pain and influenza were unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, feels awful, pain and influenza to be related to Hz/su + AS01B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had medical history of lactose intolerance and crohn's disease. The patient received Shingrix, Covid 19 vaccine and experienced lactose intolerance, crohn's disease aggravated, ulcerative colitis aggravated, felt terrible and bad flu. It was unknown if the reporter considered the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, feels awful, pain and influenza-like symptoms to be related to Covid-19 vaccine
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: Colitis ulcerative aggravated; Crohn's disease aggravated; Lactose intolerance; FELT TERRIBLE/SO BAD; ACHES AND PAINS; LIKE A BAD FLU; This case was reported by a consumer via other manufacturer and described the occurrence of colitis ulcerative aggravated in a 68-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   Previously administered products included Humira (received Humira on unknown date in 2005). Concurrent medical conditions included lactose intolerance, crohn's disease and ulcerative colitis.   On an unknown date, the patient received Hz/su + AS01B and COVID-19 VACCINE (intramuscular). On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced colitis ulcerative aggravated (serious criteria GSK medically significant), crohn's disease aggravated (serious criteria GSK medically significant), lactose intolerance, feels awful, pain and influenza. On an unknown date, the outcome of the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, pain and influenza were unknown and the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, feels awful, pain and influenza to be related to Hz/su + AS01B.  Additional details were provided as follows: The age at vaccination was not reported. The patient had medical history of lactose intolerance and crohn's disease. The patient received Shingrix, Covid 19 vaccine and experienced lactose intolerance, crohn's disease aggravated, ulcerative colitis aggravated, felt terrible and bad flu. It was unknown if the reporter considered the colitis ulcerative aggravated, crohn's disease aggravated, lactose intolerance, feels awful, pain and influenza-like symptoms to be related to Covid-19 vaccine