chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Pericardial effusion, Pleural effusion, Pleurisy, Pulmonary oedema
Clinical narrative: After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May).  Early June, patient experienced burning chest pain & difficulty breathing.  Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL).  Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion.  Patient was transferred to hospital for higher level of care.  Unknown if cardiac effects are related to vaccination or acute disease process.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory viral panel, Right ventricular failure, SARS-CoV-2 test positive, Troponin
Clinical narrative: After fully vaccinated, patient vacationed and had a negative test prior to return home (end of May).  Early June, patient experienced burning chest pain & difficulty breathing.  Found to be COVID positive, with elevated cardiac enzymes (troponin 0.45ng/mL).  Echocardiogram showed pleural effusion, pleurisy, acute congestive right ventricular heart failure, possible myocarditis vs. severe pulmonary vascular edema, and scant pericardial effusion.  Patient was transferred to hospital for higher level of care.  Unknown if cardiac effects are related to vaccination or acute disease process.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Magnetic resonance imaging heart, Troponin, Troponin increased
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram normal, Electrocardiogram abnormal, Full blood count
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging heart, Magnetic resonance imaging normal, Respiratory viral panel, SARS-CoV-2 test, Troponin increased
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound chest
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram, Myocarditis, Troponin, Troponin increased
Clinical narrative: Patient developed chest pain, I called our doctor's office and the nurse said to take him to the ER. They did EKG, blood tests, covid tests and other respiratory infection tests. His EKG was abnormal and troponin was high, the troponin continued to rise so he was admitted on the afternoon of the 5th. He was hopsitalized for four days. He had echo cardiograms, chest mri, multiple blood tests. He was treated with tordol and ibprophen. He is being treated at home with rest and Ibprophen. We have many follow up cardiologist appointments and he has to avoid exercise for up to 6 months.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 62 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 (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This report was associated with product quality complaint : 90000181992 The suspected product quality complaint has been confirmed to be confirmed no pqc was identified within the reported complaint reported. complaint is approved for void. void:y based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210613893.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Chest Pains, Myocarditis, Troponin level at 240 and then went down to 170, EKG at Emergency Room
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram normal, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Chest Pains, Myocarditis, Troponin level at 240 and then went down to 170, EKG at Emergency Room
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest Pains, Myocarditis, Troponin level at 240 and then went down to 170, EKG at Emergency Room
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Hypoaesthesia
Clinical narrative: sharp pain that was radiating from the back side of her left ear; Headache; brief sensation of a frozen face on the left side; also felt shortness of breath and she felt dizzy; also felt shortness of breath and she felt dizzy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an unspecified route of administration in the left arm on 01Jun2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Jun2021 (approximately after 30 minutes), the patient experienced brief sensation of a frozen face on the left side, she also felt shortness of breath and felt dizzy. Patient also experienced sharp pain that was radiating from the back side of her left ear and even though the frozen feeling went away after a few seconds to a minute or so the pain lasted for longer. On 02Jun2021, patient felt that pain from time to time. The patient reported that the frozen face feeling started 30 minutes after she was given the COVID vaccine and lasted for less than one minute. Probed for outcome of the sharp pain and she said that currently it was less sharper compared to yesterday, it was a little bit more dull compared to yesterday (01Jun2021). It was not frequent but she could feel it from time to time. She said these went away when the frozen face was gone. The patient stated that she had never experienced this kind of frozen face before. She was on medication but it was a medication that she had been taking and she didn't think that she had ever experienced this before. The only symptoms that she could feel on the day of reporting (02Jun2021) was a slight headache, but she took Tylenol and it had been helping. She felt like maybe she had a fever kind of but she took Tylenol and she did not actually had a fever. The outcome of the brief sensation of a frozen face on the left side, felt shortness of breath and felt dizzy was recovered on 01Jun2021 while for the other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Dizziness, Dyspnoea, Ear pain, Headache
Clinical narrative: sharp pain that was radiating from the back side of her left ear; Headache; brief sensation of a frozen face on the left side; also felt shortness of breath and she felt dizzy; also felt shortness of breath and she felt dizzy; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0180), via an unspecified route of administration in the left arm on 01Jun2021 as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Jun2021 (approximately after 30 minutes), the patient experienced brief sensation of a frozen face on the left side, she also felt shortness of breath and felt dizzy. Patient also experienced sharp pain that was radiating from the back side of her left ear and even though the frozen feeling went away after a few seconds to a minute or so the pain lasted for longer. On 02Jun2021, patient felt that pain from time to time. The patient reported that the frozen face feeling started 30 minutes after she was given the COVID vaccine and lasted for less than one minute. Probed for outcome of the sharp pain and she said that currently it was less sharper compared to yesterday, it was a little bit more dull compared to yesterday (01Jun2021). It was not frequent but she could feel it from time to time. She said these went away when the frozen face was gone. The patient stated that she had never experienced this kind of frozen face before. She was on medication but it was a medication that she had been taking and she didn't think that she had ever experienced this before. The only symptoms that she could feel on the day of reporting (02Jun2021) was a slight headache, but she took Tylenol and it had been helping. She felt like maybe she had a fever kind of but she took Tylenol and she did not actually had a fever. The outcome of the brief sensation of a frozen face on the left side, felt shortness of breath and felt dizzy was recovered on 01Jun2021 while for the other events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: she received 6 times more than the recommended dose; This is a spontaneous report from a contactable nurse. A 21-years-old female patient (reporters' niece) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 03Jun2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jun2021, the patient had overdose accidental. The reporter stated that her niece received the first dose of the Pfizer BioNTech Covid-19 Vaccine, but the vaccination site informed them that she received 6 times more than the recommended dose. They did not specify if the vaccine was undiluted. The reporter wanted to know if there is a need to proceed with the 2nd dose of the Pfizer BioNTech Covid-19 vaccine, after getting a higher than recommended (6x) dose of the first one. The outcome of the event was unknown.   Follow-up actions are needed. Further information is requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Overdose accidental and the suspect drug BNT162B2.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose
Clinical narrative: she received 6 times more than the recommended dose; This is a spontaneous report from a contactable nurse. A 21-years-old female patient (reporters' niece) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 03Jun2021 as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 03Jun2021, the patient had overdose accidental. The reporter stated that her niece received the first dose of the Pfizer BioNTech Covid-19 Vaccine, but the vaccination site informed them that she received 6 times more than the recommended dose. They did not specify if the vaccine was undiluted. The reporter wanted to know if there is a need to proceed with the 2nd dose of the Pfizer BioNTech Covid-19 vaccine, after getting a higher than recommended (6x) dose of the first one. The outcome of the event was unknown.   Follow-up actions are needed. Further information is requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Overdose accidental and the suspect drug BNT162B2.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle contractions involuntary, Muscle twitching
Clinical narrative: After 2 hours of receiving the second vaccine, Patient started to experience involuntary movement at the left arm where she received the injection. It escalated that either the left arm, the right arm, or the neck was involved in the involuntary movements. I have video evidence available upon request. Upon arrival at the ER, various visual tests were performed and after 2 hours and after consulting a pediatric neurosurgeon, Benadryl 20 mg was provided. The symptoms slowly subsided but repeated within 24 hours and 40 hours. A CT scan, full blood, and urine analysis were completed and everything came back with normal results. We visited her pediatrician on Tuesday and a Pediatric Neurologist on Wednesday following the incident, where an EEG was made.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram normal, Dyskinesia, Electroencephalogram normal, Urine analysis normal
Clinical narrative: After 2 hours of receiving the second vaccine, Patient started to experience involuntary movement at the left arm where she received the injection. It escalated that either the left arm, the right arm, or the neck was involved in the involuntary movements. I have video evidence available upon request. Upon arrival at the ER, various visual tests were performed and after 2 hours and after consulting a pediatric neurosurgeon, Benadryl 20 mg was provided. The symptoms slowly subsided but repeated within 24 hours and 40 hours. A CT scan, full blood, and urine analysis were completed and everything came back with normal results. We visited her pediatrician on Tuesday and a Pediatric Neurologist on Wednesday following the incident, where an EEG was made.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and no health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 13:47 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 08-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 inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and no health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 13:47 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 08-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 inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in left arm
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, C-reactive protein increased, Chest discomfort, Chest pain, Cold sweat
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Intensive care, Myocarditis, Pain in extremity
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pallor, Palpitations, Pyrexia, Troponin, Viral test
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram abnormal
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Troponin I increased, Vaccination complication
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Adenovirus test, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bordetella test negative, C-reactive protein increased, Cardiac telemetry, Chest discomfort, Chest pain
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chlamydia test negative, Cold sweat, Cytomegalovirus test negative, Drug screen positive, Echocardiogram normal
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Enterovirus test negative, Epstein-Barr virus test negative, Human metapneumovirus test, Human rhinovirus test
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Influenza A virus test negative, Influenza B virus test, Intensive care, Laboratory test, Mycoplasma test negative
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pain in extremity, Pallor, Palpitations, Pericarditis
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Prothrombin time prolonged, Pyrexia, Respiratory syncytial virus test negative, Respiratory viral panel, SARS-CoV-2 test negative
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Substance use, Toxoplasma serology negative, Troponin increased, Viral test negative
Clinical narrative: COVID-19 Vaccine EUA (Pfizer) Patient presented to the emergency department on 6/7/2021 for chest pain. Patient received 2nd dose COVID vaccination on 6/4/2021.  Per patient's mother, first dose was on April 15, 2021.  The next morning he woke up with pressure sensation on his chest.  Took 2 ibuprofen with resolution of symptoms.  States he had recurrence of chest pain 6/6/2021 and 6/7/2021.  Pain initially resolved with ibuprofen, however it became persistent.  No remitting or exacerbating factors for his pain.  No associated fever, leg swelling, history of cardiac disease. Final diagnosis of myopericarditis and adverse effect of vaccine.  Patient transferred to hospital.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Blood calcium normal, CSF test, Chest pain, Computerised tomogram head normal
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Electrocardiogram repolarisation abnormality
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Emotional distress, Gait inability, Lethargy, Lumbar puncture, Magnetic resonance imaging head
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Neurological examination abnormal, Photophobia, Protein total normal
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Scan with contrast, Troponin normal
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, CSF cell count normal, CSF culture negative, CSF protein normal, Hypokinesia
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Pyrexia
Clinical narrative: 17 y/o F with a hx of asthma presents to the ED for weakness and difficulty moving beginning on 6/7/2021. Pt got her second COVID-19 vaccination on 6/6/2021 and has had an intermittent fever since (Tmax 104 F).  Workup including  brain and spine MRI, and Lumbar puncture with CSF studies all normal. Of note patient had Guillan Barre Syndrome in 2016 which required 1 month of hospitalization.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Fibrin D dimer, Pulmonary embolism
Clinical narrative: Patient having trouble breathing.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient having trouble breathing.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Genital herpes
Clinical narrative: HERPES INFECTION (A BUMP OR PAINFUL BLISTER ON PENIS); This spontaneous report received from a consumer concerned a 71 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  (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 23-JUN-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced herpes infection (a bump or painful blister on penis). On 02-JUN-2021, treatment medications included: valaciclovir. The action taken with covid-19 vaccine  was not applicable. The outcome of herpes infection (a bump or painful blister on penis) was not reported. This report was non-serious. This case, involving the same patient is linked to 20210614700. This case, from the same reporter is linked to 20210612299.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Depressed level of consciousness, Dysphonia, Dyspnoea, Headache
Clinical narrative: Patient received COVID19 vaccine first dose 05/15/2021, complained 35 minutes later of"foreign body in throat" no edema, no vomiting.   patient received Covid vaccine 19 second dose 06/05/2021 @9 26 am, complained 45 minutes later of same Throat discomfort, plus near fainting,hoarseness,leg weakness for 5 minutes. Attended  ER 06/05/2021
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laryngeal discomfort, Myalgia, Nausea, Pallor, Parosmia
Clinical narrative: Patient received COVID19 vaccine first dose 05/15/2021, complained 35 minutes later of"foreign body in throat" no edema, no vomiting.   patient received Covid vaccine 19 second dose 06/05/2021 @9 26 am, complained 45 minutes later of same Throat discomfort, plus near fainting,hoarseness,leg weakness for 5 minutes. Attended  ER 06/05/2021
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Sensory disturbance, Syncope
Clinical narrative: Patient received COVID19 vaccine first dose 05/15/2021, complained 35 minutes later of"foreign body in throat" no edema, no vomiting.   patient received Covid vaccine 19 second dose 06/05/2021 @9 26 am, complained 45 minutes later of same Throat discomfort, plus near fainting,hoarseness,leg weakness for 5 minutes. Attended  ER 06/05/2021
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphonia, Foreign body in throat, Muscular weakness, Oropharyngeal discomfort, Presyncope
Clinical narrative: Patient received COVID19 vaccine first dose 05/15/2021, complained 35 minutes later of"foreign body in throat" no edema, no vomiting.   patient received Covid vaccine 19 second dose 06/05/2021 @9 26 am, complained 45 minutes later of same Throat discomfort, plus near fainting,hoarseness,leg weakness for 5 minutes. Attended  ER 06/05/2021
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood alcohol, Chest X-ray, Drug screen, Electrocardiogram, Full blood count
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Syncope, Troponin
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Electrocardiogram abnormal, Myocarditis, Pain in extremity
Clinical narrative: Within 12 hours of the injection, he felt fevers, chills, and fatigue.  Then about 48 hours from the vaccine, he developed chest pain that radiated down the arms.  He presented to the ER.  His troponins have trended up and peaked at about 1.8.  His CRP was elevated.  Toradol helped significantly with his pain.  He was pain free by the following day.  No heart failure symptoms.  No arrhythmias other than a single PVC, a single ventricular couplet, and one ventricular triplet.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin, Wolff-Parkinson-White syndrome
Clinical narrative: Within 12 hours of the injection, he felt fevers, chills, and fatigue.  Then about 48 hours from the vaccine, he developed chest pain that radiated down the arms.  He presented to the ER.  His troponins have trended up and peaked at about 1.8.  His CRP was elevated.  Toradol helped significantly with his pain.  He was pain free by the following day.  No heart failure symptoms.  No arrhythmias other than a single PVC, a single ventricular couplet, and one ventricular triplet.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Chills, Echocardiogram normal, Ejection fraction
Clinical narrative: Within 12 hours of the injection, he felt fevers, chills, and fatigue.  Then about 48 hours from the vaccine, he developed chest pain that radiated down the arms.  He presented to the ER.  His troponins have trended up and peaked at about 1.8.  His CRP was elevated.  Toradol helped significantly with his pain.  He was pain free by the following day.  No heart failure symptoms.  No arrhythmias other than a single PVC, a single ventricular couplet, and one ventricular triplet.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Pain
Clinical narrative: Within 12 hours of the injection, he felt fevers, chills, and fatigue.  Then about 48 hours from the vaccine, he developed chest pain that radiated down the arms.  He presented to the ER.  His troponins have trended up and peaked at about 1.8.  His CRP was elevated.  Toradol helped significantly with his pain.  He was pain free by the following day.  No heart failure symptoms.  No arrhythmias other than a single PVC, a single ventricular couplet, and one ventricular triplet.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Troponin increased, Ventricular extrasystoles
Clinical narrative: Within 12 hours of the injection, he felt fevers, chills, and fatigue.  Then about 48 hours from the vaccine, he developed chest pain that radiated down the arms.  He presented to the ER.  His troponins have trended up and peaked at about 1.8.  His CRP was elevated.  Toradol helped significantly with his pain.  He was pain free by the following day.  No heart failure symptoms.  No arrhythmias other than a single PVC, a single ventricular couplet, and one ventricular triplet.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Headache, Malaise, Nausea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiration abnormal
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperhidrosis, Paraesthesia
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Abdominal Pain-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Chest pain, suspected pericarditis versus myocarditis
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Pericarditis
Clinical narrative: Chest pain, suspected pericarditis versus myocarditis
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Motion sickness, Nausea, Vertigo
Clinical narrative: 20 days following 1st Moderna dose, I experienced significant vertigo (have never had previously), onset included complete loss of balance, dizziness, nausea, vomiting, which improved to dizziness and feeling of motion sickness throughout the first 24 hours. Nausea and motion sickness persisted, at varying levels, for the following 5 days. Dramamine provided some relief.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 20 days following 1st Moderna dose, I experienced significant vertigo (have never had previously), onset included complete loss of balance, dizziness, nausea, vomiting, which improved to dizziness and feeling of motion sickness throughout the first 24 hours. Nausea and motion sickness persisted, at varying levels, for the following 5 days. Dramamine provided some relief.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Catheterisation cardiac normal, Chest pain, Computerised tomogram head normal, Computerised tomogram thorax
Clinical narrative: Initially - chest pain 10 on 1-10 scale, heart rate 145 BPM, headaches, paramedics said A-fib abnormal heart rhythm, converted as they were checking; went to ER, admitted patient, stayed 5/24-5/27, gave tests including cardiac catheterization, echocardiograms, C-T scans of chest & head - all negative.  In ER also found elevated cardiac protein-enzyme. Also in ER, chest pain reduced to 3 on 1-10 scale.  Repeated some of the tests next day.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal, Headache, Heart rate abnormal, Myocardial necrosis marker increased
Clinical narrative: Initially - chest pain 10 on 1-10 scale, heart rate 145 BPM, headaches, paramedics said A-fib abnormal heart rhythm, converted as they were checking; went to ER, admitted patient, stayed 5/24-5/27, gave tests including cardiac catheterization, echocardiograms, C-T scans of chest & head - all negative.  In ER also found elevated cardiac protein-enzyme. Also in ER, chest pain reduced to 3 on 1-10 scale.  Repeated some of the tests next day.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Vaccine positive rechallenge
Clinical narrative: Patient reports headache,  dizziness, feeling a hot sensation and a dry throat within 5 minutes after vaccine.  Patient had similar reaction for first dose. Patient received a medical consult and was approved for 2nd dose of Moderna. Patient reports no shortness of breath, no chest pain, no blurred vision.  Vitals taken at 2:04pm: blood pressure:110/76, pulse: 64 and oxygen: 96%.  At 2:09pm patients vitals are taken again blood pressure: 110/71, oxygen: 98% and pulse 60. Patient reports feeling no improvement. PHN offers to call 911 but patient declines request. At 2:15pm vitals are pulse: 67, blood pressure: 111/69 and oxygen:98%. Patient alert and oriented x 4. no new symptoms reported.  At 2:20pm patient reports dry throat is improving and heat sensation is improving . Vitals are pulse:62, oxygen:96% blood pressure:110/80. Patients' dizziness slowly improves . Headache resolves completely at 2:47pm.  Patient attempts to stand up but still feels slight dizziness. Patient wait 15 more minutes and is walked out accompanied by 2 PHNs to vehicle. Patient is told it is not safe to drive while dizzy and provided with ER precautions.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: About 5 minutes after Pfizer shot, patient fainted and felt dizzy.  No shortness of breath.  Called 911 and paramedics came.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Patient had difficulty breathing after receiving COVID vaccine. She  was given her prescription for Albuterol immediately.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Myalgia, Palpitations
Clinical narrative: Shot 1. Metallic taste in mouth, awoke with heart beating really hard. Right arm muscular pain the next day that took 3 weeks to go away  Shot 2: 5/20 Arm pain that still has not gone away as of today 6/10
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Blood test, Computerised tomogram abdomen, Computerised tomogram thorax, Condition aggravated
Clinical narrative: Severe Palpitations, Rapid Heart rate at rest, walking and standing, Severe Shortness of breath, Pain on left lower abdomen after eating
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Heart rate increased, Palpitations, Ultrasound abdomen
Clinical narrative: Severe Palpitations, Rapid Heart rate at rest, walking and standing, Severe Shortness of breath, Pain on left lower abdomen after eating