chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: massive blood clot from her thigh to her ankle; incapable of walking; serious pain in my left thigh/muscle strain; serious pain in my left thigh/muscle strain; leg fell asleep; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on 11May2021 at 14:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was taking unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was on her second week of completing the vaccine. The patient reported that on Thursday night, 20May2021, she was just laying down on her couch watching Netflix with her laptop on her lap, her leg fell asleep but she didn't think anything of it because once she started walking around it went back fine. However, on 21May2021, Friday morning, she was having serious pain in her left thigh. She believed it was a muscle strain. The patient did a cold compress, warm bath and took Tylenol from Friday to Saturday. She thought it got better but by 23May2021, Sunday night, she was incapable of walking on her own and needed assistance just to go to the bathroom. On 24May2021, she went to Urgent Care and they stated that she may have a blood clot so she went to the ER (Emergency Room). While at the ER they said she had a massive blood clot from her thigh to her ankle. She would need a procedure done to remove it and was later admitted into the hospital and scheduled for the procedure. Blood thinners and suctioning out the blood clot was done as treatment. The patient been tested for COVID-19 (nasal swab) on 24May2021 with a result of negative. The outcome of the events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Presented to the ED after 2nd covid vaccine.  5 minutes after the administration patient developed throat fullness, she was administered one dose of an epi pen and symptoms were somewhat relieved.  After first dose she broke out in hives a week after, which resolved.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Computerised tomogram head, Computerised tomogram neck, Confusional state
Clinical narrative: Presented to the ED after 2nd covid vaccine.  5 minutes after the administration patient developed throat fullness, she was administered one dose of an epi pen and symptoms were somewhat relieved.  After first dose she broke out in hives a week after, which resolved.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Lumbar puncture, Pain, Photophobia, Rash
Clinical narrative: Presented to the ED after 2nd covid vaccine.  5 minutes after the administration patient developed throat fullness, she was administered one dose of an epi pen and symptoms were somewhat relieved.  After first dose she broke out in hives a week after, which resolved.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Vision blurred
Clinical narrative: Presented to the ED after 2nd covid vaccine.  5 minutes after the administration patient developed throat fullness, she was administered one dose of an epi pen and symptoms were somewhat relieved.  After first dose she broke out in hives a week after, which resolved.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Loss of consciousness, Pallor
Clinical narrative: UNRESPONSIVE; DIFFICULTY BREATHING; DIAPHORETIC; BLOOD PRESSURE 70/34; LOW HEART RATE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 134 pounds, and height was 69 inches. The patient's concurrent conditions included alcoholic, and non smoker. The patient had no known drug allergies and had no past medical history. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 26-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, after administration, the patient had a somewhat severe reaction with difficulty breathing and went unresponsive. The patient did not remember much. The Emergency Medical Services (EMS) were called and the pharmacist gave an epi pen shot to the patient. The patient was diaphoretic and unresponsive when they arrived. The EMS slowly monitored the patient and as epi kicked in and the patient came back to life. The patient's blood pressure was 70/34, and that, along with it his heart rate, started to rise. The whole process lasted 45 minutes. The EMS wanted to take him to hospital, but the patient refused. On 26-MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 70/34 mmHg, and Heart rate (NR: not provided) low. Treatment medications included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unresponsive on 26-MAY-2021, and the outcome of difficulty breathing, diaphoretic, blood pressure 70/34 and low heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607523-COVID-19 VACCINE AD26.COV2.S-Unresponsive, difficulty breathing, diaphoretic, blood pressure 70/34, low heart rate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate decreased, Hyperhidrosis
Clinical narrative: UNRESPONSIVE; DIFFICULTY BREATHING; DIAPHORETIC; BLOOD PRESSURE 70/34; LOW HEART RATE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 134 pounds, and height was 69 inches. The patient's concurrent conditions included alcoholic, and non smoker. The patient had no known drug allergies and had no past medical history. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 26-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, after administration, the patient had a somewhat severe reaction with difficulty breathing and went unresponsive. The patient did not remember much. The Emergency Medical Services (EMS) were called and the pharmacist gave an epi pen shot to the patient. The patient was diaphoretic and unresponsive when they arrived. The EMS slowly monitored the patient and as epi kicked in and the patient came back to life. The patient's blood pressure was 70/34, and that, along with it his heart rate, started to rise. The whole process lasted 45 minutes. The EMS wanted to take him to hospital, but the patient refused. On 26-MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 70/34 mmHg, and Heart rate (NR: not provided) low. Treatment medications included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unresponsive on 26-MAY-2021, and the outcome of difficulty breathing, diaphoretic, blood pressure 70/34 and low heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607523-COVID-19 VACCINE AD26.COV2.S-Unresponsive, difficulty breathing, diaphoretic, blood pressure 70/34, low heart rate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Unresponsive to stimuli
Clinical narrative: UNRESPONSIVE; DIFFICULTY BREATHING; DIAPHORETIC; BLOOD PRESSURE 70/34; LOW HEART RATE; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 134 pounds, and height was 69 inches. The patient's concurrent conditions included alcoholic, and non smoker. The patient had no known drug allergies and had no past medical history. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 26-MAY-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, after administration, the patient had a somewhat severe reaction with difficulty breathing and went unresponsive. The patient did not remember much. The Emergency Medical Services (EMS) were called and the pharmacist gave an epi pen shot to the patient. The patient was diaphoretic and unresponsive when they arrived. The EMS slowly monitored the patient and as epi kicked in and the patient came back to life. The patient's blood pressure was 70/34, and that, along with it his heart rate, started to rise. The whole process lasted 45 minutes. The EMS wanted to take him to hospital, but the patient refused. On 26-MAY-2021, Laboratory data included: Blood pressure (NR: not provided) 70/34 mmHg, and Heart rate (NR: not provided) low. Treatment medications included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from unresponsive on 26-MAY-2021, and the outcome of difficulty breathing, diaphoretic, blood pressure 70/34 and low heart rate was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607523-COVID-19 VACCINE AD26.COV2.S-Unresponsive, difficulty breathing, diaphoretic, blood pressure 70/34, low heart rate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Haemorrhage, Haemorrhage urinary tract, Urinary bladder haemorrhage
Clinical narrative: On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine.  There were no immediate reactions during the 15 minute "holding period", but the following morning, May 22nd @ ~09:00am, I was urinating blood and blood clots with very little urine evacuating.  Proceeded to the Urgent Care facility to which they immediately directed me to the ER.  Upon arrival, they had me give a urine sample which was blood red, and put me on a picc line and pushed fluids, then performed a CT and an ultrasound of my pelvic area.  During this time, my urge to urinate began to become very painful because my bladder was now fully blocked and I could only pass a small amount of blood clots.  They then had to install a large 3 way catheter to relieve the urine and allow the passing of the large blood clots coming from my hemorrhaging left kidney.  After being in the ER for ~8.5 hours, they released me with the catheter still installed with a mobile bag.  I stayed laid up for 2.5 days until Monday when all of the blood clots had passed and my urine had returned to a normal color.  They then removed the catheter and sent me on with medication to continue to take.  I have a follow up appointment, but I am still having restrictions when I urinate and now when I try to ejaculate, so I am very concerned that this has permanently injured me.  I have had ZERO issues in the past and consider myself a very healthy individual who works very hard to stay healthy.  I maintain a weight of 206-210 lbs @ 6'1" through a daily rigorous exercise program, diet, and supplements.  I don't smoke, do drugs, or drink excessively.   This event has cost me money for my deductible (because I don't use it), plus the costs of the copays, medications, and 1 day of missed work.  I have all of the paperwork from both the ER visit and Urology visits... Please advise what I can do to recoup my out of pocket costs for a vaccine that the Government has directed the population to receive.  You can reach me at this email.  Thank you.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bladder catheterisation, Bladder obstruction, Blood test, Blood urine present, Computerised tomogram
Clinical narrative: On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine.  There were no immediate reactions during the 15 minute "holding period", but the following morning, May 22nd @ ~09:00am, I was urinating blood and blood clots with very little urine evacuating.  Proceeded to the Urgent Care facility to which they immediately directed me to the ER.  Upon arrival, they had me give a urine sample which was blood red, and put me on a picc line and pushed fluids, then performed a CT and an ultrasound of my pelvic area.  During this time, my urge to urinate began to become very painful because my bladder was now fully blocked and I could only pass a small amount of blood clots.  They then had to install a large 3 way catheter to relieve the urine and allow the passing of the large blood clots coming from my hemorrhaging left kidney.  After being in the ER for ~8.5 hours, they released me with the catheter still installed with a mobile bag.  I stayed laid up for 2.5 days until Monday when all of the blood clots had passed and my urine had returned to a normal color.  They then removed the catheter and sent me on with medication to continue to take.  I have a follow up appointment, but I am still having restrictions when I urinate and now when I try to ejaculate, so I am very concerned that this has permanently injured me.  I have had ZERO issues in the past and consider myself a very healthy individual who works very hard to stay healthy.  I maintain a weight of 206-210 lbs @ 6'1" through a daily rigorous exercise program, diet, and supplements.  I don't smoke, do drugs, or drink excessively.   This event has cost me money for my deductible (because I don't use it), plus the costs of the copays, medications, and 1 day of missed work.  I have all of the paperwork from both the ER visit and Urology visits... Please advise what I can do to recoup my out of pocket costs for a vaccine that the Government has directed the population to receive.  You can reach me at this email.  Thank you.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Haemorrhage urinary tract, Impaired work ability, Renal haemorrhage, Ultrasound pelvis
Clinical narrative: On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine.  There were no immediate reactions during the 15 minute "holding period", but the following morning, May 22nd @ ~09:00am, I was urinating blood and blood clots with very little urine evacuating.  Proceeded to the Urgent Care facility to which they immediately directed me to the ER.  Upon arrival, they had me give a urine sample which was blood red, and put me on a picc line and pushed fluids, then performed a CT and an ultrasound of my pelvic area.  During this time, my urge to urinate began to become very painful because my bladder was now fully blocked and I could only pass a small amount of blood clots.  They then had to install a large 3 way catheter to relieve the urine and allow the passing of the large blood clots coming from my hemorrhaging left kidney.  After being in the ER for ~8.5 hours, they released me with the catheter still installed with a mobile bag.  I stayed laid up for 2.5 days until Monday when all of the blood clots had passed and my urine had returned to a normal color.  They then removed the catheter and sent me on with medication to continue to take.  I have a follow up appointment, but I am still having restrictions when I urinate and now when I try to ejaculate, so I am very concerned that this has permanently injured me.  I have had ZERO issues in the past and consider myself a very healthy individual who works very hard to stay healthy.  I maintain a weight of 206-210 lbs @ 6'1" through a daily rigorous exercise program, diet, and supplements.  I don't smoke, do drugs, or drink excessively.   This event has cost me money for my deductible (because I don't use it), plus the costs of the copays, medications, and 1 day of missed work.  I have all of the paperwork from both the ER visit and Urology visits... Please advise what I can do to recoup my out of pocket costs for a vaccine that the Government has directed the population to receive.  You can reach me at this email.  Thank you.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Lumbar puncture abnormal, Paraesthesia
Clinical narrative: Patient has had intermittent weakness since covid vaccine in April.  Admitted on May 11 for weakness, stroke was ruled out.  Noted to have bilateral upper and lower extremity paresthesia thought secondary to diabetes.  Readmitted on May 17, began to have frequent falls with bilateral lower extremity weakness, when he stood up his legs could not hold him.  MRI ruled out ischemic infarction.  Diagnosed with Guillain-Barre disease and ambulatory weakness.  Followed up with neurologist.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient has had intermittent weakness since covid vaccine in April.  Admitted on May 11 for weakness, stroke was ruled out.  Noted to have bilateral upper and lower extremity paresthesia thought secondary to diabetes.  Readmitted on May 17, began to have frequent falls with bilateral lower extremity weakness, when he stood up his legs could not hold him.  MRI ruled out ischemic infarction.  Diagnosed with Guillain-Barre disease and ambulatory weakness.  Followed up with neurologist.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Muscular weakness, Paraesthesia, Weight bearing difficulty
Clinical narrative: Patient has had intermittent weakness since covid vaccine in April.  Admitted on May 11 for weakness, stroke was ruled out.  Noted to have bilateral upper and lower extremity paresthesia thought secondary to diabetes.  Readmitted on May 17, began to have frequent falls with bilateral lower extremity weakness, when he stood up his legs could not hold him.  MRI ruled out ischemic infarction.  Diagnosed with Guillain-Barre disease and ambulatory weakness.  Followed up with neurologist.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a pharmacist concerned a 51 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that the patient had no history of known allergies, no chronic health condition, no history of thrombocytopenia, and no infusion and biologics.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 02-JUN-2021 09:15 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  It was reported that on 01-JUN-2021 (reported as yesterday) at 14:00, pharmacist opened a vial of Janssen COVID-19 vaccine and then they stored it in the fridge with the recommended temperature. On 02-JUN-2021, the patient was administered expired vaccine which passed recommended time limit for the punctured/opened vial. The pharmacist stated that no reported side effects from the patient at the time of call. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered was not reported. This report was serious (Other Medically Important Condition)..; Sender's Comments: 20210604758-Covid-19 vaccine ad26.cov2.s- expired vaccine used. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a pharmacist concerned a 51 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included that the patient had no history of known allergies, no chronic health condition, no history of thrombocytopenia, and no infusion and biologics.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total administered on 02-JUN-2021 09:15 for prophylactic vaccination on left deltoid. No concomitant medications were reported.  It was reported that on 01-JUN-2021 (reported as yesterday) at 14:00, pharmacist opened a vial of Janssen COVID-19 vaccine and then they stored it in the fridge with the recommended temperature. On 02-JUN-2021, the patient was administered expired vaccine which passed recommended time limit for the punctured/opened vial. The pharmacist stated that no reported side effects from the patient at the time of call. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered was not reported. This report was serious (Other Medically Important Condition)..; Sender's Comments: 20210604758-Covid-19 vaccine ad26.cov2.s- expired vaccine used. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Pleurisy, SARS-CoV-2 test
Clinical narrative: Pleurisy  Tinnitus Dizziness  Muscle aches and nerve damage
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Myalgia, Nerve injury, Pleurisy, Tinnitus
Clinical narrative: Pleurisy  Tinnitus Dizziness  Muscle aches and nerve damage
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Asymptomatic COVID-19, Cardiac monitoring, Electrocardiogram
Clinical narrative: PULMONARY EMBOLISM; ODYNOPHAGIA; This spontaneous report received from a consumer concerned a 21 year old white, Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient had woken up feeling chest pain, right upper abdominal pain that irradiated towards her right shoulder and side, odynophagia, and had noted high heart rate with her smart watch. The patient had gone to the emergency room where she was diagnosed with pulmonary embolism. The patient was hospitalized (dates and duration unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, and odynophagia on 02-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607584-covid-19 vaccine ad26.cov2.s-pulmonary embolism and odynophagia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Pulmonary pain, SARS-CoV-2 test positive, X-ray
Clinical narrative: PULMONARY EMBOLISM; ODYNOPHAGIA; This spontaneous report received from a consumer concerned a 21 year old white, Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient had woken up feeling chest pain, right upper abdominal pain that irradiated towards her right shoulder and side, odynophagia, and had noted high heart rate with her smart watch. The patient had gone to the emergency room where she was diagnosed with pulmonary embolism. The patient was hospitalized (dates and duration unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, and odynophagia on 02-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607584-covid-19 vaccine ad26.cov2.s-pulmonary embolism and odynophagia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, COVID-19, Fibrin D dimer increased, Hypoxia
Clinical narrative: PULMONARY EMBOLISM; ODYNOPHAGIA; This spontaneous report received from a consumer concerned a 21 year old white, Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient had woken up feeling chest pain, right upper abdominal pain that irradiated towards her right shoulder and side, odynophagia, and had noted high heart rate with her smart watch. The patient had gone to the emergency room where she was diagnosed with pulmonary embolism. The patient was hospitalized (dates and duration unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, and odynophagia on 02-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607584-covid-19 vaccine ad26.cov2.s-pulmonary embolism and odynophagia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: PULMONARY EMBOLISM; ODYNOPHAGIA; This spontaneous report received from a consumer concerned a 21 year old white, Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient had woken up feeling chest pain, right upper abdominal pain that irradiated towards her right shoulder and side, odynophagia, and had noted high heart rate with her smart watch. The patient had gone to the emergency room where she was diagnosed with pulmonary embolism. The patient was hospitalized (dates and duration unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, and odynophagia on 02-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607584-covid-19 vaccine ad26.cov2.s-pulmonary embolism and odynophagia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate, Odynophagia, Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; ODYNOPHAGIA; This spontaneous report received from a consumer concerned a 21 year old white, Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the patient had woken up feeling chest pain, right upper abdominal pain that irradiated towards her right shoulder and side, odynophagia, and had noted high heart rate with her smart watch. The patient had gone to the emergency room where she was diagnosed with pulmonary embolism. The patient was hospitalized (dates and duration unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism, and odynophagia on 02-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210607584-covid-19 vaccine ad26.cov2.s-pulmonary embolism and odynophagia . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Memory impairment
Clinical narrative: I've had trouble with my stomach; This is a Pfizer-sponsored program spontaneous report from a contactable consumer or other non hcp (Patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. The patient medical history was not reported. Suspect Product: Ibrance 125 mg. On 03Jun2021 after the vaccination the patient experienced trouble with her stomach. The outcome of the event was Unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort
Clinical narrative: I've had trouble with my stomach; This is a Pfizer-sponsored program spontaneous report from a contactable consumer or other non hcp (Patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. The patient medical history was not reported. Suspect Product: Ibrance 125 mg. On 03Jun2021 after the vaccination the patient experienced trouble with her stomach. The outcome of the event was Unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, C-reactive protein increased, Chest pain, Dyspepsia, Dyspnoea
Clinical narrative: Myocarditis with elevated troponin, ST elevation, chest pain, and decreased left ventricular function. Was treated with aspirin and ibuprofen. Chest pain improved, ST elevation disappeared, troponins downtrended, and left ventricular function improved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Intensive care, Malaise, Myalgia, Sleep disorder
Clinical narrative: Myocarditis with elevated troponin, ST elevation, chest pain, and decreased left ventricular function. Was treated with aspirin and ibuprofen. Chest pain improved, ST elevation disappeared, troponins downtrended, and left ventricular function improved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis with elevated troponin, ST elevation, chest pain, and decreased left ventricular function. Was treated with aspirin and ibuprofen. Chest pain improved, ST elevation disappeared, troponins downtrended, and left ventricular function improved.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Left ventricular dysfunction, Myocarditis, Troponin increased
Clinical narrative: Myocarditis with elevated troponin, ST elevation, chest pain, and decreased left ventricular function. Was treated with aspirin and ibuprofen. Chest pain improved, ST elevation disappeared, troponins downtrended, and left ventricular function improved.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram, Electrocardiogram, Headache
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Nausea, Troponin increased, Vomiting
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Pain, Troponin I increased
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram abnormal, Laboratory test, Myocarditis, Pericarditis
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased, Vomiting
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, SARS-CoV-2 test
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, Chest pain, Immunoglobulin therapy, Inflammatory marker increased, Magnetic resonance imaging heart
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocardial oedema, Myocarditis, N-terminal prohormone brain natriuretic peptide increased, Nausea, Troponin I increased
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin T increased, Troponin increased, Vomiting
Clinical narrative: Per MD-Patient in clinic 6/7/21 afternoon with chest pain and vomiting 2 days after second Covid vaccine.  Exam normal; normal BP, HR; EKG sl abn for pericarditis and since he looked OK - sent him home awaiting labs and EKG reading   Troponin came back 33 at night at patient called and advised to go to the ED; seen by provider - her note-  " We agreed that given the very high troponin level in this unknown process after COVID vaccine with an unknown natural history, that he should be in a cardiac center with ECMO, cath, and arrhythmia support.  They have taken care of 4 of these patients in the past few weeks.  Patient has the highest troponin level of the patients that have presented thus far."  Transferred to hospital   Second teen seen yesterday with same history almost - first one seems was heartburn but EKG showed mild st elevations but normal troponin  Normal CBC, ESR; crp pending
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adenovirus test, Antibody test, Bacterial test, Blood gases, Blood immunoglobulin E
Clinical narrative: 2 days prior to presentation  to hospital on 6/3, he received his second COVID-19 vaccine.  That evening, he began to have a headache which persisted throughout the evening.  The next morning on 6/4, he woke up early in the morning, was not feeling well, subsequently fell back asleep, and when he woke again he was complaining of significant headache.  He vomited 2-3 times that day.   On day of presentation 6/5, he was progressively more confused and lethargic.  He also had had increased vomiting to 6 episodes, and was unable to tolerated p.o.  He was sleeping for most of the day, and was " seeing things".  Parents report that he felt warm over the last day or 2 however did not have a documented temperature 100. He presented to Hospital ED where his heart rates were initially in the 120s, and increased to 140s to 160s.  He was afebrile T 99.3, BP 140/70, SpO2 100% in RA, RR 16. Exam nonfocal. Labs notable for Na 125, Na 125, K 4.6, Cl 90, Bicarb 18, BUN 8 Cr 0.5. WBC 12.9, Hgb and Plt normal. Glucose 112. CRP 5.8, LFTs normal, CK 182, lipase 8, troponin 0.22. No urine was able to be obtained. EKG normal with sinis tachycardia. He received a 20cc/kg NS bolus, as well as 3% hypertonic saline given the hyponatremia. CT head was done that on initial review by the medical team showed no mass, hemorrhage or shiftHe also had one episode of large diarrhea with question of stool incontinence. He was transferred to Hospital, Intubated, MRI showed nonspecific restricted diffusion and signal abnormality in the splenium of the corpus callosum. LP done. extensive infectious workup sent. Patient had troponin on presentation of 0.21 that went down initially and then rose again to 0.19 on 6/8. Cardiac echo normal function and cardiac MRI results pending.  Diagnosis of myocarditis and encephalitis. Still in hospital.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Borrelia test, C-reactive protein increased, CD4 lymphocytes, CD8 lymphocytes, CSF test
Clinical narrative: 2 days prior to presentation  to hospital on 6/3, he received his second COVID-19 vaccine.  That evening, he began to have a headache which persisted throughout the evening.  The next morning on 6/4, he woke up early in the morning, was not feeling well, subsequently fell back asleep, and when he woke again he was complaining of significant headache.  He vomited 2-3 times that day.   On day of presentation 6/5, he was progressively more confused and lethargic.  He also had had increased vomiting to 6 episodes, and was unable to tolerated p.o.  He was sleeping for most of the day, and was " seeing things".  Parents report that he felt warm over the last day or 2 however did not have a documented temperature 100. He presented to Hospital ED where his heart rates were initially in the 120s, and increased to 140s to 160s.  He was afebrile T 99.3, BP 140/70, SpO2 100% in RA, RR 16. Exam nonfocal. Labs notable for Na 125, Na 125, K 4.6, Cl 90, Bicarb 18, BUN 8 Cr 0.5. WBC 12.9, Hgb and Plt normal. Glucose 112. CRP 5.8, LFTs normal, CK 182, lipase 8, troponin 0.22. No urine was able to be obtained. EKG normal with sinis tachycardia. He received a 20cc/kg NS bolus, as well as 3% hypertonic saline given the hyponatremia. CT head was done that on initial review by the medical team showed no mass, hemorrhage or shiftHe also had one episode of large diarrhea with question of stool incontinence. He was transferred to Hospital, Intubated, MRI showed nonspecific restricted diffusion and signal abnormality in the splenium of the corpus callosum. LP done. extensive infectious workup sent. Patient had troponin on presentation of 0.21 that went down initially and then rose again to 0.19 on 6/8. Cardiac echo normal function and cardiac MRI results pending.  Diagnosis of myocarditis and encephalitis. Still in hospital.