chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Blood test, Cardiac monitoring, Computerised tomogram, Splenic infarction
Clinical narrative: atrial fibrillation; atrial fibrillation; splenic infarction; extreme left upper abdominal pain; large portion of his spleen unusable; blood clots causing that portion of his spleen to die; blood clots causing that portion of his spleen to die; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206), via an unspecified route of administration in right arm on 23Mar2021 09:00 (at the age of 68-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a health department. Medical history included atrial fibrillation (under control with medicine). The patient's concomitant medications were not reported. The patient previously took ciprofloxacin hydrochloride (CIPRO) and experienced allergies: Cipro. The patient had no COVID prior vaccination and was not COVID tested post vaccination. No other vaccine in four weeks. It was reported that within 13 days of the injunction (on 06Apr2021 at 04:00), the patient had three atrial fibrillation events on three separate days between 01:00 and 03:00 while sleeping and on day 13 was admitted to the hospital with extreme left upper abdominal pain they diagnosed with splenic infarction and rendering a large portion of his spleen unusable from blood clots causing that portion of his spleen to die. Now the patient have to take blood thinners the rest of his life. The events resulted in emergency room/department or urgent care, hospitalization for 1 day, disability or permanent damage. The events treatment included several pain shots administered then given enoxaparin sodium (LOVENOX). The outcome of the events was recovered with sequel.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenic rupture
Clinical narrative: atrial fibrillation; atrial fibrillation; splenic infarction; extreme left upper abdominal pain; large portion of his spleen unusable; blood clots causing that portion of his spleen to die; blood clots causing that portion of his spleen to die; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206), via an unspecified route of administration in right arm on 23Mar2021 09:00 (at the age of 68-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a health department. Medical history included atrial fibrillation (under control with medicine). The patient's concomitant medications were not reported. The patient previously took ciprofloxacin hydrochloride (CIPRO) and experienced allergies: Cipro. The patient had no COVID prior vaccination and was not COVID tested post vaccination. No other vaccine in four weeks. It was reported that within 13 days of the injunction (on 06Apr2021 at 04:00), the patient had three atrial fibrillation events on three separate days between 01:00 and 03:00 while sleeping and on day 13 was admitted to the hospital with extreme left upper abdominal pain they diagnosed with splenic infarction and rendering a large portion of his spleen unusable from blood clots causing that portion of his spleen to die. Now the patient have to take blood thinners the rest of his life. The events resulted in emergency room/department or urgent care, hospitalization for 1 day, disability or permanent damage. The events treatment included several pain shots administered then given enoxaparin sodium (LOVENOX). The outcome of the events was recovered with sequel.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Atrial fibrillation, Disease recurrence, Necrosis, Spleen disorder
Clinical narrative: atrial fibrillation; atrial fibrillation; splenic infarction; extreme left upper abdominal pain; large portion of his spleen unusable; blood clots causing that portion of his spleen to die; blood clots causing that portion of his spleen to die; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206), via an unspecified route of administration in right arm on 23Mar2021 09:00 (at the age of 68-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a health department. Medical history included atrial fibrillation (under control with medicine). The patient's concomitant medications were not reported. The patient previously took ciprofloxacin hydrochloride (CIPRO) and experienced allergies: Cipro. The patient had no COVID prior vaccination and was not COVID tested post vaccination. No other vaccine in four weeks. It was reported that within 13 days of the injunction (on 06Apr2021 at 04:00), the patient had three atrial fibrillation events on three separate days between 01:00 and 03:00 while sleeping and on day 13 was admitted to the hospital with extreme left upper abdominal pain they diagnosed with splenic infarction and rendering a large portion of his spleen unusable from blood clots causing that portion of his spleen to die. Now the patient have to take blood thinners the rest of his life. The events resulted in emergency room/department or urgent care, hospitalization for 1 day, disability or permanent damage. The events treatment included several pain shots administered then given enoxaparin sodium (LOVENOX). The outcome of the events was recovered with sequel.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Splenic infarction, Thrombosis
Clinical narrative: atrial fibrillation; atrial fibrillation; splenic infarction; extreme left upper abdominal pain; large portion of his spleen unusable; blood clots causing that portion of his spleen to die; blood clots causing that portion of his spleen to die; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6206), via an unspecified route of administration in right arm on 23Mar2021 09:00 (at the age of 68-years-old) as single dose for covid-19 immunisation. The vaccination facility type was a health department. Medical history included atrial fibrillation (under control with medicine). The patient's concomitant medications were not reported. The patient previously took ciprofloxacin hydrochloride (CIPRO) and experienced allergies: Cipro. The patient had no COVID prior vaccination and was not COVID tested post vaccination. No other vaccine in four weeks. It was reported that within 13 days of the injunction (on 06Apr2021 at 04:00), the patient had three atrial fibrillation events on three separate days between 01:00 and 03:00 while sleeping and on day 13 was admitted to the hospital with extreme left upper abdominal pain they diagnosed with splenic infarction and rendering a large portion of his spleen unusable from blood clots causing that portion of his spleen to die. Now the patient have to take blood thinners the rest of his life. The events resulted in emergency room/department or urgent care, hospitalization for 1 day, disability or permanent damage. The events treatment included several pain shots administered then given enoxaparin sodium (LOVENOX). The outcome of the events was recovered with sequel.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Client vaccinated for Covid with Moderna on 2/17/2021 and 3/17/2021 - specifics such as lot number not accessible to submitter. Client diagnosed positive for Covid by PCR on 4/6/2021 and she was admitted to the listed hospital on 4/7/2021 with "breathing difficulties" .  Submitter does not have access to further hospital records.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Client vaccinated for Covid with Moderna on 2/17/2021 and 3/17/2021 - specifics such as lot number not accessible to submitter. Client diagnosed positive for Covid by PCR on 4/6/2021 and she was admitted to the listed hospital on 4/7/2021 with "breathing difficulties" .  Submitter does not have access to further hospital records.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash
Clinical narrative: 26 weeks pregnant, due 8/7/2021 Headache and rash on hands at time of vaccine,  2inx4in hard raised swelling at injection site onset after 2 days lasting over 1 week
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site swelling, Pregnancy, Rash
Clinical narrative: 26 weeks pregnant, due 8/7/2021 Headache and rash on hands at time of vaccine,  2inx4in hard raised swelling at injection site onset after 2 days lasting over 1 week
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage urinary tract
Clinical narrative: blood clots in urine for 36 hours commencing about three days after second shot; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the right arm on 11Mar2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included arrhythmia from an unknown date and unknown if ongoing, and sulfa allergy from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included apixaban (ELIQUIS) for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 on 18Feb2021 (Lot Number: Unknown) in the right arm for COVID-19 immunisation. On 14Mar2021, the patient experienced blood clots in urine for 36 hours commencing about three days after second shot. No treatment given for the event. The patient with outcome of recovered from the event, blood clots in urine for 36 hours on an unknown date in Mar2021.   Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Deep vein thrombosis, Platelet factor 4, Venogram normal
Clinical narrative: I woke up on April 20,2021 to my left arm hurting. I noticed the veins in my left arm from my shoulder down my arm where popped out and blue.  I called the tele doc and she told me to go to the urgent care. I went to urgent car and she told me to go to the hospital. At the hospital they found a blood clot in my left arm within a inch of where the vaccine was administered. They ruled out with blood work that I had no diabetes hypertension or was pre disposed to blood clotting. Treatment blood work every two hours and a IV Drip of argatroban. After arriving home a perscription of eliquis blood thinners for blood clot. Blood clot is still in left arm and a a follow up apt with dr  is set and a apt with a surgeon is set for one month out.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: I woke up on April 20,2021 to my left arm hurting. I noticed the veins in my left arm from my shoulder down my arm where popped out and blue.  I called the tele doc and she told me to go to the urgent care. I went to urgent car and she told me to go to the hospital. At the hospital they found a blood clot in my left arm within a inch of where the vaccine was administered. They ruled out with blood work that I had no diabetes hypertension or was pre disposed to blood clotting. Treatment blood work every two hours and a IV Drip of argatroban. After arriving home a perscription of eliquis blood thinners for blood clot. Blood clot is still in left arm and a a follow up apt with dr  is set and a apt with a surgeon is set for one month out.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test normal, Computerised tomogram head normal, Injection site thrombosis, Magnetic resonance imaging head normal
Clinical narrative: I woke up on April 20,2021 to my left arm hurting. I noticed the veins in my left arm from my shoulder down my arm where popped out and blue.  I called the tele doc and she told me to go to the urgent care. I went to urgent car and she told me to go to the hospital. At the hospital they found a blood clot in my left arm within a inch of where the vaccine was administered. They ruled out with blood work that I had no diabetes hypertension or was pre disposed to blood clotting. Treatment blood work every two hours and a IV Drip of argatroban. After arriving home a perscription of eliquis blood thinners for blood clot. Blood clot is still in left arm and a a follow up apt with dr  is set and a apt with a surgeon is set for one month out.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pregnancy test urine negative, Ultrasound Doppler abnormal, Vein disorder
Clinical narrative: I woke up on April 20,2021 to my left arm hurting. I noticed the veins in my left arm from my shoulder down my arm where popped out and blue.  I called the tele doc and she told me to go to the urgent care. I went to urgent car and she told me to go to the hospital. At the hospital they found a blood clot in my left arm within a inch of where the vaccine was administered. They ruled out with blood work that I had no diabetes hypertension or was pre disposed to blood clotting. Treatment blood work every two hours and a IV Drip of argatroban. After arriving home a perscription of eliquis blood thinners for blood clot. Blood clot is still in left arm and a a follow up apt with dr  is set and a apt with a surgeon is set for one month out.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration, administered on the right arm, at the age of 48 years, on Mar2021  at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included vitamin b complex (VITAMIN B); astragalus mongholicus (ASTRAGALUS 6000); lysine (LYSINE) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient developed a blood clot in peroneal vein of left leg on 02Apr2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Therapeutic measures (blood thinners) were taken as a result of developed a blood clot in peroneal vein of left leg. The outcome of the event was recovered with sequelae.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, SARS-CoV-2 test
Clinical narrative: Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration, administered on the right arm, at the age of 48 years, on Mar2021  at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included vitamin b complex (VITAMIN B); astragalus mongholicus (ASTRAGALUS 6000); lysine (LYSINE) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient developed a blood clot in peroneal vein of left leg on 02Apr2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Therapeutic measures (blood thinners) were taken as a result of developed a blood clot in peroneal vein of left leg. The outcome of the event was recovered with sequelae.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient received Pfizer dose 2 after having received Moderna dose 1. This was an error by the clinic.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain
Clinical narrative: Pulmonary Embolus diagnosed 04/22/2021 at ER facility.   Started on Xarelto  Discontinued OCPs
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Mononucleosis heterophile test negative, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: Pulmonary Embolus diagnosed 04/22/2021 at ER facility.   Started on Xarelto  Discontinued OCPs
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Seizure, Syncope, Throat tightness
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up. Patient reports within three minutes of vaccination feeling of throat closing and could not swallow. Reports nausea but denies urticaria and wheezing. Two minutes later reports feeling cold and shaky as if going in and out of consciousness. Diphenhydramine administered and per patient a medic was called who reported 5-6 minutes of seizure-like activity and patient being non-responsive with blood pressure 80/palp en route to the emergency department (ED). In the ED patient received epinephrine, steroids, and diphenhydramine, monitored for several housrs, and discharged. Two days later patient reports waking up and feeling as if throat was closing up again, self-administered Epi-Pen and diphenhydramine, and returned to the ED. Steroids and diphenhydramine were adminsitered, patient was monitored, symptoms resolved, and patient was discharged. Since vaccination patient reports fatigue, dizziness, lightheadedness, persistent diarrhea, and numbness. Patient advised to continue home management and follow-up allergy testing recommended.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Consciousness fluctuating, Diarrhoea, Dizziness, Dysphagia, Fatigue
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up. Patient reports within three minutes of vaccination feeling of throat closing and could not swallow. Reports nausea but denies urticaria and wheezing. Two minutes later reports feeling cold and shaky as if going in and out of consciousness. Diphenhydramine administered and per patient a medic was called who reported 5-6 minutes of seizure-like activity and patient being non-responsive with blood pressure 80/palp en route to the emergency department (ED). In the ED patient received epinephrine, steroids, and diphenhydramine, monitored for several housrs, and discharged. Two days later patient reports waking up and feeling as if throat was closing up again, self-administered Epi-Pen and diphenhydramine, and returned to the ED. Steroids and diphenhydramine were adminsitered, patient was monitored, symptoms resolved, and patient was discharged. Since vaccination patient reports fatigue, dizziness, lightheadedness, persistent diarrhea, and numbness. Patient advised to continue home management and follow-up allergy testing recommended.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nasopharyngitis, Nausea, Nervousness, Seizure like phenomena
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up. Patient reports within three minutes of vaccination feeling of throat closing and could not swallow. Reports nausea but denies urticaria and wheezing. Two minutes later reports feeling cold and shaky as if going in and out of consciousness. Diphenhydramine administered and per patient a medic was called who reported 5-6 minutes of seizure-like activity and patient being non-responsive with blood pressure 80/palp en route to the emergency department (ED). In the ED patient received epinephrine, steroids, and diphenhydramine, monitored for several housrs, and discharged. Two days later patient reports waking up and feeling as if throat was closing up again, self-administered Epi-Pen and diphenhydramine, and returned to the ED. Steroids and diphenhydramine were adminsitered, patient was monitored, symptoms resolved, and patient was discharged. Since vaccination patient reports fatigue, dizziness, lightheadedness, persistent diarrhea, and numbness. Patient advised to continue home management and follow-up allergy testing recommended.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Unresponsive to stimuli
Clinical narrative: Moderna COVID-19 Vaccine EUA: patient presents to allergy clinic for follow-up. Patient reports within three minutes of vaccination feeling of throat closing and could not swallow. Reports nausea but denies urticaria and wheezing. Two minutes later reports feeling cold and shaky as if going in and out of consciousness. Diphenhydramine administered and per patient a medic was called who reported 5-6 minutes of seizure-like activity and patient being non-responsive with blood pressure 80/palp en route to the emergency department (ED). In the ED patient received epinephrine, steroids, and diphenhydramine, monitored for several housrs, and discharged. Two days later patient reports waking up and feeling as if throat was closing up again, self-administered Epi-Pen and diphenhydramine, and returned to the ED. Steroids and diphenhydramine were adminsitered, patient was monitored, symptoms resolved, and patient was discharged. Since vaccination patient reports fatigue, dizziness, lightheadedness, persistent diarrhea, and numbness. Patient advised to continue home management and follow-up allergy testing recommended.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram abdomen abnormal, Condition aggravated, Hepatic vein thrombosis, Liver disorder
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Transient ischaemic attack
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anticoagulant therapy, Blood test normal, Budd-Chiari syndrome, Chest pain
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Decreased appetite, Dizziness, Dyspnoea, Full blood count normal
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hemiplegic migraine, Lethargy, Lipids normal, Nausea
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, Rash, Skin warm, Troponin normal
Clinical narrative: Hospitalized with TIA due to blood clot.  Continues to have issues and will see a neurologist.  MD reported event to VAERS and she was given a number 479277.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 02Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of COVID-19 vaccine on 02Mar2021 and was scheduled for a second dose due on 25Mar2021 but because there was a thunder storm on that day, the facility cancelled her vaccination appointment. She was rescheduled by her facility on 12Apr2021, but she got sick with bronchopneumonia on an unspecified date. She was prescribed with Prednisone and antibiotics for 2 weeks and according to her doctor, she cannot take the second dose while on these medications. She asked if she needs to start over again or she can take the second dose after 2 weeks. She clarified that she have already had one dose on 02Mar2021 and they scheduled her for the second one on 25Mar2021. On that day, there was a severe storm so she cancelled it. They rescheduled it for 12Apr2021. During that time, she got "sequence bronchial trouble" and got on prednisone and azithromycin and her doctor said that she cannot take the second shot until 2 weeks after. She was through with that and that was what kept her outside at the time period so, she said she does not have to start over with another first dose and start it over again. She called to schedule with the health department, they asked her if she was at the risk as having the first shot again and her physician did not say anything about being risky to have to start over so, she does not understand while past the second shot on the 26th, so she was asking if it was okay to wait. Well, it's while to pass the period at which it would be effective because she waited since she had the first shot. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute kidney injury, Blood creatinine increased, Blood sodium decreased, Blood urea increased, Glomerulonephritis
Clinical narrative: Rapidly progressive glomerulonephritis Versus post infection Glomerulonephritis
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vasculitis
Clinical narrative: Rapidly progressive glomerulonephritis Versus post infection Glomerulonephritis
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Chest pain, Complement factor C3, Complement factor C4, Glomerulonephritis
Clinical narrative: Rapidly progressive glomerulonephritis Versus post infection Glomerulonephritis
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pneumonia, Purpura, Renal failure
Clinical narrative: Rapidly progressive glomerulonephritis Versus post infection Glomerulonephritis
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy kidney abnormal, Glomerulonephritis rapidly progressive, Leukocytosis, Post infection glomerulonephritis, Renal failure
Clinical narrative: Rapidly progressive glomerulonephritis Versus post infection Glomerulonephritis
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Computerised tomogram head, Echocardiogram, Electrocardiogram, Seizure
Clinical narrative: Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks.  The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over,  febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks.  The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over,  febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Body temperature, Cardiac arrest, Computerised tomogram head, Echocardiogram
Clinical narrative: Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks.  The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over,  febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Exercise electrocardiogram abnormal, Fall, Investigation, Pyrexia
Clinical narrative: Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks.  The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over,  febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Seizure, Troponin
Clinical narrative: Seizure; Cardiac arrest; Arrhythmia; Began convulsing and then tipped over; Began convulsing and then tipped over; 12 lead EKG without ischemic changes, arrhythmia; Febrile 38+; This is a spontaneous report from a contactable other HCP. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0169) via intramuscular route in arm left on 23Apr2021 at 12:45 as single dose for covid-19 immunisation. Historical Vaccine included first dose of bnt162b2 (Lot Number: EW0150) via intramuscular, administered in arm left on 02Apr2021at 14:15 for covid-19 immunisation. Medical history included obstructive sleep apnea, food allergy and intolerant of peanuts-causes sneezing and there were no concomitant medications. On 23Apr2021 at 18:30 the patient experienced a seizure resulting in cardiac arrest. Witnesses described patient began convulsing and then tipped over. AED applied with no shock advised. Unknown down time prior to initiation of CPR. Rhythm PEA upon arrival of EMS. 7 mins CPR before ROSC obtained. Initial Troponin 12. 12 lead EKG without ischemic changes, arrhythmia, etc. Transthoracic echo without regional wall abnormalities or significant findings. CT of head negative for acute intracranial process. No history of seizure, cardiac issues, drug use, etc. Intubated and sedated. Febrile 38+ on arrival requiring active cooling measures to maintain normothermia. The case classified as serious emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). On 23Apr2021, the patient underwent lab tests and procedures which included body temperature: 38+ on arrival requiring active cooling measures to maintain normothermia, computerised tomogram head: negative for acute intracranial process, echocardiogram: without regional wall abnormalities or significant findings, electrocardiogram: without ischemic changes, arrhythmia, investigation: pea, sars-cov-2 test: negative Nasal Swab and troponin: 12. Treatment received included multiple life support measures, treatment for seizures, etc. No covid prior vaccination. Patient had covid tested post vaccination. No other vaccine in four weeks.  The outcome of the events was not recovered.; Sender's Comments: Based on strong temporal association the causal association between the reported events seizure, cardiac arrest, arrhythmia, began convulsing and then tipped over,  febrile 38+ and the usage of the vaccine are considered related. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Peripheral swelling, Swelling face, Urticaria, Vomiting
Clinical narrative: Systemic rash with hives and itching, chest pain and shortness of breath, neck and facial edema, edema to extremities, nausea and vomiting  Benadryl 50mg PO every 4-6 hours for 4 days and then PRN for itching/rash. Medrol Dose pack as directed, Daily Pepcid PO, Zofran PO PRN
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Face oedema, Localised oedema, Nausea
Clinical narrative: Systemic rash with hives and itching, chest pain and shortness of breath, neck and facial edema, edema to extremities, nausea and vomiting  Benadryl 50mg PO every 4-6 hours for 4 days and then PRN for itching/rash. Medrol Dose pack as directed, Daily Pepcid PO, Zofran PO PRN
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral, Pruritus, Rash, Urticaria, Vomiting
Clinical narrative: Systemic rash with hives and itching, chest pain and shortness of breath, neck and facial edema, edema to extremities, nausea and vomiting  Benadryl 50mg PO every 4-6 hours for 4 days and then PRN for itching/rash. Medrol Dose pack as directed, Daily Pepcid PO, Zofran PO PRN
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Head injury, Loss of consciousness, Unresponsive to stimuli, Vision blurred
Clinical narrative: Pt completed vaccination and was at check out station with mother scheduling her second appointment.  The patient suddenly fell backwards and landed on the concrete floor hitting her head.  She was unconscious for about 30-60 secs.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Concussion, Fall, Head injury, Loss of consciousness
Clinical narrative: Pt completed vaccination and was at check out station with mother scheduling her second appointment.  The patient suddenly fell backwards and landed on the concrete floor hitting her head.  She was unconscious for about 30-60 secs.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: 30 min. s\p vaccination patient c\o itchiness to right arm then to left arm then to abdomen. Patient given Benadryl 25mg IM X1 with positive effect. Symptoms resolved prior to discharge of patient.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: 30 min. s\p vaccination patient c\o itchiness to right arm then to left arm then to abdomen. Patient given Benadryl 25mg IM X1 with positive effect. Symptoms resolved prior to discharge of patient.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Chills, Electrocardiogram
Clinical narrative: developed shortness of breath with chest pain.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pericarditis, Pyrexia, Tremor, Ultrasound chest
Clinical narrative: developed shortness of breath with chest pain.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Dyspnoea, Electrocardiogram
Clinical narrative: developed shortness of breath with chest pain.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills
Clinical narrative: Patient developed chest pain, diaphoresis and arm numbness the day following his vaccination. He presented to the ER and was noted to ST elevations and a Troponin I which peaked at 20,700 and a diagnosis of myo-pericarditis was made. Patient was discharged 4/29/21 in good condition following a normal echocardiogram on oral colchicine.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Hyperhidrosis
Clinical narrative: Patient developed chest pain, diaphoresis and arm numbness the day following his vaccination. He presented to the ER and was noted to ST elevations and a Troponin I which peaked at 20,700 and a diagnosis of myo-pericarditis was made. Patient was discharged 4/29/21 in good condition following a normal echocardiogram on oral colchicine.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Myocarditis, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: Patient developed chest pain, diaphoresis and arm numbness the day following his vaccination. He presented to the ER and was noted to ST elevations and a Troponin I which peaked at 20,700 and a diagnosis of myo-pericarditis was made. Patient was discharged 4/29/21 in good condition following a normal echocardiogram on oral colchicine.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Nausea, Retching, Throat tightness
Clinical narrative: Anaphylaxis. EMT and ambulance used at vaccine site. Hospitalization necessary. Two doses of epinephrine and steroids needed.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Anaphylaxis. EMT and ambulance used at vaccine site. Hospitalization necessary. Two doses of epinephrine and steroids needed.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis. EMT and ambulance used at vaccine site. Hospitalization necessary. Two doses of epinephrine and steroids needed.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Client received 1st dose of Pfizer vaccine on 2/5/21.  Client received 2nd dose of Pfizer vaccine on 2/27/21.  Client developed COVID symptoms on 4/18/21 and had a confirmed positive COVID (rapid test) test on 4/20/21.