chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Computerised tomogram, Confusional state, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Severe jaw pain; numbness rt side; numbness rt side hand and feet; rt eye blurriness; migraines; memory loss; Confusion; ringing rt ear.; This is a spontaneous report from a contactable consumer (patient reported for self). A 54-years-old female (non-pregnant) received first dose of bnt162b2 (COMIRNATY, Lot Number: EN5318), dose 1 via an unspecified route of administration, in the Right arm on 25Jan2021 12:00 (age at vaccination 54-years-old) as dose 1, single for COVID-19 immunisation. Other medical history and Known allergies were none. The patient was not tested for covid prior vaccination. The patient had not received any other vaccine within 4 weeks. Concomitant medications/Other medications in two weeks were none. Patient was not pregnant at time of vaccination. On 27Jan2021 00:00, the patient experienced Severe jaw pain, numbness rt (right) side of face, numbness rt side hand and foot, rt eye blurriness/ migraines, memory loss. Confusion, ringing rt ear. The adverse events resulted in healthcare professional office/clinic visit, Emergency room visit. The patient underwent lab tests and procedures which includes: Mri.Mra.CT scans (with unspecified results) on unspecified date(s). medications. neurologist. Patient was not tested for COVID post vaccination. Patient received (unspecified) treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain in jaw, Tinnitus, Vision blurred
Clinical narrative: Severe jaw pain; numbness rt side; numbness rt side hand and feet; rt eye blurriness; migraines; memory loss; Confusion; ringing rt ear.; This is a spontaneous report from a contactable consumer (patient reported for self). A 54-years-old female (non-pregnant) received first dose of bnt162b2 (COMIRNATY, Lot Number: EN5318), dose 1 via an unspecified route of administration, in the Right arm on 25Jan2021 12:00 (age at vaccination 54-years-old) as dose 1, single for COVID-19 immunisation. Other medical history and Known allergies were none. The patient was not tested for covid prior vaccination. The patient had not received any other vaccine within 4 weeks. Concomitant medications/Other medications in two weeks were none. Patient was not pregnant at time of vaccination. On 27Jan2021 00:00, the patient experienced Severe jaw pain, numbness rt (right) side of face, numbness rt side hand and foot, rt eye blurriness/ migraines, memory loss. Confusion, ringing rt ear. The adverse events resulted in healthcare professional office/clinic visit, Emergency room visit. The patient underwent lab tests and procedures which includes: Mri.Mra.CT scans (with unspecified results) on unspecified date(s). medications. neurologist. Patient was not tested for COVID post vaccination. Patient received (unspecified) treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: On the day the vaccine was received, at 1900, patient broke out in hives with itching.  In ER, patient was treated with diphenhydramine, famotidine and methylprednisolone with good response.  Patient is discharged with a prescription for prednisone and instructions to continue diphenhydramine and famotidine at home.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypersensitivity, Mouth swelling, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: On the day the vaccine was received, at 1900, patient broke out in hives with itching.  In ER, patient was treated with diphenhydramine, famotidine and methylprednisolone with good response.  Patient is discharged with a prescription for prednisone and instructions to continue diphenhydramine and famotidine at home.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: On the day the vaccine was received, at 1900, patient broke out in hives with itching.  In ER, patient was treated with diphenhydramine, famotidine and methylprednisolone with good response.  Patient is discharged with a prescription for prednisone and instructions to continue diphenhydramine and famotidine at home.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: On the day the vaccine was received, at 1900, patient broke out in hives with itching.  In ER, patient was treated with diphenhydramine, famotidine and methylprednisolone with good response.  Patient is discharged with a prescription for prednisone and instructions to continue diphenhydramine and famotidine at home.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dizziness, Dysphagia, Eye swelling, Flushing
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hyperventilation, Mouth swelling, Nausea, Paraesthesia
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Swelling face, Swollen tongue, Throat tightness
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dysgeusia, Dyspnoea, Erythema, Exophthalmos
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Induration, Laboratory test, Nausea
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photopsia, Pruritus, Rash, Retching, Swelling
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Vomiting
Clinical narrative: Tasted metal almost immediately after shot was given, nausea, extreme stomach pains, forceful vomiting, heaving, gagging, couldn?t breathe, gasping for air, rapid heart rate, face, neck ,shoulders bright red and swollen and face, neck, and shoulders hard as a rock, eyes bulging out, sweating, saw sparkles,  rash face neck, shoulder area, itchy legs
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: This is a 66 year old male with past medical history of cerebral palsy with spastic quadriplegia, seizure disorder, hypertension, GERD and congestive heart failure who presented from group home to the emergency department for persistent fever for the past few days, patient cannot provide detailed history. Fever of 101 degrees Fahrenheit, shortness of breath, and a dry cough. The patient reportedly had hypoxia with oxygen saturation between 88 and 92 on room air and outpatient workup included a chest x-ray, which showed some diffuse congestion.  He was started on doxycycline and diuresed, but his symptoms persisted.  The patient had been vaccinated for COVID-19.  Chest x-ray showed cardiomegaly with pulmonary vascular congestion. The patient's white blood cell count was 4.9.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cardiomegaly, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: This is a 66 year old male with past medical history of cerebral palsy with spastic quadriplegia, seizure disorder, hypertension, GERD and congestive heart failure who presented from group home to the emergency department for persistent fever for the past few days, patient cannot provide detailed history. Fever of 101 degrees Fahrenheit, shortness of breath, and a dry cough. The patient reportedly had hypoxia with oxygen saturation between 88 and 92 on room air and outpatient workup included a chest x-ray, which showed some diffuse congestion.  He was started on doxycycline and diuresed, but his symptoms persisted.  The patient had been vaccinated for COVID-19.  Chest x-ray showed cardiomegaly with pulmonary vascular congestion. The patient's white blood cell count was 4.9.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Nucleic acid test, Pulmonary congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: This is a 66 year old male with past medical history of cerebral palsy with spastic quadriplegia, seizure disorder, hypertension, GERD and congestive heart failure who presented from group home to the emergency department for persistent fever for the past few days, patient cannot provide detailed history. Fever of 101 degrees Fahrenheit, shortness of breath, and a dry cough. The patient reportedly had hypoxia with oxygen saturation between 88 and 92 on room air and outpatient workup included a chest x-ray, which showed some diffuse congestion.  He was started on doxycycline and diuresed, but his symptoms persisted.  The patient had been vaccinated for COVID-19.  Chest x-ray showed cardiomegaly with pulmonary vascular congestion. The patient's white blood cell count was 4.9.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: This is a 66 year old male with past medical history of cerebral palsy with spastic quadriplegia, seizure disorder, hypertension, GERD and congestive heart failure who presented from group home to the emergency department for persistent fever for the past few days, patient cannot provide detailed history. Fever of 101 degrees Fahrenheit, shortness of breath, and a dry cough. The patient reportedly had hypoxia with oxygen saturation between 88 and 92 on room air and outpatient workup included a chest x-ray, which showed some diffuse congestion.  He was started on doxycycline and diuresed, but his symptoms persisted.  The patient had been vaccinated for COVID-19.  Chest x-ray showed cardiomegaly with pulmonary vascular congestion. The patient's white blood cell count was 4.9.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Hypotonia, Myalgia, Weight decreased
Clinical narrative: Was diagnosed on 06/21/2021 with  Bells Palsy and it affected the right side of his face causing slurring of words, lost of taste and smell. Has been told by doctor that he may have Guillain-Barré syndrome. No bowel movement.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Bell's palsy, Bowel movement irregularity, Dysarthria
Clinical narrative: Was diagnosed on 06/21/2021 with  Bells Palsy and it affected the right side of his face causing slurring of words, lost of taste and smell. Has been told by doctor that he may have Guillain-Barré syndrome. No bowel movement.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: Was diagnosed on 06/21/2021 with  Bells Palsy and it affected the right side of his face causing slurring of words, lost of taste and smell. Has been told by doctor that he may have Guillain-Barré syndrome. No bowel movement.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives; itching; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (patient) reported that who received bnt162b2 (BNT162B2) formulation solution for injection, dose 1 (Lot number and expiry date was not reported) via an unspecified route of administration on 07Aug2021 as a single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing She mentioned that in her 20's she had a penicillin reaction. The patient's concomitant medications were not reported. Reporter was a consumer who was called for a follow up from Safety department. Reporter experienced hives and itching after the first dose on 07Aug2021 Saturday. Reporter was called for a follow up and as per DSU they documented it already. Reporter has seen her doctor and was still continuing to have them there might be something in the vaccine that she has a reaction to. Reporter wanted to know if she should or should not get the second dose of the vaccine. Reporter wanted to know if these medications may interfere if she ends up taking the second dose. She will be taking Hydroxyzine and Methylprednisolone before the second shot. Reporter stated that she went to her doctor today 24August2021. "It gets better sometimes and sometimes it starts all over again in the same area." Reporter said it could possibly a reaction. Reporter said that she didn't get the hives right away probably maybe the next day. It has not gone away. Reporter wanted to know if she can or cannot get the second shot. Reporter wanted to know if she was allergic to some of the ingredients of the vaccine. outcome of the events was not recovered.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Fatigue, Headache, Laboratory test, Oropharyngeal pain
Clinical narrative: Headache; Hives; white tiny bubbly spots (on arms, legs, tummy and others); Itching; Sore throat; body ache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 30Jul2021 09:45 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or Drug Store. The medical history included Hypertension, Cholesterol and known allergies: Yes. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), atorvastatin calcium (ATORVASTATIN CALCIUM), and loratadine (CLARITINE). The patient had no other vaccine in 4 weeks. The patient did not have COVID prior vaccination. On 30Jul2021 14:00, the patient had a minor reaction 4hrs and 15 minute after the administration of the vaccine which included hives, itching, white tiny bubbly spots (on arms, legs, tummy and others), next 3-4 days included headache, sore throat, body ache, and fatigue. Took Benadryl for 3 days, hives and itching were resolved, but the white spots remained. The patient reported that all symptoms had subsided except for headache. She had headaches daily since 30Jul2021. Some headaches were mild, and some were severe. Some medicines helped for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches came right back. At the time of reporting, the patient had headaches for 31 days (29Aug2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was given for events body ache and fatigue. The patient received treatment for other events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): was negative on 09Aug2021. The outcome of the events hives, itching, sore throat, body ache, and fatigue was reported as resolved on an unspecified date in 2021. The outcome of events headache and white tiny bubbly spots (on arms, legs, tummy and others) was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Headache; Hives; white tiny bubbly spots (on arms, legs, tummy and others); Itching; Sore throat; body ache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 30Jul2021 09:45 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or Drug Store. The medical history included Hypertension, Cholesterol and known allergies: Yes. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), atorvastatin calcium (ATORVASTATIN CALCIUM), and loratadine (CLARITINE). The patient had no other vaccine in 4 weeks. The patient did not have COVID prior vaccination. On 30Jul2021 14:00, the patient had a minor reaction 4hrs and 15 minute after the administration of the vaccine which included hives, itching, white tiny bubbly spots (on arms, legs, tummy and others), next 3-4 days included headache, sore throat, body ache, and fatigue. Took Benadryl for 3 days, hives and itching were resolved, but the white spots remained. The patient reported that all symptoms had subsided except for headache. She had headaches daily since 30Jul2021. Some headaches were mild, and some were severe. Some medicines helped for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches came right back. At the time of reporting, the patient had headaches for 31 days (29Aug2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was given for events body ache and fatigue. The patient received treatment for other events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): was negative on 09Aug2021. The outcome of the events hives, itching, sore throat, body ache, and fatigue was reported as resolved on an unspecified date in 2021. The outcome of events headache and white tiny bubbly spots (on arms, legs, tummy and others) was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pruritus
Clinical narrative: Headache; Hives; white tiny bubbly spots (on arms, legs, tummy and others); Itching; Sore throat; body ache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 30Jul2021 09:45 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or Drug Store. The medical history included Hypertension, Cholesterol and known allergies: Yes. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), atorvastatin calcium (ATORVASTATIN CALCIUM), and loratadine (CLARITINE). The patient had no other vaccine in 4 weeks. The patient did not have COVID prior vaccination. On 30Jul2021 14:00, the patient had a minor reaction 4hrs and 15 minute after the administration of the vaccine which included hives, itching, white tiny bubbly spots (on arms, legs, tummy and others), next 3-4 days included headache, sore throat, body ache, and fatigue. Took Benadryl for 3 days, hives and itching were resolved, but the white spots remained. The patient reported that all symptoms had subsided except for headache. She had headaches daily since 30Jul2021. Some headaches were mild, and some were severe. Some medicines helped for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches came right back. At the time of reporting, the patient had headaches for 31 days (29Aug2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was given for events body ache and fatigue. The patient received treatment for other events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): was negative on 09Aug2021. The outcome of the events hives, itching, sore throat, body ache, and fatigue was reported as resolved on an unspecified date in 2021. The outcome of events headache and white tiny bubbly spots (on arms, legs, tummy and others) was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Headache; Hives; white tiny bubbly spots (on arms, legs, tummy and others); Itching; Sore throat; body ache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 30Jul2021 09:45 (at the age of 44-year-old) as dose 1, single for COVID-19 immunization, at pharmacy or Drug Store. The medical history included Hypertension, Cholesterol and known allergies: Yes. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), atorvastatin calcium (ATORVASTATIN CALCIUM), and loratadine (CLARITINE). The patient had no other vaccine in 4 weeks. The patient did not have COVID prior vaccination. On 30Jul2021 14:00, the patient had a minor reaction 4hrs and 15 minute after the administration of the vaccine which included hives, itching, white tiny bubbly spots (on arms, legs, tummy and others), next 3-4 days included headache, sore throat, body ache, and fatigue. Took Benadryl for 3 days, hives and itching were resolved, but the white spots remained. The patient reported that all symptoms had subsided except for headache. She had headaches daily since 30Jul2021. Some headaches were mild, and some were severe. Some medicines helped for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches came right back. At the time of reporting, the patient had headaches for 31 days (29Aug2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment was given for events body ache and fatigue. The patient received treatment for other events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): was negative on 09Aug2021. The outcome of the events hives, itching, sore throat, body ache, and fatigue was reported as resolved on an unspecified date in 2021. The outcome of events headache and white tiny bubbly spots (on arms, legs, tummy and others) was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Weakness, tiredness and shortness of breath on day 2 and 3 after vaccine. Extreme amount of Swelling in both legs on day 4 of vaccine. . (thighs, calves and ankles) Swelling lasted 5 days. Very uncomfortable.
Age: 58.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Asthenia, Discomfort, Dyspnoea, Fatigue, Laboratory test
Clinical narrative: Weakness, tiredness and shortness of breath on day 2 and 3 after vaccine. Extreme amount of Swelling in both legs on day 4 of vaccine. . (thighs, calves and ankles) Swelling lasted 5 days. Very uncomfortable.
Age: 58.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Weakness, tiredness and shortness of breath on day 2 and 3 after vaccine. Extreme amount of Swelling in both legs on day 4 of vaccine. . (thighs, calves and ankles) Swelling lasted 5 days. Very uncomfortable.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram thorax, Electrocardiogram, Pericarditis
Clinical narrative: hospitalized with diagnosis of pericarditis after receiving vaccine
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Electrocardiogram, Laboratory test, Pericarditis
Clinical narrative: hospitalized with diagnosis of pericarditis after receiving vaccine
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: hospitalized with diagnosis of pericarditis after receiving vaccine
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac monitoring, Computerised tomogram, Cytogenetic analysis, Echocardiogram, Electrocardiogram
Clinical narrative: Blood clot in left portal vein to liver.; Low blood pressure; slowed heart rate; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 15:30 (Batch/Lot Number: EW0153) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 20Mar2021 04:30 PM (Batch/Lot Number: PAA165969) (at the age of 32 years) for covid-19 immunisation. There was no other vaccine in four weeks. There was no other medication in two weeks. The patient's concomitant medications were none. The patient experienced blood clot in left portal vein to liver, low blood pressure, slowed heart rate, all on 16Apr2021 04:00. The outcome of events was recovered. The patient was hospitalized for 7 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The events required treatment (Mri, ct scan, ultrasound, heparin drip, blood test, as reported). There was no COVID prior vaccination. Patient was tested for COVID (Nasal swab) on 05May2021 with test results of negative. The patient underwent lab tests and procedures which included blood pressure measurement: unknown, blood test: unknown, computerised tomogram: unknown, heparin resistance: unknown, magnetic resonance imaging: unknown, sars-cov-2 test: negative, ultrasound scan: unknown, all on 05May2021.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heart rate decreased, Hypotension, Magnetic resonance imaging, Portal vein embolism, Ultrasound scan
Clinical narrative: Blood clot in left portal vein to liver.; Low blood pressure; slowed heart rate; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 15:30 (Batch/Lot Number: EW0153) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 20Mar2021 04:30 PM (Batch/Lot Number: PAA165969) (at the age of 32 years) for covid-19 immunisation. There was no other vaccine in four weeks. There was no other medication in two weeks. The patient's concomitant medications were none. The patient experienced blood clot in left portal vein to liver, low blood pressure, slowed heart rate, all on 16Apr2021 04:00. The outcome of events was recovered. The patient was hospitalized for 7 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The events required treatment (Mri, ct scan, ultrasound, heparin drip, blood test, as reported). There was no COVID prior vaccination. Patient was tested for COVID (Nasal swab) on 05May2021 with test results of negative. The patient underwent lab tests and procedures which included blood pressure measurement: unknown, blood test: unknown, computerised tomogram: unknown, heparin resistance: unknown, magnetic resonance imaging: unknown, sars-cov-2 test: negative, ultrasound scan: unknown, all on 05May2021.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Heart rate decreased, Heparin resistance
Clinical narrative: Blood clot in left portal vein to liver.; Low blood pressure; slowed heart rate; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 15:30 (Batch/Lot Number: EW0153) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 20Mar2021 04:30 PM (Batch/Lot Number: PAA165969) (at the age of 32 years) for covid-19 immunisation. There was no other vaccine in four weeks. There was no other medication in two weeks. The patient's concomitant medications were none. The patient experienced blood clot in left portal vein to liver, low blood pressure, slowed heart rate, all on 16Apr2021 04:00. The outcome of events was recovered. The patient was hospitalized for 7 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The events required treatment (Mri, ct scan, ultrasound, heparin drip, blood test, as reported). There was no COVID prior vaccination. Patient was tested for COVID (Nasal swab) on 05May2021 with test results of negative. The patient underwent lab tests and procedures which included blood pressure measurement: unknown, blood test: unknown, computerised tomogram: unknown, heparin resistance: unknown, magnetic resonance imaging: unknown, sars-cov-2 test: negative, ultrasound scan: unknown, all on 05May2021.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Magnetic resonance imaging, Portal vein thrombosis, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: Blood clot in left portal vein to liver.; Low blood pressure; slowed heart rate; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 15:30 (Batch/Lot Number: EW0153) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. There were no known allergies. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 20Mar2021 04:30 PM (Batch/Lot Number: PAA165969) (at the age of 32 years) for covid-19 immunisation. There was no other vaccine in four weeks. There was no other medication in two weeks. The patient's concomitant medications were none. The patient experienced blood clot in left portal vein to liver, low blood pressure, slowed heart rate, all on 16Apr2021 04:00. The outcome of events was recovered. The patient was hospitalized for 7 days. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The events required treatment (Mri, ct scan, ultrasound, heparin drip, blood test, as reported). There was no COVID prior vaccination. Patient was tested for COVID (Nasal swab) on 05May2021 with test results of negative. The patient underwent lab tests and procedures which included blood pressure measurement: unknown, blood test: unknown, computerised tomogram: unknown, heparin resistance: unknown, magnetic resonance imaging: unknown, sars-cov-2 test: negative, ultrasound scan: unknown, all on 05May2021.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Fatigue, Myalgia, Pain in extremity
Clinical narrative: ARM SORENESS; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, fatigue, and muscle ache on SEP-2021. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: ARM SORENESS; FATIGUE; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2021, the patient experienced arm soreness. On SEP-2021, the patient experienced fatigue. On SEP-2021, the patient experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, fatigue, and muscle ache on SEP-2021. This report was non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Arthralgia, Asthenia, Dyspnoea, Fibrin D dimer increased
Clinical narrative: PATIENT SAID AFTER THE DOSE HE WAS IN THE HOSPITAL FOR AROUND A WEEK WITH BLOOD CLOTS IN HIS LEG.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Joint swelling, Muscle tightness, Neuropathy peripheral, Paraesthesia
Clinical narrative: PATIENT SAID AFTER THE DOSE HE WAS IN THE HOSPITAL FOR AROUND A WEEK WITH BLOOD CLOTS IN HIS LEG.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test negative, X-ray limb
Clinical narrative: PATIENT SAID AFTER THE DOSE HE WAS IN THE HOSPITAL FOR AROUND A WEEK WITH BLOOD CLOTS IN HIS LEG.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: PATIENT SAID AFTER THE DOSE HE WAS IN THE HOSPITAL FOR AROUND A WEEK WITH BLOOD CLOTS IN HIS LEG.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Malaise
Clinical narrative: Hospitalized 8/22/21 to 8/28/21 for covid pneumonia. Symptoms include fatigue and shortness of breath
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19 pneumonia, Dyspnoea, Fatigue, SARS-CoV-2 test
Clinical narrative: Hospitalized 8/22/21 to 8/28/21 for covid pneumonia. Symptoms include fatigue and shortness of breath
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, Hyponatraemia, Pulmonary mass, SARS-CoV-2 test positive
Clinical narrative: 9/9/21-77 y/o male with hx of PAF, HTN and hyperlipidemia presents body aches, SOB, and fatigue.  He recently traveled with his wife.  Last Thursday, he started to feel fatigued and lost his taste.  He also started developing SOB.  He returned and called his ENT who prescribed him Cipro and steroids due to hx of Pseudomonas sinus infection.  Despite taken these meds, he hasn't felt any better.  He admits to nausea, but no vomiting.  He is having loose stools.  Review of Systems: Constitutional:  Denies fever or chills Eyes:  Denies change in visual acuity  HENT:  Denies nasal congestion or sore throat  Respiratory:  + dry cough + SOB Cardiovascular:  Denies chest pain, palpitations, or edema  GI:  Denies bloody stools  GU:  Denies dysuria  Musculoskeletal:  Denies back pain or joint pain  Integument:  Denies rash  Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies swollen glands  Psychiatric:  Denies depression or anxiety
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: 9/9/21-77 y/o male with hx of PAF, HTN and hyperlipidemia presents body aches, SOB, and fatigue.  He recently traveled with his wife.  Last Thursday, he started to feel fatigued and lost his taste.  He also started developing SOB.  He returned and called his ENT who prescribed him Cipro and steroids due to hx of Pseudomonas sinus infection.  Despite taken these meds, he hasn't felt any better.  He admits to nausea, but no vomiting.  He is having loose stools.  Review of Systems: Constitutional:  Denies fever or chills Eyes:  Denies change in visual acuity  HENT:  Denies nasal congestion or sore throat  Respiratory:  + dry cough + SOB Cardiovascular:  Denies chest pain, palpitations, or edema  GI:  Denies bloody stools  GU:  Denies dysuria  Musculoskeletal:  Denies back pain or joint pain  Integument:  Denies rash  Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies swollen glands  Psychiatric:  Denies depression or anxiety
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ageusia, COVID-19, Chest X-ray, Computerised tomogram thorax, Diarrhoea
Clinical narrative: 9/9/21-77 y/o male with hx of PAF, HTN and hyperlipidemia presents body aches, SOB, and fatigue.  He recently traveled with his wife.  Last Thursday, he started to feel fatigued and lost his taste.  He also started developing SOB.  He returned and called his ENT who prescribed him Cipro and steroids due to hx of Pseudomonas sinus infection.  Despite taken these meds, he hasn't felt any better.  He admits to nausea, but no vomiting.  He is having loose stools.  Review of Systems: Constitutional:  Denies fever or chills Eyes:  Denies change in visual acuity  HENT:  Denies nasal congestion or sore throat  Respiratory:  + dry cough + SOB Cardiovascular:  Denies chest pain, palpitations, or edema  GI:  Denies bloody stools  GU:  Denies dysuria  Musculoskeletal:  Denies back pain or joint pain  Integument:  Denies rash  Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies swollen glands  Psychiatric:  Denies depression or anxiety
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pain, SARS-CoV-2 test positive
Clinical narrative: 9/9/21-77 y/o male with hx of PAF, HTN and hyperlipidemia presents body aches, SOB, and fatigue.  He recently traveled with his wife.  Last Thursday, he started to feel fatigued and lost his taste.  He also started developing SOB.  He returned and called his ENT who prescribed him Cipro and steroids due to hx of Pseudomonas sinus infection.  Despite taken these meds, he hasn't felt any better.  He admits to nausea, but no vomiting.  He is having loose stools.  Review of Systems: Constitutional:  Denies fever or chills Eyes:  Denies change in visual acuity  HENT:  Denies nasal congestion or sore throat  Respiratory:  + dry cough + SOB Cardiovascular:  Denies chest pain, palpitations, or edema  GI:  Denies bloody stools  GU:  Denies dysuria  Musculoskeletal:  Denies back pain or joint pain  Integument:  Denies rash  Neurologic:  Denies headache, focal weakness or sensory changes  Endocrine:  Denies polyuria or polydipsia  Lymphatic:  Denies swollen glands  Psychiatric:  Denies depression or anxiety
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Balance disorder, Deafness neurosensory, Dizziness, Magnetic resonance imaging head
Clinical narrative: lightheadedness; experiencing balance impairment issues; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in the left arm on 10Feb2021 at 19:15 (at the age of 72-year-old), dose 2, single for COVID-19 immunisation. Medical history allergy to red wine, blue cheese, iodine in IV. Concomitant medications included levothyroxine sodium (LEVOTHROID); simvastatin (ZOCOR); lisinopril. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) administered via an unspecified route of administration in the left arm on 20Jan2021 at 19:30 (at the age of 72-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 01Mar2021, the patient experienced balance impairment issues and lightheadedness. The patient stated that, he did not have any problems until about two weeks later when he started experiencing balance impairment issues and lightheadedness. The patient's primary doctor ordered a magnetic resonance imaging (MRI), which came back normal. The patient was then sent to an audiologist to determine if this could be an inner ear issue. That test was normal. However, the audiologist recommended that the patient undergo VNG testing, which he was scheduled to do at an audiology lab at the hospital on 20Oct2021. The patient was also undergoing vestibular physical therapy. The patient was currently worried if this problem could be magnified by the booster, which he would be eligible for on 10Oct2021. The patient have had no relief from the light-headedness, which continued to occur on a daily basis since Mar2021, about two weeks after his second dose of COVID-19 vaccine. The patient had no history of this problem until after the COVID-19 vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Investigation, Magnetic resonance imaging
Clinical narrative: lightheadedness; experiencing balance impairment issues; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in the left arm on 10Feb2021 at 19:15 (at the age of 72-year-old), dose 2, single for COVID-19 immunisation. Medical history allergy to red wine, blue cheese, iodine in IV. Concomitant medications included levothyroxine sodium (LEVOTHROID); simvastatin (ZOCOR); lisinopril. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248) administered via an unspecified route of administration in the left arm on 20Jan2021 at 19:30 (at the age of 72-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. On 01Mar2021, the patient experienced balance impairment issues and lightheadedness. The patient stated that, he did not have any problems until about two weeks later when he started experiencing balance impairment issues and lightheadedness. The patient's primary doctor ordered a magnetic resonance imaging (MRI), which came back normal. The patient was then sent to an audiologist to determine if this could be an inner ear issue. That test was normal. However, the audiologist recommended that the patient undergo VNG testing, which he was scheduled to do at an audiology lab at the hospital on 20Oct2021. The patient was also undergoing vestibular physical therapy. The patient was currently worried if this problem could be magnified by the booster, which he would be eligible for on 10Oct2021. The patient have had no relief from the light-headedness, which continued to occur on a daily basis since Mar2021, about two weeks after his second dose of COVID-19 vaccine. The patient had no history of this problem until after the COVID-19 vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.