chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Dysphagia, Dysphonia, Fatigue
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Migraine, Muscle twitching, Nausea, Oropharyngeal pain
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Rash, Rash erythematous, Swelling
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Tremor, Urticaria, Vision blurred
Clinical narrative: 7/27/21 after shot- 10 blurred vision. 15 mins after: loss of voice, hoarseness, throat pain, difficulty swallowing Later- nausea, stomach & abdominal pain, migraine, hives. 7/29/21- Worsening of voice loss & hoarseness, difficulty swallowing  7/30/21-  General malaise, body pain, twitching/tremors in hands, extreme fatigue begins 8/2/21- Continued symptoms from above, chest pain and palpatations, dizziness begins  8/4/21- Continued symptoms from above, Swollen, red, painful rash on face & neck begins  8/7/21-  Rash persists, Hives return
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Headache, Magnetic resonance imaging head, Migraine, Occipital neuralgia
Clinical narrative: 4 days after the shot I also developed neuropathy around the left lesser occipital nerve and on top of my head, left side; The day after my second dose, I developed a debilitating migraine that lasted for 6 days. I've never experienced a migraine like this before--it didn't respond to any drugs. When the migraine subsided; I was left with a dull persistent headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of ad-ministration, administered in arm left on 12Mar2021 08:00 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. Medical history included sjogren's syndrome. The patient had no known allergies. Concomitant medications included Nortriptylene 40 mg, Magnesium 750 mg. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 13Mar2021 at 04:00 PM, the day after her second dose, she developed a debilitating migraine that lasted for 6 days. She has never experienced a migraine like this before, it didn't respond to any drugs. When the migraine subsided, she was left with a dull persistent headache that hasn't yet resolved. This headache episodically blooms into migraines. 4 days after the shot she also developed neuropathy around the left lesser occipital nerve and on top of my head, left side and being treated with gabapentin, propranolol, triptans, and nerve injections at the headache clinic but the condition is still here. Therapeutic measures were taken as a result of the events which include multiple meds, nerve block injections, acupuncture. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Migraine, Neuropathy peripheral
Clinical narrative: 4 days after the shot I also developed neuropathy around the left lesser occipital nerve and on top of my head, left side; The day after my second dose, I developed a debilitating migraine that lasted for 6 days. I've never experienced a migraine like this before--it didn't respond to any drugs. When the migraine subsided; I was left with a dull persistent headache; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 43-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6205) via an unspecified route of ad-ministration, administered in arm left on 12Mar2021 08:00 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. Medical history included sjogren's syndrome. The patient had no known allergies. Concomitant medications included Nortriptylene 40 mg, Magnesium 750 mg. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. On 13Mar2021 at 04:00 PM, the day after her second dose, she developed a debilitating migraine that lasted for 6 days. She has never experienced a migraine like this before, it didn't respond to any drugs. When the migraine subsided, she was left with a dull persistent headache that hasn't yet resolved. This headache episodically blooms into migraines. 4 days after the shot she also developed neuropathy around the left lesser occipital nerve and on top of my head, left side and being treated with gabapentin, propranolol, triptans, and nerve injections at the headache clinic but the condition is still here. Therapeutic measures were taken as a result of the events which include multiple meds, nerve block injections, acupuncture. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Crying, Fatigue, Headache
Clinical narrative: emotional reaction which was uncontrolled crying; I was fatigued and had the chills; I was fatigued and had the chills; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Right on Apr2021 09:00 AM (age at vaccination 61-year-old) as dose 1 single for COVID-19 immunization. Medical history included diabetes. Concomitant medication included metformin and pravastatin sodium (PRAVACHOL), both drugs received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 the patient experienced emotional reaction which was uncontrolled crying, she was fatigued and had the chills. The patient was not received if treatment for reported events. The outcome of all events was reported as not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Crying, Fatigue
Clinical narrative: emotional reaction which was uncontrolled crying; I was fatigued and had the chills; I was fatigued and had the chills; This is a spontaneous report from a contactable consumer (patient herself). A 61-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8734) via an unspecified route of administration, administered in Arm Right on Apr2021 09:00 AM (age at vaccination 61-year-old) as dose 1 single for COVID-19 immunization. Medical history included diabetes. Concomitant medication included metformin and pravastatin sodium (PRAVACHOL), both drugs received within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was no diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Apr2021 the patient experienced emotional reaction which was uncontrolled crying, she was fatigued and had the chills. The patient was not received if treatment for reported events. The outcome of all events was reported as not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebrovascular accident, Computerised tomogram, Laboratory test, Magnetic resonance imaging
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA7485), via an unspecified route of administration on 23Jul2021 (at the age of 38-years-old) at dose 1, single for COVID-19 immunization. Medical history included auto-immune issue from 2015 to an unspecified date and mixed connective tissue disease. The patient's concomitant medications were reported as none. On Jul2021, the patient had a stroke. The hospital gave the patient tPA which was a medication to reverse the stroke and which thins the blood. The patient stated that there's only one medication that can stop the stroke within 4 hours of starting and that medication does it. The patient wanted to make sure that it was documented because she did not get any vaccine for years since she was nervous because of her auto-immune issue. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: FA7485), via an unspecified route of administration on 23Jul2021 (at the age of 38-years-old) at dose 1, single for COVID-19 immunization. Medical history included auto-immune issue from 2015 to an unspecified date and mixed connective tissue disease. The patient's concomitant medications were reported as none. On Jul2021, the patient had a stroke. The hospital gave the patient tPA which was a medication to reverse the stroke and which thins the blood. The patient stated that there's only one medication that can stop the stroke within 4 hours of starting and that medication does it. The patient wanted to make sure that it was documented because she did not get any vaccine for years since she was nervous because of her auto-immune issue. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Life expectancy shortened, Organ failure, Thrombosis
Clinical narrative: Patient developed headaches and presented to the hospital where she had a cardiopulmonary arrest. Found to have pancreatitis, a hepatic vein thrombus and clot in the basilic and cephalic veins of the left upper extremity.  She had severe thrombocytopenia and greatly elevated D-dimer on presentation.  Thrombocytopenia continued until IVIG and anticoagulation initiated- platelets recovered quickly after that.  HIT antibody was negative.  Serotonin release assay was negative (but was drawn after treatment initiated).  PF4 assay pending (although also drawn after treatment initiated).
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cardio-respiratory arrest, Fibrin D dimer increased, Headache, Heparin-induced thrombocytopenia test
Clinical narrative: Patient developed headaches and presented to the hospital where she had a cardiopulmonary arrest. Found to have pancreatitis, a hepatic vein thrombus and clot in the basilic and cephalic veins of the left upper extremity.  She had severe thrombocytopenia and greatly elevated D-dimer on presentation.  Thrombocytopenia continued until IVIG and anticoagulation initiated- platelets recovered quickly after that.  HIT antibody was negative.  Serotonin release assay was negative (but was drawn after treatment initiated).  PF4 assay pending (although also drawn after treatment initiated).
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic vein thrombosis, Immunoglobulin therapy, Laboratory test normal, Magnetic resonance imaging, Pancreatitis
Clinical narrative: Patient developed headaches and presented to the hospital where she had a cardiopulmonary arrest. Found to have pancreatitis, a hepatic vein thrombus and clot in the basilic and cephalic veins of the left upper extremity.  She had severe thrombocytopenia and greatly elevated D-dimer on presentation.  Thrombocytopenia continued until IVIG and anticoagulation initiated- platelets recovered quickly after that.  HIT antibody was negative.  Serotonin release assay was negative (but was drawn after treatment initiated).  PF4 assay pending (although also drawn after treatment initiated).
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet disorder, Platelet factor 4, Serum serotonin, Thrombocytopenia, Venogram
Clinical narrative: Patient developed headaches and presented to the hospital where she had a cardiopulmonary arrest. Found to have pancreatitis, a hepatic vein thrombus and clot in the basilic and cephalic veins of the left upper extremity.  She had severe thrombocytopenia and greatly elevated D-dimer on presentation.  Thrombocytopenia continued until IVIG and anticoagulation initiated- platelets recovered quickly after that.  HIT antibody was negative.  Serotonin release assay was negative (but was drawn after treatment initiated).  PF4 assay pending (although also drawn after treatment initiated).
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Venous thrombosis limb
Clinical narrative: Patient developed headaches and presented to the hospital where she had a cardiopulmonary arrest. Found to have pancreatitis, a hepatic vein thrombus and clot in the basilic and cephalic veins of the left upper extremity.  She had severe thrombocytopenia and greatly elevated D-dimer on presentation.  Thrombocytopenia continued until IVIG and anticoagulation initiated- platelets recovered quickly after that.  HIT antibody was negative.  Serotonin release assay was negative (but was drawn after treatment initiated).  PF4 assay pending (although also drawn after treatment initiated).
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: redness, swelling, lump and the spot was hot.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous
Clinical narrative: redness, swelling, lump and the spot was hot.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Mass, Skin warm, Swelling
Clinical narrative: redness, swelling, lump and the spot was hot.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Cardiac failure congestive, Cardiac pacemaker adjustment, Cardiomegaly, Hepatic ischaemia
Clinical narrative: Stomach pains in liver area.; Very tired; very painful; Hospital stated AV Block and pacemaker.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on Mar2021 at 01:00 PM (Batch/Lot Number: EN6205) (at the age of 56-year-old) as dose 1,single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included heart, asthma, and migraines. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took nadolol and experienced allergies (reported as "known allergies: Nadalol"). The patient experienced stomach pains in liver area. Very tired and very painful. Hospital stated AV Block and pacemaker. The onset of events was on 10Mar2021 at 13:00 (01:00 PM). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient was hospitalized for 8 days. Since the vaccination, the patient has been tested for COVID-19, which was a nasal swab with negative result on 20Mar2021. Therapeutic measures were taken as a result of the event which included pacemaker. The events were reported as serious - life threatening, caused/prolonged hospitalization, and disabling/incapacitating. The outcome of the events was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Mitral valve incompetence, Tricuspid valve incompetence
Clinical narrative: Stomach pains in liver area.; Very tired; very painful; Hospital stated AV Block and pacemaker.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on Mar2021 at 01:00 PM (Batch/Lot Number: EN6205) (at the age of 56-year-old) as dose 1,single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included heart, asthma, and migraines. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took nadolol and experienced allergies (reported as "known allergies: Nadalol"). The patient experienced stomach pains in liver area. Very tired and very painful. Hospital stated AV Block and pacemaker. The onset of events was on 10Mar2021 at 13:00 (01:00 PM). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient was hospitalized for 8 days. Since the vaccination, the patient has been tested for COVID-19, which was a nasal swab with negative result on 20Mar2021. Therapeutic measures were taken as a result of the event which included pacemaker. The events were reported as serious - life threatening, caused/prolonged hospitalization, and disabling/incapacitating. The outcome of the events was recovering.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Atrioventricular block, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Stomach pains in liver area.; Very tired; very painful; Hospital stated AV Block and pacemaker.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on Mar2021 at 01:00 PM (Batch/Lot Number: EN6205) (at the age of 56-year-old) as dose 1,single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included heart, asthma, and migraines. Concomitant medication included hydrochlorothiazide, lisinopril (LISINOPRIL AND HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously took nadolol and experienced allergies (reported as "known allergies: Nadalol"). The patient experienced stomach pains in liver area. Very tired and very painful. Hospital stated AV Block and pacemaker. The onset of events was on 10Mar2021 at 13:00 (01:00 PM). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), and disability or permanent damage. The patient was hospitalized for 8 days. Since the vaccination, the patient has been tested for COVID-19, which was a nasal swab with negative result on 20Mar2021. Therapeutic measures were taken as a result of the event which included pacemaker. The events were reported as serious - life threatening, caused/prolonged hospitalization, and disabling/incapacitating. The outcome of the events was recovering.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: SORENESS ALL OVER THE BODY; MISSED 2 DAYS OF WORK; LEGS AND ARMS WERE ACHY; LOW FEVER; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a parent concerned a 15 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drug allergy, liver problems, and elevated liver enzymes.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 21-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced off label use. On 21-JUL-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced soreness all over the body, missed 2 days of work, legs and arms were achy, and low fever. Laboratory data (dates unspecified) included: Hepatic enzyme (NR: not provided) slightly elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, soreness all over the body, legs and arms were achy, low fever, missed 2 days of work and product administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hepatic enzyme, Impaired work ability, Off label use, Pain, Pain in extremity
Clinical narrative: SORENESS ALL OVER THE BODY; MISSED 2 DAYS OF WORK; LEGS AND ARMS WERE ACHY; LOW FEVER; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a parent concerned a 15 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drug allergy, liver problems, and elevated liver enzymes.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 21-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced off label use. On 21-JUL-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced soreness all over the body, missed 2 days of work, legs and arms were achy, and low fever. Laboratory data (dates unspecified) included: Hepatic enzyme (NR: not provided) slightly elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, soreness all over the body, legs and arms were achy, low fever, missed 2 days of work and product administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: SORENESS ALL OVER THE BODY; MISSED 2 DAYS OF WORK; LEGS AND ARMS WERE ACHY; LOW FEVER; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a parent concerned a 15 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfa drug allergy, liver problems, and elevated liver enzymes.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 21-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUL-2021, the subject experienced off label use. On 21-JUL-2021, the subject experienced product administered to subject of inappropriate age. On an unspecified date, the subject experienced soreness all over the body, missed 2 days of work, legs and arms were achy, and low fever. Laboratory data (dates unspecified) included: Hepatic enzyme (NR: not provided) slightly elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, soreness all over the body, legs and arms were achy, low fever, missed 2 days of work and product administered to patient of inappropriate age was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: WRONG VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 11-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810486.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: WRONG VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: 11-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the subject experienced wrong vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of wrong vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810486.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 11-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination. On 03-AUG-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810488.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medication error
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 11-SEP-2021) dose was not reported, administered on 03-AUG-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination. On 03-AUG-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210810488.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram, Gait disturbance, Pain
Clinical narrative: Stated that she can hardly walk on her right leg; had sciatica on the same side that she got the vaccine; stated that it affected above her buttocks; stated that she was in pain; Stated that when she goes upstairs that her right leg is a little weak; stated that it affected her thigh area; stated that it affected her knee; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) reported herself. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not provided, Expiration date: Unknown), via an unspecified route on 20Feb2021, as a single dose for COVID-19 immunization. Medical history included two years ago she went to the eye doctor and had mild cataracts and when she went this year, she has to have cataract surgery, she had depression but that was 15 years ago, and she takes medication for it. She had the abnormal heartbeat before the vaccine. Stated that she takes Metoprolol for it. Stated that it was better controlled. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), on unknown date as a single dose for covid-19 immunization. On 26Feb2021, patient went for car ride could hardly walk on her right leg and it got progressively worst. Stated that she never had back trouble. Stated that on way to another state she stopped to use the bathroom and did not think she could make it back to the car, on unknown date in 2021, it was sciatica on same side she got vaccine, it affected above her buttocks, thigh area and knee. Stated that she could walk but she was in pain. On 12Apr2021 she could not take it anymore went to emergency and they sent her to physical therapy. She did the exercises and took a muscle relaxer ROBAXIN and was told that it could cause one to get itchy and she got itchy. They gave her opioids, but she never took it. She was taking a lot of TYLENOL and Ibuprofen and she was better now. Stated that she cannot do exercises every day because it ruins her day, and she gets pain. Stated that she does it every other day. The next day after exercises that she gets a stabbing pain in her back if she bends over, when she goes upstairs that her right leg was a little weak. She has never been like this before. The patient underwent lab test and procedure which included Computerised tomogram (CAT) scan of her back. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Gait inability, Muscular weakness, Musculoskeletal pain
Clinical narrative: Stated that she can hardly walk on her right leg; had sciatica on the same side that she got the vaccine; stated that it affected above her buttocks; stated that she was in pain; Stated that when she goes upstairs that her right leg is a little weak; stated that it affected her thigh area; stated that it affected her knee; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) reported herself. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not provided, Expiration date: Unknown), via an unspecified route on 20Feb2021, as a single dose for COVID-19 immunization. Medical history included two years ago she went to the eye doctor and had mild cataracts and when she went this year, she has to have cataract surgery, she had depression but that was 15 years ago, and she takes medication for it. She had the abnormal heartbeat before the vaccine. Stated that she takes Metoprolol for it. Stated that it was better controlled. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), on unknown date as a single dose for covid-19 immunization. On 26Feb2021, patient went for car ride could hardly walk on her right leg and it got progressively worst. Stated that she never had back trouble. Stated that on way to another state she stopped to use the bathroom and did not think she could make it back to the car, on unknown date in 2021, it was sciatica on same side she got vaccine, it affected above her buttocks, thigh area and knee. Stated that she could walk but she was in pain. On 12Apr2021 she could not take it anymore went to emergency and they sent her to physical therapy. She did the exercises and took a muscle relaxer ROBAXIN and was told that it could cause one to get itchy and she got itchy. They gave her opioids, but she never took it. She was taking a lot of TYLENOL and Ibuprofen and she was better now. Stated that she cannot do exercises every day because it ruins her day, and she gets pain. Stated that she does it every other day. The next day after exercises that she gets a stabbing pain in her back if she bends over, when she goes upstairs that her right leg was a little weak. She has never been like this before. The patient underwent lab test and procedure which included Computerised tomogram (CAT) scan of her back. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sciatica
Clinical narrative: Stated that she can hardly walk on her right leg; had sciatica on the same side that she got the vaccine; stated that it affected above her buttocks; stated that she was in pain; Stated that when she goes upstairs that her right leg is a little weak; stated that it affected her thigh area; stated that it affected her knee; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient) reported herself. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not provided, Expiration date: Unknown), via an unspecified route on 20Feb2021, as a single dose for COVID-19 immunization. Medical history included two years ago she went to the eye doctor and had mild cataracts and when she went this year, she has to have cataract surgery, she had depression but that was 15 years ago, and she takes medication for it. She had the abnormal heartbeat before the vaccine. Stated that she takes Metoprolol for it. Stated that it was better controlled. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), on unknown date as a single dose for covid-19 immunization. On 26Feb2021, patient went for car ride could hardly walk on her right leg and it got progressively worst. Stated that she never had back trouble. Stated that on way to another state she stopped to use the bathroom and did not think she could make it back to the car, on unknown date in 2021, it was sciatica on same side she got vaccine, it affected above her buttocks, thigh area and knee. Stated that she could walk but she was in pain. On 12Apr2021 she could not take it anymore went to emergency and they sent her to physical therapy. She did the exercises and took a muscle relaxer ROBAXIN and was told that it could cause one to get itchy and she got itchy. They gave her opioids, but she never took it. She was taking a lot of TYLENOL and Ibuprofen and she was better now. Stated that she cannot do exercises every day because it ruins her day, and she gets pain. Stated that she does it every other day. The next day after exercises that she gets a stabbing pain in her back if she bends over, when she goes upstairs that her right leg was a little weak. She has never been like this before. The patient underwent lab test and procedure which included Computerised tomogram (CAT) scan of her back. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Painful respiration, Troponin
Clinical narrative: Chest Pain
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Echocardiogram normal, Magnetic resonance imaging heart, Myocardial oedema
Clinical narrative: Chest Pain
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased
Clinical narrative: Chest Pain
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Fall, Headache, Heart rate decreased
Clinical narrative: fainted after JJ covid vaccine. patient as a result of fainting, head hit floor. 911 was called and patient was taken to hospital. patient recovered immediately from fainting but was taken to hospital because of possible head injury.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypertension, Loss of consciousness, Malaise, Presyncope
Clinical narrative: fainted after JJ covid vaccine. patient as a result of fainting, head hit floor. 911 was called and patient was taken to hospital. patient recovered immediately from fainting but was taken to hospital because of possible head injury.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Syncope
Clinical narrative: fainted after JJ covid vaccine. patient as a result of fainting, head hit floor. 911 was called and patient was taken to hospital. patient recovered immediately from fainting but was taken to hospital because of possible head injury.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Brain natriuretic peptide normal, Bundle branch block right, C-reactive protein increased
Clinical narrative: After 2nd Pfizer vaccine, patient noticed site reaction (arm swelled slightly but went away before patient left pharmacy). One week later, patient reported he had high blood pressure and some heart flutter. He had an EKG. Cardiologist reported myocarditis and slight heart failure. Currently patient's BP is down and no medication is needed. He is being observed for heart conditions but not being treated for them.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Condition aggravated, Electrocardiogram abnormal, Headache
Clinical narrative: After 2nd Pfizer vaccine, patient noticed site reaction (arm swelled slightly but went away before patient left pharmacy). One week later, patient reported he had high blood pressure and some heart flutter. He had an EKG. Cardiologist reported myocarditis and slight heart failure. Currently patient's BP is down and no medication is needed. He is being observed for heart conditions but not being treated for them.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Palpitations, Peripheral swelling, Red blood cell sedimentation rate normal, Troponin
Clinical narrative: After 2nd Pfizer vaccine, patient noticed site reaction (arm swelled slightly but went away before patient left pharmacy). One week later, patient reported he had high blood pressure and some heart flutter. He had an EKG. Cardiologist reported myocarditis and slight heart failure. Currently patient's BP is down and no medication is needed. He is being observed for heart conditions but not being treated for them.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Cardiac flutter, Electrocardiogram abnormal, Hypertension, Injection site swelling
Clinical narrative: After 2nd Pfizer vaccine, patient noticed site reaction (arm swelled slightly but went away before patient left pharmacy). One week later, patient reported he had high blood pressure and some heart flutter. He had an EKG. Cardiologist reported myocarditis and slight heart failure. Currently patient's BP is down and no medication is needed. He is being observed for heart conditions but not being treated for them.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: After 2nd Pfizer vaccine, patient noticed site reaction (arm swelled slightly but went away before patient left pharmacy). One week later, patient reported he had high blood pressure and some heart flutter. He had an EKG. Cardiologist reported myocarditis and slight heart failure. Currently patient's BP is down and no medication is needed. He is being observed for heart conditions but not being treated for them.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache, body ache, nausea. Fever
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated (moderna, 3/31/21, 4/28/21); onset of symptoms 7/28/21
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Hypersensitivity, Vein disorder
Clinical narrative: Seventh day bruises, allergies and veins marked with blood.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cutaneous lupus erythematosus, Paraesthesia, Rash, Skin burning sensation
Clinical narrative: Had cutaneous flareup after vaccine.   Rash on face.   Tingling and burning sensation on my back, scalp and ears,    It felt like shingles.    Dr. prescribed Mometasone Furoate Cream, USP for the rash.   Rash was reduced significantly by my May 12 appointment.     No longer had the tingling and burning sensations in my skin.  Got a rash after the second vaccine.  Presently, I have a rash on my face due to the Bermuda sun.    I now experience tingling and burning sensations on my back, scalp, arms and ears when I have the rash.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: Had cutaneous flareup after vaccine.   Rash on face.   Tingling and burning sensation on my back, scalp and ears,    It felt like shingles.    Dr. prescribed Mometasone Furoate Cream, USP for the rash.   Rash was reduced significantly by my May 12 appointment.     No longer had the tingling and burning sensations in my skin.  Got a rash after the second vaccine.  Presently, I have a rash on my face due to the Bermuda sun.    I now experience tingling and burning sensations on my back, scalp, arms and ears when I have the rash.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling cold, Feeling hot, Myalgia
Clinical narrative: Sore muscles  Lower back ache  Sore arm  Tired  Slept for about 12 hours  Got hot (not fever hot) and felt cold despite being warm  Occasional waist burning skin sensation
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Skin burning sensation, Somnolence
Clinical narrative: Sore muscles  Lower back ache  Sore arm  Tired  Slept for about 12 hours  Got hot (not fever hot) and felt cold despite being warm  Occasional waist burning skin sensation
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Minor chills started around 7pm.  By 11pm chills were moderate and accompanied by chattering teeth. Symptoms abated by 3am.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dyspnoea, Palpitations
Clinical narrative: dizziness/lighheadedness; sob; heart racing; chills
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle contractions involuntary
Clinical narrative: About a week after the second dose of the vaccine I started to have fasciculations in my left forearm. The fascinations then started occurring at random places throughout my body such as my toes, legs, pectorals muscles, shoulders, and triceps. These tend to occur more when at rest and are brief. They normally go away when I move or contract the muscle affected.  Some days they are less frequent, but others they increase in frequency and duration. They continue to occur daily.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Dizziness, Fatigue, Haemoglobin decreased, Headache
Clinical narrative: Headache, fatigue, muscle aches, dizziness, nausea and vomiting started 6-8 h after vaccine and was maximal at 40 hours.   Pancytopenia with WBC  of 2.2, platelets to 150,000 and anemia of 9.8
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Myalgia, Nausea, Pancytopenia, Platelet count normal
Clinical narrative: Headache, fatigue, muscle aches, dizziness, nausea and vomiting started 6-8 h after vaccine and was maximal at 40 hours.   Pancytopenia with WBC  of 2.2, platelets to 150,000 and anemia of 9.8
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count decreased
Clinical narrative: Headache, fatigue, muscle aches, dizziness, nausea and vomiting started 6-8 h after vaccine and was maximal at 40 hours.   Pancytopenia with WBC  of 2.2, platelets to 150,000 and anemia of 9.8
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Muscle twitching
Clinical narrative: reporting day after the shot, had twitching/shaking in contralateral RIGHT hand this is intermittent and has persisted up to this first report (to my knowledge) ALSO reports developed LEFT side hand twitching, now persistent, the day after getting Moderna #2 lot 002B21A in left deltoid on 3/1921
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated (Pfizer, 3/17/21, 4/8/21); symptom onset 8/3/21