chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Chills, Dysstasia, Laboratory test normal
Clinical narrative: ECZEMA (RASH ON CHIN AND RIGHT ARM); CAN NOT GET OUT OF BED; SEVERE JOINT PAIN ON TOTAL BODY ON MOST OF THE DAYS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 220 pounds, and height was 173 centimeters. The patient's concurrent conditions included: latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no medical history or relevant pre-existing conditions and drug abuse. Patient was not on any other medication at the time of adverse event started. Patient had no illness at time of vaccination. Patient had no history of similar event. Patient had no Adverse event after any previous vaccinations. Patient had no history of any allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and meloxicam. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. On 03-APR-2021, the patient experienced can not get out of bed. On 03-APR-2021, the patient experienced severe joint pain on total body on most of the days. On 31-JUL-2021, the patient experienced eczema (rash on chin and right arm). Laboratory data (dates unspecified) included: Blood test (NR: not provided) It came back fine and everything was fine, NORMAL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe joint pain on total body on most of the days, can not get out of bed, chills, and body aches, and the outcome of eczema (rash on chin and right arm) was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Myalgia, Pain, Pyrexia
Clinical narrative: ECZEMA (RASH ON CHIN AND RIGHT ARM); CAN NOT GET OUT OF BED; SEVERE JOINT PAIN ON TOTAL BODY ON MOST OF THE DAYS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 220 pounds, and height was 173 centimeters. The patient's concurrent conditions included: latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no medical history or relevant pre-existing conditions and drug abuse. Patient was not on any other medication at the time of adverse event started. Patient had no illness at time of vaccination. Patient had no history of similar event. Patient had no Adverse event after any previous vaccinations. Patient had no history of any allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and meloxicam. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. On 03-APR-2021, the patient experienced can not get out of bed. On 03-APR-2021, the patient experienced severe joint pain on total body on most of the days. On 31-JUL-2021, the patient experienced eczema (rash on chin and right arm). Laboratory data (dates unspecified) included: Blood test (NR: not provided) It came back fine and everything was fine, NORMAL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe joint pain on total body on most of the days, can not get out of bed, chills, and body aches, and the outcome of eczema (rash on chin and right arm) was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Chills, Eczema, Mobility decreased
Clinical narrative: ECZEMA (RASH ON CHIN AND RIGHT ARM); CAN NOT GET OUT OF BED; SEVERE JOINT PAIN ON TOTAL BODY ON MOST OF THE DAYS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 220 pounds, and height was 173 centimeters. The patient's concurrent conditions included: latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no medical history or relevant pre-existing conditions and drug abuse. Patient was not on any other medication at the time of adverse event started. Patient had no illness at time of vaccination. Patient had no history of similar event. Patient had no Adverse event after any previous vaccinations. Patient had no history of any allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and meloxicam. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. On 03-APR-2021, the patient experienced can not get out of bed. On 03-APR-2021, the patient experienced severe joint pain on total body on most of the days. On 31-JUL-2021, the patient experienced eczema (rash on chin and right arm). Laboratory data (dates unspecified) included: Blood test (NR: not provided) It came back fine and everything was fine, NORMAL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe joint pain on total body on most of the days, can not get out of bed, chills, and body aches, and the outcome of eczema (rash on chin and right arm) was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: ECZEMA (RASH ON CHIN AND RIGHT ARM); CAN NOT GET OUT OF BED; SEVERE JOINT PAIN ON TOTAL BODY ON MOST OF THE DAYS; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was 220 pounds, and height was 173 centimeters. The patient's concurrent conditions included: latex allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient had no medical history or relevant pre-existing conditions and drug abuse. Patient was not on any other medication at the time of adverse event started. Patient had no illness at time of vaccination. Patient had no history of similar event. Patient had no Adverse event after any previous vaccinations. Patient had no history of any allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination. The patient was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and meloxicam. On 01-APR-2021, the patient experienced body aches. On 01-APR-2021, the patient experienced chills. On 03-APR-2021, the patient experienced can not get out of bed. On 03-APR-2021, the patient experienced severe joint pain on total body on most of the days. On 31-JUL-2021, the patient experienced eczema (rash on chin and right arm). Laboratory data (dates unspecified) included: Blood test (NR: not provided) It came back fine and everything was fine, NORMAL.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe joint pain on total body on most of the days, can not get out of bed, chills, and body aches, and the outcome of eczema (rash on chin and right arm) was not reported. This report was non-serious.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received Moderna for first dose and and pfizer for second
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt received Moderna for first dose and and pfizer for second
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Insomnia, Respiratory tract congestion
Clinical narrative: Patient developed autoimmunity to heart and ovary glands with diffuse systemic inflammatory response resulting in chronic severe fatigue, shortness of breath and chest pain/pressure.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Patient developed autoimmunity to heart and ovary glands with diffuse systemic inflammatory response resulting in chronic severe fatigue, shortness of breath and chest pain/pressure.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Cough, Depression, Fatigue, Headache
Clinical narrative: Rash/hives within 10 minutes of receiving vaccine, followed by migraine headache, stiff neck, ear pain, sweating, flu symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Vaccination site rash
Clinical narrative: Rash/hives within 10 minutes of receiving vaccine, followed by migraine headache, stiff neck, ear pain, sweating, flu symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Influenza, Migraine, Musculoskeletal stiffness, Rash
Clinical narrative: Rash/hives within 10 minutes of receiving vaccine, followed by migraine headache, stiff neck, ear pain, sweating, flu symptoms.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Rash/hives within 10 minutes of receiving vaccine, followed by migraine headache, stiff neck, ear pain, sweating, flu symptoms.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aortic valve incompetence, Cardiac failure, Echocardiogram, Ejection fraction decreased, Left atrial enlargement
Clinical narrative: Pt. received his first dose of Moderna on 3/26/21 (Lot #  036A21A) and stated he just felt tired after it off and on. Received his 2nd dose of Moderna on 4/20/21 (Lot # 003B21A). About 2 weeks after his second dose he stated he began to fell some increasing SOB on both exertion and non-exertion however he did not seek medical attention until 6/15/2021. Since then he has been in and out of different ERs and on 7/9/21 Dx him with CHF. in the ER note, the doctor wrote that he suspected it may be related to the COVID-19 vaccine as patient has never had CHF (edema and swelling ) prior to the COVID-19 vaccine. However, patient has family history of heart issues and patient had previously been Dx with HTN. There was nothing in the ER note about a VEARS report being filed, so I told patient that we would file a report through VEARS to make sure there was follow-up on what was occurring.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular dilatation, Mitral valve incompetence, Myocarditis, N-terminal prohormone brain natriuretic peptide, Right ventricular dilatation
Clinical narrative: Pt. received his first dose of Moderna on 3/26/21 (Lot #  036A21A) and stated he just felt tired after it off and on. Received his 2nd dose of Moderna on 4/20/21 (Lot # 003B21A). About 2 weeks after his second dose he stated he began to fell some increasing SOB on both exertion and non-exertion however he did not seek medical attention until 6/15/2021. Since then he has been in and out of different ERs and on 7/9/21 Dx him with CHF. in the ER note, the doctor wrote that he suspected it may be related to the COVID-19 vaccine as patient has never had CHF (edema and swelling ) prior to the COVID-19 vaccine. However, patient has family history of heart issues and patient had previously been Dx with HTN. There was nothing in the ER note about a VEARS report being filed, so I told patient that we would file a report through VEARS to make sure there was follow-up on what was occurring.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Systolic dysfunction, Tricuspid valve incompetence, Ventricular hypokinesia
Clinical narrative: Pt. received his first dose of Moderna on 3/26/21 (Lot #  036A21A) and stated he just felt tired after it off and on. Received his 2nd dose of Moderna on 4/20/21 (Lot # 003B21A). About 2 weeks after his second dose he stated he began to fell some increasing SOB on both exertion and non-exertion however he did not seek medical attention until 6/15/2021. Since then he has been in and out of different ERs and on 7/9/21 Dx him with CHF. in the ER note, the doctor wrote that he suspected it may be related to the COVID-19 vaccine as patient has never had CHF (edema and swelling ) prior to the COVID-19 vaccine. However, patient has family history of heart issues and patient had previously been Dx with HTN. There was nothing in the ER note about a VEARS report being filed, so I told patient that we would file a report through VEARS to make sure there was follow-up on what was occurring.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure congestive, Dyspnoea, Fatigue, Oedema, Swelling
Clinical narrative: Pt. received his first dose of Moderna on 3/26/21 (Lot #  036A21A) and stated he just felt tired after it off and on. Received his 2nd dose of Moderna on 4/20/21 (Lot # 003B21A). About 2 weeks after his second dose he stated he began to fell some increasing SOB on both exertion and non-exertion however he did not seek medical attention until 6/15/2021. Since then he has been in and out of different ERs and on 7/9/21 Dx him with CHF. in the ER note, the doctor wrote that he suspected it may be related to the COVID-19 vaccine as patient has never had CHF (edema and swelling ) prior to the COVID-19 vaccine. However, patient has family history of heart issues and patient had previously been Dx with HTN. There was nothing in the ER note about a VEARS report being filed, so I told patient that we would file a report through VEARS to make sure there was follow-up on what was occurring.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Pt. received his first dose of Moderna on 3/26/21 (Lot #  036A21A) and stated he just felt tired after it off and on. Received his 2nd dose of Moderna on 4/20/21 (Lot # 003B21A). About 2 weeks after his second dose he stated he began to fell some increasing SOB on both exertion and non-exertion however he did not seek medical attention until 6/15/2021. Since then he has been in and out of different ERs and on 7/9/21 Dx him with CHF. in the ER note, the doctor wrote that he suspected it may be related to the COVID-19 vaccine as patient has never had CHF (edema and swelling ) prior to the COVID-19 vaccine. However, patient has family history of heart issues and patient had previously been Dx with HTN. There was nothing in the ER note about a VEARS report being filed, so I told patient that we would file a report through VEARS to make sure there was follow-up on what was occurring.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Started with burning, prickling and weakness in Both legs and arms and progressed to burning pain, prickling sensation, weakness in Both arms, legs and pin in legs, arms and torso. Doctor informed that I have small finer neuropathy. I had no symptoms prior to receiving vaccine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Burning sensation, Electromyogram normal, Magnetic resonance imaging normal, Muscular weakness
Clinical narrative: Started with burning, prickling and weakness in Both legs and arms and progressed to burning pain, prickling sensation, weakness in Both arms, legs and pin in legs, arms and torso. Doctor informed that I have small finer neuropathy. I had no symptoms prior to receiving vaccine.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Paraesthesia, Peripheral nervous system function test, Small fibre neuropathy
Clinical narrative: Started with burning, prickling and weakness in Both legs and arms and progressed to burning pain, prickling sensation, weakness in Both arms, legs and pin in legs, arms and torso. Doctor informed that I have small finer neuropathy. I had no symptoms prior to receiving vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: On 7/21/2021 the patient got the Pfizer COVID vaccine in the left arm, then within a few minutes (unclear, 45 seconds to2 minutes max) felt tingly in the left arm. The next thing she remembers is waking up on the floor with EMTs around her.  She endorses feeling dizzy prior to the event.  She reported her vision going blurry but denies tunnel vision.  She denies lightheadedness.   Mom was present and noted her with whole body shaking while she was sitting in a chair, and she was sliding off the chair.  Eyes were not completely open or shut.  She did not note any gaze deviation.  The shaking lasted at least 1 minute, up to 2 minutes though exact frequency is uncertain. She was very tired and "out of it" afterwards.  She felt nearly back to herself later that night, and back to herself by the next day.  Her mother reports she was very cold after the episode.  Felt to be possible convulsive syncope versus seizure.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Blood lactic acid normal, Blood magnesium normal, Blood prolactin normal, Computerised tomogram head
Clinical narrative: On 7/21/2021 the patient got the Pfizer COVID vaccine in the left arm, then within a few minutes (unclear, 45 seconds to2 minutes max) felt tingly in the left arm. The next thing she remembers is waking up on the floor with EMTs around her.  She endorses feeling dizzy prior to the event.  She reported her vision going blurry but denies tunnel vision.  She denies lightheadedness.   Mom was present and noted her with whole body shaking while she was sitting in a chair, and she was sliding off the chair.  Eyes were not completely open or shut.  She did not note any gaze deviation.  The shaking lasted at least 1 minute, up to 2 minutes though exact frequency is uncertain. She was very tired and "out of it" afterwards.  She felt nearly back to herself later that night, and back to herself by the next day.  Her mother reports she was very cold after the episode.  Felt to be possible convulsive syncope versus seizure.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram, Electroencephalogram normal, Fatigue, Feeling abnormal
Clinical narrative: On 7/21/2021 the patient got the Pfizer COVID vaccine in the left arm, then within a few minutes (unclear, 45 seconds to2 minutes max) felt tingly in the left arm. The next thing she remembers is waking up on the floor with EMTs around her.  She endorses feeling dizzy prior to the event.  She reported her vision going blurry but denies tunnel vision.  She denies lightheadedness.   Mom was present and noted her with whole body shaking while she was sitting in a chair, and she was sliding off the chair.  Eyes were not completely open or shut.  She did not note any gaze deviation.  The shaking lasted at least 1 minute, up to 2 minutes though exact frequency is uncertain. She was very tired and "out of it" afterwards.  She felt nearly back to herself later that night, and back to herself by the next day.  Her mother reports she was very cold after the episode.  Felt to be possible convulsive syncope versus seizure.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Full blood count normal, Liver function test normal, Loss of consciousness, Metabolic function test
Clinical narrative: On 7/21/2021 the patient got the Pfizer COVID vaccine in the left arm, then within a few minutes (unclear, 45 seconds to2 minutes max) felt tingly in the left arm. The next thing she remembers is waking up on the floor with EMTs around her.  She endorses feeling dizzy prior to the event.  She reported her vision going blurry but denies tunnel vision.  She denies lightheadedness.   Mom was present and noted her with whole body shaking while she was sitting in a chair, and she was sliding off the chair.  Eyes were not completely open or shut.  She did not note any gaze deviation.  The shaking lasted at least 1 minute, up to 2 minutes though exact frequency is uncertain. She was very tired and "out of it" afterwards.  She felt nearly back to herself later that night, and back to herself by the next day.  Her mother reports she was very cold after the episode.  Felt to be possible convulsive syncope versus seizure.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Toxicologic test, Tremor, Vision blurred
Clinical narrative: On 7/21/2021 the patient got the Pfizer COVID vaccine in the left arm, then within a few minutes (unclear, 45 seconds to2 minutes max) felt tingly in the left arm. The next thing she remembers is waking up on the floor with EMTs around her.  She endorses feeling dizzy prior to the event.  She reported her vision going blurry but denies tunnel vision.  She denies lightheadedness.   Mom was present and noted her with whole body shaking while she was sitting in a chair, and she was sliding off the chair.  Eyes were not completely open or shut.  She did not note any gaze deviation.  The shaking lasted at least 1 minute, up to 2 minutes though exact frequency is uncertain. She was very tired and "out of it" afterwards.  She felt nearly back to herself later that night, and back to herself by the next day.  Her mother reports she was very cold after the episode.  Felt to be possible convulsive syncope versus seizure.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Thrombosis, Ultrasound Doppler
Clinical narrative: This is follow up to a recent report.  Completed 7/26/21 temporary number 595972.  In that report I reported a DVT in my popliteal vein. Since then I have visited the ER on 8/2/21  with constant headache that lasted a week and chest pain. CT scans were performed nothing was seen. Blood work looked good. I followed up with my regular doctor on 8/3/21. During these two visits my blood pressure was 120-150/90-110. But my resting blood pressure was 110-120/70-80.  I have no history of hypertension. I was taken off work for a week and given pain pills for my leg pain and stress it could be causing.  Also magnesium and Klee-Con. Then on 8/9/21 had a telemed and it was determined my blood pressure spikes were still not handled and getting worse.  So I was put on  clonidine and taken off another week of work. I am taking my blood pressure to monitor and see if the medicine is effective.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test normal, Chest X-ray normal, Chest pain, Computerised tomogram head normal
Clinical narrative: This is follow up to a recent report.  Completed 7/26/21 temporary number 595972.  In that report I reported a DVT in my popliteal vein. Since then I have visited the ER on 8/2/21  with constant headache that lasted a week and chest pain. CT scans were performed nothing was seen. Blood work looked good. I followed up with my regular doctor on 8/3/21. During these two visits my blood pressure was 120-150/90-110. But my resting blood pressure was 110-120/70-80.  I have no history of hypertension. I was taken off work for a week and given pain pills for my leg pain and stress it could be causing.  Also magnesium and Klee-Con. Then on 8/9/21 had a telemed and it was determined my blood pressure spikes were still not handled and getting worse.  So I was put on  clonidine and taken off another week of work. I am taking my blood pressure to monitor and see if the medicine is effective.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Headache, Impaired work ability, Pain in extremity
Clinical narrative: This is follow up to a recent report.  Completed 7/26/21 temporary number 595972.  In that report I reported a DVT in my popliteal vein. Since then I have visited the ER on 8/2/21  with constant headache that lasted a week and chest pain. CT scans were performed nothing was seen. Blood work looked good. I followed up with my regular doctor on 8/3/21. During these two visits my blood pressure was 120-150/90-110. But my resting blood pressure was 110-120/70-80.  I have no history of hypertension. I was taken off work for a week and given pain pills for my leg pain and stress it could be causing.  Also magnesium and Klee-Con. Then on 8/9/21 had a telemed and it was determined my blood pressure spikes were still not handled and getting worse.  So I was put on  clonidine and taken off another week of work. I am taking my blood pressure to monitor and see if the medicine is effective.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: This is follow up to a recent report.  Completed 7/26/21 temporary number 595972.  In that report I reported a DVT in my popliteal vein. Since then I have visited the ER on 8/2/21  with constant headache that lasted a week and chest pain. CT scans were performed nothing was seen. Blood work looked good. I followed up with my regular doctor on 8/3/21. During these two visits my blood pressure was 120-150/90-110. But my resting blood pressure was 110-120/70-80.  I have no history of hypertension. I was taken off work for a week and given pain pills for my leg pain and stress it could be causing.  Also magnesium and Klee-Con. Then on 8/9/21 had a telemed and it was determined my blood pressure spikes were still not handled and getting worse.  So I was put on  clonidine and taken off another week of work. I am taking my blood pressure to monitor and see if the medicine is effective.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: Six minutes after receiving the vaccine, within the 15 minute waiting period, I suddenly became very lightheaded. Within seconds, I lost consciousness. I received footage from the security camera of this incident. Once I fainted, I had seizure like activity and was unconscious for under a minute. I have never fainted like this in my life before.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Feeling abnormal, Loss of consciousness
Clinical narrative: Six minutes after receiving the vaccine, within the 15 minute waiting period, I suddenly became very lightheaded. Within seconds, I lost consciousness. I received footage from the security camera of this incident. Once I fainted, I had seizure like activity and was unconscious for under a minute. I have never fainted like this in my life before.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Six minutes after receiving the vaccine, within the 15 minute waiting period, I suddenly became very lightheaded. Within seconds, I lost consciousness. I received footage from the security camera of this incident. Once I fainted, I had seizure like activity and was unconscious for under a minute. I have never fainted like this in my life before.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Burning sensation, Contusion, Feeling abnormal
Clinical narrative: The patient reports within 8 hours of vaccine she passed out. She reports consistent side effects including syncope and chest pain. On 8/11/21 she was admitted to the hospital with an acute CVA.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: The patient reports within 8 hours of vaccine she passed out. She reports consistent side effects including syncope and chest pain. On 8/11/21 she was admitted to the hospital with an acute CVA.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: The patient reports within 8 hours of vaccine she passed out. She reports consistent side effects including syncope and chest pain. On 8/11/21 she was admitted to the hospital with an acute CVA.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse drug reaction, Cerebrovascular accident, Chest pain, Loss of consciousness, Platelet count increased
Clinical narrative: The patient reports within 8 hours of vaccine she passed out. She reports consistent side effects including syncope and chest pain. On 8/11/21 she was admitted to the hospital with an acute CVA.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: The patient reports within 8 hours of vaccine she passed out. She reports consistent side effects including syncope and chest pain. On 8/11/21 she was admitted to the hospital with an acute CVA.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: OFF LABEL USE; USE IN PEDIATRIC POPULATION; MEDICAL ADMINISTRATION ERROR : SEQUENTIAL USE; This spontaneous report received from a health care professional concerned a 15 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07/AUG/2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination. On 05-AUG-2021, the patient experienced off label use. On 05-AUG-2021, the patient experienced use in pediatric population. On 05-AUG-2021, the patient experienced medical administration error : sequential use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, use in pediatric population and medical administration error : sequential use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210811013.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Medication error, Off label use, Product administered to patient of inappropriate age
Clinical narrative: OFF LABEL USE; USE IN PEDIATRIC POPULATION; MEDICAL ADMINISTRATION ERROR : SEQUENTIAL USE; This spontaneous report received from a health care professional concerned a 15 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07/AUG/2021) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included BNT 162 for prophylactic vaccination. On 05-AUG-2021, the patient experienced off label use. On 05-AUG-2021, the patient experienced use in pediatric population. On 05-AUG-2021, the patient experienced medical administration error : sequential use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use, use in pediatric population and medical administration error : sequential use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210811013.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Peripheral swelling, Urticaria
Clinical narrative: 2nd Covid vaccine August 9, 2021 at 3:30pm 13 minutes after second vaccine, the splotchiness began, as well as the coughing. Took 4 Benedryl per Pharmacist.  My headache that was constant after the first vaccine. I'd had some strange feelings of blood pooling but the Eliquis seemed to help.  I've now had my 2nd Covid vaccine on August 9, 2021. Taken 4 Benedryl 4 times since the 2nd injection. Headache is MUCH worse after 2nd injection. Had the same blood pooling sensation, hearing it as it passed near my inner ear area. It was on the right side this time. Also Tinnitus started within 4-6 hours, still have ringing in both ears, but not as bad as initial onset.   On the request of the pharmacy staff after initial reaction 13 minutes after 2nd injection, my doctor phoned in a prescription for an Epi Pen, which I've not yet had to use.   The strangest thing is my 2 service dogs have been stuck to me like glue since the 1st injection on July 19, 2021. They'll stare right at my face if I'm sitting down. If I get up, they get up. All hours of the day and night. Much more attentive than before the first shot, and even more after the second. They have to touch me now. At this very moment, I have one on each side of my legs (which are elevated), laying basically ON me. They will crawl on my lap and not move, as if they're protecting me. I live alone other than these 2 service dogs. They were always lovable, but would sit away from me unless they wanted to be petted. Now, I can't even go to the restroom without BOTH trying to climb onto my lap. This was never a regular routine for them.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Condition aggravated, Cough, Feeling abnormal, Genital herpes
Clinical narrative: 2nd Covid vaccine August 9, 2021 at 3:30pm 13 minutes after second vaccine, the splotchiness began, as well as the coughing. Took 4 Benedryl per Pharmacist.  My headache that was constant after the first vaccine. I'd had some strange feelings of blood pooling but the Eliquis seemed to help.  I've now had my 2nd Covid vaccine on August 9, 2021. Taken 4 Benedryl 4 times since the 2nd injection. Headache is MUCH worse after 2nd injection. Had the same blood pooling sensation, hearing it as it passed near my inner ear area. It was on the right side this time. Also Tinnitus started within 4-6 hours, still have ringing in both ears, but not as bad as initial onset.   On the request of the pharmacy staff after initial reaction 13 minutes after 2nd injection, my doctor phoned in a prescription for an Epi Pen, which I've not yet had to use.   The strangest thing is my 2 service dogs have been stuck to me like glue since the 1st injection on July 19, 2021. They'll stare right at my face if I'm sitting down. If I get up, they get up. All hours of the day and night. Much more attentive than before the first shot, and even more after the second. They have to touch me now. At this very moment, I have one on each side of my legs (which are elevated), laying basically ON me. They will crawl on my lap and not move, as if they're protecting me. I live alone other than these 2 service dogs. They were always lovable, but would sit away from me unless they wanted to be petted. Now, I can't even go to the restroom without BOTH trying to climb onto my lap. This was never a regular routine for them.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash macular, Sensation of blood flow, Sensory disturbance, Throat tightness
Clinical narrative: 2nd Covid vaccine August 9, 2021 at 3:30pm 13 minutes after second vaccine, the splotchiness began, as well as the coughing. Took 4 Benedryl per Pharmacist.  My headache that was constant after the first vaccine. I'd had some strange feelings of blood pooling but the Eliquis seemed to help.  I've now had my 2nd Covid vaccine on August 9, 2021. Taken 4 Benedryl 4 times since the 2nd injection. Headache is MUCH worse after 2nd injection. Had the same blood pooling sensation, hearing it as it passed near my inner ear area. It was on the right side this time. Also Tinnitus started within 4-6 hours, still have ringing in both ears, but not as bad as initial onset.   On the request of the pharmacy staff after initial reaction 13 minutes after 2nd injection, my doctor phoned in a prescription for an Epi Pen, which I've not yet had to use.   The strangest thing is my 2 service dogs have been stuck to me like glue since the 1st injection on July 19, 2021. They'll stare right at my face if I'm sitting down. If I get up, they get up. All hours of the day and night. Much more attentive than before the first shot, and even more after the second. They have to touch me now. At this very moment, I have one on each side of my legs (which are elevated), laying basically ON me. They will crawl on my lap and not move, as if they're protecting me. I live alone other than these 2 service dogs. They were always lovable, but would sit away from me unless they wanted to be petted. Now, I can't even go to the restroom without BOTH trying to climb onto my lap. This was never a regular routine for them.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Weight increased
Clinical narrative: 2nd Covid vaccine August 9, 2021 at 3:30pm 13 minutes after second vaccine, the splotchiness began, as well as the coughing. Took 4 Benedryl per Pharmacist.  My headache that was constant after the first vaccine. I'd had some strange feelings of blood pooling but the Eliquis seemed to help.  I've now had my 2nd Covid vaccine on August 9, 2021. Taken 4 Benedryl 4 times since the 2nd injection. Headache is MUCH worse after 2nd injection. Had the same blood pooling sensation, hearing it as it passed near my inner ear area. It was on the right side this time. Also Tinnitus started within 4-6 hours, still have ringing in both ears, but not as bad as initial onset.   On the request of the pharmacy staff after initial reaction 13 minutes after 2nd injection, my doctor phoned in a prescription for an Epi Pen, which I've not yet had to use.   The strangest thing is my 2 service dogs have been stuck to me like glue since the 1st injection on July 19, 2021. They'll stare right at my face if I'm sitting down. If I get up, they get up. All hours of the day and night. Much more attentive than before the first shot, and even more after the second. They have to touch me now. At this very moment, I have one on each side of my legs (which are elevated), laying basically ON me. They will crawl on my lap and not move, as if they're protecting me. I live alone other than these 2 service dogs. They were always lovable, but would sit away from me unless they wanted to be petted. Now, I can't even go to the restroom without BOTH trying to climb onto my lap. This was never a regular routine for them.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient already got JJ vaccine and came to the pharmacy to get Pfizer without telling us that they had previously had JJ. JJ shot discovered upon check during booster shot.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Patient already got JJ vaccine and came to the pharmacy to get Pfizer without telling us that they had previously had JJ. JJ shot discovered upon check during booster shot.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hyperhidrosis, Somnolence, Syncope, Tinnitus
Clinical narrative: Within five minutes of administering, I became very tired and lethargic. I laid my head back and shortly thereafter (within seconds) I lost consciousness and began to sieze up. I was unconscious for around 30 seconds or so before I came to. Over the course of about 30 minutes, I was sweating profusely, I had bright dancing lights in my vision, and my ears were ringing such that everything sounded like it was under water. This all eventually cleared up after a water bottle and I have not had any other symptoms aside from the achy arm.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Within five minutes of administering, I became very tired and lethargic. I laid my head back and shortly thereafter (within seconds) I lost consciousness and began to sieze up. I was unconscious for around 30 seconds or so before I came to. Over the course of about 30 minutes, I was sweating profusely, I had bright dancing lights in my vision, and my ears were ringing such that everything sounded like it was under water. This all eventually cleared up after a water bottle and I have not had any other symptoms aside from the achy arm.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hyperhidrosis, Lethargy, Loss of consciousness, Pain
Clinical narrative: Within five minutes of administering, I became very tired and lethargic. I laid my head back and shortly thereafter (within seconds) I lost consciousness and began to sieze up. I was unconscious for around 30 seconds or so before I came to. Over the course of about 30 minutes, I was sweating profusely, I had bright dancing lights in my vision, and my ears were ringing such that everything sounded like it was under water. This all eventually cleared up after a water bottle and I have not had any other symptoms aside from the achy arm.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Tinnitus
Clinical narrative: Within five minutes of administering, I became very tired and lethargic. I laid my head back and shortly thereafter (within seconds) I lost consciousness and began to sieze up. I was unconscious for around 30 seconds or so before I came to. Over the course of about 30 minutes, I was sweating profusely, I had bright dancing lights in my vision, and my ears were ringing such that everything sounded like it was under water. This all eventually cleared up after a water bottle and I have not had any other symptoms aside from the achy arm.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Periorbital swelling
Clinical narrative: Slight tingling in lips.; Very puffy eyes; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:15 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included Hbp (High Blood Pressure) and shellfish allergy. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 12:30, the patient experienced slight tingling in lips and very puffy eyes. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events slight tingling in lips and very puffy eyes was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: PPV
Symptoms: Therapeutic response unexpected
Clinical narrative: an unexpected benefit outcome; no AE; This spontaneous report was received from a male patient of unknown age reporting on himself. He had no concurrent or historical conditions, no drug allergies or reactions and he didn't take any concomitant medications.   In March 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) dose 1 (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient reported unexpected benefit outcome (no further specified). He also mentioned that he knew several people that needed booster shots of the vaccine, but he did not need booster dose himself and he had no issues after receiving his dose in March 2009. No further information was provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE/PQC reported.; an expired dose of PNEUMOVAX23 PFS was inadvertently administered to a patient.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 19-JUL-2021, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (PFS) (lot #: R033343, expiration date: 03-AUG-2020; route and dose details were not provided) for prophylaxis (expired product administered). The product never had a temperature excursion. No other adverse event (AE)/ product quality compliant (PQC) reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033343; expirationdate: 03-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about an unspecified date in 2008, the patient was inoculated by a pharmacist with the zoster vaccine live (ZOSTAVAX) vaccine at a pharmacy as recommended for the long-term prevention of shingles and other zoster-related conditions (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported). On an unknown date subsequently to vaccination, the patient was treated by a healthcare professional (HCP) for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The patient claimed damages as a result of injury to itself, loss of consortium and loss of services. The outcome of the events was unknown at the reporting time. The reported considered the aforementioned events to be related to vaccination with zoster vaccine live (ZOSTAVAX).