chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Loss of consciousness, Respiratory arrest
Clinical narrative: Child had seizure (lost consciousness and stopped breathing) 1 week after 1st dose of Pfizer COVID-19 vaccine.  Child was transported via ambulance to Hospital where she was admitted and will be spending the night.  Cause of seizure unknown at this time, no previous history of seizures.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Seizure, Urine analysis
Clinical narrative: Child had seizure (lost consciousness and stopped breathing) 1 week after 1st dose of Pfizer COVID-19 vaccine.  Child was transported via ambulance to Hospital where she was admitted and will be spending the night.  Cause of seizure unknown at this time, no previous history of seizures.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical urticaria, Pruritus, Rash maculo-papular, Urticaria
Clinical narrative: Recurring pruritic urticaria, dermatographia , maculopapular rash affecting different body areas. Responsive to daily Cetirizine but returns 24 hours after missed dose.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Blood culture, Blood gases, Blood lactic acid normal, Body temperature increased, Chest X-ray
Clinical narrative: Pt with increased lethargy  and minimally responding to questions and commands. Temp 101.3. Respirations 24.  Blood pressure: 156/60 and heart rate: 72. Patient returned back to baseline neurologic status at 1640  after Tylenol administration at 1549      CT head and CXR performed, lactic 0.7, temp down to 98.3, STAT CBC/BMP/ABGs done - Dr. reviewed scans and labs, no new orders or antibiotics. Patient now responsive and answering questions
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram head, Full blood count, Hyporesponsive to stimuli, Lethargy, Metabolic function test
Clinical narrative: Pt with increased lethargy  and minimally responding to questions and commands. Temp 101.3. Respirations 24.  Blood pressure: 156/60 and heart rate: 72. Patient returned back to baseline neurologic status at 1640  after Tylenol administration at 1549      CT head and CXR performed, lactic 0.7, temp down to 98.3, STAT CBC/BMP/ABGs done - Dr. reviewed scans and labs, no new orders or antibiotics. Patient now responsive and answering questions
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest pain, Heart rate increased, Loss of personal independence in daily activities
Clinical narrative: Starting about 2 weeks after the 2nd dose of Pfizer vaccination, I experienced chest pain, rapid heart beat and heart flutter. Since these symptoms still continue, I am filling out this form. Not able to return to normal activity state every since the 2nd dose of vaccination. Still requiring rest and strenuous activity avoidance in order to manage heart flutter and chest pain.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pain in extremity, Tendonitis, Urticaria
Clinical narrative: Hives for several days over abdomen, back, arms, hands and feet. Tendon swelling and pain in hands and feet, and marked lip swelling.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue
Clinical narrative: client vaccinated with Pfizer vaccines in March and April 2021.  Symptoms of Covid developed 11/16/2021.  nasal congestion, cough , fatigue, headache, myalgia, sore throat, loss of taste and smell.  Received treatment of monoclonal antibodies on 11/19. Reported as a breakthrough case of Covid in a vaccinated person
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: client vaccinated with Pfizer vaccines in March and April 2021.  Symptoms of Covid developed 11/16/2021.  nasal congestion, cough , fatigue, headache, myalgia, sore throat, loss of taste and smell.  Received treatment of monoclonal antibodies on 11/19. Reported as a breakthrough case of Covid in a vaccinated person
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Injury associated with device, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: Last Wednesday morning, I got up and went to the bathroom. I sat back down in my chair and my legs felt like needles and pins were sticking from my knees down.  I went back to sleep and when I woke up at 11:00, I was unable to move my arms or legs.  I spent a week in the hospital.  The paresthesia lasted for 4 days and gradually went away.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Last Wednesday morning, I got up and went to the bathroom. I sat back down in my chair and my legs felt like needles and pins were sticking from my knees down.  I went back to sleep and when I woke up at 11:00, I was unable to move my arms or legs.  I spent a week in the hospital.  The paresthesia lasted for 4 days and gradually went away.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: vaccinated with Moderna on 2/27 and 3/27/2021.  Symptoms developed on 11/22 - chills, nasal congestion Reported as case of breakthrough Covid in previously vaccinated person.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, Myalgia, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Client vaccinated in beginning and end of April x 2 with Moderna vaccines.  Symptoms started 11/20/2021 - nasal congestion, sneezing, headache, myalgia.  Reported as case of breakthrough Covid in previously vaccinated person.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: Client vaccinated in beginning and end of April x 2 with Moderna vaccines.  Symptoms started 11/20/2021 - nasal congestion, sneezing, headache, myalgia.  Reported as case of breakthrough Covid in previously vaccinated person.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: Sore at injection site, fever, headache
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac pharmacologic stress test, Cardioversion, Electrocardiogram, Procedural failure
Clinical narrative: Atrial fibrillation.  Medication prescribed immediately. Cardioversion 10/29/2021. Failed.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Atrial fibrillation.  Medication prescribed immediately. Cardioversion 10/29/2021. Failed.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Somnolence
Clinical narrative: 1. Extreme sleepiness- slept from 2:00 to 7 the next morning. Then slept over 14 hrs next three days. I continued to feel very sleepy for around 5 months, not exhausted but just sleepy 2. Severe arm pain. Could not lift my arm at all. Arm pain shooting if I moved. It got to where I could lift my arms to shoulder level without severe pain, but I still have shooting pain in both arms if I raise my arms above shoulder level. I haven't gone to a doctor because I kept thinking it would go away. 9 months later it?s not going away. I guess I'll have to make a dr appt for this. Really weird soreness that continues.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Menstruation delayed
Clinical narrative: Menstrual irregularity (late menses (5 days late), light flow) 14 days after vaccine administration
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: I had hives appear over much of my body starting about 2 weeks after getting Moderna booster. My brother, sister, and friend all had the same happen. Itchiness and bumbs pretty bad for about 6 weeks, just going away now about 12 weeks later.  We all managed our symptoms with OTC antihistamines and hydrocortisone cream.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test positive, Milk allergy
Clinical narrative: Newly developed severe allergies to milk.  Started only after receiving vaccine series. I had 2 incidents before going to the doctor and they did an allergy blood test. Prescribed epi pens
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Red skin reaction approx 4cm around injection site (L deltoid) with L axillary lymphadenopathy
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle aches, fever
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Extra dose administered, Interchange of vaccine products, Lymph node pain
Clinical narrative: Chest pain almost every day since vaccine. Chest feels tight intermittently, feels like I am having a panic attack.  This does not appear to be related to my heart or lungs.  My lymph nodes were also swollen painfully for a few days and I have since developed a rash in my armpits.  This was my booster. First two shots were Pfizer. I have never experienced these symptoms before.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Panic attack, Rash
Clinical narrative: Chest pain almost every day since vaccine. Chest feels tight intermittently, feels like I am having a panic attack.  This does not appear to be related to my heart or lungs.  My lymph nodes were also swollen painfully for a few days and I have since developed a rash in my armpits.  This was my booster. First two shots were Pfizer. I have never experienced these symptoms before.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain, Pyrexia, Rash, Rash erythematous
Clinical narrative: Injection sights soreness. Child developed a low grade fever within 24hrs that escalated into a high fever of 102 for days during the week following. She has exhibited a skin rash through out her entire body of red dots. Abdomen, back, buttocks and limbs. Days after the entire body was covered with this red rash. Fever was lingering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Fatigue, Headache, Pain
Clinical narrative: Chills, body aches, extreme fatigue and extreme headache.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Admitted to hospital with COVID 19 infection 11/24/21
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Lymphadenopathy, Migraine
Clinical narrative: Migraine, fever, chills, muscle aches, pain, exhaustion, swollen lymph nodes, cough
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Migraine, fever, chills, muscle aches, pain, exhaustion, swollen lymph nodes, cough
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: Swelling at injection site, spreading throughout left arm, swelling of lymph node in left arm pit. Swelling began 36 hours after injection. Swelling peaked 48 hours after injection.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: 27 hours post vaccine - fever, fatigue, lymphadenopathy   in arm pit and breast tenderness in the same side as the injection was given.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Patient reports shortness of breath at night and leg swelling that started after getting the covid vaccine
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Skin lesion
Clinical narrative: A lesion similar to a pox mark developed next to the injection site
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Paraesthesia
Clinical narrative: Severe paresthesia accompanied with chills. Chills lasted about 2 hours; paresthesia got better over time but lasted about 24 hours.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Post Polio syndrome symptoms. I have pain in the muscles my legs that I haven?t experienced in years. Sometimes it is very severe. The first shot brought on pain that lasted a few days but after the second shot the pain hasn?t gone away in 8 months.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immediate post-injection reaction, Influenza like illness, Metamorphopsia, Nausea
Clinical narrative: Vision distortion immediately after receipt.  Severe headaches on a daily basis since vaccination. Approximately 10 days after, nauseau and feelings of flu-like systems.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Migraine, Neck pain, Neuralgia, Visual impairment
Clinical narrative: Woke up with bad migraine on august 31,2021 which is the day after my first vaccine. I have had bad headaches since this day that won?t go away. Some days are a lot worse  than others. I also have severe neck pain and nerve pain that shoots around my neck down my back up to my eye. All of these issues are on my left side of my body. It also effects my reflexes and reaction response to different things. My vision is also effected when my headaches are severe. I have been diagnosed with possible occipital neuralgia and did not have any of these issues before getting the shot.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itching on both legs, bumps, redness
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Injection site pain, Lymphadenopathy
Clinical narrative: -Swollen lympnodes in armpit of left arm (injected arm) starting 11/24 -Pain in spleen in upper left abdomen starting 11/25 -Pain in left arm at injection site
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate irregular, Nausea, Tinnitus, Vaginal haemorrhage
Clinical narrative: First vaccine - within the first 24 hours , swollen breasts and extremely heavy menstrual bleeding lasting 5 days. Headache and arm pain lasting several days.   Second dose - within 3 hours  resting heart rate above 110 bpm for 24 hours. Stabbing pain in head behind right ear, constant ringing  in right ear that still  continues to this day.  Menstrual bleeding within the first 24 hours lasting 4 days.  Nausea and weight loss.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: First vaccine - within the first 24 hours , swollen breasts and extremely heavy menstrual bleeding lasting 5 days. Headache and arm pain lasting several days.   Second dose - within 3 hours  resting heart rate above 110 bpm for 24 hours. Stabbing pain in head behind right ear, constant ringing  in right ear that still  continues to this day.  Menstrual bleeding within the first 24 hours lasting 4 days.  Nausea and weight loss.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Please keep in mind that i may have had shingles in Jan (sine herpete) i had a positive IGM, i also has very distinctive nerve pain along upper dermotomes.    Several weeks after my covid shot, i developed a new type of nerve pain that was pins and needles  mostly in my hands and feet. but it could occuer in differnt areas.  It seemed to be clearly related to sugar intake. i first though that i had a diabetic issue, but my A1C and daily blood sugar was within normal limits.  I reduced my daily sugar intake and the pain went away, but it still has been persistant whenever i have sugar the pain comes back.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Erythema of eyelid, Eye discharge, Eyelid irritation, Periorbital swelling
Clinical narrative: Eyelid puffiness, redness and irritation: left eye. 4 days still swollen. Have been treating with antibiotic eye drops without success. Eye discharge buildup as waking up.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: In the past 14 days are any of the following symptoms new to you and not related to an existing health condition?: No symptoms noted In the past 14 days have you had close contact* with a  person who has a LABORATORY CONFIRMED case of COVID-19?: Yes exposure noted.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: In the past 14 days are any of the following symptoms new to you and not related to an existing health condition?: No symptoms noted In the past 14 days have you had close contact* with a  person who has a LABORATORY CONFIRMED case of COVID-19?: Yes exposure noted.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Cough, Myalgia
Clinical narrative: 07/21-Patient presents to the ED with complaints of fever, myalgias, back pain, chills, and cough onset earlier today. Pt reports temp high of 38.5. Denies taking medication for symptom control. Tylenol provided @ ED Intake.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 07/21-Patient presents to the ED with complaints of fever, myalgias, back pain, chills, and cough onset earlier today. Pt reports temp high of 38.5. Denies taking medication for symptom control. Tylenol provided @ ED Intake.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Chills, Cough, Myalgia, Pyrexia
Clinical narrative: 07/21-Patient presents to the ED with complaints of fever, myalgias, back pain, chills, and cough onset earlier today. Pt reports temp high of 38.5. Denies taking medication for symptom control. Tylenol provided @ ED Intake.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 7/22-Contact With And (Suspected) Exposure To COVID-19
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: 7/22-Contact With And (Suspected) Exposure To COVID-19
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 07/22-Contact With And (Suspected) Exposure To COVID-19
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: 07/22-Contact With And (Suspected) Exposure To COVID-19
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pancreatitis acute, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic COVID-19 positive. Admission for other problems
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic COVID-19 positive. Admission for other problems
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Diplopia, Facial pain, Neuralgia, Tolosa-Hunt syndrome
Clinical narrative: Caused an autoimmune response triggering a flare-up of Tolosa-Hunt Syndrome.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Tolosa-Hunt syndrome
Clinical narrative: Caused an autoimmune response triggering a flare-up of Tolosa-Hunt Syndrome.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: SEVERE NOSE BLEEDS; FEELING LIKE ABOUT TO FAINT; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FELT REALLY BAD AT 11PM THAT NIGHT; APPARENTLY SHE HAD  A REALLY BAD REACTION; REALLY BAD HEADACHE; This spontaneous report received from a parent concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy. She had no known allergies. The patient experienced constipation when treated with hydroxyzine hydrochloride for constipation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced really bad headache. On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced product administered to patient of inappropriate age. On 27-SEP-2021, the patient experienced felt really bad at 11pm that night. On 27-SEP-2021, the patient experienced apparently she had a really bad reaction. On NOV-2021, the patient experienced feeling like about to faint. On NOV-2021, the patient experienced severe nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like about to faint, and severe nose bleeds, was recovering from felt really bad at 11pm that night, had not recovered from really bad headache, and the outcome of off label use, product administered to patient of inappropriate age and apparently she had a really bad reaction was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling abnormal, Lethargy, Mobility decreased, Pain
Clinical narrative: SEVERE NOSE BLEEDS; FEELING LIKE ABOUT TO FAINT; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FELT REALLY BAD AT 11PM THAT NIGHT; APPARENTLY SHE HAD  A REALLY BAD REACTION; REALLY BAD HEADACHE; This spontaneous report received from a parent concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy. She had no known allergies. The patient experienced constipation when treated with hydroxyzine hydrochloride for constipation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced really bad headache. On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced product administered to patient of inappropriate age. On 27-SEP-2021, the patient experienced felt really bad at 11pm that night. On 27-SEP-2021, the patient experienced apparently she had a really bad reaction. On NOV-2021, the patient experienced feeling like about to faint. On NOV-2021, the patient experienced severe nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like about to faint, and severe nose bleeds, was recovering from felt really bad at 11pm that night, had not recovered from really bad headache, and the outcome of off label use, product administered to patient of inappropriate age and apparently she had a really bad reaction was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Sleep disorder
Clinical narrative: SEVERE NOSE BLEEDS; FEELING LIKE ABOUT TO FAINT; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FELT REALLY BAD AT 11PM THAT NIGHT; APPARENTLY SHE HAD  A REALLY BAD REACTION; REALLY BAD HEADACHE; This spontaneous report received from a parent concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy. She had no known allergies. The patient experienced constipation when treated with hydroxyzine hydrochloride for constipation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced really bad headache. On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced product administered to patient of inappropriate age. On 27-SEP-2021, the patient experienced felt really bad at 11pm that night. On 27-SEP-2021, the patient experienced apparently she had a really bad reaction. On NOV-2021, the patient experienced feeling like about to faint. On NOV-2021, the patient experienced severe nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like about to faint, and severe nose bleeds, was recovering from felt really bad at 11pm that night, had not recovered from really bad headache, and the outcome of off label use, product administered to patient of inappropriate age and apparently she had a really bad reaction was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse drug reaction, Epistaxis, Feeling abnormal, Headache, Off label use
Clinical narrative: SEVERE NOSE BLEEDS; FEELING LIKE ABOUT TO FAINT; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FELT REALLY BAD AT 11PM THAT NIGHT; APPARENTLY SHE HAD  A REALLY BAD REACTION; REALLY BAD HEADACHE; This spontaneous report received from a parent concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy. She had no known allergies. The patient experienced constipation when treated with hydroxyzine hydrochloride for constipation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced really bad headache. On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced product administered to patient of inappropriate age. On 27-SEP-2021, the patient experienced felt really bad at 11pm that night. On 27-SEP-2021, the patient experienced apparently she had a really bad reaction. On NOV-2021, the patient experienced feeling like about to faint. On NOV-2021, the patient experienced severe nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like about to faint, and severe nose bleeds, was recovering from felt really bad at 11pm that night, had not recovered from really bad headache, and the outcome of off label use, product administered to patient of inappropriate age and apparently she had a really bad reaction was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Presyncope, Product administered to patient of inappropriate age
Clinical narrative: SEVERE NOSE BLEEDS; FEELING LIKE ABOUT TO FAINT; OFF LABEL USE; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; FELT REALLY BAD AT 11PM THAT NIGHT; APPARENTLY SHE HAD  A REALLY BAD REACTION; REALLY BAD HEADACHE; This spontaneous report received from a parent concerned a 12 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was pretty healthy. She had no known allergies. The patient experienced constipation when treated with hydroxyzine hydrochloride for constipation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204B21A, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced really bad headache. On 27-SEP-2021, the patient experienced off label use. On 27-SEP-2021, the patient experienced product administered to patient of inappropriate age. On 27-SEP-2021, the patient experienced felt really bad at 11pm that night. On 27-SEP-2021, the patient experienced apparently she had a really bad reaction. On NOV-2021, the patient experienced feeling like about to faint. On NOV-2021, the patient experienced severe nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like about to faint, and severe nose bleeds, was recovering from felt really bad at 11pm that night, had not recovered from really bad headache, and the outcome of off label use, product administered to patient of inappropriate age and apparently she had a really bad reaction was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Hypoxia, Pneumonitis, Scar
Clinical narrative: The patient is an immunocompromised host with multiple comorbidities, being admitted with COVID-19 infection. He has mild hypoxia and a portable chest x-ray consistent with pneumonitis superimposed on scarring. Right middle lobe collapse could not be excluded. Will obtain a PA lateral, start remdesivir with dexamethasone and consult infectious disease for further recommendations.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Hypoxia, Pneumonitis
Clinical narrative: The patient is an immunocompromised host with multiple comorbidities, being admitted with COVID-19 infection. He has mild hypoxia and a portable chest x-ray consistent with pneumonitis superimposed on scarring. Right middle lobe collapse could not be excluded. Will obtain a PA lateral, start remdesivir with dexamethasone and consult infectious disease for further recommendations.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Arrhythmia, Asthenia, Blood pressure decreased, Bradycardia
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brugada syndrome, Bundle branch block right, Cardiac arrest, Cardiac assistance device user, Cardiac disorder
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure congestive, Cardiac fibrillation, Cardioversion, Chills, Confusional state
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Echocardiogram normal, Ejection fraction decreased, Electrocardiogram QRS complex normal, Electrocardiogram QT interval
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram QT interval normal, Electrocardiogram T wave normal, Electrocardiogram abnormal, Endotracheal intubation, Hypotension
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Intensive care, Loss of consciousness, Migraine, Myocarditis
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary valve incompetence, Pyrexia, Seizure, Sinus tachycardia, Sleep disorder
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Slow response to stimuli, Syncope, Tonic clonic movements, Torsade de pointes, Tricuspid valve incompetence
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, Ventricular fibrillation, Ventricular hypokinesia, Ventricular tachycardia
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood chloride increased, Blood culture negative, Blood gases abnormal
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood magnesium normal, Blood potassium normal, Carbon dioxide decreased, Cardiac arrest
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Chills, Computerised tomogram head normal, Computerised tomogram thorax abnormal, Echocardiogram
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Endotracheal intubation, Feeling abnormal, Implantable defibrillator insertion, Incontinence, Loss of consciousness
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic acidosis, Myocarditis, Pain, Pneumonia aspiration, Pyrexia
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Syncope, Temporary transvenous pacing, Tonic clonic movements, Ventricular tachycardia
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Patient stated after having 2nd Covid vaccine felt "wired".  He then developed shills, rigors and body aches .  He had 2 brief episodes of loss of consciousness with spontaneous restoration.  A few minutes after the 2nd syncopal episode had cardiac arrest.  Wife started CPR , EMS called and shocked by EMS 4 times.  Patient then had tonic clonic movements with incontinence, and intubated in the field.  Spiked a fever CT chest noted aspiration pneumonia.   In ER developed Ventricular tachycardia shocked x 2 and amiodarone/epinephrine given . Transvenous pacer placed secondary to recurrent ventricular tachycardia to increase rate to overdrive ectopy.  Transferred for further evaluation  of myocarditis and defibrillator implant
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Malaise, Mental status changes
Clinical narrative: patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.   3rd vaccine 09/28/2021
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.   3rd vaccine 09/28/2021
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Diarrhoea, Disorientation, Dyspnoea, Pyrexia
Clinical narrative: patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.patient is oriented to person and place but not to time. He is febrile here at 39.6 degrees Celsius. The patient has a difficult time participating in history but endorses a cough, shortness of breath, diarrhea, and fever that all began within the past day.   3rd vaccine 09/28/2021