chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Bell's Palsy, ongoing, under treatment now.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyskinesia, Seizure like phenomena
Clinical narrative: Patient sat down and said he was dizzy a few minutes after vaccination. Patient began to jerk his head repeatedly in a seizure-like motion.
Age: 69.0
Sex: M
Vaccine: PNC20, VARZOS
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to pharmacy on 7/24 and showed a left arm that was swollen and red all the way down to the left elbow and all the way around the arm. Patient stated that he had feelings of numbness in his left hand the night before and his whole arm was very hot to the touch. He was instructed to take Benadryl and seek out medical help if the condition got any worse.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Blood pressure increased, Bundle branch block left, Coordination abnormal, Defect conduction intraventricular
Clinical narrative: 1.  Mild ataxia  postural imbalance/lag in coordination  2. Rising BP (from hypotension to hypertensive) 3.  Rise in TROPONIN.  60, 96 4.  Change in heart imaging from 7/14 echocardiogram (pre vax) to 7/19 limited echo. Interventricular delay to incomplete LBBB on  ekgs Overnight ER to Observation admission.  Hospital
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram abnormal, Electrocardiogram abnormal, Hypertension, Hypotension, Posture abnormal
Clinical narrative: 1.  Mild ataxia  postural imbalance/lag in coordination  2. Rising BP (from hypotension to hypertensive) 3.  Rise in TROPONIN.  60, 96 4.  Change in heart imaging from 7/14 echocardiogram (pre vax) to 7/19 limited echo. Interventricular delay to incomplete LBBB on  ekgs Overnight ER to Observation admission.  Hospital
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: 1.  Mild ataxia  postural imbalance/lag in coordination  2. Rising BP (from hypotension to hypertensive) 3.  Rise in TROPONIN.  60, 96 4.  Change in heart imaging from 7/14 echocardiogram (pre vax) to 7/19 limited echo. Interventricular delay to incomplete LBBB on  ekgs Overnight ER to Observation admission.  Hospital
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: 1 day after getting vaccinated, patient developed 2 inch red rash at the injection site that was hard and tender to touch. Patient is taking zyrtec and applying ice to her thigh. She also developed fatigue and low grade temperature that improved.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Nurse Practitioner opened a new vial an didn't diluent vial prior too administering to the patient.  Patient recieved 0.2 mL of undiluted COVID Pfizer Vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Vaccine invalid due to a possible temperature issue CDC recommendation to repeat vaccine
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait inability, Heart rate increased, Injection site pain, Muscular weakness
Clinical narrative: Weakness and tingling of arms and feet, that started around 4:00 A.M. and spread to the lower back. 4:45 A.M. inability to walk, elevated heart rate of 102 resting, and 103.1 degree fever. Pins and needles in  fingertips currently actively present, extreme pain in injection site location, currently actively present.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Weakness and tingling of arms and feet, that started around 4:00 A.M. and spread to the lower back. 4:45 A.M. inability to walk, elevated heart rate of 102 resting, and 103.1 degree fever. Pins and needles in  fingertips currently actively present, extreme pain in injection site location, currently actively present.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Rash papular
Clinical narrative: Rash (raise bumps) to both lower arms (took over-the-counter Benadryl rash disappear: time 8am), had severe Headaches (took Tylenol: extra strength: time 8am) headache disappeared in about 1 1/2 hours.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Joint injury, Peripheral swelling, Pyrexia
Clinical narrative: Patient reporting arm is swollen, red, and sore from shoulder to elbow, including under the arm. It is warm to the touch, and she has a mild fever.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction, Skin warm
Clinical narrative: Patient reporting arm is swollen, red, and sore from shoulder to elbow, including under the arm. It is warm to the touch, and she has a mild fever.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain
Clinical narrative: Pain at injection  site, fatigue, mild chills
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site swelling, Sinus disorder
Clinical narrative: On 7/21/22, after the patient received the Moderna booster, the injection site started to swell. It was a golf ball size. When she stopped by the pharmacy on 7/23/22, the injection site was bigger than a palm size. Patient also has pressure headache and some sinus symptoms. She was using ice packs and antihistamine. She was advice to continue doing those and follow up with the doctor on Monday. I called and checked on the patient on 7/24/22, the injection site swelling didn't get bigger, and her sinus symptoms were also improved. Still advice patient to continue doing ice packs and antihistamine and call her doctor on Monday.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Influenza like illness, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Received shot on a Wednesday. Flu like symptoms Thursday and Friday. Friday morning red rash under injection site with minimal itching. Small raised bump within rash.  Skin intact. No open areas.  On Saturday, area became more bothersome and in the evening tried Cortisone cream.  Didn?t help. Tried baking soda paste. No relief.  No sleep Saturday night. Regular icing, a few times an hour is the only thing that helps.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Received shot on a Wednesday. Flu like symptoms Thursday and Friday. Friday morning red rash under injection site with minimal itching. Small raised bump within rash.  Skin intact. No open areas.  On Saturday, area became more bothersome and in the evening tried Cortisone cream.  Didn?t help. Tried baking soda paste. No relief.  No sleep Saturday night. Regular icing, a few times an hour is the only thing that helps.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Haematochezia, Mucous stools, Pyrexia, Somnolence
Clinical narrative: 1. Febrile to 100.5 on day following vaccine. Fever resolved with one dose of acetaminophen and a subsequent dose of ibuprofen. 2. Loss of appetite. Lasted 24 hours post-vaccine. 3. Increased sleepiness. Lasted for 36 hours post-vaccine.  4. Small amount of blood and mucus in stool. One episode, 3 days after vaccine (7/23). All treated with supportive care at home. No medical therapy sought.
Age: 51.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: He had soreness at the injection site area almost immediately. He woke up with aches, chills, and a slight to medium headache around 4:00 a.m., and was definitely feverish (hot to the touch) by 8 a.m. He's unusually tired. He has mild chills and a mild headache (it's 12:11 p.m. on the 24th, so about 20 hours after the vaccination.) This is his 2nd Covid booster and his first Moderna dose. He previously had  Pfizer for his 2-series vaccination and first booster. His first Covid booster was in late December. (I selected dose number in the series as 4--two primary and two boosters.)
Age: 51.0
Sex: M
Vaccine: COVID19, TDAP
Symptoms: Pyrexia
Clinical narrative: He had soreness at the injection site area almost immediately. He woke up with aches, chills, and a slight to medium headache around 4:00 a.m., and was definitely feverish (hot to the touch) by 8 a.m. He's unusually tired. He has mild chills and a mild headache (it's 12:11 p.m. on the 24th, so about 20 hours after the vaccination.) This is his 2nd Covid booster and his first Moderna dose. He previously had  Pfizer for his 2-series vaccination and first booster. His first Covid booster was in late December. (I selected dose number in the series as 4--two primary and two boosters.)
Age: 62.0
Sex: F
Vaccine: COVID19, PNC20, VARZOS
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Patient reports low fever, and allergic symptoms including itching, hives, and a possible rash, all begining 7/24/22 (the day after their vaccination). Patient advised on care, and recommended to begin treatment with benadryl.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Dyspnoea exertional, Quality of life decreased
Clinical narrative: I developed significant, but intermittent chest heaviness and being very out of breath with minor activities.  I, unfortunately, didn't equate it to the vaccine until I got my second shot (which I will make a second report for) and one week after that shot the symptoms became daily and much worse and led to more medical work ups and changed the quality of my life for the worse.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Heart rate increased, Pain in extremity
Clinical narrative: On July 20, the day after the vaccination, my son experienced general tiredness and pain in his arm.  He spent most of the day sitting around and reading/watching tv.  Around 5:00 PM, he mentioned that he felt like his heart was beating fast even though he was sitting on the couch.  He took some deep breaths and seemed better.  He didn't mention his heart again until the morning of July 23.  He was swimming and I noticed his hand over his heart after he had swum a lap.  I asked him if he was okay and he said he felt like his heard was beating too fast.  Since he had just been swimming, I though it was from the intense exercise.  He rested and seemed better.  Then after going to bed on July 23, he got up to go to the bathroom and told me that he felt like his heart was beating fast when he was trying to go to sleep.  He further said that since the COVID-19 vaccine, his heart hasn't felt right.  After further questioning, he said he had been having similar episodes 2-3 times a day since the vaccine.  I called Health nurse line and was advised to take my son to the emergency room.  We went to Health's Hospital where they checked his vital signs and administered and EKG.  The EKG was normal so my son was sent home with instructions to rest and take fluids.  Assuming no prolonged heart palpitations, we are to follow-up with the pediatric cardiologist on July 25 if the periodic heart palpitations continue.  If he has prolonged heart palpitations, we are to return to the emergency room.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: When I woke up Friday, my arm was a bit sore, but not too bad, and there are a small red bump, like a mosquito bite.  During the day Friday I started getting a slight headache, but 3:30 I started to get fatigued and I drove home from CDC.  When I got home, it got worse, started getting a bit of a fever and mild chills by 5:30pm.  I stayed in bed and rested the rest of the evening, I feel like the fever broke about 10pm, but stayed hot throughout the night.  Saturday morning, I woke up feeling better, like the day after being sick.  Today I am back to 100%.  The injection site is swollen a bit and red, maybe 3"X5" in size.  It is still warm to the touch.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: When I woke up Friday, my arm was a bit sore, but not too bad, and there are a small red bump, like a mosquito bite.  During the day Friday I started getting a slight headache, but 3:30 I started to get fatigued and I drove home from CDC.  When I got home, it got worse, started getting a bit of a fever and mild chills by 5:30pm.  I stayed in bed and rested the rest of the evening, I feel like the fever broke about 10pm, but stayed hot throughout the night.  Saturday morning, I woke up feeling better, like the day after being sick.  Today I am back to 100%.  The injection site is swollen a bit and red, maybe 3"X5" in size.  It is still warm to the touch.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Swelling
Clinical narrative: When I woke up Friday, my arm was a bit sore, but not too bad, and there are a small red bump, like a mosquito bite.  During the day Friday I started getting a slight headache, but 3:30 I started to get fatigued and I drove home from CDC.  When I got home, it got worse, started getting a bit of a fever and mild chills by 5:30pm.  I stayed in bed and rested the rest of the evening, I feel like the fever broke about 10pm, but stayed hot throughout the night.  Saturday morning, I woke up feeling better, like the day after being sick.  Today I am back to 100%.  The injection site is swollen a bit and red, maybe 3"X5" in size.  It is still warm to the touch.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dermatitis contact, Dyspnoea, Fatigue, Gait inability
Clinical narrative: Symptoms presented themselves one week after moderna Covid booster shot and lasted for about two weeks before dissipating. Symptoms included extremely reactive full body hives (triggered by physical contact or scratching), joint stiffness and pain (inability to walk on day three) , fatigue, temperature, swelling of throat and difficulty breathing at times. Lasting contact dermatitis after the rest of the symptoms dissipated which is still affecting me months later.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Joint stiffness, Pain, Pharyngeal swelling, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Symptoms presented themselves one week after moderna Covid booster shot and lasted for about two weeks before dissipating. Symptoms included extremely reactive full body hives (triggered by physical contact or scratching), joint stiffness and pain (inability to walk on day three) , fatigue, temperature, swelling of throat and difficulty breathing at times. Lasting contact dermatitis after the rest of the symptoms dissipated which is still affecting me months later.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Dyspnoea exertional, Electrocardiogram
Clinical narrative: One week after my first shot (received on 9/06/21) I developed intermittent chest heaviness and being out of breath with minimal activity. I made a separate vaers report for that shot as the two shots were more than one month apart.  Unfortunately I did not equate those symptoms to the vaccine until receiving the second dose (for which this report is on and it was received 1/4/22), since after the second dose it was very clear that these symptoms were 100% from the vaccine as they both initially developed and then later worsened exactly 1 week after each shot.  One week after the second dose my chest heaviness worsened and was then daily, rather than intermittent. My being out of breath was also daily and significant with even basic activities of daily life, talking, singing in car, etc.  Worse then and now in situations where I have to be masked. It has changed my quality of life for the worse, but has improved some.  I am still far from my previous baseline. I am not out of breath as often now with talking or singing or walking (as long as it's a slow pace and a flat surface).  I still get severely out of breath when trying to walk fast, walk up stairs, or walk uphill.  I do intermittently still get out of breath from just talking. or doing basic activities.  Chest heaviness is now back to being intermittent, instead of daily, but can still be significant and both things are worrisome. I am now almost 7 months out from 2nd shot and I am starting to believe I will never get better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired quality of life, Inappropriate schedule of product administration, Loss of personal independence in daily activities, Pulmonary function test, Stress echocardiogram
Clinical narrative: One week after my first shot (received on 9/06/21) I developed intermittent chest heaviness and being out of breath with minimal activity. I made a separate vaers report for that shot as the two shots were more than one month apart.  Unfortunately I did not equate those symptoms to the vaccine until receiving the second dose (for which this report is on and it was received 1/4/22), since after the second dose it was very clear that these symptoms were 100% from the vaccine as they both initially developed and then later worsened exactly 1 week after each shot.  One week after the second dose my chest heaviness worsened and was then daily, rather than intermittent. My being out of breath was also daily and significant with even basic activities of daily life, talking, singing in car, etc.  Worse then and now in situations where I have to be masked. It has changed my quality of life for the worse, but has improved some.  I am still far from my previous baseline. I am not out of breath as often now with talking or singing or walking (as long as it's a slow pace and a flat surface).  I still get severely out of breath when trying to walk fast, walk up stairs, or walk uphill.  I do intermittently still get out of breath from just talking. or doing basic activities.  Chest heaviness is now back to being intermittent, instead of daily, but can still be significant and both things are worrisome. I am now almost 7 months out from 2nd shot and I am starting to believe I will never get better.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient given a 3rd booster (Janssen to start, followed by 2 Moderna boosters, then received this fourth dose of Moderna).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given a 3rd booster (Janssen to start, followed by 2 moderna boosters, then received this fourth dose of moderna)
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Irritability, Pain, Weight bearing difficulty
Clinical narrative: Day after refusing to bear weight on left leg. Complaining of pain in left knee with extension. No signs of redness, swelling or bruising. No inciting injury. Afebrile and a bit fussier in temperament.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patients arm turned sore swallow and red with burning sensation
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Injection site redness, induration, warmth and discomfort.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Severe burning at injection site.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Cardiac stress test, Chest pain, Culture stool
Clinical narrative: Severe chest pain for over a year, extreme tiredness, no energy, panic attacks, extreme loss of weight
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Fibrin D dimer, Laboratory test, Panic attack
Clinical narrative: Severe chest pain for over a year, extreme tiredness, no energy, panic attacks, extreme loss of weight
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary function test, Weight decreased
Clinical narrative: Severe chest pain for over a year, extreme tiredness, no energy, panic attacks, extreme loss of weight
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at and around injection site
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Vaccine positive rechallenge
Clinical narrative: On 6/25/22 @ 0945 pt received dose 1 in his L arm. At 0134 on 6/26/22 he woke with a bloody nose.   On 7/23/22 @ 0915 pt received dose 2 in his L arm. At 2353 he woke with a bloody nose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Headache, Hyperbaric oxygen therapy, Influenza like illness, Magnetic resonance imaging normal
Clinical narrative: Twelve hours after COVID vaccination, in addition to the expected aches and flu like symptons, at the same time I also experienced a screaming' headache.  The headache was so painful I had to sit up in bed with an icepack on my head.  In the following days it became apparent that this was no ordinary headache, I had another brain injury. Dr. concurred on 04/11/2022.  The following activities triggered severe headaches:  screentime (phone, computer, tv), audio (podcasts, audio books, tv, long conversations), driving, reading, writing.  Since the COIVD booster injection I have had over 120 hours of hyperbaric treatments, one ozone treatement, countless hours of isolation and am still not completely healed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ozone therapy, Pain
Clinical narrative: Twelve hours after COVID vaccination, in addition to the expected aches and flu like symptons, at the same time I also experienced a screaming' headache.  The headache was so painful I had to sit up in bed with an icepack on my head.  In the following days it became apparent that this was no ordinary headache, I had another brain injury. Dr. concurred on 04/11/2022.  The following activities triggered severe headaches:  screentime (phone, computer, tv), audio (podcasts, audio books, tv, long conversations), driving, reading, writing.  Since the COIVD booster injection I have had over 120 hours of hyperbaric treatments, one ozone treatement, countless hours of isolation and am still not completely healed.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anosmia, COVID-19, Cough, Malaise, Paranasal sinus hypersecretion
Clinical narrative: COVID19 as identified by home test kit morning of 6/11/2022. Initial symptoms: general malaise and sinus drainage. Saw telehealth doc and was prescribed Paxlovid the same day. Took 1st Paxlovid dose evening of 6/11. 6/12, developed mild fever (99.8 deg) and cough. Symptoms and fever (100.5) peaked on 6/13, then began to decline. By last Paxlovid dose on 6/16 (morning), fever was almost gone (99.0) and sinus drainage and cough were greatly diminished. On 6/17, tested negative with two different home tests. On 6/19, symptoms returned along with a positive home test. By 6/21, fever was up to 100.7, sinus drainage increased and cough was productive. Fever broke on 6/23 and all symptoms began to decline but did not go away. On 6/25 lost sense of smell. Fully recovered except smell by 6/30. Sense of smell returned on 7/9.  6/16 (am) last dose
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID19 as identified by home test kit morning of 6/11/2022. Initial symptoms: general malaise and sinus drainage. Saw telehealth doc and was prescribed Paxlovid the same day. Took 1st Paxlovid dose evening of 6/11. 6/12, developed mild fever (99.8 deg) and cough. Symptoms and fever (100.5) peaked on 6/13, then began to decline. By last Paxlovid dose on 6/16 (morning), fever was almost gone (99.0) and sinus drainage and cough were greatly diminished. On 6/17, tested negative with two different home tests. On 6/19, symptoms returned along with a positive home test. By 6/21, fever was up to 100.7, sinus drainage increased and cough was productive. Fever broke on 6/23 and all symptoms began to decline but did not go away. On 6/25 lost sense of smell. Fully recovered except smell by 6/30. Sense of smell returned on 7/9.  6/16 (am) last dose
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Imaging procedure, Influenza like illness, Internal haemorrhage
Clinical narrative: I took my mother to get her booster shot; she did not feel well after and felt ill until she was taken by ambulance about two weeks later to hospital; At that time they said she had internal bleeding in her abdomen and took her off warfarin after 5 day stay in the hospital; she was sent home but still did not feel good flu like symptoms; she died of a cardiac arrest in the ambulance when they were called two days after her release from hospital.  I don't believe we ever thought to tell the hospital she had just received her booster before falling ill and it did not register with me until today that she had flu symptoms directly after and just got sicker and sicker until she died on June 20, 2022 less than a month after booster at Hospital
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise
Clinical narrative: I took my mother to get her booster shot; she did not feel well after and felt ill until she was taken by ambulance about two weeks later to hospital; At that time they said she had internal bleeding in her abdomen and took her off warfarin after 5 day stay in the hospital; she was sent home but still did not feel good flu like symptoms; she died of a cardiac arrest in the ambulance when they were called two days after her release from hospital.  I don't believe we ever thought to tell the hospital she had just received her booster before falling ill and it did not register with me until today that she had flu symptoms directly after and just got sicker and sicker until she died on June 20, 2022 less than a month after booster at Hospital
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Oedema peripheral
Clinical narrative: Very swollen and sore right armpit
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram head normal, Hypoaesthesia, Magnetic resonance imaging head normal, Magnetic resonance imaging joint
Clinical narrative: diagnosis of neuralgic amyotrophy  Arm pain and numbness within 48 hrs of first dose.  First dose received on March 22, 2021. Symptoms gone after two weeks.  Arm pain and numbness within 48 hrs of second dose. Second dose received on April 29, 2021. Symptoms more intense after second dose. Severe pain in upper shoulder and radiating down to fingers. Arm and hand weakness began within 1 week. Muscle atrophy of hand and back. Symptoms still continuing at date of report 7/24/2022.  Treatment by neurologic team consisting of pain management and physical therapy.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Muscle atrophy, Muscular weakness, Nerve conduction studies normal, Neuralgic amyotrophy
Clinical narrative: diagnosis of neuralgic amyotrophy  Arm pain and numbness within 48 hrs of first dose.  First dose received on March 22, 2021. Symptoms gone after two weeks.  Arm pain and numbness within 48 hrs of second dose. Second dose received on April 29, 2021. Symptoms more intense after second dose. Severe pain in upper shoulder and radiating down to fingers. Arm and hand weakness began within 1 week. Muscle atrophy of hand and back. Symptoms still continuing at date of report 7/24/2022.  Treatment by neurologic team consisting of pain management and physical therapy.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: diagnosis of neuralgic amyotrophy  Arm pain and numbness within 48 hrs of first dose.  First dose received on March 22, 2021. Symptoms gone after two weeks.  Arm pain and numbness within 48 hrs of second dose. Second dose received on April 29, 2021. Symptoms more intense after second dose. Severe pain in upper shoulder and radiating down to fingers. Arm and hand weakness began within 1 week. Muscle atrophy of hand and back. Symptoms still continuing at date of report 7/24/2022.  Treatment by neurologic team consisting of pain management and physical therapy.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: undilute dose was given
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest 5/14/2022
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: undilute dose given
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Painless hoarse/raspy voice getting progressively worse
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resulted in death
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vaccine (third dose) was given to a pediatric patient without being mixed
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia
Clinical narrative: I administered Pfizer vaccine to one pt and asked her to sit down for 15 minutes. While waiting, she told us that she was having numbness on the arm and if that was normal. I told her it's not normal and if she wants to wait longer than 15 minutes to make sure nothing happens. She said she will be fine and then walked off after 15 minutes. Then she came back saying she is having a shortness of breath and numbness on one side of the body. We gave her water and measured her oxygen level using pulse Ox meter which was normal. She then called ambulance. Paramedic came and examined her. They said her vitals were normal. In the end she told me she was feeling better but still feeling some numbness.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Pyrexia
Clinical narrative: Coughing, tiredness, ans fever.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/18/21, 3/19/21. Pfizer 9/7/21. Positive on 7/22/22
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/1/2021 and 3/22/2021. COVID-19 positive on 7/18/2022.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test negative
Clinical narrative: Low grade fever (100.8 rectally) for a few days followed by rash on trunk that spread to face for a few days
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer 2/3/21, 2/24/21, 9/30/21, 4/21/22. Positive on 7/22/22
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Bronchoscopy, Chest X-ray normal, Computerised tomogram thorax abnormal, Condition aggravated
Clinical narrative: Developed daily fever of between 99-102 beginning on 6/22/2022 thru 7/5/2022. Out patient chest x-ray on 6/30/2022 showed no significant changes. Placed on amoxicillin. Increased cough began on 7/2/2022. Seen in urgent care on 7/5/2022 for worsening cough and no resolution of cough and fever. Patient hospitalized on 7/5/2022 for hypoxia. Fever resolved on 7/5/2022. Patient started on oxygen on 7/5/2022. CAT Scan on 7/5/2022 showed worsening lung infiltrates. Bronchoscopy performed on 7/7/2022. To date no identifiable bacteria, virus, or fungus.  Placed on high dose IV steroids and IV antibiotics. During hospitalization required 2-6L of O2 at rest and up to 15L on exertion. Discharged on 7/ 17/2022 with home oxygen and oral steroids (tapering down from 40mg to 10 mg). Diagnosis - ?? Exacerbation of ILD? Currently requires 2L at rest and  6-8L on exertion.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fibrin D dimer increased, Full blood count normal, Hypoxia, Lung disorder
Clinical narrative: Developed daily fever of between 99-102 beginning on 6/22/2022 thru 7/5/2022. Out patient chest x-ray on 6/30/2022 showed no significant changes. Placed on amoxicillin. Increased cough began on 7/2/2022. Seen in urgent care on 7/5/2022 for worsening cough and no resolution of cough and fever. Patient hospitalized on 7/5/2022 for hypoxia. Fever resolved on 7/5/2022. Patient started on oxygen on 7/5/2022. CAT Scan on 7/5/2022 showed worsening lung infiltrates. Bronchoscopy performed on 7/7/2022. To date no identifiable bacteria, virus, or fungus.  Placed on high dose IV steroids and IV antibiotics. During hospitalization required 2-6L of O2 at rest and up to 15L on exertion. Discharged on 7/ 17/2022 with home oxygen and oral steroids (tapering down from 40mg to 10 mg). Diagnosis - ?? Exacerbation of ILD? Currently requires 2L at rest and  6-8L on exertion.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Lung infiltration, Metabolic function test normal, Pyrexia, Urine analysis normal
Clinical narrative: Developed daily fever of between 99-102 beginning on 6/22/2022 thru 7/5/2022. Out patient chest x-ray on 6/30/2022 showed no significant changes. Placed on amoxicillin. Increased cough began on 7/2/2022. Seen in urgent care on 7/5/2022 for worsening cough and no resolution of cough and fever. Patient hospitalized on 7/5/2022 for hypoxia. Fever resolved on 7/5/2022. Patient started on oxygen on 7/5/2022. CAT Scan on 7/5/2022 showed worsening lung infiltrates. Bronchoscopy performed on 7/7/2022. To date no identifiable bacteria, virus, or fungus.  Placed on high dose IV steroids and IV antibiotics. During hospitalization required 2-6L of O2 at rest and up to 15L on exertion. Discharged on 7/ 17/2022 with home oxygen and oral steroids (tapering down from 40mg to 10 mg). Diagnosis - ?? Exacerbation of ILD? Currently requires 2L at rest and  6-8L on exertion.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal discomfort, Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Right arm extreamly sore for several days.  So sore that having trouble sleeping and using the arm.  Arm still sore after 6 days. Upset stomach for 3 or 4 hours after shots.  This started about 15 minutes after the shots.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/25/21, 3/25/21. Positive on 7/22/22
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 4/9/21, 5/6/21. Positive on 7/24/22
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received 2nd COVID-19 vaccine booster in error. Not recommended at this time. No moderate or severe immunocompromised medical condition documented or verbalized.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Myalgia
Clinical narrative: Headaches, chills, muscle ache, soreness at injection site
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Tendon pain, Tendonitis
Clinical narrative: Experience severe tendon pain in knees shoulders and wrists most pronounced in joints previously  Compromised by sports injuries as a 18 year old.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: lower leg and ankles had redness and swelling; some pain. Worse on right leg.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Heavy menstrual bleeding
Clinical narrative: Monthly period went from 4-5 days to 15 days long.  Discussed with physician and decided to take birth control to help regulate cycle. Also continue to have random hemorrhaging on my extremities.  Currently have noticed 3 different occasions.  Two times on legs and once on arm.   Just had one this past week which is almost one year after first vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: See Continuation page
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: pt to ED with increasing SOB; states had a positive COVID test at PCP 9/17/21 and was given monoclonal antibodies without improvement; on NRB and NC for O2 supplementation; transitioned later to BiPAP; AKI; worsening respiratory status requiring intubation; began CRRT; pneumothorax and pneumomediastinum; transitioned to DNR and pt expired in the hospital
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Haemofiltration, Pneumomediastinum, Pneumothorax, Positive airway pressure therapy, Respiratory disorder
Clinical narrative: pt to ED with increasing SOB; states had a positive COVID test at PCP 9/17/21 and was given monoclonal antibodies without improvement; on NRB and NC for O2 supplementation; transitioned later to BiPAP; AKI; worsening respiratory status requiring intubation; began CRRT; pneumothorax and pneumomediastinum; transitioned to DNR and pt expired in the hospital
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Positive airway pressure therapy
Clinical narrative: presented with SOB that didn't improve with increasing his home oxygen  Vaccine given at clinic  information requested
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: presented with SOB that didn't improve with increasing his home oxygen  Vaccine given at clinic  information requested
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood glucose, Blood lactic acid, Brain natriuretic peptide, Cardiac imaging procedure, Chest X-ray
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Differential white blood cell count, Echocardiogram, Electrocardiogram, Full blood count
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Haematocrit, Haemoglobin, Lipase, Lipids, Low density lipoprotein
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide, Positive airway pressure therapy, Pulmonary function test, SARS-CoV-2 test negative
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep study, Troponin, Ultrasound Doppler
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Brain natriuretic peptide, Cardiac imaging procedure, Chest X-ray, Computerised tomogram
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Differential white blood cell count, Echocardiogram, Electrocardiogram, Full blood count, Laboratory test
Clinical narrative: Depleted oxygen level.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Lipase, Metabolic function test, N-terminal prohormone brain natriuretic peptide, Oxygen saturation decreased, Polymerase chain reaction
Clinical narrative: Depleted oxygen level.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, Back pain, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Confirmed Breakthrough Case   COVID-19 (Moderna) 1  02/12/2021 Moderna 038K20A   COVID-19 (Moderna) 2  03/12/2021 Moderna 030A21A
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Constipation, Cough, Laboratory test, Pleural effusion, Urine analysis
Clinical narrative: Confirmed Breakthrough Case   COVID-19 (Moderna) 1  02/12/2021 Moderna 038K20A   COVID-19 (Moderna) 2  03/12/2021 Moderna 030A21A
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: Confirmed Breakthrough Case   COVID-19 (Moderna) 1  02/12/2021 Moderna 038K20A   COVID-19 (Moderna) 2  03/12/2021 Moderna 030A21A
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Confirmed Breakthrough Case   COVID-19 (Moderna) 1  02/12/2021 Moderna 038K20A   COVID-19 (Moderna) 2  03/12/2021 Moderna 030A21A
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropod bite, Drug eruption, Extra dose administered, Neurodermatitis, Pemphigoid
Clinical narrative: rash on left foot, bullous,
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Periodic acid Schiff stain, Rash maculo-papular, Skin erosion, Skin lesion, Skin ulcer
Clinical narrative: rash on left foot, bullous,
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Superficial inflammatory dermatosis, Urticaria
Clinical narrative: rash on left foot, bullous,
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Blister, Macule, Pemphigoid
Clinical narrative: rash on left foot, bullous,
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy, Dermatitis bullous
Clinical narrative: rash on left foot, bullous,
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: She mentioned that a dermatologist has prescribed GARDASIL 9 to a 5 year old due to reoccurring genital warts which have been unsuccessfully treated with laser therapy and freezing.; No adverse event; This spontaneous report was received from a nurse, concerning a 5-year-old female patient. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date, the patient's dermatologist prescribed her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) ast treatment for genital warts which had been unsuccesfully treated with laser therapy and freeezing (strength, dose, frequency, route of administration, lot number and expiration date were not reproted).   At the time of reporting, the patient had nto received the vaccine yet, however once she receive the vaccine it would be considered as an off label use. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A medical assistant called to report an expired dose of VARIVAX was administered to a patient.  No additonal ae's and no PQC's were reported.; This spontaneous report was received from a medical assistant referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 28-JUN-2022, the patient was vaccine with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # T021826, expiration date 25-JUN-2022) to prevent varicella infection (strength, dose, frequency was not reported) (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event
Clinical narrative: no adverse event; Caller is a nurse calling on behalf of a physician to report that a dose of PROQUAD was inadvertently administered to the patient on 28JUN2022.; This spontaneous report was received from a nurse referring to an unknown age and gender patient. Pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 04-SEP-2018, the patient was vaccinated with the first dose of varicella vaccine (manufacturer unknown) and measles (+) mumps (+) rubella vaccine (MMR) (manufacturer unknown). On 29-NOV-2021, the patient received the second dose of varicella vaccine (manufacturer unknown) and measles (+) mumps (+) rubella vaccine (manufacturer unknown). On 28-JUN-2022, the patient was vaccinated with a dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection 0.5 mL (lot# U022728, expire date 16-JAN-2023) inadvertently (strength, route of administered \were not reported) for prophylaxis (accidental exposure to product). No additional adverse event was reported (no adverse event).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (viability of a vaccine given past the 30 days beyond use date, first put in the fridge in Jun 16 2022 & Date of administration Jul 18 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received 2nd booster dosage.  Patient received dose from the same vial lot and number of doses/vials were 6 doses from the same vial. Vial was initially stored in the refrigerator on 16-Jun-2022 and vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2022: Follow-up has Significant information in which case report type was turned from invalid to valid. Patient detail, suspect product name, new event, Vaccine information (Dose Description) and Supplement were updated.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash; Hives; This spontaneous case was reported by a patient family member or friend and describes the occurrence of RASH (Rash) and URTICARIA (Hives) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 10-Dec-2021 and Rash (She experienced a rash while she had COVID-19).    On 13-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced RASH (Rash) and URTICARIA (Hives). At the time of the report, RASH (Rash) and URTICARIA (Hives) outcome was unknown.            It was reported that rash and hives comes and goes and sometimes happens after a shower or when patient is out in the rain. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-611776 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patients received half a dose for booster purple border (0.25mL); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 18-Jul-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)). At the time of the report, ACCIDENTAL UNDERDOSE (Patients received half a dose for booster purple border (0.25mL)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611784 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611784:Patient 1