chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Erythema, Eye discharge, Lacrimation increased, Ocular hyperaemia
Clinical narrative: Pink eye with discharge that is getting more red everyday. I noticed her watery eyes  the day after the vaccine , but the redness was noticed 2 days after the vaccine. I (mother also got the same side effect with the vaccine, so now I know it is not a coincidence but a reaction  we have from the vaccine)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: AFTER THE VACCINATION I HAD SORE ARM AND IT WAS SAME FOR ALL OF THEM. A MONTH LATER I GOT COVID.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Injected limb mobility decreased, Pain in extremity
Clinical narrative: I was fine after both shots. My arm ached a small bit but nothing bad, but now my left arm hurts so bad sometime that i cannot lift it and there are sharp pains like being stabbed in my arm. It stays like that for hours then goes back to a dull ache that is there all the time. I now just made a Dr. appt due to the fact that I feel that it is making the left side of my back and chest ache really bad.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated, not boosted.   LOT NUMBERS OF VACCINE NOT RECORDED. COVID infection breakthrough, symptomatic.   Immunosuppressed.   Inpatient hospital stay
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXTRACTION OF MODERNA VACCINE FROM VIAL WAS NOT CONSISTENT WITH MODERNA TECHNIQUE (I.E. MORE THAN 20 DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Nocturia
Clinical narrative: Extreme dizziness and light headedness, following frequent bouts of peeing overnight.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Neuralgia, Pruritus, Rash, Rash erythematous
Clinical narrative: 6 days following vaccine I developed shingles- starting with an itchy bug bite-like bump then developing into a painful red rash with nerve pain up and down left side of body. Subsided once an antiviral treatment of Valtrex was administered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Myalgia, Pyrexia
Clinical narrative: 01/06/22: CHILLS, COUGH, FEVER, MUSCLE PAIN
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 01/06/22: CHILLS, COUGH, FEVER, MUSCLE PAIN
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Confusional state, Fall, Influenza A virus test
Clinical narrative: Brought in by EMS for altered mental status, fall, and possible seizure. Pt. COVID + 2 days prior. Abdominal pain, nausea and vomiting. Confusion
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza B virus test, Mental status changes, Nausea, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Brought in by EMS for altered mental status, fall, and possible seizure. Pt. COVID + 2 days prior. Abdominal pain, nausea and vomiting. Confusion
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond use date of 12/22/21.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, COVID-19, Computerised tomogram thorax abnormal, Lung infiltration, Lung opacity
Clinical narrative: 01/07/2022:   Event occurred after 1 dose of Janssen  vaccine.  74-year-old male who presents with abdominal pain.  Patient was brought in by EMS for 2 days of abdominal pain.  Patient states that the pain is left-sided.  He states he is also experiencing some nausea but has had no vomiting. No respiratory distress.  Remains in hospital.  plan for discharge today -Jan 11/2022.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: 01/07/2022:   Event occurred after 1 dose of Janssen  vaccine.  74-year-old male who presents with abdominal pain.  Patient was brought in by EMS for 2 days of abdominal pain.  Patient states that the pain is left-sided.  He states he is also experiencing some nausea but has had no vomiting. No respiratory distress.  Remains in hospital.  plan for discharge today -Jan 11/2022.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient Contracted COVID-19 after vaccination
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Nasal congestion, Oropharyngeal pain
Clinical narrative: stuffed nose, sore throat, flem, eyes stuck shut in morning
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anticoagulant therapy, Asthenia, Blood potassium decreased, COVID-19
Clinical narrative: Pt fully vaccinated.  COVID positive on 11/14/2021.  Admitting dx: COVID-19 pneumonia, hypoxia, ileus, acute renal failure.  The patient came because of severe diarrhea and cough with chest tightness, sharp in nature.  The patient has been sick for the past 5 days.  She was tested positive for COVID.  She was having profuse diarrhea with generalized fatigue and weakness.  Her potassium was very low that has been under a replacement.  Denying any fever.  No chills.  No blood in the stool or the urine. Treatment:  oxygen, steroids, Lovenox, hypokalemia correction, hydration. Discharged to home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest discomfort, Cough, Diarrhoea, Fatigue
Clinical narrative: Pt fully vaccinated.  COVID positive on 11/14/2021.  Admitting dx: COVID-19 pneumonia, hypoxia, ileus, acute renal failure.  The patient came because of severe diarrhea and cough with chest tightness, sharp in nature.  The patient has been sick for the past 5 days.  She was tested positive for COVID.  She was having profuse diarrhea with generalized fatigue and weakness.  Her potassium was very low that has been under a replacement.  Denying any fever.  No chills.  No blood in the stool or the urine. Treatment:  oxygen, steroids, Lovenox, hypokalemia correction, hydration. Discharged to home.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Hypoxia, Ileus, Malaise, SARS-CoV-2 test positive
Clinical narrative: Pt fully vaccinated.  COVID positive on 11/14/2021.  Admitting dx: COVID-19 pneumonia, hypoxia, ileus, acute renal failure.  The patient came because of severe diarrhea and cough with chest tightness, sharp in nature.  The patient has been sick for the past 5 days.  She was tested positive for COVID.  She was having profuse diarrhea with generalized fatigue and weakness.  Her potassium was very low that has been under a replacement.  Denying any fever.  No chills.  No blood in the stool or the urine. Treatment:  oxygen, steroids, Lovenox, hypokalemia correction, hydration. Discharged to home.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Moderna Vaccine , 2nd dose administered 7/22/21, on 8/2/21, hives appear,
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Insomnia, Pain, Pain in extremity
Clinical narrative: Chest pain.   Hurts to inhale as well as bend over. Could not sleep.     Leg and shoulder pain as well.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Painful respiration
Clinical narrative: Chest pain.   Hurts to inhale as well as bend over. Could not sleep.     Leg and shoulder pain as well.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond use date of 12/22/21.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Cough, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: 01/06/22: COUGH, PINK EYES, NC
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive 1/10/22, no taste or smell, moderna x2 no booster
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond use date of 12/22/21.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Dry cough Tiredness Fever up to 103 body aches Arm soreness at injection site
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: EXTRACTION OF THE MODERNA VACCINE FROM THE VIAL WAS NOT CONSISTENT WITH A MODERNA TECHNIQUE (I.E. MORE THAN 20 BOOSTER DOSES WERE DRAWN UP FROM THE 15ML VIAL).
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after beyond use date of 12/22/21.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Seated patient refers to itching and redness of face. Doctor ordered to administered 50mg of intramuscular BENADRYL.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling cold, Influenza virus test negative, Limb discomfort
Clinical narrative: When we were on our way home from the shot she said her arm felt funny and she was tired but other than that she was fine. Around 10:30 that night she came to us having trouble with her throat, that she couldn't breath when she was laying down in bed. She started to panic, that time I called the family doctor office and spoke with a physician on call. My husband already had her in the car heading to ER. When they were driving, she kept standing up and drinking a lot of water saying she couldn't breath. My husband called 911 as he was driving to the hospital. She was having trouble answering my husband back due to breathing issues. When they arrived at ER he brought her right back to the nurses and doctors, she was as cold as ice even her feet that were in boots. She was shaking and needed more water. She started to vomit and she was given ondansetron ODT, she was tested for COVID and the flu but was negative. She was still having issues with her throat after hours of vomiting(probably vomited 30 times while at the ER) she was given diphenhydramine.  She was released around 6:30am and we had to continue the Benadryl every 6 hours until Sunday.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Panic attack, SARS-CoV-2 test negative, Tremor, Vomiting
Clinical narrative: When we were on our way home from the shot she said her arm felt funny and she was tired but other than that she was fine. Around 10:30 that night she came to us having trouble with her throat, that she couldn't breath when she was laying down in bed. She started to panic, that time I called the family doctor office and spoke with a physician on call. My husband already had her in the car heading to ER. When they were driving, she kept standing up and drinking a lot of water saying she couldn't breath. My husband called 911 as he was driving to the hospital. She was having trouble answering my husband back due to breathing issues. When they arrived at ER he brought her right back to the nurses and doctors, she was as cold as ice even her feet that were in boots. She was shaking and needed more water. She started to vomit and she was given ondansetron ODT, she was tested for COVID and the flu but was negative. She was still having issues with her throat after hours of vomiting(probably vomited 30 times while at the ER) she was given diphenhydramine.  She was released around 6:30am and we had to continue the Benadryl every 6 hours until Sunday.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Fatigue, Inflammation
Clinical narrative: Developed fever and chills the same evening.  Took acetaminophen and went to bed, slept poorly and woke with severe athritis in several joints (left ankle and foot, right knee, both hips, lower back, right thumb and both elbows and shoulders). Maxillary and frontal sinuses were also painful and bright red spots on cheeks and forehead indicated inflammation.  Myalgias and fatigue made me feel like a had a bad flu for the next 48 hours.Then, arthritis began to subside and sinusitis, fatigue and weakness became primary symptoms.  My physician prescribed Augmentin on 1/10/22 for the "sinusitis" - in combination with continued acetaminophen, finally feeling somewhat better but not back to baseline yet, nearly a week after the booster!  This experience makes me very concerned about the vaccine mandates - since the virus is mutating towards greater infectivity/lesser morbidity, it seems unwise to require people to get a vaccine that is 1) probably not effective and 2) is likely to make them sicker than if they were naturally infected.  PLEASE consider revising your policies!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Myalgia, Polyarthritis, Poor quality sleep
Clinical narrative: Developed fever and chills the same evening.  Took acetaminophen and went to bed, slept poorly and woke with severe athritis in several joints (left ankle and foot, right knee, both hips, lower back, right thumb and both elbows and shoulders). Maxillary and frontal sinuses were also painful and bright red spots on cheeks and forehead indicated inflammation.  Myalgias and fatigue made me feel like a had a bad flu for the next 48 hours.Then, arthritis began to subside and sinusitis, fatigue and weakness became primary symptoms.  My physician prescribed Augmentin on 1/10/22 for the "sinusitis" - in combination with continued acetaminophen, finally feeling somewhat better but not back to baseline yet, nearly a week after the booster!  This experience makes me very concerned about the vaccine mandates - since the virus is mutating towards greater infectivity/lesser morbidity, it seems unwise to require people to get a vaccine that is 1) probably not effective and 2) is likely to make them sicker than if they were naturally infected.  PLEASE consider revising your policies!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinus pain, Sinusitis
Clinical narrative: Developed fever and chills the same evening.  Took acetaminophen and went to bed, slept poorly and woke with severe athritis in several joints (left ankle and foot, right knee, both hips, lower back, right thumb and both elbows and shoulders). Maxillary and frontal sinuses were also painful and bright red spots on cheeks and forehead indicated inflammation.  Myalgias and fatigue made me feel like a had a bad flu for the next 48 hours.Then, arthritis began to subside and sinusitis, fatigue and weakness became primary symptoms.  My physician prescribed Augmentin on 1/10/22 for the "sinusitis" - in combination with continued acetaminophen, finally feeling somewhat better but not back to baseline yet, nearly a week after the booster!  This experience makes me very concerned about the vaccine mandates - since the virus is mutating towards greater infectivity/lesser morbidity, it seems unwise to require people to get a vaccine that is 1) probably not effective and 2) is likely to make them sicker than if they were naturally infected.  PLEASE consider revising your policies!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint swelling, Ligament sprain, Pain
Clinical narrative: My left ankle was hurting and a little swollen on the left side from a sprain two months earlier.  The ankle was beginning to feel much better, though.  After the Moderna booster (shot #3) the right side of my left ankle and in fact the top of my left foot became swollen and there was a new pain from the right side of my left ankle.  It hurt when I was still and hurt very much while walking.  The pain woke me up at night.   The swelling and pain subsided on the tenth day after I received the Moderna booster shot.  My doctor's office was closed for the Christmas and New Year's holiday and by the time he re-opened the pain had subsided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sleep disorder
Clinical narrative: My left ankle was hurting and a little swollen on the left side from a sprain two months earlier.  The ankle was beginning to feel much better, though.  After the Moderna booster (shot #3) the right side of my left ankle and in fact the top of my left foot became swollen and there was a new pain from the right side of my left ankle.  It hurt when I was still and hurt very much while walking.  The pain woke me up at night.   The swelling and pain subsided on the tenth day after I received the Moderna booster shot.  My doctor's office was closed for the Christmas and New Year's holiday and by the time he re-opened the pain had subsided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after beyond use date of 12/22/21.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ocular discomfort, Pyrexia, Visual impairment
Clinical narrative: Approximately the day after receiving the second dose of Shingrix, the patient began to experience eye pain and low grade fever. Upon being evaluated by their eye health provider, they were treated with a steroid eye drop. Vision and eye discomfort was fully resolved within a few days of treatment.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ?Moderna COVID 19 Vaccine EUA? : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: The vaccine was given past it?s refrigeration expiration date, the date on the vial was still within date.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: I was on my period when I received the vaccine.  I got another period in 14 days of the first day of my last period.  I got another period 25 days later.  I'm usually about 33 days between periods.  My next period was 25 days.  The next period was 17 days.  The next period I missed.  The next period was 37  days.  Then my next period was 40 days.  My days of bleed have become longer also.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Antinuclear antibody positive, Chest pain, Fatigue, Inflammation, Laboratory test
Clinical narrative: I had regular symptoms of exhaustion, body aches and low-grade fever (nothing over 100.9) for the first 6 days or so. The body aches got worse into the week of Dec 27th - to the point where I could not get out of bed. The body aches continued and so did the exhaustion. On new years eve, I started having chest pains and so I went to the Emergency room. They found that I did not have a heart attack so they sent me home. I followed up with a doctor at Facility (Dr.) and I briefly mentioned that I think this was related to the COVID booster. He told me that it is highly unlikely that it is the vaccine and that adverse reactions are minimal. To this day I am still easily exhausted and have to lie down often. Dr. ordered labwork and it showed some inflammation and tested positive for ANA. Saw  rheumatologist today and again, I expressed my concerns that this is all related to the booster shot. He listened and told me there is a chance it could be, but that we are going to rule out everything else first.
Age: 34.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: I had regular symptoms of exhaustion, body aches and low-grade fever (nothing over 100.9) for the first 6 days or so. The body aches got worse into the week of Dec 27th - to the point where I could not get out of bed. The body aches continued and so did the exhaustion. On new years eve, I started having chest pains and so I went to the Emergency room. They found that I did not have a heart attack so they sent me home. I followed up with a doctor at Facility (Dr.) and I briefly mentioned that I think this was related to the COVID booster. He told me that it is highly unlikely that it is the vaccine and that adverse reactions are minimal. To this day I am still easily exhausted and have to lie down often. Dr. ordered labwork and it showed some inflammation and tested positive for ANA. Saw  rheumatologist today and again, I expressed my concerns that this is all related to the booster shot. He listened and told me there is a chance it could be, but that we are going to rule out everything else first.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dehydration, Nausea, Vomiting
Clinical narrative: SEVERE NAUSEA, VOMITTING AND DEHYDRATION.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: SEVERE NAUSEA, VOMITTING AND DEHYDRATION.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus, Vertigo
Clinical narrative: vertigo loss of hearing tinnitus
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid monitoring documentation. PT admitted 1/3/22 documented to have positive covid. PT received Janssen  3/31/21 Lot 1808980 for dose 1.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Deep vein thrombosis, Differential white blood cell count, Echocardiogram, Full blood count
Clinical narrative: Developed Upper Extremity Deep Vein Thrombosis in Left Arm
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test
Clinical narrative: Developed Upper Extremity Deep Vein Thrombosis in Left Arm
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Pain in extremity, Pruritus
Clinical narrative: arm sore, itching, blood pressure
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Cough, Pruritus, Respiratory tract irritation, Throat irritation
Clinical narrative: Significant itchiness all over scalp, neck, in eyes/nostrils/ears + a scratchy throat and coughing from upper lung irritation. Dermatologist gave me an Epi-pen after which  dermatologist ruled out potential allergy saying it was more of a flare-up of my entire immune system. It lasted 4-5 months. Two courses of steroids reduced symptoms during treatment but all symptoms reappeared with same intensity 24hrs after end of treatment.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin warm, Swelling, Swelling face
Clinical narrative: Face, neck and upper chest was red, swollen, itchy and hot for over a week.  This happened with both doses 1 and 2, but not with my booster.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Female patient refers an episode of paresthesia in her left upper extremity immediately after receiving the third dose of the Pfizer Vaccine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Case vaccinated with J&J on 5/11/2021. tested positive for covid 19 on 12/30/2021. Admitted to Hospital on 12/30/2021 and expired on 01/07/2022 while still hospitalized.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Injection site eczema, Injection site swelling, Pruritus
Clinical narrative: Localized Redness ( 3 X 2 inches ), itching. Raised area at site of injection, eczema at injection site
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Moderna COVID 19 Vaccine EUA : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Vaccine given too low on the arm, potentially outside of the deltoid muscle.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea
Clinical narrative: Hospital onset Covid-19 infection.  ED note states patient had been vaccinated.  Patient's current health status incongruent with accurate history retrieval.  No family to request information from.  Possible extenuation of patient's hospital course from infection acquisition.  Patient's Covid-19 status negative on admission 12/18/21, retest 12/27/21 also negative.  Patient extubated 1/7/22, related symptoms reported 1/8/22 = chills, SOA, increasing cough.  Fever reported 1/9/22.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Endotracheal intubation, Lung opacity, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Hospital onset Covid-19 infection.  ED note states patient had been vaccinated.  Patient's current health status incongruent with accurate history retrieval.  No family to request information from.  Possible extenuation of patient's hospital course from infection acquisition.  Patient's Covid-19 status negative on admission 12/18/21, retest 12/27/21 also negative.  Patient extubated 1/7/22, related symptoms reported 1/8/22 = chills, SOA, increasing cough.  Fever reported 1/9/22.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: 2-3 inch in diameter lump underneath my left arm, right on my armpit.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Clonus, Dizziness, Fall, Headache, Loss of consciousness
Clinical narrative: Pt developed a headache then felt lightheaded, then collapsed and had a brief clonic episode of his upper arms.  This happened later that night around 10 pm.  With that episode he also developed a headache but denies lightheadedness prior to experiencing a loss of consciousness and brief clonic movements again. with vomiting after.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pt developed a headache then felt lightheaded, then collapsed and had a brief clonic episode of his upper arms.  This happened later that night around 10 pm.  With that episode he also developed a headache but denies lightheadedness prior to experiencing a loss of consciousness and brief clonic movements again. with vomiting after.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: - Persistent at the injection site after getting Vaccine. - No treatment for 2 months after injection. - 5 physical therapy after 2 months at Orthopedics - 1 physical therapy and prescription of anti-inflammatory medicine at department of pain medicine. - No improvement
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: ?Moderna COVID 19 Vaccine EUA? : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Received COVID moderna vaccine on 01/22/21 and 02/22/21. No booster. Presented to ER on 12/2021. Presented to the hospital secondary to hypoxia and shortness of breath from COVID-19.  Was diagnosed with COVID pneumonia.  She was placed on dexamethasone and remdesivir.  With the IMC on oxygen per protocol.  Also was found to have UTI for Klebsiella pneumoniae.  She is on azithromycin and ceftriaxone.  Was on high-flow oxygen for several days titrated back eventually to oxygen via nasal cannula.  Blood pressure medications were held as she was normotensive.  Electrolytes were followed and replaced as needed.  Was noted to be anemic but without acute bleeding and transfused with 1 unit of packed red blood cells and her hemoglobin remained stable thereafter.  Physical therapy and occupational therapy saw this patient for safe mobilization.  Completed her course of remdesivir.  Completed antibiotics courses on 12/26/2021.  Clinically and via x-ray there was significant improvement in her COVID pneumonia.  Was transferred to regular floor on 01/03/2000 22. Underwent 6 minute oxygen walk on 01/05/2022 and was not needing supplemental oxygen.  She was at her baseline in declined home health care.  Was discharged home with plans for close follow-up on 01/05/2022.  Had been on Lovenox throughout her hospital stay at 40 mg b.i.d. secondary to weight. Discharged on 1/5/22
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Electrolyte substitution therapy, Haemoglobin, Hypoxia, Klebsiella infection
Clinical narrative: Received COVID moderna vaccine on 01/22/21 and 02/22/21. No booster. Presented to ER on 12/2021. Presented to the hospital secondary to hypoxia and shortness of breath from COVID-19.  Was diagnosed with COVID pneumonia.  She was placed on dexamethasone and remdesivir.  With the IMC on oxygen per protocol.  Also was found to have UTI for Klebsiella pneumoniae.  She is on azithromycin and ceftriaxone.  Was on high-flow oxygen for several days titrated back eventually to oxygen via nasal cannula.  Blood pressure medications were held as she was normotensive.  Electrolytes were followed and replaced as needed.  Was noted to be anemic but without acute bleeding and transfused with 1 unit of packed red blood cells and her hemoglobin remained stable thereafter.  Physical therapy and occupational therapy saw this patient for safe mobilization.  Completed her course of remdesivir.  Completed antibiotics courses on 12/26/2021.  Clinically and via x-ray there was significant improvement in her COVID pneumonia.  Was transferred to regular floor on 01/03/2000 22. Underwent 6 minute oxygen walk on 01/05/2022 and was not needing supplemental oxygen.  She was at her baseline in declined home health care.  Was discharged home with plans for close follow-up on 01/05/2022.  Had been on Lovenox throughout her hospital stay at 40 mg b.i.d. secondary to weight. Discharged on 1/5/22
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Packed red blood cell transfusion, Pulmonary oedema, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Received COVID moderna vaccine on 01/22/21 and 02/22/21. No booster. Presented to ER on 12/2021. Presented to the hospital secondary to hypoxia and shortness of breath from COVID-19.  Was diagnosed with COVID pneumonia.  She was placed on dexamethasone and remdesivir.  With the IMC on oxygen per protocol.  Also was found to have UTI for Klebsiella pneumoniae.  She is on azithromycin and ceftriaxone.  Was on high-flow oxygen for several days titrated back eventually to oxygen via nasal cannula.  Blood pressure medications were held as she was normotensive.  Electrolytes were followed and replaced as needed.  Was noted to be anemic but without acute bleeding and transfused with 1 unit of packed red blood cells and her hemoglobin remained stable thereafter.  Physical therapy and occupational therapy saw this patient for safe mobilization.  Completed her course of remdesivir.  Completed antibiotics courses on 12/26/2021.  Clinically and via x-ray there was significant improvement in her COVID pneumonia.  Was transferred to regular floor on 01/03/2000 22. Underwent 6 minute oxygen walk on 01/05/2022 and was not needing supplemental oxygen.  She was at her baseline in declined home health care.  Was discharged home with plans for close follow-up on 01/05/2022.  Had been on Lovenox throughout her hospital stay at 40 mg b.i.d. secondary to weight. Discharged on 1/5/22
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure diastolic decreased, Dizziness, Dizziness postural, Fatigue
Clinical narrative: Approximately 6 hours after injections I began to have body aches. The next morning (12/24/21) I had a fever of 101.8 and began to have extreme fatigue. I went to work (I am a Registered Nurse working in a ICU) took my temp around 0900 (this is post 800mg ibuprofen) and my fever was now 102.1. I took 1gm of Tylenol and reported signs and symptoms to my charge nurse. Shortly after 1000 I began to have extreme headaches, overwhelming bouts of fatigue, and began to feel faint. My blood pressure was 100/50 and pulse was 115. I had several episodes of dizziness upon standing. I felt that, at this time, I was not fit to work my shift. I notified my charge nurse and left work early ( I have a very strong support system at work). I drove home and slept for the next 14 hours. When I woke up on Christmas morning I felt better but not 100%. Looking back on the previous day I realized there were parts of the day I do not remember at all - I did not remember charting that I did on my patients, I did not know where certain items I had were placed, I did not remember if I took medicines after I left work. The total time of not feeling well lasted about 72 hours.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Malaise, Pain, Pyrexia
Clinical narrative: Approximately 6 hours after injections I began to have body aches. The next morning (12/24/21) I had a fever of 101.8 and began to have extreme fatigue. I went to work (I am a Registered Nurse working in a ICU) took my temp around 0900 (this is post 800mg ibuprofen) and my fever was now 102.1. I took 1gm of Tylenol and reported signs and symptoms to my charge nurse. Shortly after 1000 I began to have extreme headaches, overwhelming bouts of fatigue, and began to feel faint. My blood pressure was 100/50 and pulse was 115. I had several episodes of dizziness upon standing. I felt that, at this time, I was not fit to work my shift. I notified my charge nurse and left work early ( I have a very strong support system at work). I drove home and slept for the next 14 hours. When I woke up on Christmas morning I felt better but not 100%. Looking back on the previous day I realized there were parts of the day I do not remember at all - I did not remember charting that I did on my patients, I did not know where certain items I had were placed, I did not remember if I took medicines after I left work. The total time of not feeling well lasted about 72 hours.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: EXTENDED HOSPITAL STAY DUE TO COVID+ LTC PLACEMENT
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Date of Service 9/13/2021 patient was given Moderna vaccine in error, Mom and provider were both notified. Mom will have patient get the series of Pfizer vaccine.  Medical assistant was educated on age requirement for Moderna vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Gravitational oedema, Joint swelling, Lymphadenopathy
Clinical narrative: Back in May one evening my ankles started hurting and swollen. Within the next week swollen knees and ankles. On  6/5/21 went to the emergency for extreme swelling. Diagnosed me with Dependent Edema and Enlarged Lymph Nodes
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Back in May one evening my ankles started hurting and swollen. Within the next week swollen knees and ankles. On  6/5/21 went to the emergency for extreme swelling. Diagnosed me with Dependent Edema and Enlarged Lymph Nodes
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, COVID-19, Chest X-ray abnormal, Dyspnoea, Headache
Clinical narrative: 01/08/2021:Event occurred after 2nd vaccine.  Patient presents with headache and shortness of breath.  States that around noon today he had the gradual nonthunderclap onset of a bifrontal headache which is unusual for him and gradually worsening shortness of breath, . Taken to another facility and tested COVID positive  prior to transfer to hospital.  Not tested at hospital.  No cough, syncope, neck stiffness.  Patient denies: vomiting, Diarrhea, fever.  01/11/2022: remains in hospital
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Intensive care, Lung hyperinflation, Lung infiltration, Lung opacity, Pleural effusion
Clinical narrative: 01/08/2021:Event occurred after 2nd vaccine.  Patient presents with headache and shortness of breath.  States that around noon today he had the gradual nonthunderclap onset of a bifrontal headache which is unusual for him and gradually worsening shortness of breath, . Taken to another facility and tested COVID positive  prior to transfer to hospital.  Not tested at hospital.  No cough, syncope, neck stiffness.  Patient denies: vomiting, Diarrhea, fever.  01/11/2022: remains in hospital
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 01/08/2021:Event occurred after 2nd vaccine.  Patient presents with headache and shortness of breath.  States that around noon today he had the gradual nonthunderclap onset of a bifrontal headache which is unusual for him and gradually worsening shortness of breath, . Taken to another facility and tested COVID positive  prior to transfer to hospital.  Not tested at hospital.  No cough, syncope, neck stiffness.  Patient denies: vomiting, Diarrhea, fever.  01/11/2022: remains in hospital
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 14 years old and received the Moderna first dose (0.5ml) on 12/2/2021.  Moderna is currently not approved for under 18 years old.  Patient did not have any adverse reactions to the Moderna vaccine.  She felt fine and had no side effects at all.  She is doing very well.  However, because Moderna is currently not approved for 17 and younger, pfizer will be given to the patient when she comes back for her second dose.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: ?Moderna COVID 19 Vaccine EUA? : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: Covid positive through house hold contact
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ?Moderna COVID 19 Vaccine EUA? : 3 of 4 vials used to administer booster doses were punctured 21 times, instead of the max limit of 20. Vaccine storage, handling and draw were all performed with integrity. Vaccine was stored between 2 degree C and 8 degrees C until time of draw. Each vial was drawn with sequential punctures, and batched for administration. Syringes and vials were inspected prior to moving to administration table. No defect identified. Each of 3 vials where 21st dose was extracted, has all 21 doses extracted within 15-20 min.  It is not known if any patient received any of the 3 "21st' doses". 29 Patients were identified as receiving a booster dose from one of the 3 vials, where a 21st dose was drawn. However, we are not able to verify if any of these 3 "21st" doses were in fact administered.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient received Pfizer Covid shot. Staff from the front saw the patient seated on the floor in the grocery aisle. Staff came to the pharmacy where I went over to see what happened. She was with her mother and they stated she passed out. She stated she did not hit her head, she was responsive and seated. I offered to call EMS and patient and mother declined the offer. We brought a chair over to her to sit. She stated she had not eaten or had anything to drink and she said it was probably due to that. I offered her water and she said she already had Gatorade to drink and her mother was getting her something to eat. They thanked me for checking on her and remained in the aisle seated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute myocardial infarction, Blood creatinine increased, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Vaccinated with Pfizer COVID19 on 07/28/21 and 08/18/21. Presented to ER on 12/26/21 with COVID19. Presented to the ed with 3 weeks of shortness of breath found to have NSTEMI, acute CHF, and covid positive. Labs remarkable for BNP >3000, troponin 15. SCR 2.4. patient doing well on room air and dexamethasone and remdesivir held. CXR with cardiomegaly. Nephrology consulted for new AKI on CKD. Cardiology consult; rec cath but patient declining due to risk of worsening AKI/CKD, patient agreeable to stress. Currently awaiting d/c of covid precautions for stress test. Patient underwent cardiac PET scan done suggestive of mild ischemia. Patient was offered cardiac catheterization which patient declined stating for now he will continue taking medications and follow up with cardiology in the office.   Prior to discharge patient was feeling back to baseline health and did not need any oxygen.  Discharged on 1/5/22
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiomegaly, Chest X-ray abnormal, Chronic kidney disease, Dyspnoea
Clinical narrative: Vaccinated with Pfizer COVID19 on 07/28/21 and 08/18/21. Presented to ER on 12/26/21 with COVID19. Presented to the ed with 3 weeks of shortness of breath found to have NSTEMI, acute CHF, and covid positive. Labs remarkable for BNP >3000, troponin 15. SCR 2.4. patient doing well on room air and dexamethasone and remdesivir held. CXR with cardiomegaly. Nephrology consulted for new AKI on CKD. Cardiology consult; rec cath but patient declining due to risk of worsening AKI/CKD, patient agreeable to stress. Currently awaiting d/c of covid precautions for stress test. Patient underwent cardiac PET scan done suggestive of mild ischemia. Patient was offered cardiac catheterization which patient declined stating for now he will continue taking medications and follow up with cardiology in the office.   Prior to discharge patient was feeling back to baseline health and did not need any oxygen.  Discharged on 1/5/22
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial ischaemia, Positron emission tomogram abnormal, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: Vaccinated with Pfizer COVID19 on 07/28/21 and 08/18/21. Presented to ER on 12/26/21 with COVID19. Presented to the ed with 3 weeks of shortness of breath found to have NSTEMI, acute CHF, and covid positive. Labs remarkable for BNP >3000, troponin 15. SCR 2.4. patient doing well on room air and dexamethasone and remdesivir held. CXR with cardiomegaly. Nephrology consulted for new AKI on CKD. Cardiology consult; rec cath but patient declining due to risk of worsening AKI/CKD, patient agreeable to stress. Currently awaiting d/c of covid precautions for stress test. Patient underwent cardiac PET scan done suggestive of mild ischemia. Patient was offered cardiac catheterization which patient declined stating for now he will continue taking medications and follow up with cardiology in the office.   Prior to discharge patient was feeling back to baseline health and did not need any oxygen.  Discharged on 1/5/22
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Back pain, Blood test, Bone pain, Chest discomfort
Clinical narrative: It started a few minutes after with a nauseous but that happened with the first two doses. About four five hours after.  Extreme fatigue rash two lumps under my left arm pit ringing in my ears. As the day progressed and into Thursday Friday really bad fever chills achy bones tightening in my chest and a pain on the right side of my back. Early Thursday morning I almost went to the ER but decided to wait it out. Around Sunday symptoms started to lesson but still experienced very exhausted and little fever. As of Tuesday 1/11 still experiencing fatigue lumps have gone down not painful my ears are ringing less only when I lay down and my chest is still a little tight of and on. I had to take three sick days from work. With the second dose I was so nervous I went to the dr to check. This dose (booster) symptoms was worse than the first two.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Impaired work ability, Nausea, Pyrexia
Clinical narrative: It started a few minutes after with a nauseous but that happened with the first two doses. About four five hours after.  Extreme fatigue rash two lumps under my left arm pit ringing in my ears. As the day progressed and into Thursday Friday really bad fever chills achy bones tightening in my chest and a pain on the right side of my back. Early Thursday morning I almost went to the ER but decided to wait it out. Around Sunday symptoms started to lesson but still experienced very exhausted and little fever. As of Tuesday 1/11 still experiencing fatigue lumps have gone down not painful my ears are ringing less only when I lay down and my chest is still a little tight of and on. I had to take three sick days from work. With the second dose I was so nervous I went to the dr to check. This dose (booster) symptoms was worse than the first two.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tinnitus
Clinical narrative: It started a few minutes after with a nauseous but that happened with the first two doses. About four five hours after.  Extreme fatigue rash two lumps under my left arm pit ringing in my ears. As the day progressed and into Thursday Friday really bad fever chills achy bones tightening in my chest and a pain on the right side of my back. Early Thursday morning I almost went to the ER but decided to wait it out. Around Sunday symptoms started to lesson but still experienced very exhausted and little fever. As of Tuesday 1/11 still experiencing fatigue lumps have gone down not painful my ears are ringing less only when I lay down and my chest is still a little tight of and on. I had to take three sick days from work. With the second dose I was so nervous I went to the dr to check. This dose (booster) symptoms was worse than the first two.