chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I waited 30 minutes after the vaccine at the pharmacy and then left. At my home I started to feel terrible and started vomiting and could not stop vomiting for 24 hours.  I had terrible muscle pain, vertigo, loss of sensation in the opposite hand, pins and needles all through my body, extreme fatigue, could not think, delusions.  My parents took me to the hospital when they could not stop vomiting with over the counter meds and they were backed up for  hours.  The next morning I contacted an online virtual care doctor through telehealth app and he prescribed me dissolvable Zofran pills.  I had to take double dose to finally stop the vomiting.  I still feel nauseous, weak, brain fog and body aches. I have never felt sicker in my whole life despite having the regular flu many times in the past.  I have not seen people report extreme vomiting so I believe this was an adverse reaction.  I am terrified of ever having the second shot and most likely will not be doing it if I had this reaction on the first one.  I literally felt like I was dying from the way I felt after receiving that vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Heart rate increased, Ventricular extrasystoles
Clinical narrative: Elevated heart rate  (160 bpm) for over an hour. Determined to be AFib and was prescribed Eloquis and motropolol.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itching bumps all over body -  continually having new bumps  daily. Was advised to start Zyrtec BID for 6 weeks to help with the itching.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death, Encephalopathy
Clinical narrative: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. 69/M PMHx of metastatic prostate Ca and non-Hodgkins lymphoma, systolic HFrEF, DMII, chronic prednisone therapy and chronic anemia. Presented from clinic on 11/19/21 w/acute hypoxic respiratory failure 2/2 Covid-19 PNA. Tx'd w/remdisivir, dexamethasone, vanc, cefepime, pressors and HFNC. O2 demands cont. to increase transferred to ICU on 11/26, intubated 11/30. Developed acute encephalopathy,  severe sepsis w/multi-organ failure and shock. Expired 12/09/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Endotracheal intubation, Intensive care, Multiple organ dysfunction syndrome, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. 69/M PMHx of metastatic prostate Ca and non-Hodgkins lymphoma, systolic HFrEF, DMII, chronic prednisone therapy and chronic anemia. Presented from clinic on 11/19/21 w/acute hypoxic respiratory failure 2/2 Covid-19 PNA. Tx'd w/remdisivir, dexamethasone, vanc, cefepime, pressors and HFNC. O2 demands cont. to increase transferred to ICU on 11/26, intubated 11/30. Developed acute encephalopathy,  severe sepsis w/multi-organ failure and shock. Expired 12/09/21.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Shock
Clinical narrative: Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. 69/M PMHx of metastatic prostate Ca and non-Hodgkins lymphoma, systolic HFrEF, DMII, chronic prednisone therapy and chronic anemia. Presented from clinic on 11/19/21 w/acute hypoxic respiratory failure 2/2 Covid-19 PNA. Tx'd w/remdisivir, dexamethasone, vanc, cefepime, pressors and HFNC. O2 demands cont. to increase transferred to ICU on 11/26, intubated 11/30. Developed acute encephalopathy,  severe sepsis w/multi-organ failure and shock. Expired 12/09/21.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Erythema, Peripheral swelling, Ultrasound scan
Clinical narrative: 3 or 4 days after the booster I had a red and swollen arm. I experienced lumps in my breast where I already had a mastectomy. I noticed it about the last week in November. I went to the doctor on 12/06/2021. They did an ultrasound and it showed there were 3 lumps on the side of the breast, where there was scar tissue from the mastectomy. They were not able to biopsy so they scheduled a lump biopsy on next Wednesday. I am having surgery next week so it has obviously progressed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Product storage error
Clinical narrative: Pfizer covid vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended. Patient reboosted on 12/07/2021 per recommendations from Pfizer.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site scab
Clinical narrative: SCAB AND SIGNIFICANT BRUSE AROUND INJECTION SITE 11 DAYS AFTER  BOOSTER  INJECTION.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Pain, Palpitations
Clinical narrative: I had a racing heart for over 24 hours (85-95 bpm) as well as extreme tiredness, headache, and body aches.  I could not really leave bed for more than a day.  My heart rate remained elevated for almost a week after until returning back to normal around 60.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: When manually uploading  vaccination records into vaccination reporting website I noticed that that the incorrect vaccine was administered to adolescent.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Cardiac discomfort, Chest discomfort, Chest pain, Dizziness
Clinical narrative: Came home and had headache/dizziness. Over the next week, the vertigo got worse. I also developed a very fast heart  upon going from sitting to standing. I had constant chest pains. I could not climb the stairs or go on a walk without being dizzy and having heart/chest issues. My lymph nodes and head were so inflamed I could not touch my scalp or neck area without being in pain. I lost my menstrual cycle for 6 months. These were never issues before the vaccine.  I went to the ER 4 times. No one knew how to help me. It took 3 months to get back to a life where I could do things. I now still feel fatigued, but am doing better.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Heart rate increased, Inflammation
Clinical narrative: Came home and had headache/dizziness. Over the next week, the vertigo got worse. I also developed a very fast heart  upon going from sitting to standing. I had constant chest pains. I could not climb the stairs or go on a walk without being dizzy and having heart/chest issues. My lymph nodes and head were so inflamed I could not touch my scalp or neck area without being in pain. I lost my menstrual cycle for 6 months. These were never issues before the vaccine.  I went to the ER 4 times. No one knew how to help me. It took 3 months to get back to a life where I could do things. I now still feel fatigued, but am doing better.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Musculoskeletal discomfort, Pain of skin, Quality of life decreased, Tenderness
Clinical narrative: Came home and had headache/dizziness. Over the next week, the vertigo got worse. I also developed a very fast heart  upon going from sitting to standing. I had constant chest pains. I could not climb the stairs or go on a walk without being dizzy and having heart/chest issues. My lymph nodes and head were so inflamed I could not touch my scalp or neck area without being in pain. I lost my menstrual cycle for 6 months. These were never issues before the vaccine.  I went to the ER 4 times. No one knew how to help me. It took 3 months to get back to a life where I could do things. I now still feel fatigued, but am doing better.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Came home and had headache/dizziness. Over the next week, the vertigo got worse. I also developed a very fast heart  upon going from sitting to standing. I had constant chest pains. I could not climb the stairs or go on a walk without being dizzy and having heart/chest issues. My lymph nodes and head were so inflamed I could not touch my scalp or neck area without being in pain. I lost my menstrual cycle for 6 months. These were never issues before the vaccine.  I went to the ER 4 times. No one knew how to help me. It took 3 months to get back to a life where I could do things. I now still feel fatigued, but am doing better.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: hospitalized. On 2 L nasal canula (no O2 at home). history of kidney transplant
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test normal, Chills, Dizziness, Ear discomfort
Clinical narrative: After I got the vaccination on 02/10/2021 I got sick with chills, fever, body ache like I had the Flu which I expected it but on 02/11/2021 I almost fainted and 02/13/2021 I was feeling dizzy and it started progressing very bad, I was so dizzy that I couldn't walk. I contacted my doctor, I got an appointment and explained what happened because I couldn't get rid of my dizziness and the popping in my ears. The popping went away but dizziness is still there and I still have to deal with it. There nothing much I can do. I think I went back to the doctor the end of August because I was still dizzy, I was referred to see Neurologist and he said that everything looked fine and now I have an appointment with ENT this Friday because I'm still dealing with the dizziness. I have notice that when I walk I lean to the right side and is not making any sense so I really want to know what's going on. I do know this has something to do with the vaccine. I do believe that this 2nd dose gave me vertigo. Much better now but still dizzy and I don't know what to do. I really want to get the booster but what if I get worse then the 2nd dose? I'm kind of scared.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Pain, Presyncope, Pyrexia, Vertigo
Clinical narrative: After I got the vaccination on 02/10/2021 I got sick with chills, fever, body ache like I had the Flu which I expected it but on 02/11/2021 I almost fainted and 02/13/2021 I was feeling dizzy and it started progressing very bad, I was so dizzy that I couldn't walk. I contacted my doctor, I got an appointment and explained what happened because I couldn't get rid of my dizziness and the popping in my ears. The popping went away but dizziness is still there and I still have to deal with it. There nothing much I can do. I think I went back to the doctor the end of August because I was still dizzy, I was referred to see Neurologist and he said that everything looked fine and now I have an appointment with ENT this Friday because I'm still dealing with the dizziness. I have notice that when I walk I lean to the right side and is not making any sense so I really want to know what's going on. I do know this has something to do with the vaccine. I do believe that this 2nd dose gave me vertigo. Much better now but still dizzy and I don't know what to do. I really want to get the booster but what if I get worse then the 2nd dose? I'm kind of scared.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Rash behind ear started on 04/01/2021, then spread chest, my groin, my waist and my hands, but not where I received the shot. No discharge or drainage, just red raised flat bumps, and it itched very bad. Took Zyrtec, and Pepcid and the symptoms did go away.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt received full dose Moderna instead of Moderna Booster dose.  No adverse effects noted at the time of vaccination or after observation.  Pt stable and released from the vaccination site.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Illness, Impaired driving ability, Impaired work ability
Clinical narrative: Hives like symptoms began with severe itching and swelling beginning on the back of neck and shoulders, then spread to include legs, hands and feet. Did not respond to external creams much, so after two weeks I scheduled an allergist appt. Tried to go off any antihistamines for 2-3 days before the appt, and both times on the third day it became unbearable and pt (myself) took an antihistamine. I tried zyrtec first, it only helped a little. Then tried bernadryl. Benadryl was 6 hour version, name brand. Itching and  swelling became so bad the day I saw the allergist (Premier Allergist member, FNP) that it began to affect my hands and feet, and private parts. Any friction such as washing of hands and wiping myself clean caused immediate swelling and redness, and deep painful itching that did not improve with scratching or creams (benadryl or cortisone). It caused problems with sleep, driving (due to the hands and feet), and sanitation (hard to wash hands or face, shower). Benadryl helped significantly but wore off after about 6-7 hours, so I needed to take it 3 times a day and for bed to avoid active swelling/itching. Allergist prescribed prednisone for 5 days that Wednesday, and it had no effect so I took benadryl again Saturday evening and into the weekend. Met with allergist to followup on 12/14/21 and told her I was unable to get off the anti histamines long enough to do allergy testing. She suggested continuation of the benadryl then allergy testing once the reaction has improved. I did try switching detergents etc to make sure that wasn't the issue, and it seemed to have no effect. Allergist stated she has had several patients with the same response after the Moderna booster, and to report it for the sake of documentation for the manufacturer.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Sleep disorder, Swelling
Clinical narrative: Hives like symptoms began with severe itching and swelling beginning on the back of neck and shoulders, then spread to include legs, hands and feet. Did not respond to external creams much, so after two weeks I scheduled an allergist appt. Tried to go off any antihistamines for 2-3 days before the appt, and both times on the third day it became unbearable and pt (myself) took an antihistamine. I tried zyrtec first, it only helped a little. Then tried bernadryl. Benadryl was 6 hour version, name brand. Itching and  swelling became so bad the day I saw the allergist (Premier Allergist member, FNP) that it began to affect my hands and feet, and private parts. Any friction such as washing of hands and wiping myself clean caused immediate swelling and redness, and deep painful itching that did not improve with scratching or creams (benadryl or cortisone). It caused problems with sleep, driving (due to the hands and feet), and sanitation (hard to wash hands or face, shower). Benadryl helped significantly but wore off after about 6-7 hours, so I needed to take it 3 times a day and for bed to avoid active swelling/itching. Allergist prescribed prednisone for 5 days that Wednesday, and it had no effect so I took benadryl again Saturday evening and into the weekend. Met with allergist to followup on 12/14/21 and told her I was unable to get off the anti histamines long enough to do allergy testing. She suggested continuation of the benadryl then allergy testing once the reaction has improved. I did try switching detergents etc to make sure that wasn't the issue, and it seemed to have no effect. Allergist stated she has had several patients with the same response after the Moderna booster, and to report it for the sake of documentation for the manufacturer.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives like symptoms began with severe itching and swelling beginning on the back of neck and shoulders, then spread to include legs, hands and feet. Did not respond to external creams much, so after two weeks I scheduled an allergist appt. Tried to go off any antihistamines for 2-3 days before the appt, and both times on the third day it became unbearable and pt (myself) took an antihistamine. I tried zyrtec first, it only helped a little. Then tried bernadryl. Benadryl was 6 hour version, name brand. Itching and  swelling became so bad the day I saw the allergist (Premier Allergist member, FNP) that it began to affect my hands and feet, and private parts. Any friction such as washing of hands and wiping myself clean caused immediate swelling and redness, and deep painful itching that did not improve with scratching or creams (benadryl or cortisone). It caused problems with sleep, driving (due to the hands and feet), and sanitation (hard to wash hands or face, shower). Benadryl helped significantly but wore off after about 6-7 hours, so I needed to take it 3 times a day and for bed to avoid active swelling/itching. Allergist prescribed prednisone for 5 days that Wednesday, and it had no effect so I took benadryl again Saturday evening and into the weekend. Met with allergist to followup on 12/14/21 and told her I was unable to get off the anti histamines long enough to do allergy testing. She suggested continuation of the benadryl then allergy testing once the reaction has improved. I did try switching detergents etc to make sure that wasn't the issue, and it seemed to have no effect. Allergist stated she has had several patients with the same response after the Moderna booster, and to report it for the sake of documentation for the manufacturer.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Heart rate increased, Palpitations
Clinical narrative: Rapid heart rate at rest, dizziness, chest pain, heart palpitations
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A few hours after I developed hives all over my body resulting in me taking Zyrtec and Benadryl this persisted and got worse so after about 6 weeks I reached out to my PCP who gave me a Kenalog shot and advised to take a Pepcid/ Allegra mixture to help with the symptoms. And currently I have to take Benadryl nightly just to sleep because the hives are just so bad and taking the Pepcid/Allegra mixture twice daily as well.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Erythema, Myalgia, Swelling, Tenderness
Clinical narrative: Patient had Moderna booster on 12/6, started  Saturday  with back of right leg muscle pain and now on side has a bump. The size of half dollar and is slight red and tender to touch. Thinks the right leg is swollen but unsure.  Positive for DVT within the right popliteal and posterior tibial veins.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: CHILDS DATE OF BIRTH WRITTEN AS AND AGE WRITTEN AS 12 ON SIGNED CONSENT. CHILD IDENTIFIED IN  (#149071164) WITH DATE OF BIRTH.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Inflammation, Pain
Clinical narrative: I had headaches and 101-102 temperature for 4 days and incision where my lumpectomy was done was very sensitive, inflamed and painful. My doctor put me on antibiotics even though it been over a month since my surgery.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: 9:36 am Patient reported feeling dizzy. Denies chest pain, shortness of breath or any other symptoms . Patient seen in clinic  today 12-14-2021 with Primary care provider and report given. Patient given granola bar and water during visit. Patient stayed in clinic for observation. Reports " Feeling better." 11:20 am  Dr, notified, reassess patient and okay for patient to  be dismissed.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: chills, fever, body aches, headache
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Booster vaccine was given 4 months early. (Staff member had no adverse reactions.) I am just reporting the booster was given to early.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, SARS-CoV-2 test
Clinical narrative: Pt received Pfizer vaccines on 05/16/21 and 06/06/21. Pt presented to the ED on 12/02/21 for an emergent colonoscopy. Pt was tested for COVID on 12/06/21. Pt did not have a fever and was no hypoxic.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, In vitro fertilisation
Clinical narrative: Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer and state regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebral infarction, Electrocardiogram, Magnetic resonance imaging, Myocardial ischaemia
Clinical narrative: After receiving the 1st dose of Pfizer 01/22/2021, started experiencing symptoms 01/25/2021 of loss of vision in the left eye (3 mins). 02/2021 "Silent" Heart Attack diagnosed Blood Clot found in Left ventricle, treatment increased Blood Pressure medication. 11/2021 2 infarcts found in the Visual Cortex, Follow-Up Neurologist Ophthalmologist appt.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: After receiving the 1st dose of Pfizer 01/22/2021, started experiencing symptoms 01/25/2021 of loss of vision in the left eye (3 mins). 02/2021 "Silent" Heart Attack diagnosed Blood Clot found in Left ventricle, treatment increased Blood Pressure medication. 11/2021 2 infarcts found in the Visual Cortex, Follow-Up Neurologist Ophthalmologist appt.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Aspiration, Asthenia, Atrial fibrillation, COVID-19, Condition aggravated
Clinical narrative: PMH:  ESRD on hemodialysis, DMT2, DCHF, PAF; to ED with generalized weakness, found to be positive for COVID; metabolic encephalopathy; fevers and rapid A Fib; treated with antibiotics; pt lost pulse and was unresponsive; pt had vomited and aspirated; CPR initiated; intubated on mechanical ventilation; pt to ICU; remained unresponsive; pt transitioned to comfort care per family; family en route to hosp and pt found to have no pulse; family declined CPR; pt died in the hosp
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Endotracheal intubation, Intensive care, Mechanical ventilation, Metabolic encephalopathy
Clinical narrative: PMH:  ESRD on hemodialysis, DMT2, DCHF, PAF; to ED with generalized weakness, found to be positive for COVID; metabolic encephalopathy; fevers and rapid A Fib; treated with antibiotics; pt lost pulse and was unresponsive; pt had vomited and aspirated; CPR initiated; intubated on mechanical ventilation; pt to ICU; remained unresponsive; pt transitioned to comfort care per family; family en route to hosp and pt found to have no pulse; family declined CPR; pt died in the hosp
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse absent, Pyrexia, Resuscitation, SARS-CoV-2 test positive, Unresponsive to stimuli
Clinical narrative: PMH:  ESRD on hemodialysis, DMT2, DCHF, PAF; to ED with generalized weakness, found to be positive for COVID; metabolic encephalopathy; fevers and rapid A Fib; treated with antibiotics; pt lost pulse and was unresponsive; pt had vomited and aspirated; CPR initiated; intubated on mechanical ventilation; pt to ICU; remained unresponsive; pt transitioned to comfort care per family; family en route to hosp and pt found to have no pulse; family declined CPR; pt died in the hosp
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: PMH:  ESRD on hemodialysis, DMT2, DCHF, PAF; to ED with generalized weakness, found to be positive for COVID; metabolic encephalopathy; fevers and rapid A Fib; treated with antibiotics; pt lost pulse and was unresponsive; pt had vomited and aspirated; CPR initiated; intubated on mechanical ventilation; pt to ICU; remained unresponsive; pt transitioned to comfort care per family; family en route to hosp and pt found to have no pulse; family declined CPR; pt died in the hosp
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Thrombosis
Clinical narrative: Blood clots in L arm.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer and state regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: My period started over a week early, which has never happened in my life. It began five days after receiving the Moderna booster.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Mom states child complained of HA X2-3 days. She gave tylenol 160 mg chewable tablets on days he complained. No other symptoms or an other adverse events. Child received dose one on 11/17/21 and dose two on 12/1/21, dose two was due on 12/8/21.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: CHILDS DATE OF BIRTH WRITTEN ON SIGNED CONSENT. CHILD IDENTIFIED IN DATABASE WITH DIFFERENT DATE OF BIRTH. CHILD IS TOO YOUNG FOR VACCINE.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer and state regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Myalgia, Occupational exposure to SARS-CoV-2, Pyrexia
Clinical narrative: Exposure at work. Onset of symptoms the day of his testing, 12/9/21.  Current symptoms include myalgias, fevers, cough, without dyspnea.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Exposure at work. Onset of symptoms the day of his testing, 12/9/21.  Current symptoms include myalgias, fevers, cough, without dyspnea.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Pneumonia aspiration, SARS-CoV-2 test negative
Clinical narrative: Moderna COVID-19 Vaccine EUA: two days after receiving  immunization patient presented hypoxic to emergency department. Hospitalized for aspiration pneumonia. Administered antimicrobials and oxygen. Discharged to home medically stable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Pyrexia
Clinical narrative: No adverse reaction to the vaccine. He had the normal reaction to the vaccine such as mild fever that resolved within 2 days.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer and state regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product storage error
Clinical narrative: Pfizer covid vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended. Patient was re-vaccinated on 12/02/21 as recommended by Pfizer.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pallor
Clinical narrative: Pt received Moderna booster. Approx 5 min after receiving vaccine Pt felt faint and temporarily lost consciousness. Pt was pale and sweaty. Pt regained consciousness within 1 with stimulation. Pt alert and oriented when she became conscious. Pt remained dizzy, nauseated, and somewhat pale. Pt stated she had not yet eaten today. Pulse 60s, O2 sat >95%. BP within normal limits. EMS called to site for further evaluation. Pt left. Partner stated Pt had same response to 1st dose of Moderna vaccine, but no adverse response to 2nd dose. No medication given.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received the Pfizer COVID vaccine for 5-11 yo, when he should have received an age appropriate 12-17 yo COVID vaccine dose. Pt had no s/s of allergy or adverse reaction. On-site provider and pharmacist were notified. Per MD , based on CDC recommendation, patient will return in 21 days to receive the appropriate dose of Pfizer 12-17 yo COVID vaccine. Parents and patient notified, aware of incident and agreed with plan.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Inflammation, Pyrexia
Clinical narrative: I had 24 hours later, headache, fever, chills for 24 hrs. I was fine. The rashes started on 31Oct2021, I thought it was bug bites and it was itchy. I woke up and it was fine. 1Nov2021 and the rash turned into hives. I called the doctor as it progressed everywhere and even on my scalp - for a week. Got antihistamine and steroid and 70per cent better and got more antihistamine, rash the has changed and now if I touch my skin its red, inflamed and itchy.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: I had 24 hours later, headache, fever, chills for 24 hrs. I was fine. The rashes started on 31Oct2021, I thought it was bug bites and it was itchy. I woke up and it was fine. 1Nov2021 and the rash turned into hives. I called the doctor as it progressed everywhere and even on my scalp - for a week. Got antihistamine and steroid and 70per cent better and got more antihistamine, rash the has changed and now if I touch my skin its red, inflamed and itchy.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Janssen vaccine that expired 12/11/21 given on 12/13/21 in error. No adverse effects noted.  Contacted Manufacturer regarding the incident. Manufacturer supports stability up to 6 weeks post expiration and does not recommend a repeat dose.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram neck, Computerised tomogram normal, Headache, Lumbar puncture normal
Clinical narrative: Severe headache; BP 178/98
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient had a syncopal episode post vaccine administration and was assessed by local Fire Department.  Refused all treatment and transport.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: generalized hives and rash all over her body that started 12/2/21. stabilized after taking benadryl x2.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PHARMACIST GAVE PATIENT INFLUENZA VACCINE ON 11/30/21.  PHARMACIST WAS NOT AWARE UNTIL BILLING THE VACCINE THAT THE PATIENT HAD ALSO BEEN GIVEN A DOSE A WEEK PRIOR ON 11/23/21.  PATIENT DID NOT COMPLAIN OF ANY ADVERSE EVENT OR SIDE EFFECT DUE TO THE EXTRA DOSE.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Full blood count normal, Headache, Influenza virus test negative, Oropharyngeal pain
Clinical narrative: Fever, headache, sore throat, body aches, fatigue
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Streptococcus test, White blood cell count normal
Clinical narrative: Fever, headache, sore throat, body aches, fatigue
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: I constantly smell smoke like cigarette smoke all day long, 24 hrs a day
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna ID Case ID CEA-1261.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19, COVID-19 pneumonia, Death
Clinical narrative: Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/24/2021 and 3/17/2021 .68/F PMHx DMII, HTN, morbidly obese, hypo and hyperthyroidism, asthma and depression. Covid-19 + was going to get monoclonal antibody infusion but sats were in the low 80's subsequently told to report to the ED.  Presented with acute hypoxic respiratory failure 2/2 Covid-19 PNA.  Tx'd w/decadron, Tocilizumab, remdisivir, Lovenox and O2. Per pt. request care not escalated beyond non-invasive ventilation. Expired 12/09/21.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mechanical ventilation, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/24/2021 and 3/17/2021 .68/F PMHx DMII, HTN, morbidly obese, hypo and hyperthyroidism, asthma and depression. Covid-19 + was going to get monoclonal antibody infusion but sats were in the low 80's subsequently told to report to the ED.  Presented with acute hypoxic respiratory failure 2/2 Covid-19 PNA.  Tx'd w/decadron, Tocilizumab, remdisivir, Lovenox and O2. Per pt. request care not escalated beyond non-invasive ventilation. Expired 12/09/21.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pfizer covid vaccine was stored outside of manufacturer's recommendation. Specifically, the vaccine was frozen longer than recommended. Patient was re-vaccinated on 11/30/2021 due to Pfizer recommendations.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive covid test in fully vaccinated pt
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Atrial flutter, Blood test, Cardiac stress test, Chest pain
Clinical narrative: On Monday 2-8-2021 I attempted to work out and was very short of breath and had a high heart rate. My heart rate went into afib after I stopped working out out. My doctor sent me to a cardiologist who diagnosed afib with a stress test, echocardiogram and an EKG. I had a stress test the next day and was put on flecainide and a metoprolol beta blocker. I still felt bad after a few weeks. The doctor took me off of the metoprolol and doubled the dose of the flecainide. I then went into atrial flutter and the doctor placed me back on the metoprolol and eloquist in September.  In November I went back into afib and had to have cardioversion to shock the heart back into rhythm and I was scheduled for Ablasion.  I saw two doctors. I visited the ER on October 21st with chest pain.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: On Monday 2-8-2021 I attempted to work out and was very short of breath and had a high heart rate. My heart rate went into afib after I stopped working out out. My doctor sent me to a cardiologist who diagnosed afib with a stress test, echocardiogram and an EKG. I had a stress test the next day and was put on flecainide and a metoprolol beta blocker. I still felt bad after a few weeks. The doctor took me off of the metoprolol and doubled the dose of the flecainide. I then went into atrial flutter and the doctor placed me back on the metoprolol and eloquist in September.  In November I went back into afib and had to have cardioversion to shock the heart back into rhythm and I was scheduled for Ablasion.  I saw two doctors. I visited the ER on October 21st with chest pain.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient was given an adult dose of the Pfizer vaccine 0.3 mL, instead of the 0.2 pediatric dose.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: CHILD'S DATE OF BIRTH WRITTEN UNSPECIFIED DATE AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS FATHER. CHILD IDENTIFIED IN SYSTEM WITH DATE OF BIRTH AS UNSPECIFIED DATE. CHILD TOO YOUNG FOR VACCINE.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Loss of consciousness
Clinical narrative: patient hadnt ate much (oatmeal) and stated he was nervous about getting the shot in general. We offered him some candy after the shot but he declined. Within 10 minutes he rose his hand...and then passed out.  he was warm, and we offered him water, he decided to eat his treat. and then we used cold washcloth and ice pack to keep him cool. elevated legs and he recovered completely.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage at 10w 6 days. I have had three healthy and normal pregnancies previously.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Atrial fibrillation, Blood magnesium, Blood test, Chest X-ray
Clinical narrative: Symptoms started a day after vaccination was taken. Had breathing difficulty and SOB.  3 days after vaccination patient was at a restaurant and had increased breathing difficulty. 911 was called. Taken to hospital and was diagnosed to be in A-Fib.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Full blood count, Lactic acidosis, Metabolic function test, SARS-CoV-2 test negative
Clinical narrative: Symptoms started a day after vaccination was taken. Had breathing difficulty and SOB.  3 days after vaccination patient was at a restaurant and had increased breathing difficulty. 911 was called. Taken to hospital and was diagnosed to be in A-Fib.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Symptoms started a day after vaccination was taken. Had breathing difficulty and SOB.  3 days after vaccination patient was at a restaurant and had increased breathing difficulty. 911 was called. Taken to hospital and was diagnosed to be in A-Fib.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: Blood clots in my lungs, symptoms: shortness of breath,difficulty breathing, chest pain, and back pain. Time and date was September 29th at 1:00pm
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary thrombosis
Clinical narrative: Blood clots in my lungs, symptoms: shortness of breath,difficulty breathing, chest pain, and back pain. Time and date was September 29th at 1:00pm
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Pt received Moderna vaccines on 02/13/21 and 03/13/21. Pt was admitted to the rehab unit on 11/24/21. While admitted, pt developed a low-grade fever and was tested for COVID which came back positive.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Condition aggravated, Constipation, Musculoskeletal stiffness, Pyrexia
Clinical narrative: After I got home I didn't feel sore. The next morning I developed a fever so I took a Tylenol. About 4 or 5 hours later I felt fine since then. I felt a little stiffness in my left arm, but after 3rd day I was fine. I started feeling uncomfortable with my tummy. I had chronic constipation on December 7th. On December 9th I took a laxative for it, and I started to feel better.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Delirium, Laboratory test, Magnetic resonance imaging, Mood altered
Clinical narrative: I started having change of mood 03/12/2021 on delirium the following week on the 15th that it progressed that I was taken to PCP doctor on the 19th on the same day I went to Medical same day. I was admitted. They started me on IV antibiotic and fluids. I didn't respond as fast as they hoped. They kept me on fluids and IV antibiotics for 5 days. I was off on them on the evening of the 24th and then released on the 26th. Was told to go to Dr. for a follow up and that was on 4/2/2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea exertional, Fibrin D dimer increased
Clinical narrative: Developed 5d later shortness of breath with exertion, running workout, less with speed walking, walking stairs in house, and some chest tightness without radiating pain in arm or jaw. It did improve about 10d after, but still felt SOB at times. Began having L rib and back discomfort and more chest discomfort with SOB 10 weeks later. 11/8/21 presented to PCP with the discomfort and D Dimer was abnormal and chest X-ray abnormal.  ER evaluation and D Dimer repeated with other tests, D Dimer cont being abnormal with CT chest abnormal for PE L lung.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Musculoskeletal discomfort, Pulmonary embolism
Clinical narrative: Developed 5d later shortness of breath with exertion, running workout, less with speed walking, walking stairs in house, and some chest tightness without radiating pain in arm or jaw. It did improve about 10d after, but still felt SOB at times. Began having L rib and back discomfort and more chest discomfort with SOB 10 weeks later. 11/8/21 presented to PCP with the discomfort and D Dimer was abnormal and chest X-ray abnormal.  ER evaluation and D Dimer repeated with other tests, D Dimer cont being abnormal with CT chest abnormal for PE L lung.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna ID Case ID CEA-1261.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Mobility decreased, Sleep disorder
Clinical narrative: The first dose of the vaccine caused extreme cramping and bleeding but the second dose is the one which I am reporting.   Two days after receiving the second Moderna vaccine I started having the most painful menstrual cycle I have ever experienced in my life.  It is also the heaviest case of bleeding that I have ever experienced.   The pain was so severe, I was unable to get out of bed or do anything for a few days. I was on 800 milligrams of motrin twice per day and I had a heating pad on my stomach or lower back at all times of the day or night. I was unable to sleep due to the pain.   I went through an entire tampax regular size box in less than a day and a half. Meanwhile, I was bleeding through all of my clothes for several days and soaked my sheets in blood the first night.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Cough, Eye pruritus, Nasal congestion, Pain
Clinical narrative: sinus headache, nonproductive cough, fever, chills, body aches, sinus congestion, nasal congestion, wheezing, sneezing, itchy eyes for few days. . starting 12/10/21
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sinus congestion, Sinus headache, Sneezing, Wheezing
Clinical narrative: sinus headache, nonproductive cough, fever, chills, body aches, sinus congestion, nasal congestion, wheezing, sneezing, itchy eyes for few days. . starting 12/10/21
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Limb discomfort
Clinical narrative: Diabetic; pregnant; last full meal 17 hours ago. After injection, felt numbness and heaviness in right arm. BP: 110/62; pulse: 68; respiratory rate 16.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Erythema, Extra dose administered, Mechanical urticaria, Pruritus
Clinical narrative: 11 days after receiving booster, I developed intense itching various places on body (neck, hands, chest, back, arms, legs, waist).  Any place I scratched (even lightly) would turn red, swell, and develop hives.  The reaction moves all over my body.  I saw an allergist 12/9/2021 who diagnosed the condition as Acute Dermatographic Urticaria.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: 11 days after receiving booster, I developed intense itching various places on body (neck, hands, chest, back, arms, legs, waist).  Any place I scratched (even lightly) would turn red, swell, and develop hives.  The reaction moves all over my body.  I saw an allergist 12/9/2021 who diagnosed the condition as Acute Dermatographic Urticaria.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dyspnoea, Fatigue, Mechanical urticaria, Rash
Clinical narrative: got her covid and flu shot. she has been getting rashes since the second covid shot. she got the covid shot on 11/23/21. had severe erythematous, urticaria with dermatographia that started on 11/26/21. no other symptoms of being ill, exposures to allergies. she had some shortness of breath associated. also had severe fatigue and upset stomach. the rash still comes and goes. the rash is hot to touch.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: got her covid and flu shot. she has been getting rashes since the second covid shot. she got the covid shot on 11/23/21. had severe erythematous, urticaria with dermatographia that started on 11/26/21. no other symptoms of being ill, exposures to allergies. she had some shortness of breath associated. also had severe fatigue and upset stomach. the rash still comes and goes. the rash is hot to touch.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Condition aggravated, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA: four months after completing immunization patient hospitalized for breakthrough COVID-19 infection and heart failure exacerbation. COVID-19 managed with dexamethasone, COVID-19 MAB, and remdesivir. Discharged to home medically stable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling, pain, and warmness around injection site since receiving vaccine on 12/11/21 which she is still experiencing today 12/14/21.  She reported applying ice pack and taking ibuprofen, which has not helped for pain.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Death
Clinical narrative: Pt is deceased after cardiopulmonary arrest.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Grandmother states child has not complained of any symptoms. Child received first dose on 11/17/21 and dose two was administered on 12/01/21, was due 12/8/21.