chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test negative
Clinical narrative: Severe rash occurred on the body, back, and thigh.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a 3rd dose of the Shingrix Zoster vaccine. Patient had received 2 doses previously on 8-28-2018 and 3-4-2019 and then was inappropriately given a 3rd dose on 9-29-2021. Patient did not report any adverse effects from the vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypoaesthesia, Nausea
Clinical narrative: chest pain, headache , nausea, jaw numbness
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash pruritic, Sleep deficit, Urticaria
Clinical narrative: Both shots (my first was lot number ER 8730 also Pfizer) caused me to be covered in hives from head to toe for 4 weeks. I was without hives prior to injections both times. I do not respond to antihistamines which forced me to wait till the vaccine took affect. Then I had to take 2 rounds of medrol dose packs to relieve the hives on top of getting 2 injections of xolair every month (I have to split up the injections because they also caused me problems so I go every other week. I?ve been getting them nonstop for years). I took in total 4 dose packs of steroids to get my hives under control and prior to that it felt like I had chicken pox .  They caused me severe sleep deprivation and everything else that goes along with being covered in extremely itchy rashes. I know they say there aren?t any sulfas in the vaccine but something triggered my allergenic response and it was intolerable and insufferable.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea, Menstruation irregular
Clinical narrative: Abnormal period cycle with incredibly light, frequent bleeding for 8 weeks, followed by abnormal, heavy cycles.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Miscarriage at 10 weeks gestation with estimated due date of 07/12/2022. Medical history: one previous successful pregnancy, no prior history of miscarriage.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Electrocardiogram, Fatigue
Clinical narrative: Tiredness loss of consciousness fainting vomiting dizziness a lot of body ache headache tiredness physical exhaustion shortness of breath, no appetite, hospitalization due to loss of consciousness and severe headache even now I have a headache and fatigue is sometimes unbearable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Pain, Syncope, Vomiting
Clinical narrative: Tiredness loss of consciousness fainting vomiting dizziness a lot of body ache headache tiredness physical exhaustion shortness of breath, no appetite, hospitalization due to loss of consciousness and severe headache even now I have a headache and fatigue is sometimes unbearable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Woke the next morning with just a sore arm. Progressed to headache, nausea, fever, severe body aches, and weakness approx 18hrs post vaccine.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Woke the next morning with just a sore arm. Progressed to headache, nausea, fever, severe body aches, and weakness approx 18hrs post vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysmenorrhoea
Clinical narrative: Intense menstrual cramps and abdominal discomfort, resolved when period ended
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Joint swelling
Clinical narrative: 2 days after Moderna jab, left underarm tenderness. 4 days after Moderna jab, extraordinary joint pain and swelling in left knee. Previous left knee ACL replacement in 2009 and meniscus tear surgery 2010.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives outbreak, all over the entire body, constant, does not respond to generation 1 or 2 H1 antihistamines or H2 antihistamines. Partially effective with prednisone 20 mg  once in the morning, hives will start coming back at night
Age: 0.33
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Deep vein thrombosis, Pleuritic pain
Clinical narrative: I developed left sided pleuritic chest pain without reason, as this seemed to resolve, a DVT to right leg developed.  As this resolved, a spontaneous left chest pleuritic chest pain developed 12/13/21, and is still active.  I do not wish to seek medical help.  I am taking large doses of ibuprofen for pain.  Concern for PE, is a concern.  I received the J and J vaccine.  I have no significant medical problems and was relatively active immediately prior to this starting in November.  As such sedentary activity was not a precursor when symptoms started.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cyanosis, Echocardiogram, Electrocardiogram, Heart rate decreased
Clinical narrative: The order of events starting at 11:00am on 12/10/2021 were: Nausea, Low Grade Fever, Vomited, Passed Out, Lost Consciousness, Unresponsive, Low/No Pulse, Blue Skin Tone. The Throwing up to losing consciousness happened within a 5 minute period. Ambulance taken from facility to a local Hospital. More Throwing Up. Monitored at hospital for hours and then sent home that night. Following up with Cardiologist and Neurologist to ensure no problems/issues.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza virus test, Loss of consciousness, Nausea, Pulse absent, Pyrexia
Clinical narrative: The order of events starting at 11:00am on 12/10/2021 were: Nausea, Low Grade Fever, Vomited, Passed Out, Lost Consciousness, Unresponsive, Low/No Pulse, Blue Skin Tone. The Throwing up to losing consciousness happened within a 5 minute period. Ambulance taken from facility to a local Hospital. More Throwing Up. Monitored at hospital for hours and then sent home that night. Following up with Cardiologist and Neurologist to ensure no problems/issues.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Unresponsive to stimuli, Vomiting
Clinical narrative: The order of events starting at 11:00am on 12/10/2021 were: Nausea, Low Grade Fever, Vomited, Passed Out, Lost Consciousness, Unresponsive, Low/No Pulse, Blue Skin Tone. The Throwing up to losing consciousness happened within a 5 minute period. Ambulance taken from facility to a local Hospital. More Throwing Up. Monitored at hospital for hours and then sent home that night. Following up with Cardiologist and Neurologist to ensure no problems/issues.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pain of skin, Rash
Clinical narrative: Got shingles on my right chest and back.  Started feeling something on my right chest around Monday December 6th.  It changed to stinging pain on my surface of my skin later the week. On Thursday December 9th, I noticed the rash is appearing and the next day recognizable rash is on my right chest. On Saturday December 11th, I went to urgent care. The doctor there diagnosed it as shingles and prescribed Valtrex.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise
Clinical narrative: The mornign after getting the vaccination she woke up and said she didn't feel well then passed out.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: THERE IS TECHNICALLY NO ADVERSE EVENT TO REPORT. THE 3RD DOSE WAS ADMINISTERED ONLY 100 DAYS AFTER THE 2ND DOSE AND THE PATIENT IS NOT IMMUNICOMPROMISED. THE PATIENT HAS REPORTED NO ILL EFFECTS THUS FAR
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscular weakness, Nausea, Pain
Clinical narrative: After 30 minutes, I developed nausea, a severe headache, chills, sever body aches, and muscle weakness. The headache and nausea went away approximately 24 hours later, however; the chills, body aches and muscle weakness took 5 days to recover from the date of injection.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pallor, Syncope, Wheelchair user
Clinical narrative: Syncopal event post admin approximately 2-3 mins after moving from vaccine tent to observation area. Was in seated position during episode. Witnessed by friend sitting next to them. A&O x 3 upon evaluation, diaphoretic, pale, VSS. Provided water and snacks, wheelchair to cot for further observation. Patient informed that had similar episode before with a blood draw and was very nervous prior to admin of vaccine. VS checked before leaving, vss, no longer diaphoretic. Advised on safety prior to future vaccines.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Diarrhoea, Fatigue, Migraine
Clinical narrative: Upset stomach, poor appetite (eating only crackers & jello for 3 days), watery diarrhea, fatigue, migraine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain
Clinical narrative: I feel pain increasing with time. It is close to the shoulder joint. My left shoulder is limited in motion. I just take pain relieve (ibuprofen).  Because I do not have insurance, still I have not gone to Doctor. It looks like to be an emergency. So, I can get Emergency Medical Assistance. In the same shoulder, I got flu vaccine at the same time. So it is 2 vaccines very close in the very upper arm.   It is one of the worst times, a nurse gave me a vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, FLU4
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: I feel pain increasing with time. It is close to the shoulder joint. My left shoulder is limited in motion. I just take pain relieve (ibuprofen).  Because I do not have insurance, still I have not gone to Doctor. It looks like to be an emergency. So, I can get Emergency Medical Assistance. In the same shoulder, I got flu vaccine at the same time. So it is 2 vaccines very close in the very upper arm.   It is one of the worst times, a nurse gave me a vaccine.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Loss of personal independence in daily activities, Muscular weakness, Pain in extremity
Clinical narrative: Significant loss of strength in right arm.  For example,  I have difficulty with simple, everysay tasks such as opening a jar or holding/ carrying my child when I was able to do so prior.  I also experience continous pain and discomfort in my right arm.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives like rash across the body including back of head, neck, abdomen, chest, arms, and groin. Urgent care provided an oral steroid prescription.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Disorientation, Immediate post-injection reaction, Syncope
Clinical narrative: Fainted immediately after shot. Disoriented.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient was hospitalized for COVID after having 2 shots of moderna on 2/2/2021 and 3/2/2021 No booster was given.  Of note: pt on mtx for RA
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia, Nausea
Clinical narrative: At approximately 10 pm, 6 hours after injection, I developed severe body and muscle pain and weakness and chills.  I developed a severe headache and nausea.  The nausea lasted approximately 2 hours and then went away.  The muscle pain and weakness lasted 5 days after the injection was given, and now has gone away.  The headache has come and gone daily since the second injection on 12/9/21, and even with tylenol, the headache has still not gone away.  The chills that I had lasted 3 days after the injection, and went away very quickly after the time period I mentioned.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: At approximately 10 pm, 6 hours after injection, I developed severe body and muscle pain and weakness and chills.  I developed a severe headache and nausea.  The nausea lasted approximately 2 hours and then went away.  The muscle pain and weakness lasted 5 days after the injection was given, and now has gone away.  The headache has come and gone daily since the second injection on 12/9/21, and even with tylenol, the headache has still not gone away.  The chills that I had lasted 3 days after the injection, and went away very quickly after the time period I mentioned.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Given past beyond use date, no adverse event associated
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Headache, Immediate post-injection reaction, Joint stiffness, Myalgia
Clinical narrative: Immediately after 1st dose began whole body myalgias, headaches and joint stiffness. Worsened after 2nd dose- continues to this day, 12/10/21, Almost cannot work due to joint/muscle inflammation
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myositis
Clinical narrative: Immediately after 1st dose began whole body myalgias, headaches and joint stiffness. Worsened after 2nd dose- continues to this day, 12/10/21, Almost cannot work due to joint/muscle inflammation
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram abnormal, Seizure
Clinical narrative: Patient had an observed seizure that lasted about 30 seconds. Patient had a full evaluation by a medical provider. Provider did an EKG that showed patient in Atrail fibrillation. Patient transported via ambulance to the emergency department at this time in stable condition.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: What is happening: I am experiencing skin itching all over my body everyday almost since 2 Dec, 2021. Red spots with pimple type look that are very itchy randomly appear all over my body and after a while disappear and appear somewhere else. Possible link: I had my booster shot of Moderna on 18 November and just around two weeks from that I started experiencing this. Wondering if there is a possible connection.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: I received the Moderna Booster shot on 11/29/21. The next day I noticed some joint pain in my hands and legs and hips. The joint pain in my hands (specifically my thumbs) has continued to get worse and now is very painful (12/14/21). You product insert, delivered to me at the time of the injection, says the possible side effect of joint pain should resolve within a few days. It has not resolved, it has gotten much worse! I need a response from you, please. I will contact my doctor, but in the meantime, what can I do to fix this?
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: The 14-year-old female was given Pfizer COVID-19 vaccine 10 mcg dose (child 5-11 dose) for a first dose instead of the 30 mcg (adult dose).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Feeling abnormal, Hallucination
Clinical narrative: Hallucinations, and other.  Took 1 Delta8 gummy, as sold to me by being CBD only, stated Hmp 25mg, on jar, by an unlicensed store. Purchased in April 2021, had not used until 12/9. Had received Covid Moderna boosted on 12/8, and on 12/9 was achy all over. Was drinking coffee, and took 1 gummy; 2 hours later, heart rate high, was dizzy, unbalanced, hallucinating, could not complete a sentence, or a thought or a task, confused as to time of day, season. Paranoid. Felt stoned- and had not had any experience like this, in 50 years, since I smoked pot at age 17. Felt desperate, cold not find the poison-control number, called a friend for help; was readying to go to the hospital. Hospital is full of Covid so I remained at home, drinking copious amounts of water, watched a film. formed myself to stay awake, so that I did not fall asleep; I was fearful that I would stop breathing. I use no illicit drugs, little liquor, no smoking, only prescriptions, no anti-anxiety meds, am a medical nurse...never had experienced this situation. 5 hours after symptoms started, I began clearing and 7 hours after the start, felt much closer to normal. Scared! Did not seek medical care.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Paranoia, Poverty of speech
Clinical narrative: Hallucinations, and other.  Took 1 Delta8 gummy, as sold to me by being CBD only, stated Hmp 25mg, on jar, by an unlicensed store. Purchased in April 2021, had not used until 12/9. Had received Covid Moderna boosted on 12/8, and on 12/9 was achy all over. Was drinking coffee, and took 1 gummy; 2 hours later, heart rate high, was dizzy, unbalanced, hallucinating, could not complete a sentence, or a thought or a task, confused as to time of day, season. Paranoid. Felt stoned- and had not had any experience like this, in 50 years, since I smoked pot at age 17. Felt desperate, cold not find the poison-control number, called a friend for help; was readying to go to the hospital. Hospital is full of Covid so I remained at home, drinking copious amounts of water, watched a film. formed myself to stay awake, so that I did not fall asleep; I was fearful that I would stop breathing. I use no illicit drugs, little liquor, no smoking, only prescriptions, no anti-anxiety meds, am a medical nurse...never had experienced this situation. 5 hours after symptoms started, I began clearing and 7 hours after the start, felt much closer to normal. Scared! Did not seek medical care.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide increased, Chest X-ray normal, Chest discomfort, Dyspnoea, Fatigue
Clinical narrative: Had my pfizer booster on 11/22/2021. Perfectly ok until 11/23 when I experienced SOB, fatigue, weight gain and chest pressure bad enough to see PMD who put me on diuretic. Labs showed BNP on 145. Cardiologist increased my ARB. Chest x-ray was ok.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Had my pfizer booster on 11/22/2021. Perfectly ok until 11/23 when I experienced SOB, fatigue, weight gain and chest pressure bad enough to see PMD who put me on diuretic. Labs showed BNP on 145. Cardiologist increased my ARB. Chest x-ray was ok.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: After receiving the Pfizer Covid booster, broke out in full body rash/hives, about 36 hours after.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache
Clinical narrative: Headache "Pressure in my face" Narrative: NO MEDICAL ATTENTION WAS SOUGHT 2/2/ REPORTED "Bad headache pressure in my face."
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: As reported by Employee: "sore arm" Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, Fever, Diarrhea, NauseaVomiting, shivering, site soreness, tiredness Narrative:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Headache, Fever, Diarrhea, NauseaVomiting, shivering, site soreness, tiredness Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Dizziness, Headache, Myalgia & Fever Narrative: As reported by Employee 6/24/2021: ***************************************** "1/13/21 I received 2nd dose I had very bad headache, dizzy, fever, Body ache for 3dyas after that I was Ok"
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Headache Chills and fatigue Narrative:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative: As reported by Employee 6/24/2021: ***************************************** "12/23/20 I received 1st dose I had very bad headache, Body ache and slight fever for a day"
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Asymptomatic 14 days post vaccine break through Narrative: Asymptomatic 14 days post vaccine break through
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Tremor, Wheezing
Clinical narrative: CoughWheeze shakiness Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Nausea, Neuralgia, Rash
Clinical narrative: Rash, NauseaVomiting, CHEST PAIN, LEFT ARM "NERVE PAIN", REDNESS LEFT ARM Narrative:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Rash, NauseaVomiting, CHEST PAIN, LEFT ARM "NERVE PAIN", REDNESS LEFT ARM Narrative:
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Fatigue, Nausea
Clinical narrative: Anaphylaxis characterized by inability to speak, swallow, and sensation of throat tightening, treated immediately with first oral benadryl, then EpiPen,  and then IV solumedrol in the ER
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dysphagia, Speech disorder, Throat tightness
Clinical narrative: Anaphylaxis characterized by inability to speak, swallow, and sensation of throat tightening, treated immediately with first oral benadryl, then EpiPen,  and then IV solumedrol in the ER
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: I experienced loss of feeling in my feet, thighs and legs. It also caused nerve damage and I could not walk.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Hypoaesthesia, Nerve injury
Clinical narrative: I experienced loss of feeling in my feet, thighs and legs. It also caused nerve damage and I could not walk.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Body temperature increased, Myalgia, Pain in extremity
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced fever of 100.1 degrees Fahrenheit, leg muscle soreness, sore throat, chills, fatigue and tested positive for covid-19 (confirmed covid-19 infection) which leads to confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211232994-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number series-1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 14-DEC-2021, the patient experienced fever of 100.1 degrees Fahrenheit, leg muscle soreness, sore throat, chills, fatigue and tested positive for covid-19 (confirmed covid-19 infection) which leads to confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211232994-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blindness unilateral, Diarrhoea, Injection site rash, Magnetic resonance imaging
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vaccination complication, Vomiting
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blindness unilateral, Computerised tomogram, Conversion disorder, Electroencephalogram
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Headache, Impaired work ability, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Speech disorder, Venogram, Vision blurred, Vomiting
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user
Clinical narrative: Vomiting,  severe headache, blind in right eye blurry in left.  In wheelchair due to functional neurological disorder. Seizures falls black outs speech problems. Unable to work due to shot.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site mass, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: he has had a lump in arm ever since getting 2nd shot,tried to report to Pfizer directly, but he said they didn't take report
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: he has had a lump in arm ever since getting 2nd shot,tried to report to Pfizer directly, but he said they didn't take report
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Limb mass
Clinical narrative: Site: Swelling at Injection Site-Medium, Additional Details: he has had a lump in arm ever since getting 2nd shot,tried to report to Pfizer directly, but he said they didn't take report
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: STINGING ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke, clot, and breast cancer. On left arm patient had lymph node removed from breast cancer surgery. The patient was previously treated with covid-19 vaccine ad26. cov2. s(suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 04-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered on 18-JUN-2021 for prophylactic vaccination on her right arm. On an unspecified date, patient had experienced low platelets (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 11855191, expiry: Unknown) dose was not reported (dose number in series 2), 1 in total, administered on 06-DEC-2021 for prophylactic vaccination on right arm as a booster dose. No concomitant medications were reported.  On 06-DEC-2021, the patient experienced stinging on the injection site at the time of the shot (dose number in series 2). The patient rubbed cannabidiol (CBD) oil on the injection site and she believed it help to relieve the symptom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging on the injection site on DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20210902865.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: STINGING ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 90 year old female. The patient's height, and weight were not reported. The patient's past medical history included: stroke, clot, and breast cancer. On left arm patient had lymph node removed from breast cancer surgery. The patient was previously treated with covid-19 vaccine ad26. cov2. s(suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 04-AUG-2021) dose was not reported (dose number in series 1), 1 total, administered on 18-JUN-2021 for prophylactic vaccination on her right arm. On an unspecified date, patient had experienced low platelets (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 11855191, expiry: Unknown) dose was not reported (dose number in series 2), 1 in total, administered on 06-DEC-2021 for prophylactic vaccination on right arm as a booster dose. No concomitant medications were reported.  On 06-DEC-2021, the patient experienced stinging on the injection site at the time of the shot (dose number in series 2). The patient rubbed cannabidiol (CBD) oil on the injection site and she believed it help to relieve the symptom. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stinging on the injection site on DEC-2021. This report was non-serious. This case, involving the same patient is linked to 20210902865.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: EXTREME Hives  Now highly allergic to shellfish and Advil  Hospitalized for anaphylactic shock
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood test normal, Drug hypersensitivity, Food allergy, Urticaria
Clinical narrative: EXTREME Hives  Now highly allergic to shellfish and Advil  Hospitalized for anaphylactic shock
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Psychotic disorder
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Echocardiogram, Eyelid disorder, Facial paralysis
Clinical narrative: day after shot, patient noticed right side of face was paralyzed, couldnt smile or wink with right eye, speech difficulty
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paresis, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: day after shot, patient noticed right side of face was paralyzed, couldnt smile or wink with right eye, speech difficulty
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Speech disorder
Clinical narrative: day after shot, patient noticed right side of face was paralyzed, couldnt smile or wink with right eye, speech difficulty
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial fibrillation, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pfizer vaccines on 3/12, 4/2/21 Positive for COVID by PCR on 11/1/21 Hospitalized  from 11/1-12/10/21 Expired on 12/10/21 d/t Pneumonia d/t COVID 19 Previous VAERS report completed, reference # 698495
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Hypoxia, Malaise, Mobility decreased
Clinical narrative: Pfizer vaccines on 3/12, 4/2/21 Positive for COVID by PCR on 11/1/21 Hospitalized  from 11/1-12/10/21 Expired on 12/10/21 d/t Pneumonia d/t COVID 19 Previous VAERS report completed, reference # 698495
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Pfizer vaccines on 3/12, 4/2/21 Positive for COVID by PCR on 11/1/21 Hospitalized  from 11/1-12/10/21 Expired on 12/10/21 d/t Pneumonia d/t COVID 19 Previous VAERS report completed, reference # 698495
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, SARS-CoV-2 test positive
Clinical narrative: Pfizer vaccines on 3/12, 4/2/21 Positive for COVID by PCR on 11/1/21 Hospitalized  from 11/1-12/10/21 Expired on 12/10/21 d/t Pneumonia d/t COVID 19 Previous VAERS report completed, reference # 698495
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Migraine
Clinical narrative: patient had a migraine 2 day after got up on 04Nov with a fairly bad Headache that had progressed from being a minimal headache on the day of my vaccination.; headache/ fairly bad headache/ mind headache/ moderate to severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 16:00 (Lot number: FF2589) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Headache" (ongoing). Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Bnt162b2 (Dose 1, Time: 16:30, Anatomical site of injection: Right arm, Batch/ Lot number: 30135BA), administration date: 07Oct2021, for Covid-19 immunization, reaction(s): "Nausea". The following information was reported: HEADACHE (non-serious) with onset 03Nov2021 08:00, outcome "recovered" (17Nov2021), described as "headache/ fairly bad headache/ mind headache/ moderate to severe headache"; MIGRAINE (non-serious) with onset 05Nov2021, outcome "unknown", described as "patient had a migraine 2 day after got up on 04Nov with a fairly bad Headache that had progressed from being a minimal headache on the day of my vaccination.". The event "headache/ fairly bad headache/ mind headache/ moderate to severe headache" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional information: Facility type vaccine: Pharmacy or Drug Store. had a moderate to severe headache for about 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Migraine, SARS-CoV-2 test
Clinical narrative: patient had a migraine 2 day after got up on 04Nov with a fairly bad Headache that had progressed from being a minimal headache on the day of my vaccination.; headache/ fairly bad headache/ mind headache/ moderate to severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 16:00 (Lot number: FF2589) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Headache" (ongoing). Concomitant medication(s) included: TYLENOL taken for headache. Vaccination history included: Bnt162b2 (Dose 1, Time: 16:30, Anatomical site of injection: Right arm, Batch/ Lot number: 30135BA), administration date: 07Oct2021, for Covid-19 immunization, reaction(s): "Nausea". The following information was reported: HEADACHE (non-serious) with onset 03Nov2021 08:00, outcome "recovered" (17Nov2021), described as "headache/ fairly bad headache/ mind headache/ moderate to severe headache"; MIGRAINE (non-serious) with onset 05Nov2021, outcome "unknown", described as "patient had a migraine 2 day after got up on 04Nov with a fairly bad Headache that had progressed from being a minimal headache on the day of my vaccination.". The event "headache/ fairly bad headache/ mind headache/ moderate to severe headache" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional information: Facility type vaccine: Pharmacy or Drug Store. had a moderate to severe headache for about 2 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Balance disorder, Blood test, Diplegia, Gait disturbance
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient took concomitant medications (not reported). No other vaccine in four weeks. The following information was reported: PARAESTHESIA (hospitalization, disability), HYPOAESTHESIA (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "Tingling and numbness in toes"; DIPLEGIA (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "temporary bilateral leg paralysis"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "balance and walking issues"; SPEECH DISORDER (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "speech impairment"; MEMORY IMPAIRMENT (hospitalization, disability), COGNITIVE DISORDER (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "memory and cognition impairment". The patient was hospitalized for paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder (hospitalization duration: 1 day(s)). The events "tingling and numbness in toes", "tingling and numbness in toes", "temporary bilateral leg paralysis", "balance and walking issues", "balance and walking issues", "speech impairment", "memory and cognition impairment" and "memory and cognition impairment" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results, notes: Nasal Swab/since the vaccination. Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder. Treatment received for the adverse event included Physical therapy, medication
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immune-mediated adverse reaction, Laboratory test, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient took concomitant medications (not reported). No other vaccine in four weeks. The following information was reported: PARAESTHESIA (hospitalization, disability), HYPOAESTHESIA (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "Tingling and numbness in toes"; DIPLEGIA (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "temporary bilateral leg paralysis"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "balance and walking issues"; SPEECH DISORDER (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "speech impairment"; MEMORY IMPAIRMENT (hospitalization, disability), COGNITIVE DISORDER (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "memory and cognition impairment". The patient was hospitalized for paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder (hospitalization duration: 1 day(s)). The events "tingling and numbness in toes", "tingling and numbness in toes", "temporary bilateral leg paralysis", "balance and walking issues", "balance and walking issues", "speech impairment", "memory and cognition impairment" and "memory and cognition impairment" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results, notes: Nasal Swab/since the vaccination. Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder. Treatment received for the adverse event included Physical therapy, medication
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 41 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 09Aug2021 (Lot number: FC3181) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient took concomitant medications (not reported). No other vaccine in four weeks. The following information was reported: PARAESTHESIA (hospitalization, disability), HYPOAESTHESIA (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "Tingling and numbness in toes"; DIPLEGIA (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "temporary bilateral leg paralysis"; BALANCE DISORDER (hospitalization, disability), GAIT DISTURBANCE (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "balance and walking issues"; SPEECH DISORDER (hospitalization, disability) with onset 11Aug2021, outcome "not recovered", described as "speech impairment"; MEMORY IMPAIRMENT (hospitalization, disability), COGNITIVE DISORDER (hospitalization, disability) all with onset 11Aug2021, outcome "not recovered" and all described as "memory and cognition impairment". The patient was hospitalized for paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder (hospitalization duration: 1 day(s)). The events "tingling and numbness in toes", "tingling and numbness in toes", "temporary bilateral leg paralysis", "balance and walking issues", "balance and walking issues", "speech impairment", "memory and cognition impairment" and "memory and cognition impairment" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) unknown results, notes: Nasal Swab/since the vaccination. Therapeutic measures were taken as a result of paraesthesia, hypoaesthesia, diplegia, balance disorder, gait disturbance, speech disorder, memory impairment, cognitive disorder. Treatment received for the adverse event included Physical therapy, medication