chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was administered Moderna booster 0.25 mL at age 17. Patient was 2 months before 18th birthday. Reviewed error with patient's mom. She stated he had no atypical reaction and even no typical reactions at all.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt said that almost exactly 1 week after vaccination she noticed tingling and numbness all over body. It got better as time went on; became less intense and focused to only hands and sometimes feet. Still after 6 months post-vaccination she still has numbness in mostly right hand and sometimes feet.  She has not sought and treatment or medical advice as of yet.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, TD
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Phone call to School /Nurse 02/23/2022 regarding the incident and need for pt. to have Hep A  repeated. Was unable to leave phone message  with pt.  He  had been advised on day of immunizations at health  department  to return in 4 weeks for additional immunizations, will administer repeated dose of Hep A at that time.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac murmur, Chronic obstructive pulmonary disease, Computerised tomogram normal, Condition aggravated, Cough
Clinical narrative: 03/05/2021 2 days after vaccination. I was out walking and at the bottom of the hill, which I would normally do daily. I was having to rest and when I went to my home, I found my oxygen was down to 89%. I am normally at 96%. A few months later, I came down with something like a virus and have been having major issues with shortness of breath and the enzymes I was taking weren't as effective as usual. I went to my pulmonologist for lung issues and then I went to a cardiovascular specialist however they did not find anything remarkable on test results other than a slight heart murmur. Dr. stated that it seems her COPD has been in a way activated and placed me on steroids to help with the inflammation in my lungs. Symptoms that are still going on are mainly the shortness of breath that is still causing major issues and a terrible cough.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exercise tolerance decreased, Lung disorder, Oxygen saturation decreased, Pneumonitis
Clinical narrative: 03/05/2021 2 days after vaccination. I was out walking and at the bottom of the hill, which I would normally do daily. I was having to rest and when I went to my home, I found my oxygen was down to 89%. I am normally at 96%. A few months later, I came down with something like a virus and have been having major issues with shortness of breath and the enzymes I was taking weren't as effective as usual. I went to my pulmonologist for lung issues and then I went to a cardiovascular specialist however they did not find anything remarkable on test results other than a slight heart murmur. Dr. stated that it seems her COPD has been in a way activated and placed me on steroids to help with the inflammation in my lungs. Symptoms that are still going on are mainly the shortness of breath that is still causing major issues and a terrible cough.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram normal, Viral infection
Clinical narrative: 03/05/2021 2 days after vaccination. I was out walking and at the bottom of the hill, which I would normally do daily. I was having to rest and when I went to my home, I found my oxygen was down to 89%. I am normally at 96%. A few months later, I came down with something like a virus and have been having major issues with shortness of breath and the enzymes I was taking weren't as effective as usual. I went to my pulmonologist for lung issues and then I went to a cardiovascular specialist however they did not find anything remarkable on test results other than a slight heart murmur. Dr. stated that it seems her COPD has been in a way activated and placed me on steroids to help with the inflammation in my lungs. Symptoms that are still going on are mainly the shortness of breath that is still causing major issues and a terrible cough.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect noted. Patient received Moderna vaccine booster expired on 10/13/2021.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: First dose was given on 1/04/2022 at the hospital where she delivered baby.  Second dose was given at 4:49pm on 3/3/2022. In the evening of 3/3/22 she felt overly tired. Her symptoms got worse on the morning of 3/4/22 including  throbbing headache, fever of 102, severe full body muscle pain, injection site pain.  She also reported her face got swollen (facial skin got tighter) and severe numbness arms and hands and tingling of fingers. Also, she is very dizzy and confused.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia, Paraesthesia, Pyrexia, Swelling face
Clinical narrative: First dose was given on 1/04/2022 at the hospital where she delivered baby.  Second dose was given at 4:49pm on 3/3/2022. In the evening of 3/3/22 she felt overly tired. Her symptoms got worse on the morning of 3/4/22 including  throbbing headache, fever of 102, severe full body muscle pain, injection site pain.  She also reported her face got swollen (facial skin got tighter) and severe numbness arms and hands and tingling of fingers. Also, she is very dizzy and confused.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Caesarean section, Laboratory test, Pre-eclampsia, Seizure
Clinical narrative: About 7 months after injection, I had a sudden onset to preeclampsia that led to an eclamptic seizure. Had to have an emergency c section at 28 weeks. Baby did survive. I was hospitalized for an additional 5 days to stabalized blood pressure. It took about 5 weeks for blood pressure to come back to normal.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: About 7 months after injection, I had a sudden onset to preeclampsia that led to an eclamptic seizure. Had to have an emergency c section at 28 weeks. Baby did survive. I was hospitalized for an additional 5 days to stabalized blood pressure. It took about 5 weeks for blood pressure to come back to normal.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pharyngeal swelling, Urticaria
Clinical narrative: Allergic reaction. Hives on face and full body. Throat swelling
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Palpitations
Clinical narrative: Heart Palpitations treated with medication
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted. Resident administered expired Moderna Vaccine  expiration 10/13/2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unknown
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal, Memory impairment
Clinical narrative: Patient described symptoms of "brain fog" two days after receiving the vaccine and it lasted for about 4 weeks.  She said she was very forgetful and confused a lot of the time.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Echocardiogram, Full blood count, Metabolic function test, Pyrexia
Clinical narrative: fever, tachycardia, PACs. Tachycardia to 160s. Fever to 39C.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles, Tachycardia, Troponin
Clinical narrative: fever, tachycardia, PACs. Tachycardia to 160s. Fever to 39C.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Inflammation, Laboratory test, Pain, Pain in extremity
Clinical narrative: I went to the emergency room on 02/12/2022- pain in my right leg from the blood clot. No real treatment, they just said to use heat and try to be active. Recommended to use the suppression socks. Diagnosis was superficial blood clots. Vascular surgeon said where it was was not considered a danger to go to my lungs. I just talked to my doctor's off today about a deep vein clot that I found, these that are inflamed and hurt, I have 2 more spots that are very sore. One is in the back of my calf and the other one is in my ankle. I don't have chest pains or shortness of breath. Nobody knows why this is happening because I have been on a blood thinner for 25 years, so it should not be happening. The fact that I got 2 more after the ER is a concern. If it is not better by Monday, I will have to see my vascular doctor. I have a follow up with my doctor on Monday.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Phlebitis, Thrombosis, Ultrasound Doppler
Clinical narrative: I went to the emergency room on 02/12/2022- pain in my right leg from the blood clot. No real treatment, they just said to use heat and try to be active. Recommended to use the suppression socks. Diagnosis was superficial blood clots. Vascular surgeon said where it was was not considered a danger to go to my lungs. I just talked to my doctor's off today about a deep vein clot that I found, these that are inflamed and hurt, I have 2 more spots that are very sore. One is in the back of my calf and the other one is in my ankle. I don't have chest pains or shortness of breath. Nobody knows why this is happening because I have been on a blood thinner for 25 years, so it should not be happening. The fact that I got 2 more after the ER is a concern. If it is not better by Monday, I will have to see my vascular doctor. I have a follow up with my doctor on Monday.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse effects noted, Resident administered expired Moderna Vaccine expiration date 10/13/2021.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccine administered through mis-identified patient
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness
Clinical narrative: 5 minutes after shot patient became unconscious and dropped to floor and recovered in 1 minute. called 911 . Ems took him to hospital for further investigation.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4, HPV9
Symptoms: Electrocardiogram abnormal, Fall, Loss of consciousness, Malaise, Sinus tachycardia
Clinical narrative: Woke up the day after her vaccines, walked to the bathroom, was not feeling well, Mom witnessed her pass out briefly and fall to the floor. no head trauma. Awake within seconds. Shaking of her arms for 2 seconds. Went to the ER. ECG performed, showing sinus tachycardia. Symptoms were improved, so no further work-up or treatments were needed. Back to baseline now.
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4, HPV9
Symptoms: Tremor
Clinical narrative: Woke up the day after her vaccines, walked to the bathroom, was not feeling well, Mom witnessed her pass out briefly and fall to the floor. no head trauma. Awake within seconds. Shaking of her arms for 2 seconds. Went to the ER. ECG performed, showing sinus tachycardia. Symptoms were improved, so no further work-up or treatments were needed. Back to baseline now.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Rash erythematous
Clinical narrative: Fever chills severe headache severe body aches full body bright red rash
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Effect noted, Resident administered expired Booster  Moderna vaccine, expired on 10/13/2021.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injection site reaction, Local reaction
Clinical narrative: None stated.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Eleven-year-old patient was inadvertently given Pfizer BioNTech for ages 12+.  Patient should have received pediatric Pfizer BioNTech.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: Per patient started to have heavy bleeding, halt on menstruation then ongoing menstruation for 3 weeks  after receiving pfizer vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Antinuclear antibody positive, Injection site pain
Clinical narrative: Went to PCP on 12/1/21.  Pain at injection site area..   Treatment:  Naprosyn, 2 week course; twice a day with no relief.  Blood work ordered due to no relief.  Referral to rheumatologist after blood work results.  Rheumatologist appointment date 3/29/22.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst removal, Dermal cyst, Discomfort, Infection, Inflammation
Clinical narrative: Within 24 hours a sebaceous cyst on my back became inflamed and infected. Cyst was removed January 27 and was put on Augmentin for the infection. When starting augmentin I became consistently itchy at night. I spoke with my doc at a follow up appointment and she advised to stop taking the antibiotic if hives appeared. Hives appeared February 4 so I discontinued the antibiotics. The hives continued popping up after stopping the antibiotics, I followed up with my doc as I believe this has to do with the booster but she was not convinced. I'm still dealing with spontaneous hives multiple times a week. They typically start on my feet and travel up my legs but more recently they've started showing up on my chest and arms. There are days they are severely itchy and other days they just show up and are uncomfortable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 24 hours a sebaceous cyst on my back became inflamed and infected. Cyst was removed January 27 and was put on Augmentin for the infection. When starting augmentin I became consistently itchy at night. I spoke with my doc at a follow up appointment and she advised to stop taking the antibiotic if hives appeared. Hives appeared February 4 so I discontinued the antibiotics. The hives continued popping up after stopping the antibiotics, I followed up with my doc as I believe this has to do with the booster but she was not convinced. I'm still dealing with spontaneous hives multiple times a week. They typically start on my feet and travel up my legs but more recently they've started showing up on my chest and arms. There are days they are severely itchy and other days they just show up and are uncomfortable.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Fourteen-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Mucous stools, Vomiting
Clinical narrative: Bloody mucous in stool on 3/3 Vomited once 3/4
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Effects.   Resident received expired Moderna Vaccine, expired on 10/13/2021
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Guillain-Barre syndrome, Laboratory test, Pain in extremity, Syncope
Clinical narrative: ER Hospital on 9/14/2021 ER Hospital on 12/20/2021 ER Hospital on 12/03/2021 ER Hospital on 12/27/2021 through 01/03/2022 Covid-19 (Mrna) Vaccine (Pfizer) Guillian-Barre Syndrome, ascending paralysis syncope and L hand painful thumb
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Twelve-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Twelve-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient complained of feeling dizzy 15 minutes post injection. Denies pain, SOB, blurred vision, headache, allergies, and other serious health concerns.  Assessed patient status and vital signs within normal range. No medical interventions. Gave a juice box and continued to monitor for additional 15 minutes. Observed patient ambulate out of clinic safely with no distress.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Neuralgia, Restless legs syndrome
Clinical narrative: Pt notes sudden and significant increase in bilateral neuropathic pain and increasing restless leg syndrome symptoms.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Patient had two previous Pfizer covid vaccines and was intended to get a Pfizer covid booster.  Medical Assistant accidentally injected Janssen Covid vaccine, and only gave 0.3 ml.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect noted. Resident received expired booster Moderna vaccine, expired on 10/13/2021.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardioversion, Dyspnoea, Resuscitation, Syncope, Wheezing
Clinical narrative: Patient collapsed in the parking lot as he was making his way to his car.  Paramedics performed CPR for over 10 minutes. AED was utilized however, NO shock was advised.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac assistance device user, Cardio-respiratory arrest, Death, Dyspnoea, General physical condition abnormal
Clinical narrative: Patient collapsed in the parking lot as he was making his way to his car.  Paramedics performed CPR for over 10 minutes. AED was utilized however, NO shock was advised.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Respiration abnormal, Resuscitation, Syncope, Wheezing
Clinical narrative: Patient collapsed in the parking lot as he was making his way to his car.  Paramedics performed CPR for over 10 minutes. AED was utilized however, NO shock was advised.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Twelve-year-old patient was inadvertently given Moderna which is indicated for ages 18 and up.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Mobility decreased
Clinical narrative: Severe body ache, headache, fatigue, and weakness. Severe pain at the injection site, unable to my move arm. Fever 103.2 F., nausea, vomiting, and heart palpitation.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Palpitations, Pyrexia, Vomiting
Clinical narrative: Severe body ache, headache, fatigue, and weakness. Severe pain at the injection site, unable to my move arm. Fever 103.2 F., nausea, vomiting, and heart palpitation.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Contusion, Injection site pain, Injection site swelling, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain and swelling that began at injection site and spread gradually down entire arm, left side of torso, and both left and right shoulder blades. Looks like bruising, feels like fire.
Age: 29.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Severe pain and swelling that began at injection site and spread gradually down entire arm, left side of torso, and both left and right shoulder blades. Looks like bruising, feels like fire.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: The Covid-19 Pediatric vaccine administered to the patient was inadvertently not diluted by the pharmacist. It was given at around 5:00 pm on March 4,2022. Upon discovering of the undiluted vaccine, the administering pharmacist called the patient's mother, apologized about the incident, explaining the vaccine was not diluted, and that the patient received a little stronger dose of the vaccine. The pharmacy manager also called Pfizer to inquire about what they could advise proper steps to do. As of this reporting, we are advised to report the incident to the VAERS website. The administering pharmacist advised the mother to monitor the patient and the pharmacist will also monitor the patient of unusual side effect. The patient's mother is not upset but the pharmacist deeply apologized about the unintentional vaccination of undiluted pediatric Covid-19 vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Twelve-year-old patient was inadvertently given Moderna which is indicated for ages 18 and up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects noted. Resident received expired modern vaccine, expired on 10/13/2021
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Fatigue, Heavy menstrual bleeding, Menstrual disorder, Pain
Clinical narrative: Miscarriage 3 months after first shot. Continue to have issues with my menstrual cycle which went away and then became worse after my third vaccine. Dull achy pain 24/7 in my lower abdominal, extremely painful menstrual cycles and fatigue. Extremely heavy cycles that are uncontrollable and constant abdominal pain.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects. Patient received Moderna vaccine expired on 10/13/2021.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Four-year-old patient was inadvertently given pediatric Pfizer BioNTech which is indicated for ages 5-11.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse effects. Resident received expired Moderna vaccine, expired on 10/13/2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Horrible very loud high pitched tinnitus.  Its constant 24/7 it never stops
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Effect noted. Resident received expired Moderna vaccine, expired on 10/13/2021.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Itching/burning rash beginning in the night following vaccination. Given hydrocortisone ointment, oral prednisone, oral diphenhydramine- two hours later, significant reduction in symptoms.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: Extreme fatigue, slept almost continuously for 48 hours, Temp 101- 102 for 36 hours Headaches, muscle and joint aches gradually resolving over 10 weeks Brain fog, inability to concentrate, focus, read, etc, for 6 weeks, gradually resolving during weeks 6-8  Starting about week ten or 12, significant slow worsening of pre-existing peripheral neuropathy Past  5 weeks, slowly progressing pain in hands, diagnosis pending
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Myalgia, Neuropathy peripheral, Pain in extremity
Clinical narrative: Extreme fatigue, slept almost continuously for 48 hours, Temp 101- 102 for 36 hours Headaches, muscle and joint aches gradually resolving over 10 weeks Brain fog, inability to concentrate, focus, read, etc, for 6 weeks, gradually resolving during weeks 6-8  Starting about week ten or 12, significant slow worsening of pre-existing peripheral neuropathy Past  5 weeks, slowly progressing pain in hands, diagnosis pending
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Extreme fatigue, slept almost continuously for 48 hours, Temp 101- 102 for 36 hours Headaches, muscle and joint aches gradually resolving over 10 weeks Brain fog, inability to concentrate, focus, read, etc, for 6 weeks, gradually resolving during weeks 6-8  Starting about week ten or 12, significant slow worsening of pre-existing peripheral neuropathy Past  5 weeks, slowly progressing pain in hands, diagnosis pending
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse effect noted. Resident received expired modern vaccine, expired on 10/13/2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Agitation, Diarrhoea, Flatulence, Headache
Clinical narrative: Around 5pm I was at work and began feeling stomach cramps and a feeling of flatulence. Approximately 6pm I started to become mildly agitated with a mild headache with intermittent stomach cramps and repeated flatulence. The cramping and gas continued and severe diarrhea started at 8:15pm and has been ongoing.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Impaired work ability, Pain
Clinical narrative: I received my third shot booster on 3-3-22 at local store. On Friday morning 3-4-22 when I got up I had body aches and took 2 Ibuprofen tablets, these did no good at all. I had chills all day. I ended up leaving work around 12:30p.m. I felt so bad with the body aches and chills. Ended up taking 2 Tylenols which after 1 hour helped me feel better.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse effect Noted. Resident received expired Moderna vaccine, expired on 10/13/2021.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation error
Clinical narrative: -Patient received undiluted Pfizer Peds 5-11 Vaccine -Patient contracted and notified and denies any s/s of adverse reactions at this time.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: -Patient received undiluted Pfizer Peds 5-11 Vaccine -Patient contacted and denies any s/s of adverse reaction at this time
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product preparation error
Clinical narrative: Patient received undiluted Pfizer Peds 5-11 vaccine -Patient contacted to inform - Denies any s/s of Adverse reactions
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Injection site pain, Pyrexia
Clinical narrative: Fever  3 days    diarrhea  3 days       sore  ( point of injection )  2 day
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Skin warm
Clinical narrative: About 1hr after receiving the vaccine. I was driving & my body felt warm, then a itchy, burning sensation started. I felt it on my neck, chest, back, legs & it were hot to the touch. It got worse through out the day. I had to take a Benadryl, it helped. But the next day it came back, I went to my PCP.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hypertension, Immediate post-injection reaction, Oropharyngeal discomfort, Pharyngeal hypoaesthesia
Clinical narrative: Narrative:  patient developed immediate reaction following 2nd dose of Pfizer Covid vaccine. Patient began to shake, developed shortness of breath, and throat felt funny. Patient took epi-pen that her husband carried for her from the allergist. Patient has no history of asthma or hypoxia. Patient was hypertensive and tachycardia, throat was "numb" and patient had hives that developed under the blood pressure cuff.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tremor, Urticaria
Clinical narrative: Narrative:  patient developed immediate reaction following 2nd dose of Pfizer Covid vaccine. Patient began to shake, developed shortness of breath, and throat felt funny. Patient took epi-pen that her husband carried for her from the allergist. Patient has no history of asthma or hypoxia. Patient was hypertensive and tachycardia, throat was "numb" and patient had hives that developed under the blood pressure cuff.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fall
Clinical narrative: Narrative: Patient received COVID-19 vaccine on 10/29/21. On 10/30/21 patient reported "excruciating back pain" that led to a fall.
Age: 56.0
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: Narrative: HISTORICAL FROM ANOTHER LOCATION. NO DETAILS AVAILABLE
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Narrative: Patient administered COVID booster on 10/29/21. On 10/30/21, patient was found to have a 99.9F fever and was given tylenol; physician attributed fever to recent vaccine administration.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Narrative:  Patient given COVID booster on 10/29/21. Patient developed low-grade fever with one episode of emesis on 10/30/2021.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Narrative: Patient received Moderna vaccine 2/13/21 and 3/13/21. Per 11/12/21 primary care note, patient developed "heart symptoms" within a month of the vaccine, and patient reported his cardiologist said this was an adverse reaction to the vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Narrative: patient diagnosed next day with an infection and treated at another location.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Insomnia, Palpitations, Panic attack, SARS-CoV-2 test
Clinical narrative: Tinnitus; Palpitations; Panic attacks; Anxiety; Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 15:30 (Lot number: EN6199) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Tinnitus"; PALPITATIONS (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Palpitations"; PANIC ATTACK (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Panic attacks"; ANXIETY (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Anxiety"; INSOMNIA (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Insomnia". The events "tinnitus", "palpitations", "panic attacks", "anxiety" and "insomnia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tinnitus, palpitations, panic attack, anxiety, insomnia. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine No prolonged hospitalization reported.The adverse event result in doctor or other healthcare professional office/clinic visit.Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; Palpitations; Panic attacks; Anxiety; Insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 15:30 (Lot number: EN6199) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Tinnitus"; PALPITATIONS (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Palpitations"; PANIC ATTACK (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Panic attacks"; ANXIETY (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Anxiety"; INSOMNIA (disability) with onset 02Apr2021 08:00, outcome "not recovered", described as "Insomnia". The events "tinnitus", "palpitations", "panic attacks", "anxiety" and "insomnia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of tinnitus, palpitations, panic attack, anxiety, insomnia. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine No prolonged hospitalization reported.The adverse event result in doctor or other healthcare professional office/clinic visit.Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait inability, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sharp shooting pain in head/ Headaches; Excruciating painful body ache; Could not walk; Blisters on tongue; Sore throat; Severe chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 23:00 (at the age of 58-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes, HP (hypersensitivity pneumonitis), chickengunya (chikungunya virus infection), alcohol allergy and allergy to CT (computed tomography) dye and. The patient's known allergies noted alcohol pad allergy. The patient received an unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via an unspecified route of administration in the left arm on 13Mar2021 at 23:00 (at the age of 58-year-old) as dose 1, single for COVID-19 immunization. The patient previously received Demerol and hydrocodone which caused allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 15:00, the patient experienced sharp shooting pain in head, excruciating painful body ache, could not walk, blisters on tongue, sore throat, headaches and severe chills. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient tab and narrative were amended.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue blistering
Clinical narrative: Sharp shooting pain in head/ Headaches; Excruciating painful body ache; Could not walk; Blisters on tongue; Sore throat; Severe chills; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 23:00 (at the age of 58-year-old) as dose 2, single for COVID-19 immunization. Medical history included diabetes, HP (hypersensitivity pneumonitis), chickengunya (chikungunya virus infection), alcohol allergy and allergy to CT (computed tomography) dye and. The patient's known allergies noted alcohol pad allergy. The patient received an unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207) via an unspecified route of administration in the left arm on 13Mar2021 at 23:00 (at the age of 58-year-old) as dose 1, single for COVID-19 immunization. The patient previously received Demerol and hydrocodone which caused allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 15:00, the patient experienced sharp shooting pain in head, excruciating painful body ache, could not walk, blisters on tongue, sore throat, headaches and severe chills. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient tab and narrative were amended.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fibrin D dimer, Heparin-induced thrombocytopenia test, Immunology test, Platelet count
Clinical narrative: VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; SPLANCHNIC VEIN THROMBOSIS; This spontaneous report was received from literature. This report concerned a 33 year old male of unspecified race and ethnicity. The objective of this study was to check the effectiveness of platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) with PF4-dependent p-selectin expression assay (PEA) in patients associated with vaccine induced thrombotic thrombocytopenia (VITT). 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 (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine induced thrombotic thrombocytopenia, and splanchnic vein thrombosis. The patient was hospitalized. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, PF4 Polyanion Enzyme Linked Immunosorbent Assays (ELISA) was positive (there were persistent anti-PF4 antibodies for 6 months during follow ups) , Fibrin D dimer was more than 10000 , Platelet count 31000 /uL, and Serotonin release assay result was not reported. Treatment medications (dates unspecified) included: bivalirudin, Argatroban, Dexamethasone and apixaban with direct oral anticoagulants. He was also given high dose intravenous immunoglobulin G. It was also reported that the timing of symptom onset after vaccination was 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the splanchnic vein thrombosis and vaccine induced thrombotic thrombocytopenia was not reported. The authors emphasized that the associated VITT antibodies persisted for greater than 5 months in platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) while the PEA became negative earlier. Thus, it was concluded that the patients with VITT demonstrate long term ELISA positivity, although functional assays become seronegative earlier during the course of recovery. The data suggest that the uncomplexed PF4 ELISA is sensitive and significantly more specific for the detection of VITT than currently available tests. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220249430-COVID-19 VACCINE AD26.COV2.S-splanchnic vein thrombosis and vaccine induced thrombotic thrombocytopenia . This event(s) is labeled and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome, Visceral venous thrombosis
Clinical narrative: VACCINE INDUCED THROMBOTIC THROMBOCYTOPENIA; SPLANCHNIC VEIN THROMBOSIS; This spontaneous report was received from literature. This report concerned a 33 year old male of unspecified race and ethnicity. The objective of this study was to check the effectiveness of platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) with PF4-dependent p-selectin expression assay (PEA) in patients associated with vaccine induced thrombotic thrombocytopenia (VITT). 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 (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine induced thrombotic thrombocytopenia, and splanchnic vein thrombosis. The patient was hospitalized. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not Reported, PF4 Polyanion Enzyme Linked Immunosorbent Assays (ELISA) was positive (there were persistent anti-PF4 antibodies for 6 months during follow ups) , Fibrin D dimer was more than 10000 , Platelet count 31000 /uL, and Serotonin release assay result was not reported. Treatment medications (dates unspecified) included: bivalirudin, Argatroban, Dexamethasone and apixaban with direct oral anticoagulants. He was also given high dose intravenous immunoglobulin G. It was also reported that the timing of symptom onset after vaccination was 8 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the splanchnic vein thrombosis and vaccine induced thrombotic thrombocytopenia was not reported. The authors emphasized that the associated VITT antibodies persisted for greater than 5 months in platelet factor 4 (PF4) polyanion enzyme linked immunosorbent assays (ELISA) while the PEA became negative earlier. Thus, it was concluded that the patients with VITT demonstrate long term ELISA positivity, although functional assays become seronegative earlier during the course of recovery. The data suggest that the uncomplexed PF4 ELISA is sensitive and significantly more specific for the detection of VITT than currently available tests. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220249430-COVID-19 VACCINE AD26.COV2.S-splanchnic vein thrombosis and vaccine induced thrombotic thrombocytopenia . This event(s) is labeled and is therefore considered potentially related.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an Intramuscular route of administration in the arm left on 08Apr2021 (at the age of 19-year-old) as dose 1, 0.5 mL single for COVID-19 immunization. Medical history was not reported. Concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 mL of vaccine instead of 0.3 mL. The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment was received. The clinical outcome of the event was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: General tab, products tab, events tab and narrative were amended.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Biopsy skin, Blood lactic acid, Computerised tomogram, Electromyogram
Clinical narrative: small fiber neuropathy, large fiber neuropathy, down beating nystigmus, nausea,100pecent balance impairment . tinnitus, hypercussis, vestibular system stopped working related to central pathology, moderate fall risk, injured left arm swollen down back and towrist. red swollen armsfor months, vaginal bleeding, rectal bleeding, m emory problems. fatty liver, lactic acid high
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic steatosis, Hyperacusis, Joint swelling, Laboratory test, Limb injury
Clinical narrative: small fiber neuropathy, large fiber neuropathy, down beating nystigmus, nausea,100pecent balance impairment . tinnitus, hypercussis, vestibular system stopped working related to central pathology, moderate fall risk, injured left arm swollen down back and towrist. red swollen armsfor months, vaginal bleeding, rectal bleeding, m emory problems. fatty liver, lactic acid high
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Memory impairment, Nausea, Neuropathy peripheral, Peripheral swelling
Clinical narrative: small fiber neuropathy, large fiber neuropathy, down beating nystigmus, nausea,100pecent balance impairment . tinnitus, hypercussis, vestibular system stopped working related to central pathology, moderate fall risk, injured left arm swollen down back and towrist. red swollen armsfor months, vaginal bleeding, rectal bleeding, m emory problems. fatty liver, lactic acid high
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Skin reaction, Small fibre neuropathy, Tinnitus, Ultrasound scan
Clinical narrative: small fiber neuropathy, large fiber neuropathy, down beating nystigmus, nausea,100pecent balance impairment . tinnitus, hypercussis, vestibular system stopped working related to central pathology, moderate fall risk, injured left arm swollen down back and towrist. red swollen armsfor months, vaginal bleeding, rectal bleeding, m emory problems. fatty liver, lactic acid high
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vestibular disorder
Clinical narrative: small fiber neuropathy, large fiber neuropathy, down beating nystigmus, nausea,100pecent balance impairment . tinnitus, hypercussis, vestibular system stopped working related to central pathology, moderate fall risk, injured left arm swollen down back and towrist. red swollen armsfor months, vaginal bleeding, rectal bleeding, m emory problems. fatty liver, lactic acid high