chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Biopsy heart normal, Blood test, Chemotherapy, Echocardiogram normal
Clinical narrative: I had a fast heartbeat approx 1-hour post vaccine and then it calmed down.. Two weeks later (4/2/21)) I had another arrhythmia but much stronger and then it calmed down with 10 mg Inderal, 4 days later my arrhythmia was strong once again, high HR and I was rushed to the hospital and transferred to my transplant hospital and was admitted for cardiac rejection workup including echo, biopsy,  plasmapheresis, chemo, and IVIG treatments, blood tests etc from 4/8/21 to 4/21/21.  -- I have not had any further Covid vaccinations but did receive a dose of Evushield on 2/25/22. I am currently taking 30 mg per day of Inderal to control tachycardia.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Immunoglobulin therapy, Plasmapheresis, Tachycardia
Clinical narrative: I had a fast heartbeat approx 1-hour post vaccine and then it calmed down.. Two weeks later (4/2/21)) I had another arrhythmia but much stronger and then it calmed down with 10 mg Inderal, 4 days later my arrhythmia was strong once again, high HR and I was rushed to the hospital and transferred to my transplant hospital and was admitted for cardiac rejection workup including echo, biopsy,  plasmapheresis, chemo, and IVIG treatments, blood tests etc from 4/8/21 to 4/21/21.  -- I have not had any further Covid vaccinations but did receive a dose of Evushield on 2/25/22. I am currently taking 30 mg per day of Inderal to control tachycardia.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Tinnitus  experienced twice lasting 20 min.  Some slight ringing also.  Diminished hearing on L ear.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Amylase increased, Arthritis, Aspartate aminotransferase increased, Autoantibody negative
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase normal, Bone marrow oedema, C-reactive protein normal, Cardiolipin antibody positive, Complement factor C3
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Complement factor C4, Differential white blood cell count normal, Full blood count normal, Gamma-glutamyltransferase normal, Investigation
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Juvenile idiopathic arthritis, Laboratory test normal, Lipase normal, Magnetic resonance imaging abnormal, Musculoskeletal stiffness
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test negative, Pain in extremity, Peripheral swelling, Red blood cell sedimentation rate normal, Scan with contrast abnormal
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Tendon sheath disorder, Thyroid function test normal, Urine analysis normal
Clinical narrative: She received the 3rd dose of the COVID-19 vaccine in mid-January 2022. About two months later, she started experiencing finger pain and swelling along with morning stiffness. She was evaluated by pediatric rheumatology on 4/25/2022; at that time, she was found to have on physical exam signs of arthritis of  most of her fingers. She was diagnosed with polyarticular juvenile idiopathic arthritis and was started on methotrexate and etanercept therapy.  Her response to therapy will be determined at her next follow up visit in early August 2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Headache, Nasal congestion
Clinical narrative: Breakout infection of COVID-19 with mild-to-moderate symptoms, including high fever, severe chills, body and joint aches, severe headache, chest and nasal congestion, sore throat.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pulmonary congestion, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Breakout infection of COVID-19 with mild-to-moderate symptoms, including high fever, severe chills, body and joint aches, severe headache, chest and nasal congestion, sore throat.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Amnesia, Condition aggravated, Headache, Seizure
Clinical narrative: Seizure activity and headache activity increased. Had not had any seizures for over 9months. Had been controlled with medication. Seizures activity now is not controlled and also now experiencing memory loss and absent seizures
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Adverse drug reaction, Asthenia, Fatigue, Feeling hot
Clinical narrative: After injection client felt immediately hot requesting ice pack and feeling very weak. Client had to lie down due to extreme weakness. Client requested water and after several sips c/o stomach pain and nausea. Client continued with not feeling well with c/o stomach aches, hot, weak "just wanting to sleep", no energy, and muscle jumping. After approx. one and a half hours client left clinic with grandmother but still very weak and tired. Client had some anxiety about getting vaccine today but also experiencing side effects to vaccine. VS Stable BP 86/52 HR 74.  2-11-22  Phoned client's mother and she verbalized that pt was feeling better since 11:30AM but was not well enough to go to school today.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of personal independence in daily activities, Malaise, Mobility decreased, Muscle twitching
Clinical narrative: After injection client felt immediately hot requesting ice pack and feeling very weak. Client had to lie down due to extreme weakness. Client requested water and after several sips c/o stomach pain and nausea. Client continued with not feeling well with c/o stomach aches, hot, weak "just wanting to sleep", no energy, and muscle jumping. After approx. one and a half hours client left clinic with grandmother but still very weak and tired. Client had some anxiety about getting vaccine today but also experiencing side effects to vaccine. VS Stable BP 86/52 HR 74.  2-11-22  Phoned client's mother and she verbalized that pt was feeling better since 11:30AM but was not well enough to go to school today.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Somnolence
Clinical narrative: After injection client felt immediately hot requesting ice pack and feeling very weak. Client had to lie down due to extreme weakness. Client requested water and after several sips c/o stomach pain and nausea. Client continued with not feeling well with c/o stomach aches, hot, weak "just wanting to sleep", no energy, and muscle jumping. After approx. one and a half hours client left clinic with grandmother but still very weak and tired. Client had some anxiety about getting vaccine today but also experiencing side effects to vaccine. VS Stable BP 86/52 HR 74.  2-11-22  Phoned client's mother and she verbalized that pt was feeling better since 11:30AM but was not well enough to go to school today.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Headache, Injection site pain, Insomnia
Clinical narrative: soreness at injection site (bearable); insomnia and headache
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fluid retention, Pulmonary hypertension, Pyrexia, Therapeutic product ineffective
Clinical narrative: patient reported around 05/10/2022 being in the hospital for a few days. she received the covid vaccine (pfizer) due to the requirement of her employment. after receiving the vaccine, she experienced fluid retention, fever, and shortness of breath and had to use her oxygen. she believes that the vaccine is the cause of the symptoms. her doctor stated that the pulmonary hypertension medications had stopped working for 7-8 days and was not related to the vaccine. she feels a lot better, and things are getting back to normal. exact date of admission, length of stay and discharge are unknown. no other information is known. product lot number and expiration date were systematically retrieved from the dispensing system.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: warm (not hot) red swelling at administration site (Right deltoid) about 3 to 4 inches in diameter
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaemia, Biopsy small intestine abnormal, Duodenitis, Full blood count, Gastritis
Clinical narrative: GI bleeding resulting in anemia with Hgb down to 9 and had clean based ulcer found on EGD and H pylori negative, she had the Covid vaxbooster 11/15. Just 10 days prior to the PUD.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gastrointestinal haemorrhage, Haemoglobin decreased, Helicobacter test negative, Oesophagogastroduodenoscopy abnormal, Ulcer
Clinical narrative: GI bleeding resulting in anemia with Hgb down to 9 and had clean based ulcer found on EGD and H pylori negative, she had the Covid vaxbooster 11/15. Just 10 days prior to the PUD.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dyspnoea, Seizure
Clinical narrative: self described seizure, difficulty breathing, inability to talk
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Productive cough
Clinical narrative: Pt states he has had an increase in phlegm and cough since that time
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Diarrhoea, Myalgia, Pyrexia
Clinical narrative: 11/29/21 presents to EC ED for "fevers, chills, myalgias, cough, and diarrhea". PMHx of " idiopathic membranous glomerulopathy, hypertension, hyperlipidemia, prediabetes, GERD".
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Confusional state, SARS-CoV-2 test positive
Clinical narrative: 12/03/21 presents to EC ED for "increased confusion". PMHx of "hypertension, hyperlipidemia, dementia"
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: 12/04/21 presents to ED for "sob and fatigue". PMHx of "renal transplant, CAD, AFib"
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Dizziness, SARS-CoV-2 test positive
Clinical narrative: 12/07/21 presents to EC ED for "Dizziness, cough, diarrhea". PMHx of "lung cancer and TCC"
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Lethargy, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: 12/08/21 presents to EC ED for "tachycardia" " lethargic with generalized weakness". PMHx of "CAD s/p CABG, HFpEF (EF 55% 10/9/21), AFib, HTN, HLD, OSA on CPAP"
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Lethargy, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: 12/08/21 presents to EC ED for "tachycardia" " lethargic with generalized weakness". PMHx of "CAD s/p CABG, HFpEF (EF 55% 10/9/21), AFib, HTN, HLD, OSA on CPAP"
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized 3/20 , heart and liver transplant on 4/20/22, of death on 5/27/2022,
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Heart transplant, Liver transplant
Clinical narrative: Hospitalized 3/20 , heart and liver transplant on 4/20/22, of death on 5/27/2022,
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Investigation, Palpitations, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: About 2 to 3 weeks after getting the booster. I noticed my heart was not beating right. I was feeling it in my chest, and I felt that it was wrong. I kept talking to different doctors, and they all kept saying that is normal, especially if you get covid. Everyone in my house had covid except me. I kept testing negative for covid, but all the doctors told me to just presume that I had covid. It kept going on for 2 months but all my doctors kept saying it was long covid. This lasted for months. All the doctors just kept saying it was covid related. 3.5 months later it was ongoing so much that I had a stroke on April 7th. So this was going on from the end of November until the beginning of April. Where I had the stroke was in the cerebellum, which is really rare to get a stroke there. My GI doctor told me to report this. I refuse to not believe this is vaccine related, since I was perfectly fine prior to getting these vaccines. I did not contract covid prior to the vaccines, but I do blame the vaccines for this and I refuse to get any more. I do not have high blood pressure, I am not overweight. I am generally a very healthy person, so it is really out of no where that someone like me would have had a stroke normally.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: About 2 to 3 weeks after getting the booster. I noticed my heart was not beating right. I was feeling it in my chest, and I felt that it was wrong. I kept talking to different doctors, and they all kept saying that is normal, especially if you get covid. Everyone in my house had covid except me. I kept testing negative for covid, but all the doctors told me to just presume that I had covid. It kept going on for 2 months but all my doctors kept saying it was long covid. This lasted for months. All the doctors just kept saying it was covid related. 3.5 months later it was ongoing so much that I had a stroke on April 7th. So this was going on from the end of November until the beginning of April. Where I had the stroke was in the cerebellum, which is really rare to get a stroke there. My GI doctor told me to report this. I refuse to not believe this is vaccine related, since I was perfectly fine prior to getting these vaccines. I did not contract covid prior to the vaccines, but I do blame the vaccines for this and I refuse to get any more. I do not have high blood pressure, I am not overweight. I am generally a very healthy person, so it is really out of no where that someone like me would have had a stroke normally.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood calcium decreased, Blood test normal, Cerebrovascular accident, Computerised tomogram normal
Clinical narrative: About 2 to 3 weeks after getting the booster. I noticed my heart was not beating right. I was feeling it in my chest, and I felt that it was wrong. I kept talking to different doctors, and they all kept saying that is normal, especially if you get covid. Everyone in my house had covid except me. I kept testing negative for covid, but all the doctors told me to just presume that I had covid. It kept going on for 2 months but all my doctors kept saying it was long covid. This lasted for months. All the doctors just kept saying it was covid related. 3.5 months later it was ongoing so much that I had a stroke on April 7th. So this was going on from the end of November until the beginning of April. Where I had the stroke was in the cerebellum, which is really rare to get a stroke there. My GI doctor told me to report this. I refuse to not believe this is vaccine related, since I was perfectly fine prior to getting these vaccines. I did not contract covid prior to the vaccines, but I do blame the vaccines for this and I refuse to get any more. I do not have high blood pressure, I am not overweight. I am generally a very healthy person, so it is really out of no where that someone like me would have had a stroke normally.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, Heart rate irregular, Magnetic resonance imaging normal, Post-acute COVID-19 syndrome
Clinical narrative: About 2 to 3 weeks after getting the booster. I noticed my heart was not beating right. I was feeling it in my chest, and I felt that it was wrong. I kept talking to different doctors, and they all kept saying that is normal, especially if you get covid. Everyone in my house had covid except me. I kept testing negative for covid, but all the doctors told me to just presume that I had covid. It kept going on for 2 months but all my doctors kept saying it was long covid. This lasted for months. All the doctors just kept saying it was covid related. 3.5 months later it was ongoing so much that I had a stroke on April 7th. So this was going on from the end of November until the beginning of April. Where I had the stroke was in the cerebellum, which is really rare to get a stroke there. My GI doctor told me to report this. I refuse to not believe this is vaccine related, since I was perfectly fine prior to getting these vaccines. I did not contract covid prior to the vaccines, but I do blame the vaccines for this and I refuse to get any more. I do not have high blood pressure, I am not overweight. I am generally a very healthy person, so it is really out of no where that someone like me would have had a stroke normally.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Interchange of vaccine products, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 55 year old female. Initial information was processed along with the additional information received on 25-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, obesity, chronic kidney disease, sulfa allergy, and contrast dye allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 25-MAR-2021 for prophylactic vaccination. Age at time of vaccination was 54 years old. The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 018F21A, expiry: UNKNOWN) dose was not reported, administered to the right arm on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2022 patient received non-company suspect drug nirmatrelvir and ritonavir (Paxlovid) (form of admin, route of admin, batch number and expiry were not reported) therapy pack administered for the treatment of covid-19 and was stopped on 08-MAY-2022. On 12-MAY-2022, 18:00, 4 days after completing Paxlovid treatment patient had sore throat and achiness (coded as confirmed covid-19 infection) (dose number in series 2). The patient was tested positive for covid (coded as confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232824.; Sender's Comments: V0-20220547535-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK, COVID19, COVID19
Symptoms: 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 via other manufacturer (Pfizer) concerned a 55 year old female. Initial information was processed along with the additional information received on 25-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, obesity, chronic kidney disease, sulfa allergy, and contrast dye allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered 1 in total to the right arm on 25-MAR-2021 for prophylactic vaccination. Age at time of vaccination was 54 years old. The patient received non-company suspect vaccine elasomeran (Moderna covid-19 vaccine) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 018F21A, expiry: UNKNOWN) dose was not reported, administered to the right arm on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-MAY-2022 patient received non-company suspect drug nirmatrelvir and ritonavir (Paxlovid) (form of admin, route of admin, batch number and expiry were not reported) therapy pack administered for the treatment of covid-19 and was stopped on 08-MAY-2022. On 12-MAY-2022, 18:00, 4 days after completing Paxlovid treatment patient had sore throat and achiness (coded as confirmed covid-19 infection) (dose number in series 2). The patient was tested positive for covid (coded as confirmed clinical vaccination failure) (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000232824.; Sender's Comments: V0-20220547535-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 2:29 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 2:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  No temperature excursion reported. The reporter confirmed no side effects were reported.  Treatment information was not reported.
Age: 35.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 2:29 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 2:29 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  No temperature excursion reported. The reporter confirmed no side effects were reported.  Treatment information was not reported.
Age: 39.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 3:26 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 3:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. No temperature excursion reported. On 20 Apr 2022, vaccine was removed from freezer.
Age: 39.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2022 at 3:26 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Apr-2022 at 3:26 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and was removed from freezer on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided. No treatment medication was provided. No temperature excursion reported. On 20 Apr 2022, vaccine was removed from freezer.
Age: 63.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022 at 2:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The vaccine was removed from the freezer on 05-May-2022. The reporter confirmed no side effects were reported. No temperature excursion occurred.  No treatment information was provided.
Age: 63.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022 at 2:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022 at 2:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-apr-2022 and was removed from freezer on 5-may-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The vaccine was removed from the freezer on 05-May-2022. The reporter confirmed no side effects were reported. No temperature excursion occurred.  No treatment information was provided.
Age: 29.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022 at 4:41 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022 at 4:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided. No temperature excursion reported.
Age: 29.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022; Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022 at 4:41 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-May-2022 at 4:41 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Vaccine expired on 2-Apr-2022 and Removed from freezer on 6-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided. No temperature excursion reported.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Systemic: Bell's Palsy-Severe
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine increased, Deep vein thrombosis, Fatigue, Mobility decreased, Pain in extremity
Clinical narrative: Patient presented to hospital with multiple blood clots (3) in lower extremity. unknown if related directly to immunization, long covid status, or being immobile due to expected side effects of immunization. Patient given blood thinners in the hospital ER then released home to continue taking  blood thinners for next 30 days
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count, Ultrasound Doppler abnormal
Clinical narrative: Patient presented to hospital with multiple blood clots (3) in lower extremity. unknown if related directly to immunization, long covid status, or being immobile due to expected side effects of immunization. Patient given blood thinners in the hospital ER then released home to continue taking  blood thinners for next 30 days
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Immobile, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Patient presented to hospital with multiple blood clots (3) in lower extremity. unknown if related directly to immunization, long covid status, or being immobile due to expected side effects of immunization. Patient given blood thinners in the hospital ER then released home to continue taking  blood thinners for next 30 days
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported. Vaccine was frozen for more than 2 weeks then administered to the patient. Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event reported.  Vaccine was frozen for more than 2 weeks then administered to the patient.  Per Pfizer, they don't have stability information for vaccine stored in this manner so we are considereing the dose invalid and are offering another dose to the patient.