chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Pain in extremity, Scan with contrast, Sleep disorder
Clinical narrative: The morning following vaccination I awoke suddenly from sharp, shocking electrical pain to my left calf.  The pain was intermittent but frequent.  Throughout the day, the pain moved to my left chest.  The chest pain was best described as an electrical shock.  It was frequent but intermittent for the following three months.  During the episodes, it would take my breath away and I had to stop all activity until it resolved.  As soon as symptoms started, I began taking aspirin daily at a dose of 324 mg.    I am an emergency nurse and had repeatedly witnessed the way patients were treated if they had concerns of adverse vaccine-related events.  Because of this, I did not immediately seek care regarding my symptoms.  After about 2 months of continued symptoms, I went to see my primary doctor who focused on thanking me for getting the vaccine and re-assuring me that it was completely safe.  She did an EKG, chest XR, CBC, CMP and a thyroid test.  She did not want to do a d-dimer, troponin, inflammatory markers or a holter monitor.  The tests she did run, although seemingly inadequate, were normal.  Flash forward to the present in which I now have a diagnosis of dilated cardiomyopathy with a rate-dependent, wide-complex left bundle branch block.  I have had no lifestyle habits that would have caused this and my genetic test was negative for cardiac markers.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Anticoagulant therapy, Atrial fibrillation, Atrial flutter, Blood potassium normal, Blood thyroid stimulating hormone decreased
Clinical narrative: Palpitations evaluated in Primary Care clinic 12/1/22. Exam, EKG & lab work normal, Zio patch ordered.  Paroxysmal atrial fibrillation diagnosed 12/28/22. Refrral made to Cardiac Electrophysiology. Evaluation completed 1/25/23, started on Flecainide 50 mg bid, Metoprolol ER 25 mg qd, Eliquis 5 mg bid. Side effects of drug were not tolerable and while AF Symptoms lessened they did not disappear completely, so on 3/7/23 Flecainide was DC'd and Ablation scheduled for 4/6/23 Outpatient Pulmonary Vein Isolation via wide area circumferential radiofrequency catheter ablation was performed, with additional ablation of cavotricuspid isthmus and external direct current cardioversion of AF triggered possibly by atrial flutter.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Cardiac ablation, Cardioversion, Echocardiogram normal, Ejection fraction normal, Electrocardiogram ambulatory abnormal
Clinical narrative: Palpitations evaluated in Primary Care clinic 12/1/22. Exam, EKG & lab work normal, Zio patch ordered.  Paroxysmal atrial fibrillation diagnosed 12/28/22. Refrral made to Cardiac Electrophysiology. Evaluation completed 1/25/23, started on Flecainide 50 mg bid, Metoprolol ER 25 mg qd, Eliquis 5 mg bid. Side effects of drug were not tolerable and while AF Symptoms lessened they did not disappear completely, so on 3/7/23 Flecainide was DC'd and Ablation scheduled for 4/6/23 Outpatient Pulmonary Vein Isolation via wide area circumferential radiofrequency catheter ablation was performed, with additional ablation of cavotricuspid isthmus and external direct current cardioversion of AF triggered possibly by atrial flutter.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Electrocardiogram normal, Full blood count normal, Laboratory test normal, Palpitations, Renal function test normal
Clinical narrative: Palpitations evaluated in Primary Care clinic 12/1/22. Exam, EKG & lab work normal, Zio patch ordered.  Paroxysmal atrial fibrillation diagnosed 12/28/22. Refrral made to Cardiac Electrophysiology. Evaluation completed 1/25/23, started on Flecainide 50 mg bid, Metoprolol ER 25 mg qd, Eliquis 5 mg bid. Side effects of drug were not tolerable and while AF Symptoms lessened they did not disappear completely, so on 3/7/23 Flecainide was DC'd and Ablation scheduled for 4/6/23 Outpatient Pulmonary Vein Isolation via wide area circumferential radiofrequency catheter ablation was performed, with additional ablation of cavotricuspid isthmus and external direct current cardioversion of AF triggered possibly by atrial flutter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid-19 on March 11, 2023 I experienced congestion, coughing, and I was taking ibuprofen for my symptoms and I was also prescribed cetirizine for my congestion and I was using FLONASE as well for the stuffy nose.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: swelling and redness > 5 cm in size
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Headache, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test negative
Clinical narrative: I had a sore throat, congestion, and a headache. I contacted my doctor and was prescribed amoxicillin. I also took ibuprofen. I decided to take a COVID-19 test because I had a dentist appointment and I ended up testing positive. I contacted my doctor but was not prescribed medication. I took another COVID-19 test on day 10 and tested negative.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I had a sore throat, congestion, and a headache. I contacted my doctor and was prescribed amoxicillin. I also took ibuprofen. I decided to take a COVID-19 test because I had a dentist appointment and I ended up testing positive. I contacted my doctor but was not prescribed medication. I took another COVID-19 test on day 10 and tested negative.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cough, Dry mouth, Dyspnoea, Hypoacusis, Nasal disorder
Clinical narrative: I had dry mouth, difficulty breathing, and long-term cough. I tested negative for COVID-19 several times. I went to the doctor and they gave me an inhaler which did not do anything. I got to the point to where I couldn't hear properly in my right ear. It was sinus blockage and I had to get surgery on my nose cavity so I could breathe better. This helped but I just got an infection in my nose, and I am still coughing and stuffy.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nasal operation, SARS-CoV-2 test negative, Sinonasal obstruction, Upper respiratory tract infection
Clinical narrative: I had dry mouth, difficulty breathing, and long-term cough. I tested negative for COVID-19 several times. I went to the doctor and they gave me an inhaler which did not do anything. I got to the point to where I couldn't hear properly in my right ear. It was sinus blockage and I had to get surgery on my nose cavity so I could breathe better. This helped but I just got an infection in my nose, and I am still coughing and stuffy.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: I thought I had a sore throat. I woke up from a nap in the afternoon with a fever. I had low fever, a headache and fatigue. The symptoms lasted for one day. I treated the symptoms with ibuprofen and within 24 hours I was recovered. I did not receive any treatment. I completely recovered.
Age: 51.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Had a fever, so tested for COVID-19 and it was positive. Contacted doctor and was prescribed Paxlovid. Taking doses right now and starting to feel better.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Blood iron
Clinical narrative: Polymyalgia rheumatica began within days of vaccine. Never had it before.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Blood uric acid, C-reactive protein, Electrophoresis protein, Full blood count, Immunology test
Clinical narrative: Polymyalgia rheumatica began within days of vaccine. Never had it before.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Iron binding capacity total, Laboratory test, Metabolic function test, Polymyalgia rheumatica, Red blood cell sedimentation rate
Clinical narrative: Polymyalgia rheumatica began within days of vaccine. Never had it before.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Rheumatoid factor, Serology test, Serum ferritin
Clinical narrative: Polymyalgia rheumatica began within days of vaccine. Never had it before.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: 4/7/23 develop temperature of 104F and very irritable.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Rash, Rash papular, Skin warm
Clinical narrative: I took the Prevnar 20 INJ 0.5ml on 04/3/2023 and i developed a rash that is 6x10in size. The rash is hot and raised, i had to go to doctor and was prescribed antibiotics and must take Benadryl.
Age: 53.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Cough, Dyspnoea, Malaise, Oropharyngeal pain
Clinical narrative: I had vaccination on 10/14/2022. On 04/07/2023 I woke up with I felt crummy. On 04/08/2023 I started to experience cough extreme body and muscle aches extreme sore throat and shortness of breath with a low grade fever. I tested COVID-19 positive the evening of 04/08/2023. I haven't contacted a physical as of yet on 04/10/2023.
Age: 53.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I had vaccination on 10/14/2022. On 04/07/2023 I woke up with I felt crummy. On 04/08/2023 I started to experience cough extreme body and muscle aches extreme sore throat and shortness of breath with a low grade fever. I tested COVID-19 positive the evening of 04/08/2023. I haven't contacted a physical as of yet on 04/10/2023.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Oropharyngeal pain, Pain
Clinical narrative: I tested positive for COVID-19 on 12/01/2022. The infection was mild. I had a sore throat, a little chills for about a day and a half. No big fever. I did have body aches and fatigue. I was given PAXLOVID on 12/03/2022 and I took one dose. I felt so horrible that I stopped taking it after that one dose. The only thing I recall taking was TYLENOL and that was for the body aches I had the first couple days.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID-19 on 12/01/2022. The infection was mild. I had a sore throat, a little chills for about a day and a half. No big fever. I did have body aches and fatigue. I was given PAXLOVID on 12/03/2022 and I took one dose. I felt so horrible that I stopped taking it after that one dose. The only thing I recall taking was TYLENOL and that was for the body aches I had the first couple days.
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: bivalent dose given instead of intended monovalent
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Headache
Clinical narrative: I developed a headache, cough, fever, body aches, loss of sense of smell and taste. I did a COVID-19 test and it was positive. I called my doctor, and they prescribed me Paxlovid. I felt better after a couple of days of taking it. The cough lasted a couple of weeks along with my loss of sense and smell. The COVID-19 seemed to suppress the efficacy of my antidepressant medication like my body was reacting as if I stopped taking it.  I have no lingering side effects.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I developed a headache, cough, fever, body aches, loss of sense of smell and taste. I did a COVID-19 test and it was positive. I called my doctor, and they prescribed me Paxlovid. I felt better after a couple of days of taking it. The cough lasted a couple of weeks along with my loss of sense and smell. The COVID-19 seemed to suppress the efficacy of my antidepressant medication like my body was reacting as if I stopped taking it.  I have no lingering side effects.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Chronic obstructive pulmonary disease, Hypoxia
Clinical narrative: R09.02 HYPOXEMIA 6/3/2022 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE) R09.02 HYPOXEMIA 6/3/2022 ACUTE NON ST ELEVATION MI
Age: 81.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Malaise, Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: I was not feeling well and I thought I had a sinus infection. My sinus hurt, I had a lot of phlegm and a high fever. I ended up doing a COIVD-19 Home Test and it was positive. I did reach out to my health care provider, and it was too late to get on a medication. I did end up feeling better after COVID but I had a sinus infection as well following it and I had to go in for an antibiotic as well.
Age: 81.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Sinus pain, Sinusitis
Clinical narrative: I was not feeling well and I thought I had a sinus infection. My sinus hurt, I had a lot of phlegm and a high fever. I ended up doing a COIVD-19 Home Test and it was positive. I did reach out to my health care provider, and it was too late to get on a medication. I did end up feeling better after COVID but I had a sinus infection as well following it and I had to go in for an antibiotic as well.
Age: 68.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, Cough, Fatigue, Feeling cold, SARS-CoV-2 test positive
Clinical narrative: I had a cough that was not productive, I felt really cold, I was getting tired from doing anything. I took a home COVID-19 test, that came back positive. Once it came back positive, I called my doctor's office, spoke to the NP, who gave me the state sponsored number so that I could get a prescription for PAXLOVID. I started feeling within three to for days of taking the antiviral medication, I did not get rebound COVID-19.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Mother inquired about giving  pt the polio vaccine along with other vaccines due at 15 month well child check up (Dtap and PedvaxHIB), Mother agreed to Kinrix vaccine (Dtap and Polio), vaccine was administered, when I went to chart vaccine I found out that Kinrix is for ages 4-6 years,  pt was monitored in office for 15 min after vaccine was administered, pt had no adverse effects at that time
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: R09.02 HYPOXIA 12/9/2021 ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 65.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Acoustic stimulation tests, Cerumen removal, Hypoacusis, Magnetic resonance imaging head normal, Sudden hearing loss
Clinical narrative: Sudden hearing loss occurred causing muffled hearing in right ear.   (1) First had ear wax removed at urgent care (2) PCP prescribed prednisone with no success - 10 mg for 7 days  (3) After confirming audiological exam, ENT administered inner ear shots of prednisone over at 3/4 day intervals over 3 weeks with no success.  (4)  met with audiologist for hearing aid selection and hearing consult
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Bacteraemia, COVID-19 pneumonia, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2021 COVID-19 PNEUMONIA R09.02 HYPOXEMIA 12/15/2021 COVID-19 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2021 BACTEREMIA R09.02 HYPOXEMIA 12/15/2021 BACTEREMIA
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: being treated for chronic cough that was getting worse despite nebulizer treatments, went to er and tested positive for covid 19 on  3.30.23; hospitialized 3.30-4.1.23.  Probable exposure at a pizza place on 3.25.23
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiogenic shock, Chronic respiratory failure, Respiratory failure, Shock
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/8/2022 CARDIOGENIC SHOCK J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/4/2022 CARDIOGENIC SHOCK R57.0 CARDIOGENIC SHOCK 4/4/2022 CARDIOGENIC SHOCK R57.9 SHOCK, UNSPECIFIED 4/4/2022 CARDIOGENIC SHOCK
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cyanosis, Dyspnoea, Electrocardiogram abnormal, Heart rate decreased
Clinical narrative: Decrease of Heart rate to 40s, Oxygen levels dropped to 50s, shortness of breath, loss of energy, lips turned blue
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Oxygen saturation decreased
Clinical narrative: Decrease of Heart rate to 40s, Oxygen levels dropped to 50s, shortness of breath, loss of energy, lips turned blue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Vaccine expired on 3/30/23 and was given to early.
Age: 62.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Asthenia, Blood test normal, Dyspnoea, Electrocardiogram normal, Mobility decreased
Clinical narrative: I started feeling weak that I couldn't get up like I couldn't move. The doctors ran blood test. I still have tingling in my feet. I had shortness of breath. I had to take deep breaths from time to time.
Age: 62.0
Sex: M
Vaccine: COVID19-2, VARZOS
Symptoms: Paraesthesia, SARS-CoV-2 test negative
Clinical narrative: I started feeling weak that I couldn't get up like I couldn't move. The doctors ran blood test. I still have tingling in my feet. I had shortness of breath. I had to take deep breaths from time to time.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test normal, Magnetic resonance imaging normal, Tremor
Clinical narrative: I have developed mild sporadic tremors in my hands and in my neck/head. I haven't received any treatment.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: severe rash and hive everywhere but the face, come on around 1 to 2 pm daily, location does not matter in car walking sitting etc. Horrible !!!
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Anticoagulant therapy, Bell's palsy, Blood test normal
Clinical narrative: I woke up and felt a tingling on my tongue, which gradually spread to my lip and right cheek. Soon afterwards, I went to the ER and underwent a CT scan and bloodwork. I was admitted to the hospital. They didn't think that I had had a stroke, but the following day, I underwent an MRA, which confirmed that I had had a brain aneurysm, not a stroke. I was in the hospital for at least three days. They put me on aspirin. The following week, I had an appointment with the neurosurgeon, who explained to me after he had performed an angiogram that the aneurysm was 7 mm, which was rather large, and that I would need to undergo surgery. On 9/19/2023, I had a stent put in. It was surgically inserted into the groin and into the brain. I was admitted to the hospital for about four days, during which time I was in the ICU. Before the surgery, I was put on a blood thinner called Brilinta; I still take it twice a day. Originally, it was planned that I would take it until about May 2023, but a stenosis has been found on the same artery where the aneurysm was located, so my period of taking the Brilenta may be extended until July 2023. At the present time, I'm doing okay. The doctor says that the aneurysm is almost gone. In May 2023, I am scheduled to undergo an MRA to see the status of the aneurysm and the stenosis. In about October 2022, I had a bout of Bell's palsy. I was hospitalized for a couple of days, because they wanted to ensure that I hadn't had a stroke, which I had not. They prescribed prednisone to treat it, and it took probably a couple of weeks before the Bell's palsy was resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral artery stenosis, Cerebral artery stent insertion, Computerised tomogram head normal, Intensive care, Intracranial aneurysm
Clinical narrative: I woke up and felt a tingling on my tongue, which gradually spread to my lip and right cheek. Soon afterwards, I went to the ER and underwent a CT scan and bloodwork. I was admitted to the hospital. They didn't think that I had had a stroke, but the following day, I underwent an MRA, which confirmed that I had had a brain aneurysm, not a stroke. I was in the hospital for at least three days. They put me on aspirin. The following week, I had an appointment with the neurosurgeon, who explained to me after he had performed an angiogram that the aneurysm was 7 mm, which was rather large, and that I would need to undergo surgery. On 9/19/2023, I had a stent put in. It was surgically inserted into the groin and into the brain. I was admitted to the hospital for about four days, during which time I was in the ICU. Before the surgery, I was put on a blood thinner called Brilinta; I still take it twice a day. Originally, it was planned that I would take it until about May 2023, but a stenosis has been found on the same artery where the aneurysm was located, so my period of taking the Brilenta may be extended until July 2023. At the present time, I'm doing okay. The doctor says that the aneurysm is almost gone. In May 2023, I am scheduled to undergo an MRA to see the status of the aneurysm and the stenosis. In about October 2022, I had a bout of Bell's palsy. I was hospitalized for a couple of days, because they wanted to ensure that I hadn't had a stroke, which I had not. They prescribed prednisone to treat it, and it took probably a couple of weeks before the Bell's palsy was resolved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Paraesthesia, Paraesthesia oral
Clinical narrative: I woke up and felt a tingling on my tongue, which gradually spread to my lip and right cheek. Soon afterwards, I went to the ER and underwent a CT scan and bloodwork. I was admitted to the hospital. They didn't think that I had had a stroke, but the following day, I underwent an MRA, which confirmed that I had had a brain aneurysm, not a stroke. I was in the hospital for at least three days. They put me on aspirin. The following week, I had an appointment with the neurosurgeon, who explained to me after he had performed an angiogram that the aneurysm was 7 mm, which was rather large, and that I would need to undergo surgery. On 9/19/2023, I had a stent put in. It was surgically inserted into the groin and into the brain. I was admitted to the hospital for about four days, during which time I was in the ICU. Before the surgery, I was put on a blood thinner called Brilinta; I still take it twice a day. Originally, it was planned that I would take it until about May 2023, but a stenosis has been found on the same artery where the aneurysm was located, so my period of taking the Brilenta may be extended until July 2023. At the present time, I'm doing okay. The doctor says that the aneurysm is almost gone. In May 2023, I am scheduled to undergo an MRA to see the status of the aneurysm and the stenosis. In about October 2022, I had a bout of Bell's palsy. I was hospitalized for a couple of days, because they wanted to ensure that I hadn't had a stroke, which I had not. They prescribed prednisone to treat it, and it took probably a couple of weeks before the Bell's palsy was resolved.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 6/10/2022 ACUTE RENAL FAILURE, UNSPECIFIED
Age: 46.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Benign breast neoplasm, Mammogram normal, Ultrasound scan normal
Clinical narrative: I went for a mammogram screening I brought up that I had found lump on both breasts. I had noticed that the right side was bigger than the left side. On February 23, 2023, I had an ultrasound of my breast done. The results for both the mammogram and the ultrasound were negative for anything unusual, just extra breast tissue.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, COVID-19, Chest X-ray, Dyspnoea, General symptom
Clinical narrative: I probably was infected on 01/01/2023, and I was in the hospital. I had all the classic symptoms of COVID-19. I've had COVID-19 four times now. I had breathing issues and headache, and generalized symptoms. I went to the hospital around 01/10/2023 until the beginning of February. I had COVID-19, RSV, and Pneumonia all at the same time. I was in the hospital for 2-3 weeks. They discharged me and had me on oxygen 24 hours a day. I'm still on oxygen, but less of a dosage. Around 8 to 10 hours daily.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Laboratory test, Malaise, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: I probably was infected on 01/01/2023, and I was in the hospital. I had all the classic symptoms of COVID-19. I've had COVID-19 four times now. I had breathing issues and headache, and generalized symptoms. I went to the hospital around 01/10/2023 until the beginning of February. I had COVID-19, RSV, and Pneumonia all at the same time. I was in the hospital for 2-3 weeks. They discharged me and had me on oxygen 24 hours a day. I'm still on oxygen, but less of a dosage. Around 8 to 10 hours daily.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I probably was infected on 01/01/2023, and I was in the hospital. I had all the classic symptoms of COVID-19. I've had COVID-19 four times now. I had breathing issues and headache, and generalized symptoms. I went to the hospital around 01/10/2023 until the beginning of February. I had COVID-19, RSV, and Pneumonia all at the same time. I was in the hospital for 2-3 weeks. They discharged me and had me on oxygen 24 hours a day. I'm still on oxygen, but less of a dosage. Around 8 to 10 hours daily.
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was <3 years old at the time of administration.  She received Tdap instead of DTap.  Family did not report any physical adverse reaction.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Eye irritation, Fatigue, Feeling hot
Clinical narrative: I started experiencing symptoms on January 1, 2023 increased problems with walking increase a fib and tiredness extreme low energy and easily fatigued; Stamina is off; irritation in my eyes and episode could last as long as an hour. Everyday I feel as if I have a low grade fever.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Laboratory test
Clinical narrative: I started experiencing symptoms on January 1, 2023 increased problems with walking increase a fib and tiredness extreme low energy and easily fatigued; Stamina is off; irritation in my eyes and episode could last as long as an hour. Everyday I feel as if I have a low grade fever.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood loss anaemia, Pulmonary embolism
Clinical narrative: I26.99 ACUTE PULMONARY EMBOLISM 8/31/2022 ACUTE PULMONARY EMBOLISM I26.99 ACUTE PULMONARY EMBOLISM 8/31/2022 ANEMIA DUE TO BLOOD LOSS
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid w a home test  pn 4.2.23 after exposure to wife who tested postive on 3.30.23.  Rec'd paxlovid treatment
Age: 77.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Vertigo
Clinical narrative: 2/1/2023 In the evening I had a bout of vertigo. I called the nurse line and they advised I take a trip to the ER. In the ER they checked vitals, was given something for nausea. Spent a few hours in the ER and sent me home. The vertigo slowly went away. Methocarbamol was prescribed from the ER. Took a week to fully go away.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Abdominal pain, COVID-19, Cough, Fatigue, Malaise
Clinical narrative: My COVID-19 symptoms started on 02/28/2023 in the afternoon. I  had a sore throat, cough, chest congestion, abdominal pain, fever, nausea, and severe fatigue.  On 03/01/23023 I did a COVID-19 home test which was positive. I called my doctor's office right away and set up a telehealth with my doctor. She prescribe me Paxlovid and gave me refill for Albuterol.  After 8 days  later  on 03/08/2023  I tested negative.
Age: 64.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: My COVID-19 symptoms started on 02/28/2023 in the afternoon. I  had a sore throat, cough, chest congestion, abdominal pain, fever, nausea, and severe fatigue.  On 03/01/23023 I did a COVID-19 home test which was positive. I called my doctor's office right away and set up a telehealth with my doctor. She prescribe me Paxlovid and gave me refill for Albuterol.  After 8 days  later  on 03/08/2023  I tested negative.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hyperlipidaemia
Clinical narrative: Pfizer vaccine was administered outside of our facility - reported by patient  J96.00 ACUTE RESPIRATORY FAILURE 12/23/2021 HYPERLIPIDEMIA
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of VAQTA was inadvertently administered to a patient.; This spontaneous report was received from health care professional and refers to an 80-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), 1mL, (lot #, route of administration and anatomical location were not reported) expiration date: 02-MAR-2023, administered for prophylaxis. At the reporting time, no adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Diabetes mellitus
Clinical narrative: first shingle shot turned him diabetic; This serious case was reported by a consumer via interactive digital media and described the occurrence of diabetes in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included hypoglycemia (was hypoglycemic all his life).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced diabetes (Verbatim: first shingle shot turned him diabetic) (serious criteria GSK medically significant). The outcome of the diabetes was not reported.   It was unknown if the reporter considered the diabetes to be related to Shingles vaccine.     It was unknown if the company considered the diabetes to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-Mar-2023 The case was received from the patient's friend via interactive digital media. The reporter reported that the shingles were terrible, but a few people did the shot was worse one example of a friend of him/her (the patient) had the first shingles shot and turned him diabetic, be careful. The follow-up could not be possible as no contact details were available.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired Moderna Covid-19 vaccine (monovalent) was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered) and NO ADVERSE EVENT (No adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine (monovalent) was administered).    No concomitant medication was reported.    No treatment information was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: Submitting limited AE for possible deviation to the authorized vaccine schedule; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Submitting limited AE for possible deviation to the authorized vaccine schedule).    No concomitant medications were reported.     A nurse who works basically with the homeless population states that they have a young lady patient who got her 3rd and 4th shot on Oct and Dec-2022. They were asking if they were able to tell them from the lot numbers if these 2 doses were the bivalent or the monovalent. When agent requested for the lot numbers, HCP realized that they did not had them on hand.  No treatment medications were reported.   Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023; No adverse event; We had a nurse gave an expired vaccine on 06Apr2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 06-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had a nurse gave an expired vaccine on 06Apr2023) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 07-Mar-2023, administration of vaccine 6-Apr-2023).    No concomitant medication were reported.  Patient received Monovalent adult dose. Vial size was 5.5 mL. The vial was initially stored in the refrigerator on  07-Mar-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered >12 hours after initial vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot on 30-Mar-2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 07-Apr-2023 at 8:45 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Apr-2023 at 8:45 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours after initial vial puncture).    No concomitant medications was reported.  Vial was removed from the refrigerator and initially punctured at 8:30 AM on 6-APR-2023. Vaccine sat at room temperature up until administration after being initially punctured.  No treatment medications was reported.
Age: 96.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: a red spot and big blotch on her arm that is 6 inches long/it was itchy; a red spot and big blotch on her arm that is 6 inches long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 96-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 96 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious) with onset Mar2023, outcome "not recovered", described as "a red spot and big blotch on her arm that is 6 inches long"; RASH PRURITIC (non-serious) with onset Mar2023, outcome "not recovered", described as "a red spot and big blotch on her arm that is 6 inches long/it was itchy". The events "a red spot and big blotch on her arm that is 6 inches long/it was itchy" and "a red spot and big blotch on her arm that is 6 inches long" required emergency room visit. Therapeutic measures were taken as a result of rash pruritic, rash macular. Additional information: Caller reports where they gave her the shot, she has a red spot and big blotch on her arm (vaccinated arm) that is 6 inches long and she still has the redness. Caller described it as "hit with a baseball" and stated that it stayed red for Saturday and Sunday. She went to the ER on Sunday and they put some hydrocortisone cream on it because it was itchy. Caller states it seems to be spreading lower than the circle they marked around it. Caller stated that the redness has gone down near the elbow. Caller mentioned that the upper part is not as red but the bottom part is still red. Caller asks, is this part of any side effect and what else can they could they do about it?   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 5 (booster), single (Lot number: GH9697), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Report about Covid treatment yes, Reporter type patient, vaccine was received, No other medication in 2weeks, Product COVID 19 Treatment, start date 27Mar2023, stop date 01Apr2023. This is a notification generated from the system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process. Refer to the below table for details. Product Quality Group Provided investigational results for Comirnaty the investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot GH9697. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 22Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 16Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 17Feb2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "overactive bladder" (unspecified if ongoing); "herniated disc" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05May2022, outcome "unknown", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 multivalent nos (COVID-19 VACCINE MULTIVALENT NOS MANUFACTURER UNKNOWN), in Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "sinusitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.