chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of ACT-HIB with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00663712) and transmitted to Sanofi on 30-Jun-2021.  This case involves a patient with unknown demography who received an expired dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On 30-Jun-2021, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number was not reported) which was expired on unknown date via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  It was reported that "calling regarding ACTHIB. Caller stated that the vaccine is expired and was given to a patient today and would like to know their next steps. All were assisting other callers. Case placed in proxy for call back. Caller stated that she will be leaving the office soon and would like to contact provider".  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired daptacel was given to a patient/ no AE; Initial information was received on 01-Jul-2021 regarding an unsolicited valid non-serious case received from a Consumer via Medical Information (Reference number- 00665216) and transmitted to Sanofi on 01-Jul-2021.  This case involves a one-year-old female patient while receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] reported that expired DAPTACEL was given to a patient with no adverse event (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE (HIB) for prophylactic vaccination and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 30-Jun-2021, the patient received 0.5 ml (total) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5624AA, expiry date 10-Jun-2021] via intramuscular route in right thigh for prophylactic vaccination.  It was reported, "A Medical Assistant reporting on behalf of a consumer on Daptacel having a medication error described as the Daptacel dose being expired on the day of administration. Caller stated that expired DAPTACEL was given to a patient on yesterday. Caller would like to know what to do next regarding matter. Product used: Used. Still using product: No.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Hypotension, Nausea, Tremor
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: EMS was activated and patient was taken from Clinic by Paramedics.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After administration of Jansen vaccine in less than one minute, patiet had a syncopal episode. He recovered within few minutes. Vital sigs within normal range. He stated he had not eaten or drink anything since night before. 911 was called.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After administration of Jansen vaccine in less than one minute, patiet had a syncopal episode. He recovered within few minutes. Vital sigs within normal range. He stated he had not eaten or drink anything since night before. 911 was called.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Autopsy, Chest X-ray normal, Computerised tomogram thorax abnormal, Cough, Death
Clinical narrative: Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021.  She was diagnosed with new aggressive possible lymphoma or lung cancer for which she  ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin.  She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital  for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis  on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Differential white blood cell count normal, Full blood count normal, Haemoptysis, Mediastinal mass
Clinical narrative: Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021.  She was diagnosed with new aggressive possible lymphoma or lung cancer for which she  ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin.  She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital  for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis  on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Pulmonary mass, Respiratory failure, Weight decreased
Clinical narrative: Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021.  She was diagnosed with new aggressive possible lymphoma or lung cancer for which she  ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin.  She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital  for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis  on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Echocardiogram, Heart rate increased, Right atrial dilatation, Right atrial enlargement
Clinical narrative: Increased Heart rate to 100bps, with episodes of up to 200bps Had Comprehensive Echo and the results showed that the right atrium is dilated to 55mm  Increased Diltiazem medication to 240
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension, Injection site pain, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium
Age: 100.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Oxygen saturation decreased, SARS-CoV-2 test positive
Clinical narrative: Died of COVID-19 illness on 06/02/2021 Symptoms: low oxygen levels
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient became dizzy and fell out of chair in waiting area around 7 minutes post-vaccination. He revived almost immediately and reported that he felt dizzy. He was given a bottle of water and a snack and was monitored for 30 minutes. Patient recovered well.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Seizure, Syncope, Unresponsive to stimuli, Vomiting
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Medium, Systemic: Vomiting-Mild, Additional Details: Patient got the vaccine and was fine sat down and after 5 minutes fainted. Then got back consciousness then had seizure and lost consciousness. Then was ok but went to hospital to be evaluated.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Injection site pain, Nausea, Syncope
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Myocarditis, Pyrexia
Clinical narrative: Sharp chest pains when inhaling, shortness of breath, and  mild fever. They lasted for about 5 days, but I never went to the doctor because I was unaware of Myocarditis as a side effect prior to taking the shot.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: EMPLOYEE REPORTS HEADACHE 3 HOURS AFTER VACCINATION. CHILLS, NAUSEA, BODY ACHES "LATER THAT NIGHT."  TYLENOL 800MG WAS TAKEN 1130PM 07/08/2021 AND TYLENOL 800MG 5AM 07/09/2021. SYMPTOMS ARE STILL PRESENT AT THIS TIME. EMPLOYEE WILL REPORTEDLY GO TO URGENT CARE TO BE SEEN THIS MORNING.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Feeling abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Adverse event (fainting) occured today at time of immunization. Pt fainted near immediately, regained consciousness in about 15-20 seconds, then seemed a bit dazed for several minutes. Pt stayed at the pharmacy for about 17-18 min and seemed to recover by the end and walked out with her parents. Parents noted that this is a normal reaction to vaccines, but this time did seem to be the most severe compared to past events.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash, first all over my face. Comes and goes, then my neck and upper shoulders. Some now on arms and fingers
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: headache,  pain at injection site, painful/swollen axial lymph nodes x 2day
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Cardiac arrest, Condition aggravated
Clinical narrative: From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA   Died of COVID-19 illness on 06/13/2021
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary artery disease, Death, Dementia, Hypoxic-ischaemic encephalopathy, Pneumonia aspiration
Clinical narrative: From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA   Died of COVID-19 illness on 06/13/2021
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test positive
Clinical narrative: From EMR: Immediate cause of death: acute hypoxemic respiratory failure (2 days from onset to death) Secondary conditions leading to death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions present at time of death: coronary artery disease, Parkinson dementia, pulmonary embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST, COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA   Died of COVID-19 illness on 06/13/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ED/Hospitalization within 6 weeks of receiving COVID vaccination.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood test, Electrocardiogram, Specialist consultation
Clinical narrative: Two weeks after the vaccine I had a sudden and extreme elevation in blood pressure. My blood pressure is always been perfect. It has come down but it is Taken 2 or 3 months for it to come down.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: ED/Hospitalization within 6 weeks of receiving COVID vaccination.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Syncope, Tilt table test
Clinical narrative: Vasovagyl Syncope
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got second shot in left arm.  To this day in a lot of pain.  Cannot even lift half gallon of milk.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chills, Headache
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Nausea, Pain, Paraesthesia, Pyrexia
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Mild, Systemic: Nausea-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Weakness-Mild
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pain, Rash
Clinical narrative: Developed rash on the tops of both feet. Small blisters, painful. Treating with calamine lotion and foot powder. So far the rash appears to be clearing on it's own.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: ED visits/Hospitalization within 6 weeks of receiving COVID vaccination. Admission 3/14, presently admitted. Second dose received 6/4.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea
Clinical narrative: Shortness of breath couldn?t breath,  heart stressed. Symptoms have gotten better after one week, but still  slightly present ten days after second dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: pt experienced dizziness and lost of hearing - husband administered epipen-Mild, Additional Details: immediately after the vaccine was administered, pt experienced dizziness and loss of hearing. husband administered pt 1 epipen and pt started to feel better. paramedics were called to the scene. they evaluated pt and vitals were wnl, breathing was wnl. pt was taken to er by ambulance. pt was conscious the entire time.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory distress syndrome, COVID-19, Death, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Died of COVID-19 illness on 06/14/2021  Immediate Cause of Death: Acute respiratory distress syndrome with respiratory failure Due To or as a Consequence Of: COVID-19 infection Interval between Onset & Death: 4 days  COD listed as ACUTE RESPIRATORY DISTRESS SYNDROME WITH RESPIRATORY FAILURE INTERVAL BETWEEN ONSET & DEATH and COVID-19 INFECTION INTERVAL BETWEEN ONSET & DEATH
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: After recieving the pfizer covid-19 vaccine, Patient briefly passed out while sitting down less than 5 minutes after the vaccine. Subsequently his mother screamed out for help, I ran over took his pulse, which was present but slightly faint, and almost used the epipen but he came back to consciousness before it was injected. Upon inital observation when I came over the patient was very pale and sweaty. We called 911 and shortly thereafter the medics took him to emergency room.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pallor, Paraesthesia, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: After recieving the pfizer covid-19 vaccine, Patient briefly passed out while sitting down less than 5 minutes after the vaccine. Subsequently his mother screamed out for help, I ran over took his pulse, which was present but slightly faint, and almost used the epipen but he came back to consciousness before it was injected. Upon inital observation when I came over the patient was very pale and sweaty. We called 911 and shortly thereafter the medics took him to emergency room.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: After recieving the pfizer covid-19 vaccine, Patient briefly passed out while sitting down less than 5 minutes after the vaccine. Subsequently his mother screamed out for help, I ran over took his pulse, which was present but slightly faint, and almost used the epipen but he came back to consciousness before it was injected. Upon inital observation when I came over the patient was very pale and sweaty. We called 911 and shortly thereafter the medics took him to emergency room.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pain, Painful respiration, Peripheral swelling
Clinical narrative: Large lump on left arm in less than 12 hours after injection, hurt to breathe, Pain everywhere, lot of pain in sides of waist and around to the back, pain in chest
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Asthma, Blood test normal, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Injection site pain  Fever Nausea  Diarrhea  Body aches  Mild asthma symptoms
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Injection site pain  Fever Nausea  Diarrhea  Body aches  Mild asthma symptoms
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Mild
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Adenocarcinoma, Aspiration pleural cavity, Asthenia, Computerised tomogram abdomen, Computerised tomogram abnormal
Clinical narrative: Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21  with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions.  Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion.  It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment.  He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home.  There was no fever no hemoptysis chest pain or pleuritic pain.   Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen.  He had a CT of the abdomen and pelvis which was negative for any malignant spread.  Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Cytology abnormal, Dyspnoea, Histology abnormal, Hypophagia
Clinical narrative: Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21  with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions.  Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion.  It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment.  He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home.  There was no fever no hemoptysis chest pain or pleuritic pain.   Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen.  He had a CT of the abdomen and pelvis which was negative for any malignant spread.  Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Increased bronchial secretion, Pleural effusion, Pneumonia
Clinical narrative: Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21  with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions.  Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion.  It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment.  He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home.  There was no fever no hemoptysis chest pain or pleuritic pain.   Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen.  He had a CT of the abdomen and pelvis which was negative for any malignant spread.  Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose of COVID vaccine administered
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test, Chills, Contusion, Fatigue, Helicobacter test negative
Clinical narrative: severe fatigue, fever chills within 24 hrs lasting 2 days after second dose fatigue, bruises, petechiae after second vaccine diagnosed with ITP on 5-20-21
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: severe fatigue, fever chills within 24 hrs lasting 2 days after second dose fatigue, bruises, petechiae after second vaccine diagnosed with ITP on 5-20-21
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blister, Rash, Rash pruritic
Clinical narrative: Blisters and severe rash on arms and legs,  itchy, red  and white. After second dose, rash spread to chest and under arms.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site soreness persists six months after vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood sodium decreased, Diarrhoea, Dyspepsia
Clinical narrative: Admitted from ED on 7/8/21 with c/o nausea, diarrhea, body aches, headache, SOB, malaise, diffuse muscle cramps.  Headache on L side worsening.  Also c/o heartburn
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Malaise, Muscle spasms, Nausea
Clinical narrative: Admitted from ED on 7/8/21 with c/o nausea, diarrhea, body aches, headache, SOB, malaise, diffuse muscle cramps.  Headache on L side worsening.  Also c/o heartburn
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, White blood cell count increased
Clinical narrative: Admitted from ED on 7/8/21 with c/o nausea, diarrhea, body aches, headache, SOB, malaise, diffuse muscle cramps.  Headache on L side worsening.  Also c/o heartburn
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Tinnitus
Clinical narrative: Mild tinnitus  has become much more severe with occasional earaches. Still ongoing 2 months after first vaccine.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose of Covid-19 vaccine administered
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest pain, Dizziness, Dyspnoea, Hyperhidrosis
Clinical narrative: Initially, some dizziness, racing heart and shortness of breath within half an hour of shot. We thought it could be because of my alcohol sensitivity, which causes similar feelings when inhaled. Nurses said I could try getting fresh air. I stood outside for 15 minutes and started to feel better, except for the racing heart beat.  I went home.  A few hours later, the racing heart beat came back and was worse. I had mild chest pain, an itching arm and was sweating. I called a help line and was told that can happen sometimes and that it was okay to take Tylenol now, so I did.   The next day my heart was racing worse. I used a blood pressure cuff and checked my pulse rate. My BP was 181/90, which is high for me, especially on the linsopril. My pulse rate was 101 BPM. I also developed a fever and a painful and itchy rash on my arm. When I called the advice line they said that was still within non-emergency range. It went on like this for two weeks.   When I saw a doctor for something else, I mentioned all of it and they said I may be allergic to the shot. I was given prednisone for symptoms related to Lupus and my swollen arm. I was told I could get the second shot a f little later than originally planned.  However, even with prednisone and a pulse rate back down to 88 (high for me), I continue to have chest pains off and on. The swollen arm with a weird rash lasted for 5 weeks. I have to have a scan with contrast dye to monitor my brain tumor and insurance won?t approve them doing both at once, so still trying to schedule a look at my heart.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling, Pyrexia, Rash, Rash pruritic
Clinical narrative: Initially, some dizziness, racing heart and shortness of breath within half an hour of shot. We thought it could be because of my alcohol sensitivity, which causes similar feelings when inhaled. Nurses said I could try getting fresh air. I stood outside for 15 minutes and started to feel better, except for the racing heart beat.  I went home.  A few hours later, the racing heart beat came back and was worse. I had mild chest pain, an itching arm and was sweating. I called a help line and was told that can happen sometimes and that it was okay to take Tylenol now, so I did.   The next day my heart was racing worse. I used a blood pressure cuff and checked my pulse rate. My BP was 181/90, which is high for me, especially on the linsopril. My pulse rate was 101 BPM. I also developed a fever and a painful and itchy rash on my arm. When I called the advice line they said that was still within non-emergency range. It went on like this for two weeks.   When I saw a doctor for something else, I mentioned all of it and they said I may be allergic to the shot. I was given prednisone for symptoms related to Lupus and my swollen arm. I was told I could get the second shot a f little later than originally planned.  However, even with prednisone and a pulse rate back down to 88 (high for me), I continue to have chest pains off and on. The swollen arm with a weird rash lasted for 5 weeks. I have to have a scan with contrast dye to monitor my brain tumor and insurance won?t approve them doing both at once, so still trying to schedule a look at my heart.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Muscular weakness, Nervousness, Pallor, Seizure
Clinical narrative: After vaccination, patient stood up and walked around the room. She started bouncing and acting a little nervous. I asked if she was feeling light headed woozy, she said a little bit. I sat her back in the chair. After about 30 seconds she fell sideways to the arm of the chair then slouched forward. I caught her before she went all the way to the floor and leaned her back into the chair, she then seized for approximately 3-5 seconds. Grandpa (legal guardian) was in the room and helped me get her to the floor where she came out for a few seconds and opened her eyes for 5-10 seconds passed out again then seized again for 3-5 seconds. She then woke up on the floor and was alert and looking around.  She was very pale, I elevated her feet for a while and had her lay on the floor for 7-10 minutes.  I then had her sit up on the floor and provided a bottle of water and put cold compress on the back of her neck.  She stayed seated on the floor for about 5-7 minutes before I had her move to the chair to sit again with back against the back of the chair. She continued to sit there sipping water and talking for 7 minutes or so. Learned at this point that patient had not eaten breakfast and has passed out after a vaccination in the past (had not marked on the intake form). After 7 minutes or so, had the patient try to stand. She said her legs were wobbly, so I had her sit back down for several more minutes. Her coloring was much better at this point.  After another several minutes we tried standing again and she felt better at that point. Had her just stand in the room for about 3 minutes before walking to the waiting room. Had her then sit in the waiting room for 5 minutes then she walked out with grandpa. They were going to get breakfast. Grandpa was going to call MD to discuss the events and follow up as necessary as well as to discuss plan going forward concerning the second dose.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: After vaccination, patient stood up and walked around the room. She started bouncing and acting a little nervous. I asked if she was feeling light headed woozy, she said a little bit. I sat her back in the chair. After about 30 seconds she fell sideways to the arm of the chair then slouched forward. I caught her before she went all the way to the floor and leaned her back into the chair, she then seized for approximately 3-5 seconds. Grandpa (legal guardian) was in the room and helped me get her to the floor where she came out for a few seconds and opened her eyes for 5-10 seconds passed out again then seized again for 3-5 seconds. She then woke up on the floor and was alert and looking around.  She was very pale, I elevated her feet for a while and had her lay on the floor for 7-10 minutes.  I then had her sit up on the floor and provided a bottle of water and put cold compress on the back of her neck.  She stayed seated on the floor for about 5-7 minutes before I had her move to the chair to sit again with back against the back of the chair. She continued to sit there sipping water and talking for 7 minutes or so. Learned at this point that patient had not eaten breakfast and has passed out after a vaccination in the past (had not marked on the intake form). After 7 minutes or so, had the patient try to stand. She said her legs were wobbly, so I had her sit back down for several more minutes. Her coloring was much better at this point.  After another several minutes we tried standing again and she felt better at that point. Had her just stand in the room for about 3 minutes before walking to the waiting room. Had her then sit in the waiting room for 5 minutes then she walked out with grandpa. They were going to get breakfast. Grandpa was going to call MD to discuss the events and follow up as necessary as well as to discuss plan going forward concerning the second dose.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed  (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tachycardia, Tremor
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: patient describes shakiness, anxiety, swelling under and around arm, and pain. Reports taking 600 mg ibuprofen on tues and wed  (600 mg po bid on Tues and Wed) "went away a bit and came back a little bit"
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose of Covid-19 dose administered
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I received a call from the a representative at the Pharmacy stating that the had given an EXPIRED Vaccine to my daughter. He wanted us to come back into the store and get another shot. I was so unset. I need minute to get my self together. He went on to say that i could bring her back in 6/8/2021 the same day of the expired vaccine was given. However, he would recommend that I give it a day or two before  bringing her back in. Also, while on the call he did apologize and said that the best thing he could is offer me a GIFT CARD!!. I felt to say that to a parent who?s daughter was just given an expired vaccines was totally unprofessional and insulting.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Impaired work ability
Clinical narrative: I had abdominal pain and diarrhea about two weeks post vaccination. The abdominal pain lasted maybe three days or so. The diarrhea lasted about 3-4 days as well actually. I was also a little fatigued, and that's all I can remember right now. I was self-medicating and did leave work one of the days, I went home sick. I still occasionally have abdominal pain. I contacted the doctor but received no medications or care.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Visual Changes/Disturbances-Severe
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Clostridium difficile colitis, Clostridium test positive, Colitis, Computerised tomogram abdomen, Computerised tomogram abnormal
Clinical narrative: Patient is a 76-year-old male with a past medical history significant for dementia, CVA 5 years ago with right-sided hemiparesis, functional parapalegia/wheelchair bound, chronically aphasic, hypertension, type 2 diabetes which is diet controlled and history of BPH who presented to the emergency room on 1/26/2021 with diarrhea that began on jan 18th 2021 and was admitted to the hospital..  Patient spouse reported that the patient got his first dose of the Moderna vaccine on January 14 and then the patient began having a fever on January 18 of 103 degrees and then developed diarrhea which continued.  He was started on Imodium by his PCP on 121 with minimal results and was encouraged to follow a brat diet.  He was then encouraged by the PCP to come to the ER for further evaluation of dehydration or colitis.  Patient was on  trimethoprim 100 mg daily for chronic UTIs which was discontinued on admission and therafter.  In the ER he tested positive for C. difficile and he was started on vancomycin p.o. 4 times daily.  He was also noted to be hypotensive and dehydrated and was started on IV fluids.  He remained in the hospital for 4 days and was discharged home on 1/30/21 on vancomycin orally for 10 days with improvement. . He returned back to the hospital on 3/17-3/19 for recurrent c difficile, sepsis and colitis and was discharged on a prolonged vancomycin taper with improvement. He returned back to the hospital from 6/26-7/2 for again c difficile colitis, ileus and sepsis and was seen by infectious disease and gastroenterology and was discharged home on vancomycin orally qid for a prolonged taper. If he again fails this treatment the plan will be for a fecal transplant. He was again admitted on 7/6/21 and remains hospitalized with severe c difficile colitis/diarrhea not responsive to treatment. Now having some streaks of blood in stool. Stool occult blood was neg on admission, however. Also now has concurrent Pseudomonas UTI.  CT abd/pelvis 7/7 showed "Marked irregular thickening of the wall of the rectum demonstrating cystic changes. Findings extend into the distal sigmoid colon. Differential diagnosis includes severe protosigmoiditis and neoplasm." and "increased feces throughout the colon consistent with constipation." Pt has been having 2-3 watery BM's per day since admission.  Infectious disease  concerned about possible undiagnosed malignancy, which may be driving his clinical picture rather than C diff. Recommended colonoscopy and to continue PO vanc x 10 days then resume taper. -pt was transferred to hospital for GI involvement for a colonoscopy/sigmoidoscopy on 7/8/21 where he remains hospitalized awaiting further work up.