chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Intensive care, Oral herpes, Oxygen saturation decreased, Pneumomediastinum
Clinical narrative: Patient is DECEASED.  Hospitalized 1.30.22 - 3.14.22 (died).  COVID-19 positive (2.3.22).  Fully vaccinated (no booster) Discharge Provider: Withheld Primary Care Physician at Discharge: Withheld Admission Date: 1/30/2022 Date of Death: 3/14/22 Time of Death:  5:47 PM Preliminary Cause of Death: Respiratory failure with hypoxia  Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure  Pneumonia of both lungs due to infectious organism, unspecified part of lung  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present Acute respiratory failure with hypoxia  HOSPITAL COURSE: Patient is a 74 year old female with past medical history significant for stage IV mantle cell lymphoma diagnosed 12/2019 on maintenance Rituxan, PVT on Xarelto, prior ESBL UTI, history of colovaginal fistula s/p sigmoid colectomy. She initially tested positive for COVID 12/14 and was treated with monoclonals without hospitalization. She was admitteed1/23-1/25 with leg pain and was found to be hypoxic - treated as possible pneumonia. She presented to the ED 1/30 with progressive SOB/dyspnea. Initial CTA w/o PE but did show patchy GGO through bilateral lung fields and new bronchiectasis involving RML and lung bases, and newly identified centrilobular emphysema. She was treated with broad spectrum antibiotics. She underwent bronchoscopy 2/3 - COVID positive on film array otherwise infectious workup negative. She had progressive worsening of oxygen needs progressing to HFNC. Repeat CTA 2/9 with worsening airspace disease. Repeat CTA again on 2/17 without remarkable changes. Patient transferred to the ICU 2/20 for worsening oxygen requirements. Failed HFNC and NRB with desaturations to 60% and was intubated 2/22 and subsequently paralyzed for vent dyssynchrony. Her course was complicated by AKI with hyperkalemia which improved with supportive care. Paralytic gtt was stopped 2/25.  Liver US with dopplers 2/26 showed cirrhotic morphology with sequela of portal hypertension and negative for PV thrombus. Doppler US on 3/3 (+) for left peroneal vein DVT. Lip lesions (+) for HSV. Trach placed 3/9, PEG placed 3/10. 3/11 echo was normal, although study was limited. Course now complicated by pneumomomediastinum with extensive sub Q air, hypotension, hypernatremia and Enterobacter VAP. Family mtng today with Dr. explaining clinical course as well as new VAP and pneumomediastinum.  Family was in agreement to transition to comfort care at this time.  Pt passed peacefully at 1747.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Pneumonia bacterial, Portal hypertension, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is DECEASED.  Hospitalized 1.30.22 - 3.14.22 (died).  COVID-19 positive (2.3.22).  Fully vaccinated (no booster) Discharge Provider: Withheld Primary Care Physician at Discharge: Withheld Admission Date: 1/30/2022 Date of Death: 3/14/22 Time of Death:  5:47 PM Preliminary Cause of Death: Respiratory failure with hypoxia  Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure  Pneumonia of both lungs due to infectious organism, unspecified part of lung  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present Acute respiratory failure with hypoxia  HOSPITAL COURSE: Patient is a 74 year old female with past medical history significant for stage IV mantle cell lymphoma diagnosed 12/2019 on maintenance Rituxan, PVT on Xarelto, prior ESBL UTI, history of colovaginal fistula s/p sigmoid colectomy. She initially tested positive for COVID 12/14 and was treated with monoclonals without hospitalization. She was admitteed1/23-1/25 with leg pain and was found to be hypoxic - treated as possible pneumonia. She presented to the ED 1/30 with progressive SOB/dyspnea. Initial CTA w/o PE but did show patchy GGO through bilateral lung fields and new bronchiectasis involving RML and lung bases, and newly identified centrilobular emphysema. She was treated with broad spectrum antibiotics. She underwent bronchoscopy 2/3 - COVID positive on film array otherwise infectious workup negative. She had progressive worsening of oxygen needs progressing to HFNC. Repeat CTA 2/9 with worsening airspace disease. Repeat CTA again on 2/17 without remarkable changes. Patient transferred to the ICU 2/20 for worsening oxygen requirements. Failed HFNC and NRB with desaturations to 60% and was intubated 2/22 and subsequently paralyzed for vent dyssynchrony. Her course was complicated by AKI with hyperkalemia which improved with supportive care. Paralytic gtt was stopped 2/25.  Liver US with dopplers 2/26 showed cirrhotic morphology with sequela of portal hypertension and negative for PV thrombus. Doppler US on 3/3 (+) for left peroneal vein DVT. Lip lesions (+) for HSV. Trach placed 3/9, PEG placed 3/10. 3/11 echo was normal, although study was limited. Course now complicated by pneumomomediastinum with extensive sub Q air, hypotension, hypernatremia and Enterobacter VAP. Family mtng today with Dr. explaining clinical course as well as new VAP and pneumomediastinum.  Family was in agreement to transition to comfort care at this time.  Pt passed peacefully at 1747.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tracheostomy, Ultrasound Doppler abnormal, Ultrasound liver abnormal
Clinical narrative: Patient is DECEASED.  Hospitalized 1.30.22 - 3.14.22 (died).  COVID-19 positive (2.3.22).  Fully vaccinated (no booster) Discharge Provider: Withheld Primary Care Physician at Discharge: Withheld Admission Date: 1/30/2022 Date of Death: 3/14/22 Time of Death:  5:47 PM Preliminary Cause of Death: Respiratory failure with hypoxia  Discharge Disposition: Deceased DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure  Pneumonia of both lungs due to infectious organism, unspecified part of lung  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present Acute respiratory failure with hypoxia  HOSPITAL COURSE: Patient is a 74 year old female with past medical history significant for stage IV mantle cell lymphoma diagnosed 12/2019 on maintenance Rituxan, PVT on Xarelto, prior ESBL UTI, history of colovaginal fistula s/p sigmoid colectomy. She initially tested positive for COVID 12/14 and was treated with monoclonals without hospitalization. She was admitteed1/23-1/25 with leg pain and was found to be hypoxic - treated as possible pneumonia. She presented to the ED 1/30 with progressive SOB/dyspnea. Initial CTA w/o PE but did show patchy GGO through bilateral lung fields and new bronchiectasis involving RML and lung bases, and newly identified centrilobular emphysema. She was treated with broad spectrum antibiotics. She underwent bronchoscopy 2/3 - COVID positive on film array otherwise infectious workup negative. She had progressive worsening of oxygen needs progressing to HFNC. Repeat CTA 2/9 with worsening airspace disease. Repeat CTA again on 2/17 without remarkable changes. Patient transferred to the ICU 2/20 for worsening oxygen requirements. Failed HFNC and NRB with desaturations to 60% and was intubated 2/22 and subsequently paralyzed for vent dyssynchrony. Her course was complicated by AKI with hyperkalemia which improved with supportive care. Paralytic gtt was stopped 2/25.  Liver US with dopplers 2/26 showed cirrhotic morphology with sequela of portal hypertension and negative for PV thrombus. Doppler US on 3/3 (+) for left peroneal vein DVT. Lip lesions (+) for HSV. Trach placed 3/9, PEG placed 3/10. 3/11 echo was normal, although study was limited. Course now complicated by pneumomomediastinum with extensive sub Q air, hypotension, hypernatremia and Enterobacter VAP. Family mtng today with Dr. explaining clinical course as well as new VAP and pneumomediastinum.  Family was in agreement to transition to comfort care at this time.  Pt passed peacefully at 1747.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster, Lip blister, Migraine
Clinical narrative: High fever first 48 hours / migraine. Then developed shingles blisters on my chest. A patch of about 8. Today noticed two shingles blisters under my lip.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High fever first 48 hours / migraine. Then developed shingles blisters on my chest. A patch of about 8. Today noticed two shingles blisters under my lip.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture, Blood pressure abnormal, Brain natriuretic peptide increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is now DECEASED (3.19.22).  Hospitalized 3.12.22 - 3.17.22.  COVID-19 positive (3.12.22).  Fully vaccinated PLUS booster.   Admission Date: 3/12/2022 Discharge Date: Mar 17, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia Pneumonia of both lower lobes due to infectious organism  Sepsis without acute organ dysfunction, due to unspecified organism (HCC) HOSPITAL COURSE: Patient is a 88 y.o. male who presented to the ED with shortness of breath. He was hospitalized at Hospital at the end of January with COVID pneumonia and again hospitalized at Hospital 3/2-3/5 for a fall and pneumonia. His admission CXR showed right lower lobe and ligula pneumonia. He was treated with a 5 day course of rocephin/azithro as well as PO prednisone for COPD exacerbation. At discharge he was sent to other facility for SAR and his lasix was held due to soft blood pressures. Over the last 3 days he had been feeling worse with increased cough and shortness of breath.  In the ED the patient had labs showing leukocytosis, elevated procalcitonin at 0.37, an elevated BNP at 8989. He was hypoxic on arrival and required supplemental oxygen at 2L. He had a CXR showing severe airspace disease in the right lung and left lower lobe concerning for pneumonia. The patient had blood cultures obtained and was started on vanco, cefepime and azithro due to his recent IV antibiotic treatment. He was admitted to the hospitalist team for admission and further management.  Broad spectrum antibiotics were continued.  Patient was evaluated by Medical nutrition and recommendations were followed.  PT/OT evaluated advised SNF.  SLP evaluated and recommended close supervision but did not advise any dietary adjustments.  Discussed with daughter regarding clinical picture and patient has expressed not wanting further treatment.  Daughter/MD advised transition patient to comfort care.  On board arrange for discharge back to Assisted Living and life circles to navigate hospice and outpatient equipment. Patient clinically improved and hemodynamically stable for discharge.  Patient and daughter voiced understanding was agreeable with plan of care discharge.  She also expressed the desire for him to have no further testing or returns to the ED or hospital.  We reviewed his home medications and discontinued any medications which did not directly result in symptom management.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chronic obstructive pulmonary disease, Condition aggravated, Cough, Death
Clinical narrative: Patient is now DECEASED (3.19.22).  Hospitalized 3.12.22 - 3.17.22.  COVID-19 positive (3.12.22).  Fully vaccinated PLUS booster.   Admission Date: 3/12/2022 Discharge Date: Mar 17, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia Pneumonia of both lower lobes due to infectious organism  Sepsis without acute organ dysfunction, due to unspecified organism (HCC) HOSPITAL COURSE: Patient is a 88 y.o. male who presented to the ED with shortness of breath. He was hospitalized at Hospital at the end of January with COVID pneumonia and again hospitalized at Hospital 3/2-3/5 for a fall and pneumonia. His admission CXR showed right lower lobe and ligula pneumonia. He was treated with a 5 day course of rocephin/azithro as well as PO prednisone for COPD exacerbation. At discharge he was sent to other facility for SAR and his lasix was held due to soft blood pressures. Over the last 3 days he had been feeling worse with increased cough and shortness of breath.  In the ED the patient had labs showing leukocytosis, elevated procalcitonin at 0.37, an elevated BNP at 8989. He was hypoxic on arrival and required supplemental oxygen at 2L. He had a CXR showing severe airspace disease in the right lung and left lower lobe concerning for pneumonia. The patient had blood cultures obtained and was started on vanco, cefepime and azithro due to his recent IV antibiotic treatment. He was admitted to the hospitalist team for admission and further management.  Broad spectrum antibiotics were continued.  Patient was evaluated by Medical nutrition and recommendations were followed.  PT/OT evaluated advised SNF.  SLP evaluated and recommended close supervision but did not advise any dietary adjustments.  Discussed with daughter regarding clinical picture and patient has expressed not wanting further treatment.  Daughter/MD advised transition patient to comfort care.  On board arrange for discharge back to Assisted Living and life circles to navigate hospice and outpatient equipment. Patient clinically improved and hemodynamically stable for discharge.  Patient and daughter voiced understanding was agreeable with plan of care discharge.  She also expressed the desire for him to have no further testing or returns to the ED or hospital.  We reviewed his home medications and discontinued any medications which did not directly result in symptom management.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fall, Hypoxia, Leukocytosis, Lung disorder
Clinical narrative: Patient is now DECEASED (3.19.22).  Hospitalized 3.12.22 - 3.17.22.  COVID-19 positive (3.12.22).  Fully vaccinated PLUS booster.   Admission Date: 3/12/2022 Discharge Date: Mar 17, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia Pneumonia of both lower lobes due to infectious organism  Sepsis without acute organ dysfunction, due to unspecified organism (HCC) HOSPITAL COURSE: Patient is a 88 y.o. male who presented to the ED with shortness of breath. He was hospitalized at Hospital at the end of January with COVID pneumonia and again hospitalized at Hospital 3/2-3/5 for a fall and pneumonia. His admission CXR showed right lower lobe and ligula pneumonia. He was treated with a 5 day course of rocephin/azithro as well as PO prednisone for COPD exacerbation. At discharge he was sent to other facility for SAR and his lasix was held due to soft blood pressures. Over the last 3 days he had been feeling worse with increased cough and shortness of breath.  In the ED the patient had labs showing leukocytosis, elevated procalcitonin at 0.37, an elevated BNP at 8989. He was hypoxic on arrival and required supplemental oxygen at 2L. He had a CXR showing severe airspace disease in the right lung and left lower lobe concerning for pneumonia. The patient had blood cultures obtained and was started on vanco, cefepime and azithro due to his recent IV antibiotic treatment. He was admitted to the hospitalist team for admission and further management.  Broad spectrum antibiotics were continued.  Patient was evaluated by Medical nutrition and recommendations were followed.  PT/OT evaluated advised SNF.  SLP evaluated and recommended close supervision but did not advise any dietary adjustments.  Discussed with daughter regarding clinical picture and patient has expressed not wanting further treatment.  Daughter/MD advised transition patient to comfort care.  On board arrange for discharge back to Assisted Living and life circles to navigate hospice and outpatient equipment. Patient clinically improved and hemodynamically stable for discharge.  Patient and daughter voiced understanding was agreeable with plan of care discharge.  She also expressed the desire for him to have no further testing or returns to the ED or hospital.  We reviewed his home medications and discontinued any medications which did not directly result in symptom management.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Procalcitonin increased, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is now DECEASED (3.19.22).  Hospitalized 3.12.22 - 3.17.22.  COVID-19 positive (3.12.22).  Fully vaccinated PLUS booster.   Admission Date: 3/12/2022 Discharge Date: Mar 17, 2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia Pneumonia of both lower lobes due to infectious organism  Sepsis without acute organ dysfunction, due to unspecified organism (HCC) HOSPITAL COURSE: Patient is a 88 y.o. male who presented to the ED with shortness of breath. He was hospitalized at Hospital at the end of January with COVID pneumonia and again hospitalized at Hospital 3/2-3/5 for a fall and pneumonia. His admission CXR showed right lower lobe and ligula pneumonia. He was treated with a 5 day course of rocephin/azithro as well as PO prednisone for COPD exacerbation. At discharge he was sent to other facility for SAR and his lasix was held due to soft blood pressures. Over the last 3 days he had been feeling worse with increased cough and shortness of breath.  In the ED the patient had labs showing leukocytosis, elevated procalcitonin at 0.37, an elevated BNP at 8989. He was hypoxic on arrival and required supplemental oxygen at 2L. He had a CXR showing severe airspace disease in the right lung and left lower lobe concerning for pneumonia. The patient had blood cultures obtained and was started on vanco, cefepime and azithro due to his recent IV antibiotic treatment. He was admitted to the hospitalist team for admission and further management.  Broad spectrum antibiotics were continued.  Patient was evaluated by Medical nutrition and recommendations were followed.  PT/OT evaluated advised SNF.  SLP evaluated and recommended close supervision but did not advise any dietary adjustments.  Discussed with daughter regarding clinical picture and patient has expressed not wanting further treatment.  Daughter/MD advised transition patient to comfort care.  On board arrange for discharge back to Assisted Living and life circles to navigate hospice and outpatient equipment. Patient clinically improved and hemodynamically stable for discharge.  Patient and daughter voiced understanding was agreeable with plan of care discharge.  She also expressed the desire for him to have no further testing or returns to the ED or hospital.  We reviewed his home medications and discontinued any medications which did not directly result in symptom management.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID infection
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mechanical urticaria, Pruritus, Urticaria
Clinical narrative: I received my booster shot of the Moderna Vaccine on 11/28/21 and my adverse symptoms started on 12/16/21. In the morning of 12/16/21, I woke up with an unbearably itchy scalp that lasted the entire day with no moments of relief. It wasn't until I took one of my relatives prescribed antihistamines that I got some sort of relief. The extreme itchiness moved in huge, hive like patches around my body for at least one week. My primary care physician prescribed me my own antihistamines; one for the morning (Loratadine)  and one for the evening (Hydroxyzine). After that dreadful first week, my body developed dermatographia and presented several patches of itchy hives at all hours of the day. I continued to have recurring flare-ups that transitioned into half of them being itchy and the other half non-itchy red streaks. Showers and exercising made the condition worse. Scratching and prolonged pressure triggers the uticaria. Itchiness has improved with the antihistamine treatment but can still feel at times itching under the skin but bearable enough to not have to itch it. I still have the occasional hives and definitely still have the uticaria/dermatographia. I am writing this on 3/22/22 and am still taking the antihistamines in addition to vitamin C (1,000 mg) everyday and vitamin D3 (2000IU) everyday since the start of the symptoms.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin abrasion, Skin exfoliation, Wound
Clinical narrative: After 2 days I began to see circular abrasion that looked like calluses on my hands. Days later they began to spread and open up.  Then I more severe circular abrasions on my chest breast and stomach area. Then uncontrollable peeling of my hands and feet.  Extreme itching all over my whole body.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Balance disorder, Deafness, Dizziness, Ear discomfort
Clinical narrative: Vertigo, dizziness began and was treated with Meclizine 25.  Vertigo/dizziness, vomiting, difficult walking continued for about 3 hours until after taking meclizine.  Meclizine resulting in sleeping upon the next day symptoms were gone.  Similar events occurred after the second vaccination which was received on 04/13/21.  Meclizine was taken and the symptoms were gone.  However, balance issues, fullness in ears and ear ringing occurred.  ENT visit resulted in detection of hearing loss and tinnitus.  As of 3/22/2022 tinnitus is present in both ears and is continuous.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Electronystagmogram, Gait disturbance, Tinnitus, Vertigo, Vomiting
Clinical narrative: Vertigo, dizziness began and was treated with Meclizine 25.  Vertigo/dizziness, vomiting, difficult walking continued for about 3 hours until after taking meclizine.  Meclizine resulting in sleeping upon the next day symptoms were gone.  Similar events occurred after the second vaccination which was received on 04/13/21.  Meclizine was taken and the symptoms were gone.  However, balance issues, fullness in ears and ear ringing occurred.  ENT visit resulted in detection of hearing loss and tinnitus.  As of 3/22/2022 tinnitus is present in both ears and is continuous.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Oedema peripheral, Skin discolouration, Tenderness
Clinical narrative: sore to touch (day 1), swelling under arm upon waking (day2), burning under arm (day3),black and blue spot under arm, and yellow/red area under arm later in day (day 4).
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Erythema, Pruritus, Rash macular, Skin warm
Clinical narrative: Nothing at the time, but a few days later - developed serious itchiness over the entire body and redness.  Presently, experiencing chronic spontaneous urticaria daily on my arms and hands. This occurs at nighttime, where I initially become very itchy and then develop macular wheels that flare and are warm. T
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Nothing at the time, but a few days later - developed serious itchiness over the entire body and redness.  Presently, experiencing chronic spontaneous urticaria daily on my arms and hands. This occurs at nighttime, where I initially become very itchy and then develop macular wheels that flare and are warm. T
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Urticaria
Clinical narrative: Approximately 10 days after receiving the booster of the Moderna Covid vaccine, I suddenly broke out in hives. This first occurred during the evening hours. Hives were on my face, neck, wrists and torso. I took Benadryl and thought it might be a reaction to being upset. Since that evening, I will break out in hives every 24 hours primarily on my hands, fingers, feet and torso. If I take Zyrtec, I can avoid the daily case of hives. If I skip or forget the Zyrtec, then the hives return at the 24 hour mark. Reactions almost always occur during the evening hours. From my research, this is called chronic spontaneous urticaria. There are many documented cases of this after the COVID 19 booster.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Experienced extreme soar arm pain at 8pm out of no where, followed by body chills, and by day 3 I ended up with really bad painful case of diarrhea. Leaving me with loss of appetite and unable to tolerate any sort of fluids.   The second dose left me with 15 minutes of having it and standing up with fatigue, dizziness, I had two month of my mental periods ending up 10 days late and came back with vengeance. I also noticed that I ended up with green boogers when I blow my nose. As well as a fatigue that I can not keep my eyes open for very long. I was doing better with out the vaccine. I can no longer do my make up and have difficulty to brush my teeth at night.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dyschezia, Fatigue, Fluid intake reduced, Loss of personal independence in daily activities, Menstruation delayed
Clinical narrative: Experienced extreme soar arm pain at 8pm out of no where, followed by body chills, and by day 3 I ended up with really bad painful case of diarrhea. Leaving me with loss of appetite and unable to tolerate any sort of fluids.   The second dose left me with 15 minutes of having it and standing up with fatigue, dizziness, I had two month of my mental periods ending up 10 days late and came back with vengeance. I also noticed that I ended up with green boogers when I blow my nose. As well as a fatigue that I can not keep my eyes open for very long. I was doing better with out the vaccine. I can no longer do my make up and have difficulty to brush my teeth at night.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal mucosal discolouration, Pain in extremity, Secretion discharge
Clinical narrative: Experienced extreme soar arm pain at 8pm out of no where, followed by body chills, and by day 3 I ended up with really bad painful case of diarrhea. Leaving me with loss of appetite and unable to tolerate any sort of fluids.   The second dose left me with 15 minutes of having it and standing up with fatigue, dizziness, I had two month of my mental periods ending up 10 days late and came back with vengeance. I also noticed that I ended up with green boogers when I blow my nose. As well as a fatigue that I can not keep my eyes open for very long. I was doing better with out the vaccine. I can no longer do my make up and have difficulty to brush my teeth at night.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Chest discomfort, Dyspnoea, Hypoaesthesia, Muscle spasms
Clinical narrative: Arrhythmia, shortness of breath, pounding in the chest, cramps and numbness in the legs.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody, Blood test, Full blood count, Histamine level, Mechanical urticaria
Clinical narrative: Received Moderna booster on December 8. Developed dermatographic urticaria on December 23. Dermatographic urticaria has persisted since December 23 and is ongoing. Consulted with both a dermatologist and an allergist. Allergist advised that she had seen many patients with this reaction, specifically to the COVID-19 booster. Treatment plan is Zyrtec 10mg BID until hives resolve.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thyroid function test
Clinical narrative: Received Moderna booster on December 8. Developed dermatographic urticaria on December 23. Dermatographic urticaria has persisted since December 23 and is ongoing. Consulted with both a dermatologist and an allergist. Allergist advised that she had seen many patients with this reaction, specifically to the COVID-19 booster. Treatment plan is Zyrtec 10mg BID until hives resolve.
Age: 65.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Computerised tomogram normal, Neck mass
Clinical narrative: I found a small lump just able left clavicle while rubbing neck. Went to doctor Monday morning 12-13-2021. Got antibiotics and went for recheck on 12-23-2021. Lump still present so Doctor ordered CT scan which I had in January 2022 and results said no masses. So presumable this is either a small cyst or just enlarled lymph node from vaccine. Doctor said don't worry unless it doubles in size.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate decreased
Clinical narrative: WITHIN 48 HOURS OF MY SECOND DOSE OF THE VACCINE, MY HEART RATE DROPPED SIGNIFICANTLY. I HAVE HAD SINUS TACHYCARDIA (HIGH HEART RATE) FOR YEARS AND TAKE A BETA-BLOCKER TO SLOW MY HEART RATE DOWN. 48 HOURS AFTER MY SECOND SHOT, I FELT VERY DIZZY AND WEAK AND MY WATCH THAT MONITORS MY HEART RATE ALERTED ME THAT MY HEART RATE HAD BEEN IN THE 40'S FOR MORE THAN 10 MINUTES. WITH MY MEDICATION MY HEART WOULD NORMALLY BE IN THE HIGH 60'S-70'S SO THIS WAS QUITE A DROP FOR ME. I CONTACTED MY HEART DR WHO TOLD ME IF I COULD NOT GET MY HEART RATE UP TO AT LEAST 50 TO GO TO THE E.R. I DRANK SOME COFFEE AND WALKED UNTIL MY HEART RATE CAME UP. THIS LASTED FOR SEVERAL DAYS AND I WAS ADVISED TO CUT BACK ON MY BETA BLOCKER DOSAGE UNTIL MY HEART RATE COULD COME BACK UP. IT HAS BEEN 6 MONTHS NOW SINCE MY VACCINE AND MY HEART RATE IS STILL LOWER THAN WHAT IT WAS PRIOR TO THE SHOTS. I AM STILL ON THE REDUCED DOSE OF MY BETA-BLOCKER. WHILE IT MAY SEEAM A GOOD THING THAT MY HEART RATE HAS SLOWED, IT WAS VERY UNEXPECTED AND DANGEROUS. THE DAYS FOLLOWING MY SECOND SHOT MY HEART RATE EVEN DROPPED INTO THE 30'S. I WORRY ABOUT THIS BECAUSE WE DON NOT KNOW IF THIS IS A PERMANANT REDUCTION, OR IF MY TACHCARDIA WILL RETURN AND IF SO,WHEN? THERE WERE NO OTHER CHANGES IN MEDICATION OR LIFESTYLE THAT WOULD HAVE CAUSED THIS REDUCTION.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: 1st dose:22Dec2020;2nd dose:08Jan2021; On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size but not raised and only lasted about 1 week; On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size but not raised and only lasted about 1 week; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2021 (Lot number: EL3248) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Insulin resistance" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT; METFORMIN; CYTOMEL. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot number: EK5730,, Prev dose lot unknown=False,, Prev dose administration date=22Dec2020 , Prev dose number=1, Prev dose vaccine location=Right arm), administration date: 22Dec2020, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size", "Vaccination site erythema". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "1st dose:22Dec2020;2nd dose:08Jan2021"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "On dose 1 and 2 of Pfizer Covid vaccine, saw a much smaller red warm spot about quarter to half dollar in size but not raised and only lasted about 1 week".  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: On 02/14/21, Patient received his first COVID Moderna vaccine.  On 02/27/2021, Patient received his second dose of Moderna, 13 days from the first Moderna dose,.  Note that he was supposed to have 28 days in between (with up to a 4 day grace period). Patient received a Moderna Booster on 10/29/21. No adverse reactions were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Muscle twitching, Paraesthesia
Clinical narrative: Tingling; Muscle twitching; Ice cold feeling in veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose1, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch number: Not available/provided at time of report completion), administration date: 13Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "Tingling"; MUSCLE TWITCHING (non-serious), outcome "recovered", described as "Muscle twitching"; FEELING COLD (non-serious), outcome "recovered", described as "Ice cold feeling in veins". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: fever; feeling unwell; nausea; vomiting; administration date=Nov2021, prev dose dose number=1/administration date=14Jan2022 , dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 15:00 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Jan2022 15:00, outcome "unknown", described as "administration date=Nov2021, prev dose dose number=1/administration date=14Jan2022 , dose number=2"; PYREXIA (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "feeling unwell"; NAUSEA (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of pyrexia, malaise, nausea, vomiting.  Additional information: Reporter type was Patient. Age group was Child (2-11 Years). Facility type vaccine: Doctor's office/urgent care. No other vaccine in four weeks. No other medications in two weeks. patient did not have covid prior vaccination and No Covid tested post vaccination. No Known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: fever; feeling unwell; nausea; vomiting; administration date=Nov2021, prev dose dose number=1/administration date=14Jan2022 , dose number=2; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 15:00 (Batch/Lot number: unknown) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Jan2022 15:00, outcome "unknown", described as "administration date=Nov2021, prev dose dose number=1/administration date=14Jan2022 , dose number=2"; PYREXIA (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "fever"; MALAISE (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "feeling unwell"; NAUSEA (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "nausea"; VOMITING (non-serious) with onset 15Jan2022 19:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of pyrexia, malaise, nausea, vomiting.  Additional information: Reporter type was Patient. Age group was Child (2-11 Years). Facility type vaccine: Doctor's office/urgent care. No other vaccine in four weeks. No other medications in two weeks. patient did not have covid prior vaccination and No Covid tested post vaccination. No Known allergies and other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: 33130BA) at the age of 69 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: TINNITUS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Tinnitus left ear 6 days after 3rd vaccine (the booster) which has persisted since then"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Having follow up referrals to specialists as had impacted well being and work". The events "tinnitus left ear 6 days after 3rd vaccine (the booster) which has persisted since then" and "having follow up referrals to specialists as had impacted well being and work" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, loss of personal independence in daily activities. The patient received steroid as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Dec2021 (Lot number: 33130BA) at the age of 69 years as dose 3 (booster), single for Covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Right), administration date: 15Mar2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200, Location of injection: Arm Left), administration date: 22Feb2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: TINNITUS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Tinnitus left ear 6 days after 3rd vaccine (the booster) which has persisted since then"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Having follow up referrals to specialists as had impacted well being and work". The events "tinnitus left ear 6 days after 3rd vaccine (the booster) which has persisted since then" and "having follow up referrals to specialists as had impacted well being and work" were evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus, loss of personal independence in daily activities. The patient received steroid as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been not tested for COVID-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Grimacing, Tic
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 15:30 (Lot number: FL00070) at the age of 8 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TIC (non-serious) with onset 26Jan2022, outcome "not recovered", described as "Developed multiple motor tics". The event "developed multiple motor tics" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tic. Additional information: Patient administered bnt162b2 on 03Feb2022 08:15 (Lot number: FL00070) as dose 2, tris single for Covid-19 immunisation. Patient does not experience Covid-19 prior to vaccination, patient not tested COVID test post vaccination and not administered any other vaccine in last four weeks and no other medication in last two weeks. Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tic
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 15:30 (Lot number: FL00070) at the age of 8 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: TIC (non-serious) with onset 26Jan2022, outcome "not recovered", described as "Developed multiple motor tics". The event "developed multiple motor tics" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tic. Additional information: Patient administered bnt162b2 on 03Feb2022 08:15 (Lot number: FL00070) as dose 2, tris single for Covid-19 immunisation. Patient does not experience Covid-19 prior to vaccination, patient not tested COVID test post vaccination and not administered any other vaccine in last four weeks and no other medication in last two weeks. Follow-up attempts are completed. No further information is expected. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous thrombosis, Magnetic resonance imaging
Clinical narrative: [Pfizer Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given on 12/14/2021. On pt noticed headache on Sunday (1/16) described as generalized, aching and constant with associated photophobia and phonophobia. The headache continued, with associated daily vomiting. on 1/25 Brain MRI showed CVST. Potential etiologies include occult malignancy and exposure to the Covid 19 vaccine. This has been very rarely associated with thrombocytopenia and extensive VST, although there are very few cases in which this occurred without thrombocytopenia. Extensive venous sinus thrombosis involving the middle third and posterior third of the superior sagittal sinus, the paramedian aspects of multiple draining cortical veins at the vertex, the medial left transverses sinus the entire right transverse sinus, right sigmoid sinus, right jugular bulb and proximal right jugular vein.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Cerebral venous thrombosis, Headache, Jugular vein thrombosis, Magnetic resonance imaging head abnormal
Clinical narrative: [Pfizer Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given on 12/14/2021. On pt noticed headache on Sunday (1/16) described as generalized, aching and constant with associated photophobia and phonophobia. The headache continued, with associated daily vomiting. on 1/25 Brain MRI showed CVST. Potential etiologies include occult malignancy and exposure to the Covid 19 vaccine. This has been very rarely associated with thrombocytopenia and extensive VST, although there are very few cases in which this occurred without thrombocytopenia. Extensive venous sinus thrombosis involving the middle third and posterior third of the superior sagittal sinus, the paramedian aspects of multiple draining cortical veins at the vertex, the medial left transverses sinus the entire right transverse sinus, right sigmoid sinus, right jugular bulb and proximal right jugular vein.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Phonophobia, Photophobia, Sigmoid sinus thrombosis, Superior sagittal sinus thrombosis, Transverse sinus thrombosis
Clinical narrative: [Pfizer Vaccine] use for COVID-19 under Emergency Use Authorization (EUA): booster given on 12/14/2021. On pt noticed headache on Sunday (1/16) described as generalized, aching and constant with associated photophobia and phonophobia. The headache continued, with associated daily vomiting. on 1/25 Brain MRI showed CVST. Potential etiologies include occult malignancy and exposure to the Covid 19 vaccine. This has been very rarely associated with thrombocytopenia and extensive VST, although there are very few cases in which this occurred without thrombocytopenia. Extensive venous sinus thrombosis involving the middle third and posterior third of the superior sagittal sinus, the paramedian aspects of multiple draining cortical veins at the vertex, the medial left transverses sinus the entire right transverse sinus, right sigmoid sinus, right jugular bulb and proximal right jugular vein.