chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Dysuria, Lung consolidation, Myalgia, Nausea
Clinical narrative: Narrative COVID infection after completion of COVID vaccine series: 02/09/2021 COVID vaccine dose #1 03/02/2021 COVID vaccine dose #2 07/04/2021 Pt reported onset of decrease appetite and nausea, right-sided myalgia, and burning with urination. 07/10/2021 Pt presented to ED c/o decreased appetite, right-sided myalgia, burning with urination, and smelling cigarette smoke. Minimal non-productive cough present. Stated that has not needed to increase O2 use at home (hx of COPD). CTA showed LUL consolidation. 07/10/2021 Pt admitted to inpatient service. Decadron and Zithromax administered. 07/12/2021 MD attending reported pt no longer smelling cigarette smoke. Pt continued coughing and having right-sided myalgia. Continuation of Decadron therapy. Stated that remdesivir therapy would be initiated if pt's O2 needs increased above baseline (2L at home). 07/13/2021 MD attending reported pt experienced SOB and labored breathing above baseline (put on 3L O2). Remdesivir initiated. Continuation of Decadron therapy. Pt experienced "acute on chronic right shoulder pain" that has worsened. Ketorolac ordered. 07/13/2021 Azithromycin d/c (pt received 4 days of tx) 07/14/2021 Continuation of remdesivir therapy
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test positive
Clinical narrative: Narrative COVID infection after completion of COVID vaccine series: 02/09/2021 COVID vaccine dose #1 03/02/2021 COVID vaccine dose #2 07/04/2021 Pt reported onset of decrease appetite and nausea, right-sided myalgia, and burning with urination. 07/10/2021 Pt presented to ED c/o decreased appetite, right-sided myalgia, burning with urination, and smelling cigarette smoke. Minimal non-productive cough present. Stated that has not needed to increase O2 use at home (hx of COPD). CTA showed LUL consolidation. 07/10/2021 Pt admitted to inpatient service. Decadron and Zithromax administered. 07/12/2021 MD attending reported pt no longer smelling cigarette smoke. Pt continued coughing and having right-sided myalgia. Continuation of Decadron therapy. Stated that remdesivir therapy would be initiated if pt's O2 needs increased above baseline (2L at home). 07/13/2021 MD attending reported pt experienced SOB and labored breathing above baseline (put on 3L O2). Remdesivir initiated. Continuation of Decadron therapy. Pt experienced "acute on chronic right shoulder pain" that has worsened. Ketorolac ordered. 07/13/2021 Azithromycin d/c (pt received 4 days of tx) 07/14/2021 Continuation of remdesivir therapy
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Patient was a 80y male. Being treated outpatient and passed away at home. Cause of death is unknown. Patient received COVID vaccines on 01/07/2021 and 02/02/2021. Due to the time frame vaccinations are likely not related to the death.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: Narrative: COVID infection after completion of COVID vaccine series: 02/04/2021 COVID vaccine dose #1 02/25/2021 COVID vaccine dose #2 07/09/2021 Pt presented to ED c/o 5-day hx of SOB, fever and chills, and non-productive cough. Stated that other family members had symptoms and recent dx of COVID (close contact exposure). 07/09/2021 positive per nasopharyngeal swab 07/09/2021 Pt administered IV azithromycin and Decadron and placed on 2L NC. Attempted to be discharged, but experienced desaturation on room air. 07/09/2021 Pt admitted to inpatient service. 07/10/2021 Pharmacy approved use of remdesivir as pt met criteria. (Day 1 of 5-day course) 07/11/2021 MD attending reported pt improving symptomatically. Day 2 of remdesivir therapy. Continuation of Decadron. 07/12/2021 MD attending reported pt improving. Day 3 or remdesivir therapy. Continuation of Decadron. 07/13/2021 MD attending reported pt continued feeling better and had been off O2 support for some time in the morning but back on 2L NC. Discussed possible discharge after completion of remdesivir course. Day 4 of remdesivir therapy. Continuation of Decadron.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection after completion of COVID vaccine series: 02/04/2021 COVID vaccine dose #1 02/25/2021 COVID vaccine dose #2 07/09/2021 Pt presented to ED c/o 5-day hx of SOB, fever and chills, and non-productive cough. Stated that other family members had symptoms and recent dx of COVID (close contact exposure). 07/09/2021 positive per nasopharyngeal swab 07/09/2021 Pt administered IV azithromycin and Decadron and placed on 2L NC. Attempted to be discharged, but experienced desaturation on room air. 07/09/2021 Pt admitted to inpatient service. 07/10/2021 Pharmacy approved use of remdesivir as pt met criteria. (Day 1 of 5-day course) 07/11/2021 MD attending reported pt improving symptomatically. Day 2 of remdesivir therapy. Continuation of Decadron. 07/12/2021 MD attending reported pt improving. Day 3 or remdesivir therapy. Continuation of Decadron. 07/13/2021 MD attending reported pt continued feeling better and had been off O2 support for some time in the morning but back on 2L NC. Discussed possible discharge after completion of remdesivir course. Day 4 of remdesivir therapy. Continuation of Decadron.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: Pt was a 83yo male who was admitted to the hospital and transferred downtown, where he expired on 7/9/2021. No other information was presented. Pt received the COVID vaccines on 2/22/2021 and 3/22/2021. Vaccine unlikely to be related to cause of death.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Fatigue, Headache
Clinical narrative: Narrative: Pt received Johnson & Johnson covid vaccine 4/3/21. Next day had headache and fatigue. The next day had pain in hip sicket were old injury was. 4 days post vaccine had migraine and pain in scar tissue in right arm. 5 days post vaccine had diarrhea and abd pain which resolved.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Scar pain
Clinical narrative: Narrative: Pt received Johnson & Johnson covid vaccine 4/3/21. Next day had headache and fatigue. The next day had pain in hip sicket were old injury was. 4 days post vaccine had migraine and pain in scar tissue in right arm. 5 days post vaccine had diarrhea and abd pain which resolved.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Pneumonia bacterial, Respiratory failure
Clinical narrative: Narrative: Pt is a 81y male with a h/o CAD with PTCA over 30 years ago, Crohns disease, T2DM, Sleep apnea-no CPAP, Cervical stenosis SP ACDF 3/4-RP abscess on chronic antibiotics & obesity died on on 07/07/2021. Patient was confirmed with COVID-19 on 06/08/2021. MD notes state death was caused by hypoxic respiratory failure secondary to COVID Pneumonia and bacterial pneumonia. Pt received covid vaccines on 01/14/2021 and 02/11/2021. Covid-19 vaccination failure led to patient's covid-19 infection ultimately causing patient's death.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: Narrative: Pt is a 81y male with a h/o CAD with PTCA over 30 years ago, Crohns disease, T2DM, Sleep apnea-no CPAP, Cervical stenosis SP ACDF 3/4-RP abscess on chronic antibiotics & obesity died on on 07/07/2021. Patient was confirmed with COVID-19 on 06/08/2021. MD notes state death was caused by hypoxic respiratory failure secondary to COVID Pneumonia and bacterial pneumonia. Pt received covid vaccines on 01/14/2021 and 02/11/2021. Covid-19 vaccination failure led to patient's covid-19 infection ultimately causing patient's death.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  Pt is a 93y male w/ history of Alzheimer's Disease and Depression. Patient received the COVID vaccines on 01/08/2021 and 02/05/2021. Pt died on 5/30/2021. Due to the time frame the vaccines are not likely to be linked to the cause of death.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain, Asthenia, Cough, Dyspnoea, Flushing
Clinical narrative: Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient states he received 2 vaccines yesterday at clinic, "I got a flu vaccine and a shingles vaccine." Patient states when he got home, he developed body aches, "horrible abdominal pain", flushing, cough, wheezing. States he is worse today, "my teeth hurt today, my cheeks are swollen, and I am having some difficulty breathing, and I'm very weak." Recommended he call EMS, patient declined (see AMA disclaimer, below), "I'm only a mile away from the hospital, I will have a friend drive me to ER now."
Age: 57.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pain, Swelling face, Toothache, Wheezing
Clinical narrative: Narrative:  Patient contacted telephone triage nurse today requesting advice. Patient states he received 2 vaccines yesterday at clinic, "I got a flu vaccine and a shingles vaccine." Patient states when he got home, he developed body aches, "horrible abdominal pain", flushing, cough, wheezing. States he is worse today, "my teeth hurt today, my cheeks are swollen, and I am having some difficulty breathing, and I'm very weak." Recommended he call EMS, patient declined (see AMA disclaimer, below), "I'm only a mile away from the hospital, I will have a friend drive me to ER now."
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Heart rate increased, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Anaphylactic. immediate racing heart, shortness of breath, burning in arm, swelling and twitching of left hand, metallic taste in mouth, and after 15 minutes facial and lip swelling. Pharmacist called EMT's and gave a double dose of Benadryl orally. Allergic reaction subsided after Benadryl administered. I was advised by EMT's and Pharmacists to contact local dept. of health and be switched to a medical facility for my second dose.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Burning sensation, Dysgeusia, Dyspnoea, Hypersensitivity
Clinical narrative: Anaphylactic. immediate racing heart, shortness of breath, burning in arm, swelling and twitching of left hand, metallic taste in mouth, and after 15 minutes facial and lip swelling. Pharmacist called EMT's and gave a double dose of Benadryl orally. Allergic reaction subsided after Benadryl administered. I was advised by EMT's and Pharmacists to contact local dept. of health and be switched to a medical facility for my second dose.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Lip swelling, Muscle twitching, Palpitations, Peripheral swelling
Clinical narrative: Anaphylactic. immediate racing heart, shortness of breath, burning in arm, swelling and twitching of left hand, metallic taste in mouth, and after 15 minutes facial and lip swelling. Pharmacist called EMT's and gave a double dose of Benadryl orally. Allergic reaction subsided after Benadryl administered. I was advised by EMT's and Pharmacists to contact local dept. of health and be switched to a medical facility for my second dose.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face
Clinical narrative: Anaphylactic. immediate racing heart, shortness of breath, burning in arm, swelling and twitching of left hand, metallic taste in mouth, and after 15 minutes facial and lip swelling. Pharmacist called EMT's and gave a double dose of Benadryl orally. Allergic reaction subsided after Benadryl administered. I was advised by EMT's and Pharmacists to contact local dept. of health and be switched to a medical facility for my second dose.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I experienced numbness in the right side of my face, and it started drooping (symptoms of a stroke) starting 5 hours after the vaccine. I contacted my heart doctor the following morning and they told me to go to the emergency room to rule out a stroke. When I went, they determined I had Bell's Palsy. I was given eye patches and told to wait it out. I still don't have full vision recovery in my right eye and my upper lip on the right side is still drooping. Also, the right side of my sinuses are still affected. I'm still having intermittent nervousness that is more pronounced than before the vaccine.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blindness unilateral, Facial paralysis, Hypoaesthesia, Nervousness
Clinical narrative: I experienced numbness in the right side of my face, and it started drooping (symptoms of a stroke) starting 5 hours after the vaccine. I contacted my heart doctor the following morning and they told me to go to the emergency room to rule out a stroke. When I went, they determined I had Bell's Palsy. I was given eye patches and told to wait it out. I still don't have full vision recovery in my right eye and my upper lip on the right side is still drooping. Also, the right side of my sinuses are still affected. I'm still having intermittent nervousness that is more pronounced than before the vaccine.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Sinus disorder
Clinical narrative: I experienced numbness in the right side of my face, and it started drooping (symptoms of a stroke) starting 5 hours after the vaccine. I contacted my heart doctor the following morning and they told me to go to the emergency room to rule out a stroke. When I went, they determined I had Bell's Palsy. I was given eye patches and told to wait it out. I still don't have full vision recovery in my right eye and my upper lip on the right side is still drooping. Also, the right side of my sinuses are still affected. I'm still having intermittent nervousness that is more pronounced than before the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash that began in my leg, with itching under the skin. It then moved all over my upper body, and it turned red and was very irritating. It went up my entire side and back, up my neck, face, and even my head.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash that began in my leg, with itching under the skin. It then moved all over my upper body, and it turned red and was very irritating. It went up my entire side and back, up my neck, face, and even my head.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Feeling abnormal, Fibrin D dimer increased, Haematoma, Headache
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Migraine, Nodule, Ocular discomfort
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Scan normal
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest discomfort, Cough, Feeling abnormal, Heavy menstrual bleeding
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Interchange of vaccine products, Menstruation irregular, Pain, Pyrexia
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 12/7 Seem to have allergy issues and wrote it off because I was around a cat. 12/8 Aches and feeling strange. My period came early and heavy. 12/17 Antigen test and PCR because was going to visit someone who was immunocompromised. Took the antigen and PCR. Both my test came back positive and I had breakthru COVID. Quarantined for 10 days from first notice of issue. This ended on 12/25. OTC suggested to address fever and cough. Also was given a regimen on how to quarantine with others in house. Still have a cough and pressure in chest and have not recovered.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Echocardiogram, Intensive care, Magnetic resonance imaging, Pulmonary embolism
Clinical narrative: Presented to ED with syncope and chest pain with recent chest pain and dyspnea on exertion. Acute saddle pulmonary embolism found. Bilateral pulmonary embolectomy and PFO closure performed. Post operatively he was taken to the ICU.  His post care consisted of 5 days. Lines and CTs were Dced when criterias were met. Patient was then transferred to the step down unit and pacing wires were removed at the appropriate time.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thromboembolectomy, Ultrasound Doppler, Ultrasound scan
Clinical narrative: Presented to ED with syncope and chest pain with recent chest pain and dyspnea on exertion. Acute saddle pulmonary embolism found. Bilateral pulmonary embolectomy and PFO closure performed. Post operatively he was taken to the ICU.  His post care consisted of 5 days. Lines and CTs were Dced when criterias were met. Patient was then transferred to the step down unit and pacing wires were removed at the appropriate time.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial septal defect repair, Chest pain, Dyspnoea exertional, Intensive care, Pulmonary embolism
Clinical narrative: Presented to ED with syncope and chest pain with recent chest pain and dyspnea on exertion. Acute saddle pulmonary embolism found. Bilateral pulmonary embolectomy and PFO closure performed. Post operatively he was taken to the ICU.  His post care consisted of 5 days. Lines and CTs were Dced when criterias were met. Patient was then transferred to the step down unit and pacing wires were removed at the appropriate time.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Syncope, Thromboembolectomy
Clinical narrative: Presented to ED with syncope and chest pain with recent chest pain and dyspnea on exertion. Acute saddle pulmonary embolism found. Bilateral pulmonary embolectomy and PFO closure performed. Post operatively he was taken to the ICU.  His post care consisted of 5 days. Lines and CTs were Dced when criterias were met. Patient was then transferred to the step down unit and pacing wires were removed at the appropriate time.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Antinuclear antibody negative, Atelectasis, Blood culture negative, Cardiomegaly
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Chills, Computerised tomogram thorax abnormal, Dyspnoea
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukocytosis, Lung infiltration, Pericardial drainage, Pericardial effusion, Pyrexia
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia
Clinical narrative: Presented to ED for evaluation of shortness of breath over the last 2 weeks, progressively worsening.  Intermittent fevers and chills.  Received Pfizer vaccine #1 about 5 days prior to onset of symptoms.  Has had multiple negative Covid tests since that time. Fever dyspnea and tachycardia with work-up initiated from intake.  CTA chest has been ordered which demonstrates no PE but concern for pericardial effusion and pleural effusions. Chest x-ray revealed enlarged cardiac silhouette with bibasilar infiltrates versus atelectasis.  CT scan of the chest revealed no evidence of pulmonary embolism but was notable for large pericardial effusion. Pericardiocentesis performed and patient discharged. Patient presented to ED again on 9/30/21 with chest pain or shortness of breath. He was found have moderate size pericardial effusion.  No evidence of tamponade.  He was febrile with a leukocytosis.  Placed on antibiotics.  Cardiology was consulted and started on a prednisone taper.  Fevers resolved.  Leukocytosis improved.  No source of infection was identified and blood cultures were negative at 48 hours of antibiotics were discontinued.  Also sent ANA/autoimmune work-up which was also negative prior to discharge.  Advised to follow-up with cardiology in the next 1 to 2 weeks.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Magnetic resonance imaging
Clinical narrative: dizzy; cannot walk; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 14Dec2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 91-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 13:00 (Lot number: EN6198) as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose- 1st; Date- 30Jan2021, Time- 2 PM; Anatomical site of injection: Left arm; Batch/ Lot number: EL9264), administration date: 30Jan2021, for COVID-19 immunization. The following information was reported: DIZZINESS (disability) with onset 22Feb2021, outcome "not recovered", described as "dizzy"; GAIT DISTURBANCE (non-serious) with onset 22Feb2021, outcome "not recovered", described as "cannot walk". The events "dizzy" and "cannot walk" were evaluated at the physician office visit. The events were described as follows: The patient had the second shot the 2nd week of Feb2021. Three days later (as reported), she was very dizzy. Now 10 months later, she continued being extremely dizzy. The patient stated that dizziness was listed as one of the side effects of the vaccine and asked if a way to counteract this has been found. She has been to several different doctors none of whom have been able to help. The dizziness was at a point now where she cannot walk without a walker to keep from falling. It has taken over my life to the point that she has to just sit most of the time to avoid a fall. The patient asked what she can do to stop the dizziness. The patient reported that  two days after the and Pfizer vaccine for Covid 19 she got dizzy. The dizziness was constant / continuous and does not stop. It was debilitating. She cannot walk without assistance and cannot live her life as she was used to. She has had 3 MRIs to determine cause of dizziness and all have come back with normal results. She believed the vaccine has poisoned her. She has gone to the ENT and they have determined it was not crystals in her ears. She has visited the eye doctors and nothing there. Her neurologist was stumped. She just wanted her life back. Seriousness criteria: Persistent/significant disability/ incapacity (as reported). The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (27Aug2021) normal; (05Sep2021) normal; (16Oct2021) normal. Therapeutic measures were taken as a result of dizziness, gait disturbance reported as "MRIs continuous dizziness from this date on".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Magnetic resonance imaging
Clinical narrative: dizzy; cannot walk; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 14Dec2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 91-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Feb2021 13:00 (Lot number: EN6198) as dose 2, single for COVID-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose- 1st; Date- 30Jan2021, Time- 2 PM; Anatomical site of injection: Left arm; Batch/ Lot number: EL9264), administration date: 30Jan2021, for COVID-19 immunization. The following information was reported: DIZZINESS (disability) with onset 22Feb2021, outcome "not recovered", described as "dizzy"; GAIT DISTURBANCE (non-serious) with onset 22Feb2021, outcome "not recovered", described as "cannot walk". The events "dizzy" and "cannot walk" were evaluated at the physician office visit. The events were described as follows: The patient had the second shot the 2nd week of Feb2021. Three days later (as reported), she was very dizzy. Now 10 months later, she continued being extremely dizzy. The patient stated that dizziness was listed as one of the side effects of the vaccine and asked if a way to counteract this has been found. She has been to several different doctors none of whom have been able to help. The dizziness was at a point now where she cannot walk without a walker to keep from falling. It has taken over my life to the point that she has to just sit most of the time to avoid a fall. The patient asked what she can do to stop the dizziness. The patient reported that  two days after the and Pfizer vaccine for Covid 19 she got dizzy. The dizziness was constant / continuous and does not stop. It was debilitating. She cannot walk without assistance and cannot live her life as she was used to. She has had 3 MRIs to determine cause of dizziness and all have come back with normal results. She believed the vaccine has poisoned her. She has gone to the ENT and they have determined it was not crystals in her ears. She has visited the eye doctors and nothing there. Her neurologist was stumped. She just wanted her life back. Seriousness criteria: Persistent/significant disability/ incapacity (as reported). The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (27Aug2021) normal; (05Sep2021) normal; (16Oct2021) normal. Therapeutic measures were taken as a result of dizziness, gait disturbance reported as "MRIs continuous dizziness from this date on".  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Chills, Cough, Encephalopathy
Clinical narrative: Patient recently diagnosed with COVID-19 who presents with ongoing generalized fatigue and dry cough, with interval development of hypoxemia, transient encephalopathy and rigors following COVD-10 mAB infusion (REGEN-COV) day of presentation. During her admission her encephalopathy that prompted her presenting to the hospital had resolved.  Her oxygenation was maintained on 2LNC and she desaturated to the high 80s on RA with ambulation.  Her cough was controlled with codeine cough syrup which she has at home.  She received a loading dose and one maintenance dose of remdesevir, and one dose of dexamethasone which was initially held while pt was considering a clinical trial.  The patient was offered the opportunity to go home and she graciously agreed.  She will continue to monitor her clinical course while in isolation on home oxygen.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoxia, Lung opacity
Clinical narrative: Patient recently diagnosed with COVID-19 who presents with ongoing generalized fatigue and dry cough, with interval development of hypoxemia, transient encephalopathy and rigors following COVD-10 mAB infusion (REGEN-COV) day of presentation. During her admission her encephalopathy that prompted her presenting to the hospital had resolved.  Her oxygenation was maintained on 2LNC and she desaturated to the high 80s on RA with ambulation.  Her cough was controlled with codeine cough syrup which she has at home.  She received a loading dose and one maintenance dose of remdesevir, and one dose of dexamethasone which was initially held while pt was considering a clinical trial.  The patient was offered the opportunity to go home and she graciously agreed.  She will continue to monitor her clinical course while in isolation on home oxygen.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Encephalopathy, Fatigue
Clinical narrative: Patient recently diagnosed with COVID-19 who presents with ongoing generalized fatigue and dry cough, with interval development of hypoxemia, transient encephalopathy and rigors following COVD-10 mAB infusion (REGEN-COV) day of presentation. During her admission her encephalopathy that prompted her presenting to the hospital had resolved.  Her oxygenation was maintained on 2LNC and she desaturated to the high 80s on RA with ambulation.  Her cough was controlled with codeine cough syrup which she has at home.  She received a loading dose and one maintenance dose of remdesevir, and one dose of dexamethasone which was initially held while pt was considering a clinical trial.  The patient was offered the opportunity to go home and she graciously agreed.  She will continue to monitor her clinical course while in isolation on home oxygen.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoxia, Oxygen saturation decreased
Clinical narrative: Patient recently diagnosed with COVID-19 who presents with ongoing generalized fatigue and dry cough, with interval development of hypoxemia, transient encephalopathy and rigors following COVD-10 mAB infusion (REGEN-COV) day of presentation. During her admission her encephalopathy that prompted her presenting to the hospital had resolved.  Her oxygenation was maintained on 2LNC and she desaturated to the high 80s on RA with ambulation.  Her cough was controlled with codeine cough syrup which she has at home.  She received a loading dose and one maintenance dose of remdesevir, and one dose of dexamethasone which was initially held while pt was considering a clinical trial.  The patient was offered the opportunity to go home and she graciously agreed.  She will continue to monitor her clinical course while in isolation on home oxygen.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site rash, Vaccination site urticaria
Clinical narrative: 12/28/21: This is a 36yo patient with PMH of POTS, epiploic appendagitis s/p appendectomy, cholecystectomy, lupus, endometriosis, hypothyroidism, fatty liver, and gastroparesis who presented to the ED with abdominal pain, nausea, vomiting, and diarrhea.  She is found to be COVID-19 positive and GI is consulted for her abdominal pain, nausea, vomiting, and diarrhea.  Please note: Patient received first dose Pfizer vaccine on 4/16/2021 Lot # ER8730 and the second dose on 5/7/2021 Lot # ER8732
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, COVID-19, Diarrhoea, Nausea, SARS-CoV-2 test positive
Clinical narrative: 12/28/21: This is a 36yo patient with PMH of POTS, epiploic appendagitis s/p appendectomy, cholecystectomy, lupus, endometriosis, hypothyroidism, fatty liver, and gastroparesis who presented to the ED with abdominal pain, nausea, vomiting, and diarrhea.  She is found to be COVID-19 positive and GI is consulted for her abdominal pain, nausea, vomiting, and diarrhea.  Please note: Patient received first dose Pfizer vaccine on 4/16/2021 Lot # ER8730 and the second dose on 5/7/2021 Lot # ER8732
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 12/28/21: This is a 36yo patient with PMH of POTS, epiploic appendagitis s/p appendectomy, cholecystectomy, lupus, endometriosis, hypothyroidism, fatty liver, and gastroparesis who presented to the ED with abdominal pain, nausea, vomiting, and diarrhea.  She is found to be COVID-19 positive and GI is consulted for her abdominal pain, nausea, vomiting, and diarrhea.  Please note: Patient received first dose Pfizer vaccine on 4/16/2021 Lot # ER8730 and the second dose on 5/7/2021 Lot # ER8732
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemolytic anaemia
Clinical narrative: presented to the hospital on 12/17/21, a week after Moderna booster administration with hemoglobin of 9.4 from baseline of around 14, and elevated bilirubin to 4.5 (indirect 3.7), he was found to have elevated retic count to 12.6, undetectable haptoglobin, elevated LDH 414 and was admitted for hemolytic anemia. Coombs test was positive with IgG . he was started on oral prednisone 100mg daily, Hgb initially went down to 7.6 but stabilized around that after 5 days  patient was discharged on 12./22/21 with oral prednisone and outpatient follow up.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood bilirubin increased, Blood bilirubin unconjugated increased, Blood immunoglobulin G, Blood lactate dehydrogenase increased, Coombs test positive
Clinical narrative: presented to the hospital on 12/17/21, a week after Moderna booster administration with hemoglobin of 9.4 from baseline of around 14, and elevated bilirubin to 4.5 (indirect 3.7), he was found to have elevated retic count to 12.6, undetectable haptoglobin, elevated LDH 414 and was admitted for hemolytic anemia. Coombs test was positive with IgG . he was started on oral prednisone 100mg daily, Hgb initially went down to 7.6 but stabilized around that after 5 days  patient was discharged on 12./22/21 with oral prednisone and outpatient follow up.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Haptoglobin, Reticulocyte count increased
Clinical narrative: presented to the hospital on 12/17/21, a week after Moderna booster administration with hemoglobin of 9.4 from baseline of around 14, and elevated bilirubin to 4.5 (indirect 3.7), he was found to have elevated retic count to 12.6, undetectable haptoglobin, elevated LDH 414 and was admitted for hemolytic anemia. Coombs test was positive with IgG . he was started on oral prednisone 100mg daily, Hgb initially went down to 7.6 but stabilized around that after 5 days  patient was discharged on 12./22/21 with oral prednisone and outpatient follow up.
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria, Vomiting
Clinical narrative: -Emesis -Hives
Age: 8.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: -Emesis -Hives
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt called facility to state that he received his booster dose at facility on 12/23/21 and received a call later that day that he had received an undiluted dose of Pfizer but had no further guidance.  Pt reports that he has had a hard time regulating his body temperature alternating between chills and sweats since receiving his booster.  Pt has taken ibuprofen and tylenol per his report to help with symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Incorrect dose administered, Product preparation issue, Temperature regulation disorder
Clinical narrative: Pt called facility to state that he received his booster dose at facility on 12/23/21 and received a call later that day that he had received an undiluted dose of Pfizer but had no further guidance.  Pt reports that he has had a hard time regulating his body temperature alternating between chills and sweats since receiving his booster.  Pt has taken ibuprofen and tylenol per his report to help with symptoms.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature fluctuation, Chills, Hyperhidrosis, Incorrect dose administered, Product preparation issue
Clinical narrative: Pt called facility to state that he received his booster dose at facility on 12/23/21 and received a call later that day that he had received an undiluted dose of Pfizer but had no further guidance.  Pt reports that he has had a hard time regulating his body temperature alternating between chills and sweats since receiving his booster.  Pt has taken ibuprofen and tylenol per his report to help with symptoms.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A, 020A21A and 038B21A) for COVID-19 vaccination.     The patient's past medical history included Chest discomfort, Hearing loss, Cataracts, Inguinal pain, Neck pain, Obstructive sleep apnea syndrome, Glucose tolerance impaired, Dizziness, Lung cancer, Renal insufficiency, Dyspnea, Fatigue, Skin cancer, Gastroenteritis, Vitamin D deficiency, Bronchitis, Osteoarthritis, Uric acid, Colon cancer, Prostate cancer, Lumbar disc disease, Epicondylitis, Coronary artery disease, Hypercholesterolemia, Colon diverticulitis, Hypogonadism and Shoulder pain. Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine. Concomitant products included TESTOSTERONE CIPIONATE (TESTOSTERONE CYPIONATE) for Hypogonadism, ACETYLSALICYLIC ACID (ASPIRIN 81), FISH OIL, GLUCOSAMINE SULFATE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), SERENOA REPENS FRUIT (SAW PALMETTO [SERENOA REPENS FRUIT]), ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]), VITAMIN D3, GLYCERYL TRINITRATE (NITROSTAT), EZETIMIBE, ISOSORBIDE MONONITRATE, ROSUVASTATIN CALCIUM, CLOPIDOGREL BISULFATE (PLAVIX) and PANTOPRAZOLE SODIUM for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: increased increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had to take FLUVAX,PNEUMOVAX,TD BOOSTER vaccines patient has to check for hemoccult or sigmoid   This case was linked to MOD-2021-424036 (Patient Link).