chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: The patient is a 45 year(s) old Female complaining of shortness of breath. patient arrives EMS from Dialysis where she did complete her 4 hour treatment. PT reports that she has had a cough for a few days, patient is HOH and wear hearing aid in her right ear. Fever on arrival. 02-01-2024 17:15 Acute shortness of breath occurring while in dialysis.  The patient developed shortness of breath and cough today.  She was found to have a fever upon presentation to the emergency department.  Patient's oxygen saturation was identified in the 70s on room air by medics.  The patient did complete her dialysis session today.  The patient states that she has been ill for the past week but describes acute worsening today with the onset of cough, labored respirations.  She states in the past week she has been experiencing nasal drainage and mild cough.  The patient has been vaccinated for COVID-19 with a total of 3 shots.  She did not have preceding fever prior to this event this evening.  On arrival the patient demonstrated oxygen saturation in the 80s on room air.  She has no past history of pulmonary disease other than hypoventilation of obesity.  Patient is rather hard of hearing and appeared in distress.  This limited my ability to provide further history of present illness and review of systems could not be fully obtained, as well.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: received Kinrix in error in stead of Pediarix
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt came  to office for a HPV vaccine and was given Dtap vaccine instead by Medical Assistant. Health Center work flow is to have medical provider verify vaccine and Medical Provider verified vaccine. Father and pt notified of error immediately. Pt doing well after vaccine and agreed to have correct HPV vaccine administered on right arm by myself RN. Pt was observed for 15 minutes after vaccine given and doing well. Scheduled follow-up appointment for 03/22/24.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Anaemia, Angiogram pulmonary abnormal, Back pain, Bilirubin conjugated
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin increased, Blood creatinine normal, Blood lactic acid, Blood potassium decreased, Blood urea normal
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Chills, Computerised tomogram abdomen abnormal, Dyspnoea
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Enterovirus infection, Enterovirus test positive, Haematocrit normal, Haemoglobin decreased
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lung consolidation, Neutrophil count increased, Neutrophil percentage increased, Pain, Platelet count normal
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Productive cough, Pyrexia, Respiratory distress, Rhinovirus infection
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sinus tachycardia, White blood cell count increased
Clinical narrative: ED Provider Note 2/12/24:  The patient is a 55 year(s) old Male complaining of shortness of breath, lower back pain. Pt states that he is having trouble breathing and he is having lower back pain.  Pt family states that pt had fever at home last night that broke around 0100 this morning.  Temp normal this morning.  Pt is concerned about pneumonia, has chronic lung issues and is on home oxygen. Pt family did not bring oxygen in with them from the car, states it is too bulky to carry, pt is satting 70's on room air. Pt placed on oxygen in triage, 6L NC. 02-12-2024 19:43 55-year-old male with history of anemia, lung injury will on oxygen chronically, hypertension, diabetes, hemophilia A, hep C with hepatocellular carcinoma presents to the ED for evaluation of shortness of breath.  Since yesterday the patient's been coughing, having fevers.  Complaining of low back pain.  Denies any difficulty urinating.  Has a wet sounding cough and feeling short of breath.  Denies fevers but says he is felt body aches and chills.  His nebulizer at home broke and he has not been able to use his inhalers for the last several days.  Arrives on room air because he does not have a portable oxygen machine.  Patient is on 20 mg of prednisone daily.  Review of systems negative except as documented in the HPI. Emergency Department Course and Clinical Decision Making Patient arrives in respiratory distress but has been off his oxygen for some time getting to the hospital.  He was placed back on nasal cannula, complaining of back pain and his pain was treated with Tylenol.  Chest x-ray significant for bilateral consolidation concerning for pneumonia.  He test positive for COVID, rhinovirus and enterovirus on bio fire testing.  Labs concerning for leukocytosis of 20, platelets are normal, stable anemia, lactic acid was 3, PT is also elevated with INR of 1.4, patient is not on anticoagulants.  BUN and creatinine are in the normal range, potassium is 3.3, because of patient's elevated bilirubin new back pain in the setting of leukocytosis CT scan of the abdomen was obtained which shows increased dilation of the CBD approximately 10 mm on the CT, his known hepatic mass is stable consistent with treated neoplasm, CT pulmonary angiogram does not show evidence of PE but does show bilateral pneumonia consistent with what was seen on the chest x-ray.  For concerns of sepsis patient was given Rocephin and azithromycin initially but with a concerning abdominal findings was started on Zosyn.    At 2000 I called regional hospital to arrange transfer for the patient to go to their facility given the hyperbilirubinemia and the likely need of MRCP which we cannot obtain at this time, will also likely need ERCP and GI to intervene during this hospitalization.  Currently waiting to hear back from hospital, patient is unwilling to be transferred elsewhere because of frustration with hospital stay has had at another location before.  His pain is better after Tylenol and he was given his home dose of Suboxone.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: The arm the vaccine was given in became red and hot the day after vaccination.  around day 6 it became less red and became a little itchy for 1 more day.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Fatigue, Hypersomnia
Clinical narrative: About 8 hours after shot, I became dizzy (room spinning, nausea, unable to move without falling over). It lasted ~6 hours. Then was very tired and slept for 12 hours (maybe more). Had 3 more episodes of debilitating vertigo, one lasting several days. Last episode was at end of Dec 2021.  Continue having very mild vertigo, not debilitating, but have to be careful when performing activities that require quick movements (turning quickly).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Mobility decreased, Nausea, VIIIth nerve injury, Vertigo
Clinical narrative: About 8 hours after shot, I became dizzy (room spinning, nausea, unable to move without falling over). It lasted ~6 hours. Then was very tired and slept for 12 hours (maybe more). Had 3 more episodes of debilitating vertigo, one lasting several days. Last episode was at end of Dec 2021.  Continue having very mild vertigo, not debilitating, but have to be careful when performing activities that require quick movements (turning quickly).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional, Vestibular neuronitis
Clinical narrative: About 8 hours after shot, I became dizzy (room spinning, nausea, unable to move without falling over). It lasted ~6 hours. Then was very tired and slept for 12 hours (maybe more). Had 3 more episodes of debilitating vertigo, one lasting several days. Last episode was at end of Dec 2021.  Continue having very mild vertigo, not debilitating, but have to be careful when performing activities that require quick movements (turning quickly).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antinuclear antibody, Antinuclear antibody positive, Arthralgia, Asthma
Clinical narrative: During first 2-3 weeks after vaccine, I began having lots of fatigue (unable to work an entire day), joint pain (fingers, wrists, feet and ankles) and general flu-ish feeling with random fevers. The fatigue and joint got worse over next several months. The joint pain was excruciating (unable to do anything with hands, 7 on pain scale).  Started getting rashes (purple spider web) on my legs when cold, Raynaud's in hands and feet. I was getting random, round bruises on my lower legs and arms. Extremely dry skin, painfully dry eyes. I've had severe allergic reactions to several drugs (2 antibiotics, 1 other), one requiring the use of my EpiPen. My perviously well-controlled asthma became poorly controlled, necessitating the use of more asthma medication. I've been diagnosed with Ranynaud's and an autoimmune disease, possible lupus and/or Sjogren's. I'm currently being followed by a rheumatologist. I'm currently taking Plaquenil and diclofenac. I now take Wixela and Singulair (for asthma).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, C-reactive protein increased, Condition aggravated, Contusion, Fatigue
Clinical narrative: During first 2-3 weeks after vaccine, I began having lots of fatigue (unable to work an entire day), joint pain (fingers, wrists, feet and ankles) and general flu-ish feeling with random fevers. The fatigue and joint got worse over next several months. The joint pain was excruciating (unable to do anything with hands, 7 on pain scale).  Started getting rashes (purple spider web) on my legs when cold, Raynaud's in hands and feet. I was getting random, round bruises on my lower legs and arms. Extremely dry skin, painfully dry eyes. I've had severe allergic reactions to several drugs (2 antibiotics, 1 other), one requiring the use of my EpiPen. My perviously well-controlled asthma became poorly controlled, necessitating the use of more asthma medication. I've been diagnosed with Ranynaud's and an autoimmune disease, possible lupus and/or Sjogren's. I'm currently being followed by a rheumatologist. I'm currently taking Plaquenil and diclofenac. I now take Wixela and Singulair (for asthma).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Influenza, Musculoskeletal disorder, Protein urine present, Pyrexia
Clinical narrative: During first 2-3 weeks after vaccine, I began having lots of fatigue (unable to work an entire day), joint pain (fingers, wrists, feet and ankles) and general flu-ish feeling with random fevers. The fatigue and joint got worse over next several months. The joint pain was excruciating (unable to do anything with hands, 7 on pain scale).  Started getting rashes (purple spider web) on my legs when cold, Raynaud's in hands and feet. I was getting random, round bruises on my lower legs and arms. Extremely dry skin, painfully dry eyes. I've had severe allergic reactions to several drugs (2 antibiotics, 1 other), one requiring the use of my EpiPen. My perviously well-controlled asthma became poorly controlled, necessitating the use of more asthma medication. I've been diagnosed with Ranynaud's and an autoimmune disease, possible lupus and/or Sjogren's. I'm currently being followed by a rheumatologist. I'm currently taking Plaquenil and diclofenac. I now take Wixela and Singulair (for asthma).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Raynaud's phenomenon
Clinical narrative: During first 2-3 weeks after vaccine, I began having lots of fatigue (unable to work an entire day), joint pain (fingers, wrists, feet and ankles) and general flu-ish feeling with random fevers. The fatigue and joint got worse over next several months. The joint pain was excruciating (unable to do anything with hands, 7 on pain scale).  Started getting rashes (purple spider web) on my legs when cold, Raynaud's in hands and feet. I was getting random, round bruises on my lower legs and arms. Extremely dry skin, painfully dry eyes. I've had severe allergic reactions to several drugs (2 antibiotics, 1 other), one requiring the use of my EpiPen. My perviously well-controlled asthma became poorly controlled, necessitating the use of more asthma medication. I've been diagnosed with Ranynaud's and an autoimmune disease, possible lupus and/or Sjogren's. I'm currently being followed by a rheumatologist. I'm currently taking Plaquenil and diclofenac. I now take Wixela and Singulair (for asthma).
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Mild pain at injection site,tired, muscle pain, shivering, stomach pain. No treatment yet. No outcome yet.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Angina pectoris, Cardiac flutter, Fatigue, Heart rate increased, Hypoaesthesia
Clinical narrative: Within a week I developed swelling in my left calf leg lasting for 2-3 days. I believe this was DVT. Within a week I experienced a fluttering/fast heart rate, occasional pain in my heart, and in the evening before bed/at bed my out breath/exhale would disappear lasting for a month and my breathing was not normal. I also had neurological symptoms of numbness and tingling in my hands and feet during the middle of the night lasting until present day. Blurred vision at times during the day while working. Itchy skin, puffy and swollen face, rash on face. My lymph nodes became enlarged (gulf ball sized) lasting for 6 - 8 weeks and painful at times. Additionally I experienced extreme fatigue.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Lymph node pain, Lymphadenopathy, Paraesthesia, Peripheral swelling, Pruritus
Clinical narrative: Within a week I developed swelling in my left calf leg lasting for 2-3 days. I believe this was DVT. Within a week I experienced a fluttering/fast heart rate, occasional pain in my heart, and in the evening before bed/at bed my out breath/exhale would disappear lasting for a month and my breathing was not normal. I also had neurological symptoms of numbness and tingling in my hands and feet during the middle of the night lasting until present day. Blurred vision at times during the day while working. Itchy skin, puffy and swollen face, rash on face. My lymph nodes became enlarged (gulf ball sized) lasting for 6 - 8 weeks and painful at times. Additionally I experienced extreme fatigue.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Respiration abnormal, Swelling face, Vision blurred, White blood cell count normal
Clinical narrative: Within a week I developed swelling in my left calf leg lasting for 2-3 days. I believe this was DVT. Within a week I experienced a fluttering/fast heart rate, occasional pain in my heart, and in the evening before bed/at bed my out breath/exhale would disappear lasting for a month and my breathing was not normal. I also had neurological symptoms of numbness and tingling in my hands and feet during the middle of the night lasting until present day. Blurred vision at times during the day while working. Itchy skin, puffy and swollen face, rash on face. My lymph nodes became enlarged (gulf ball sized) lasting for 6 - 8 weeks and painful at times. Additionally I experienced extreme fatigue.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Hot flush
Clinical narrative: hot flashes; hot flashes; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 86-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hot flashes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization, reaction(s): "hot flashes". The following information was reported: HOT FLUSH (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "hot flashes".  Additional information: The patient was wondering if there have been any reports of the return of hot flashes as a result of the Pfizer Covid vaccine. She was burning up! The Covid vaccine was the only thing she can think of that might be the cause.  The patient did read of another incidence of hot flashes from the vaccine and needed an answer. The patient was informed that there was no specific information about hot flashes but one of the reported side effects of the vaccine included fever as per attached PRD. She wanted to know if the problem she was having right now was related to the vaccine. She added that she had been getting the hot flushes for over a year now. She had been getting the Pfizer Covid-19 vaccines as well. Her last dose of the Pfizer Covid-19 vaccine was last fall, around Sep or Oct 2023. She wanted to know if there was an "accumulation effect" that resulted to getting hot flushes.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; Caller reported dose of MMR II was inadvertently administered.  Patient had already received 2 doses prior- so this was a third dose.; PROQUAD on 10/31/2023, MMR II 11/29/2023; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 31-OCT-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On 29-NOV-2023, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration).  On 30-JAN-2024, the patient was vaccinated with the second dose (also reported as the third dose) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), at a dose of 0.5 milliliter (ml) (strength, anatomical site of vaccination and route of administration were not reported; lot number W035040, expiration date was reported and validated as 10-MAY-2024) as prophylaxis (extra dose administered). No additional adverse events (AEs) reported.
Age: 15.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Pharmacist reported that patient received the first dose of GARDASIL 9 in March 2023 and never completed the series. Patient received the second dose of GARDASIL 9 on 10-FEB-2024; No additional AE reported; This spontaneous report was received from a pharmacist and refers to a 16-year-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in March 2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The patient never completed the series. The reproter was unable to provide exact date of administration or the lot number and expiration date of the vaccine as it was not administered in her facility.   On 10-FEB-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (lot #X019862, expiration date: 14-FEB-2025), administered for prophylaxis (strength, dose and route of administration were not provided).   No further information provided. No additional AE reported.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product storage error, Rash
Clinical narrative: It was reported that that there was a temperature excursion; This patient developed a bumpy rash on face and chest; This spontaneous report was received from registered nurse, concerning a 1-year-old female patient.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 26-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, (lot #W008712, has been verified to be valid, expiration date not reported, but upon internal validation established as 14-MAR-2024) administered for prophylaxis (strength, and route of administration were not provided); with hepatitis a vaccine inact (HAVRIX)  administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, (lot #W007040, has been verified to be valid, expiration date not reported, but upon internal validation established as  29-FEB-2024) (albumin status: recombinant human albumin (rHa) administered for prophylaxis (strength, and route of administration were not provided). It was reported that that there was a temperature excursion with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  On 28-SEP-2023 (also reported as "two days following vaccination"), the patient developed a bump rash on face and chest (rash papular). Treatment suggested: watch for any increase or worsening and can use diphenhydramine hydrochloride (BENADRYL) as necessary. If worsening contact clinic or go to emergency room. However on unknown date, she recovered from the event. Have not heard from mom or any other issue. Additional information was not expected  The action taken with the vaccines was not applicable.   The causal relationship between rash popular and the vaccines was not reported.  This is one of the several cases reported from the same source.; Sender's Comments:  US-009507513-2401USA005218: US-009507513-2402USA005568:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in left arm and on 18Feb2021 as dose 2, single (Lot number: EM9810), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension (managed)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #1: Pfizer/ Dose #2: Pfizer/ Dose #3: Moderna/ Dose #4: Pfizer". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 31Jan2024 to 04Feb2024. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 59-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: mild swelling possible lump and redness about 1-2 inches below the injection site; mild swelling possible lump and redness about 1-2 inches below the injection site; mild swelling possible lump and redness about 1-2 inches below the injection site; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Feb2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed; unknown manufacturer), for Covid-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Feb2024, outcome "not recovered" and all described as "mild swelling possible lump and redness about 1-2 inches below the injection site".  Additional Information: Patient wanted to know if what to do if experiencing mild swelling possible lump and redness about 1-2 inches below the injection site. Patient confirmed he had Pfizer Covid vaccine booster on Saturday, a day or two later noticed, yesterday and today 1 inch below it, there is a lump there, the lump is about an inch or two wide it is palpable and is somewhat pinkish and reddish in color and can't seem to go away. Further reported that developed something that doesn't seem to be going away. Has lump or mild swelling and redness about 1 inch below injection spot, not at actual injection spot. Lump is 1 or 2 inches in diameter, somewhat reddish or pinkish and there is a little bit lump to it. Didn't know what to do about. Clarified by caller, there is swelling, area is a little swollen.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome, X-ray
Clinical narrative: has Covid now; had Covid; had Covid; long Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure-hypertension" (unspecified if ongoing). There were no concomitant medications. The patient had no family medical history relevant to adverse events. The following information was reported: POST-ACUTE COVID-19 SYNDROME (medically significant) with onset 2022, outcome "unknown", described as "long Covid"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "had Covid"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "has Covid now". Clinical course reported as follow: The patient experienced extreme long Covid. The patient clarified, it will be 2 years in May2024, that she had the long Covid. Caller is patient, has Covid now, had Covid about a year ago in 2022, got extreme long Covid. Took Paxlovid at that time as treatment. The patient had both vaccine and both boosters, and Paxlovid, it was horrible. With the long Covid, went to Emergency Room because chest was tight, went for X-ray. Clarified, caller not admitted to hospital, just went to Emergency Room. Clarified, past Covid vaccines and booster taken were all Pfizer. Clarified, caller has not yet taken Paxlovid during current experience with Covid, does not have it yet. The patient underwent the following laboratory tests and procedures: X-ray: Not provided.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional information: Caller advised that he had the Comirnaty vaccine in September and was wondering if he was due for another shot. Caller would like to know if it was recommended to wear a mask. He did not want to catch anything and he had a cold currently. Patient was advised that it was definitely recommended to wear a mask especially for his age.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.