chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: VARCEL, MMR
Symptoms: Pneumonitis, Polymerase chain reaction positive, Respiratory depression, Skin lesion, Varicella virus test positive
Clinical narrative: Hospitalized on 3/9/24 for group A Strep bacteremia in setting of 1 week of rash consistent with chickenpox. Transferred from Medical Center after 23 day hospitalization to another Hospital for further care of probable primary immunodeficiency and skin ulcers related to chickenpox.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Site of injection turned red, hot, and itchy.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Needle came off during injection thus reducing the amount of dose the patient received.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Laboratory test abnormal, Mobility decreased, Peripheral swelling, Pyomyositis, Skin ulcer
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Streptococcal bacteraemia, Varicella, Varicella virus test positive
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Adrenalitis, Autopsy, Cytogenetic analysis abnormal, Death, Disseminated varicella zoster virus infection
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Endotracheal intubation, Gene mutation, Hepatitis viral, Immunodeficiency, Lung assist device therapy
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Morbillivirus test positive, Pneumonia measles, Pneumonia viral, Respiratory failure, Scar
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, UNK
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: Hospitalized due to left thigh swelling, decreased left leg movement in setting of diagnosis of chickenpox previous week. Found to have group A Strep bacteremia and pyomyositis. Transferred from Medical Center after 25 day hospitalization to another Hospital for further management of skin ulcerations and evaluation for primary immunodeficiency.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Condition aggravated, Depressed level of consciousness, Hypertension, Hypokalaemia
Clinical narrative: Admit date: 4/5/2024  Discharge date: 4/15/2024   Admitting Physician: MD   Discharge Physician: MD  Reason for Admission: altered mental status Procedures: L EVD on 4/5/24  Consultations: Neurology, Neurosurgery, Palliative Care, and Physical Medicine   Hospital Course: Pt is an 80 YO female with a PMHx of resistant HTN, MI, T2DM, depression, and barrett's esophagus without dysplasia who presented with altered mental status. She was found to have large intraventricular hemorrhage and got admitted to CCU. Pt had L EVD placed between 4/5 and 4/10 and her systolic blood pressure was controlled with goal under 150. Due to her resistant hypertension and hypokalemia, HCTZ got replaced with torsemide and spironolactone with good BP control. Due to Pt's somnolence, which made it difficult to participate in therapy, she was started on ritalin. This greatly improved her alertness and allowed her to go to the WV IPR. Pt discharged to IPR in stable condition.   Of note, Pt's family was interested in comfort care in case she decompensates.   Pt discharged with potassium chloride 20 mEq BID and started on spironolactone for hypertension and hypokalemia.  Unresulted Labs:   Outstanding Issues:  Needs repeat CT head w/o contrast in ~3 weeks   Outpatient Diagnostic Tests and Procedures: Needs repeat CT head w/o contrast in ~3 weeks    Homecare Arrangements: N/A  Discharge disposition:  WV IPR Discharged to Inpatient Rehab Facility
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Intraventricular haemorrhage, Mental status changes, Somnolence, Ventricular drainage
Clinical narrative: Admit date: 4/5/2024  Discharge date: 4/15/2024   Admitting Physician: MD   Discharge Physician: MD  Reason for Admission: altered mental status Procedures: L EVD on 4/5/24  Consultations: Neurology, Neurosurgery, Palliative Care, and Physical Medicine   Hospital Course: Pt is an 80 YO female with a PMHx of resistant HTN, MI, T2DM, depression, and barrett's esophagus without dysplasia who presented with altered mental status. She was found to have large intraventricular hemorrhage and got admitted to CCU. Pt had L EVD placed between 4/5 and 4/10 and her systolic blood pressure was controlled with goal under 150. Due to her resistant hypertension and hypokalemia, HCTZ got replaced with torsemide and spironolactone with good BP control. Due to Pt's somnolence, which made it difficult to participate in therapy, she was started on ritalin. This greatly improved her alertness and allowed her to go to the WV IPR. Pt discharged to IPR in stable condition.   Of note, Pt's family was interested in comfort care in case she decompensates.   Pt discharged with potassium chloride 20 mEq BID and started on spironolactone for hypertension and hypokalemia.  Unresulted Labs:   Outstanding Issues:  Needs repeat CT head w/o contrast in ~3 weeks   Outpatient Diagnostic Tests and Procedures: Needs repeat CT head w/o contrast in ~3 weeks    Homecare Arrangements: N/A  Discharge disposition:  WV IPR Discharged to Inpatient Rehab Facility
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was given by MA  whole vial of covid vaccine 6m<5 years without dilution
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Angiogram pulmonary normal, Asthenia, Blood glucose increased, COVID-19
Clinical narrative: Admit date: 4/16/2024   Discharge date: 4/22/24  Attending Physician at the Time of Discharge: D.O.  Primary Care Physician: MD  Reason for Admission: Patient is a 70 y/o male with PmHx notable for COPD, atrial fibrillation, CAD, hypertension, DIABETES MELLITUS 2 and recent diagnosis of Adenocarcinoma of left lung presents with dyspnea. Patient reports worsening dyspnea that started 3 weeks ago, both present at rest and exertion. Associated with productive cough, poor oral intake with continued weight loss. Denies leg edema, chest pain, fever, chills. Had COVID twice before. Denies recent medication changes or travel. Patient had recent admission for COPD exacerbation from 04/03 to 04/08. He reports slightly feeling better but his dyspnea never improved.   In the ED, patient arrived w/ stable VS, although had a transient hypotension.  Labs notable for severe hyperglycemia, AKI, lactic acidosis. Pt is being admitted  to our service for management and evaluation of dyspnea with COVID infection, AKI.    Brief Summary of Hospital Stay:  COVID-19 infection - with  chronic obstructive pulmonary disease exacerbation in context of left lung adenocarcinoma with chronic respiratory failure- patient back on his 2 L of oxygen. Lungs clear. Continue steroids - 20mg for 5 more days. Possible superimposed bacterial PNA -  Continue antibiotics and steroids. DC on po Keflex and Doxy. Hemoptysis - This has now resolved with holding eliquis. Recent CTA did not show any PE. Resume eliquis in few days.   DM2- monitor BS today BS have been stable.  On lantus 50u bid. Blood sugar likely elevated due to steroids.  Resume home dose insulin.   Weakness - evaluated by PT, OT - home with assist.    Atrial fibrillation- Eliquis. Hold Eliquis for few more days. Reported taking DAPT  -not clear why he still needs plavix. Will DC plavix for now.     CAD - Hx CABG 2021. Stable. No CP now. On ASA, statin. DC plavix.   Hx HFpEF - stable , compensated.   BP 155/81  | Pulse 89  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.88 m  | Wt 85.3 kg  | SpO2 98%  | BMI 24.14 kg/m²   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care Services
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Chronic respiratory failure, Condition aggravated, Dyspnoea at rest, Dyspnoea exertional
Clinical narrative: Admit date: 4/16/2024   Discharge date: 4/22/24  Attending Physician at the Time of Discharge: D.O.  Primary Care Physician: MD  Reason for Admission: Patient is a 70 y/o male with PmHx notable for COPD, atrial fibrillation, CAD, hypertension, DIABETES MELLITUS 2 and recent diagnosis of Adenocarcinoma of left lung presents with dyspnea. Patient reports worsening dyspnea that started 3 weeks ago, both present at rest and exertion. Associated with productive cough, poor oral intake with continued weight loss. Denies leg edema, chest pain, fever, chills. Had COVID twice before. Denies recent medication changes or travel. Patient had recent admission for COPD exacerbation from 04/03 to 04/08. He reports slightly feeling better but his dyspnea never improved.   In the ED, patient arrived w/ stable VS, although had a transient hypotension.  Labs notable for severe hyperglycemia, AKI, lactic acidosis. Pt is being admitted  to our service for management and evaluation of dyspnea with COVID infection, AKI.    Brief Summary of Hospital Stay:  COVID-19 infection - with  chronic obstructive pulmonary disease exacerbation in context of left lung adenocarcinoma with chronic respiratory failure- patient back on his 2 L of oxygen. Lungs clear. Continue steroids - 20mg for 5 more days. Possible superimposed bacterial PNA -  Continue antibiotics and steroids. DC on po Keflex and Doxy. Hemoptysis - This has now resolved with holding eliquis. Recent CTA did not show any PE. Resume eliquis in few days.   DM2- monitor BS today BS have been stable.  On lantus 50u bid. Blood sugar likely elevated due to steroids.  Resume home dose insulin.   Weakness - evaluated by PT, OT - home with assist.    Atrial fibrillation- Eliquis. Hold Eliquis for few more days. Reported taking DAPT  -not clear why he still needs plavix. Will DC plavix for now.     CAD - Hx CABG 2021. Stable. No CP now. On ASA, statin. DC plavix.   Hx HFpEF - stable , compensated.   BP 155/81  | Pulse 89  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.88 m  | Wt 85.3 kg  | SpO2 98%  | BMI 24.14 kg/m²   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care Services
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoptysis, Hyperglycaemia, Hypophagia, Hypotension, Laboratory test abnormal
Clinical narrative: Admit date: 4/16/2024   Discharge date: 4/22/24  Attending Physician at the Time of Discharge: D.O.  Primary Care Physician: MD  Reason for Admission: Patient is a 70 y/o male with PmHx notable for COPD, atrial fibrillation, CAD, hypertension, DIABETES MELLITUS 2 and recent diagnosis of Adenocarcinoma of left lung presents with dyspnea. Patient reports worsening dyspnea that started 3 weeks ago, both present at rest and exertion. Associated with productive cough, poor oral intake with continued weight loss. Denies leg edema, chest pain, fever, chills. Had COVID twice before. Denies recent medication changes or travel. Patient had recent admission for COPD exacerbation from 04/03 to 04/08. He reports slightly feeling better but his dyspnea never improved.   In the ED, patient arrived w/ stable VS, although had a transient hypotension.  Labs notable for severe hyperglycemia, AKI, lactic acidosis. Pt is being admitted  to our service for management and evaluation of dyspnea with COVID infection, AKI.    Brief Summary of Hospital Stay:  COVID-19 infection - with  chronic obstructive pulmonary disease exacerbation in context of left lung adenocarcinoma with chronic respiratory failure- patient back on his 2 L of oxygen. Lungs clear. Continue steroids - 20mg for 5 more days. Possible superimposed bacterial PNA -  Continue antibiotics and steroids. DC on po Keflex and Doxy. Hemoptysis - This has now resolved with holding eliquis. Recent CTA did not show any PE. Resume eliquis in few days.   DM2- monitor BS today BS have been stable.  On lantus 50u bid. Blood sugar likely elevated due to steroids.  Resume home dose insulin.   Weakness - evaluated by PT, OT - home with assist.    Atrial fibrillation- Eliquis. Hold Eliquis for few more days. Reported taking DAPT  -not clear why he still needs plavix. Will DC plavix for now.     CAD - Hx CABG 2021. Stable. No CP now. On ASA, statin. DC plavix.   Hx HFpEF - stable , compensated.   BP 155/81  | Pulse 89  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.88 m  | Wt 85.3 kg  | SpO2 98%  | BMI 24.14 kg/m²   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care Services
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Lactic acidosis, Lung adenocarcinoma, Productive cough, Weight decreased
Clinical narrative: Admit date: 4/16/2024   Discharge date: 4/22/24  Attending Physician at the Time of Discharge: D.O.  Primary Care Physician: MD  Reason for Admission: Patient is a 70 y/o male with PmHx notable for COPD, atrial fibrillation, CAD, hypertension, DIABETES MELLITUS 2 and recent diagnosis of Adenocarcinoma of left lung presents with dyspnea. Patient reports worsening dyspnea that started 3 weeks ago, both present at rest and exertion. Associated with productive cough, poor oral intake with continued weight loss. Denies leg edema, chest pain, fever, chills. Had COVID twice before. Denies recent medication changes or travel. Patient had recent admission for COPD exacerbation from 04/03 to 04/08. He reports slightly feeling better but his dyspnea never improved.   In the ED, patient arrived w/ stable VS, although had a transient hypotension.  Labs notable for severe hyperglycemia, AKI, lactic acidosis. Pt is being admitted  to our service for management and evaluation of dyspnea with COVID infection, AKI.    Brief Summary of Hospital Stay:  COVID-19 infection - with  chronic obstructive pulmonary disease exacerbation in context of left lung adenocarcinoma with chronic respiratory failure- patient back on his 2 L of oxygen. Lungs clear. Continue steroids - 20mg for 5 more days. Possible superimposed bacterial PNA -  Continue antibiotics and steroids. DC on po Keflex and Doxy. Hemoptysis - This has now resolved with holding eliquis. Recent CTA did not show any PE. Resume eliquis in few days.   DM2- monitor BS today BS have been stable.  On lantus 50u bid. Blood sugar likely elevated due to steroids.  Resume home dose insulin.   Weakness - evaluated by PT, OT - home with assist.    Atrial fibrillation- Eliquis. Hold Eliquis for few more days. Reported taking DAPT  -not clear why he still needs plavix. Will DC plavix for now.     CAD - Hx CABG 2021. Stable. No CP now. On ASA, statin. DC plavix.   Hx HFpEF - stable , compensated.   BP 155/81  | Pulse 89  | Temp 36.7 °C (Oral)  | Resp 18  | Ht 1.88 m  | Wt 85.3 kg  | SpO2 98%  | BMI 24.14 kg/m²   The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Discharged to Home Health Care Services
Age: 43.0
Sex: F
Vaccine: FLUA4, TDAP
Symptoms: Injected limb mobility decreased, Muscle tightness, Pain in extremity
Clinical narrative: Pt presenting today in clinic > 1 month after vaccine and with sore arm, muscle tension and reduced range of motion in left arm. had rec'd Tetanus and flu in that arm on 3/20/2024
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Fibrin D dimer, Pulmonary embolism
Clinical narrative: Bilateral pulmonary emboli, admitted in-patient, treated with anticoagulants, discharged to home on Eliquis
Age: 86.0
Sex: U
Vaccine: COVID19-2, RSV
Symptoms: Contusion, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: Abnormal bruising and pain started day after vaccination. Patient felt non-specific flu-like symptoms of fatigue and generally did not feel well on the day after vaccination, symptoms started to improve except bruising is still severe on 4/24, 5 days later.  Dark bruising covering 70% of lateral arm.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Ear infection, Extra dose administered, Pyrexia
Clinical narrative: Patient was given extra dose of Prevnar 20 on 04/18/2024. This was patients 5th dose of Prevnar. 4th dose received in January 2024. Pt  has had a fever since day of 5th dose. Pt was seen in office this morning and dx with ear infection which would explain fever. Pt is being seen again this afternoon to confirm ear infection by a different provider.
Age: 57.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Arthralgia, Injection site irritation, Injection site pain, Magnetic resonance imaging, Orthosis user
Clinical narrative: Irritation and pain at injection site-progressed in 15 minutes; pain down elbow, right wrist, right side of hand pain...disipated at 11pm that night-since 11pm still experiencing pain, wears brace everyday...area in wrist, top of hand, right side of hand...had surgery back in 2005
Age: 57.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Pain in extremity, X-ray
Clinical narrative: Irritation and pain at injection site-progressed in 15 minutes; pain down elbow, right wrist, right side of hand pain...disipated at 11pm that night-since 11pm still experiencing pain, wears brace everyday...area in wrist, top of hand, right side of hand...had surgery back in 2005
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Dizziness, Dyspnoea, Feeling abnormal, Pain in extremity
Clinical narrative: The patient's throat was feeling like it was closing in and was also having a hard time breathing . As soon at she got to the car she felt like she couldn't breathe and was going to pass out. The right arm was very sore with swelling that lasted about a week. Now she felt weak, and oxygen went down to 70. Fluid has been building up in lungs. When walking everything feels like it is falling apart and not feeling normal. She went to the E.R. after feeling so bad and was hospitalized for one day. Today she will be going to her pulmonary physician.
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Peripheral swelling, Pulmonary oedema, Throat tightness
Clinical narrative: The patient's throat was feeling like it was closing in and was also having a hard time breathing . As soon at she got to the car she felt like she couldn't breathe and was going to pass out. The right arm was very sore with swelling that lasted about a week. Now she felt weak, and oxygen went down to 70. Fluid has been building up in lungs. When walking everything feels like it is falling apart and not feeling normal. She went to the E.R. after feeling so bad and was hospitalized for one day. Today she will be going to her pulmonary physician.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Irritability, Migraine, Vision blurred, Visual impairment
Clinical narrative: on 04/10/24 I started having blurry vision/fussiness after receiving Moderna covid shot on 04/08/24. It was quick and went away. Thinking nothing of it i pushed it aside,  then on 04/18/24 i was at home eating lunch and out of no where my eyes started blurring again and this time it was worse to where I couldn't see the letters/numbers on my phone up close to my face. I was going to go to E.R due to not being able to see objects around me but decided maybe I needed to sleep. I slept for an hour and woke up with a huge migraine. The migraine did go away after a while. I returned to work on 04/19/24 and i asked the employee health nurse if what I was experiencing was a side effect and she stated no. She then called me back an hour later and told me that her supervisor said to go to urgent care, urgent care directed me to Optometry and they took a look at my eyes and dilated them and stated it was due to Little to no sleep and too much caffeine. I did tell him that my eyes have never done this before. I returned to work after and finished my shift out. Currently at work on 04/24/24 in Pharmacy and around 10:15AM my left eye started to fuzz/blur and it's hard for my eyes to focus. I now have a migraine and everything seems brighter than their supposed to be. It is now going on 15 days since first event.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dizziness, Headache, Influenza virus test negative
Clinical narrative: headache, dizzy, shoulder and back pain, upper respitory issues
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: headache, dizzy, shoulder and back pain, upper respitory issues
Age: 54.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Injected limb mobility decreased, Magnetic resonance imaging, Quality of life decreased, X-ray limb
Clinical narrative: Patient self reported left shoulder pain and limited mobility of shoulder starting a few hours after vaccine administration, which has lasted for several months following  vaccine. Patient reports this has impacted her quality of life. She has since sought orthopedic specialty care for her shoulder, as well as physical therapy.
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Asthenia, Chest discomfort, Chest pain, Computerised tomogram, Echocardiogram
Clinical narrative: Inflammatory Cardiac Reaction pericarditis / pluerisy   chest pain; fluid around heart; valve damage; fever and extreme fatigue medication Colchicine caused kidney stones and another ER Visit severe on-going chest pressure and debilitating fatigue (undergoing treatment)
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Fatigue, Pericardial effusion, Pericarditis, Pleurisy, Pyrexia
Clinical narrative: Inflammatory Cardiac Reaction pericarditis / pluerisy   chest pain; fluid around heart; valve damage; fever and extreme fatigue medication Colchicine caused kidney stones and another ER Visit severe on-going chest pressure and debilitating fatigue (undergoing treatment)
Age: 42.0
Sex: F
Vaccine: FLUA4
Symptoms: Traumatic heart injury
Clinical narrative: Inflammatory Cardiac Reaction pericarditis / pluerisy   chest pain; fluid around heart; valve damage; fever and extreme fatigue medication Colchicine caused kidney stones and another ER Visit severe on-going chest pressure and debilitating fatigue (undergoing treatment)
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Crying, Cyanosis, Lethargy, Pallor, Ultrasound abdomen normal
Clinical narrative: On 04/17/2024, patient received Vaxelis vaccine at  11:00 A.M. Approximately 3.5 hours later, she began vomiting. The first vomiting episode produced a large amount of vomitus and she became pale and lethargic. This condition persisted. When her mom called at 4 P.M., she was instructed to come back to the office immediately. When examined at 4:30 P.M., the patient was pale, lethargic and had circumoral cyanosis. The cyananosis improved with crying. The mother was referred immediately to Emergency Department for further evaluation and management. There, the patient received I.V. hydration and an abdominal ultrasound was performed. The result was normal, via report the following day.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Vomiting
Clinical narrative: On 04/17/2024, patient received Vaxelis vaccine at  11:00 A.M. Approximately 3.5 hours later, she began vomiting. The first vomiting episode produced a large amount of vomitus and she became pale and lethargic. This condition persisted. When her mom called at 4 P.M., she was instructed to come back to the office immediately. When examined at 4:30 P.M., the patient was pale, lethargic and had circumoral cyanosis. The cyananosis improved with crying. The mother was referred immediately to Emergency Department for further evaluation and management. There, the patient received I.V. hydration and an abdominal ultrasound was performed. The result was normal, via report the following day.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Mass
Clinical narrative: Patient developed a lump in groin one week after the first Covid shot.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose administered to patient. no adverse events noted following administration. Moderna notified.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, HIBV, PNC20, RV5
Symptoms: Extra dose administered
Clinical narrative: Erroneous gave 2 Hib vaccines on the same day.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine Administration error. Vaccine was expired at time of injection. Vaccine Expired Jan 31, 2024 and was administered on 2/3/2024. Patient was notified and counseled on need for additional vaccine. Patient declined another booster
Age: 11.0
Sex: M
Vaccine: COVID19-2, HEP, HEPA, HPV9, IPV, MMRV, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient syncope when I was done applying immunizations. I laid the patient down on the bed. Took vitals 11:00 bp 96/55 HR58 11:05 90/51 HR 64 O 100% 11:10 BP 98/77 HR 75 O100% 11:20 BP 94/60 HR59 O100%. Took BG was 95. Watched patient for about 50 minutes. Gave juice, water and crackers. Patient vomited and stated that he felt better.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 0.08
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Irritability, Product administered to patient of inappropriate age, Pyrexia, Somnolence
Clinical narrative: Vaccines given prior to eligibility date. Checked with family daily for 3 days after administration. Had low fever, sleepiness, and fussiness on day of administration, but no additional side effects beyond the first 24 hours
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects needed.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Day after the vaccination in the evening patient developed low grade fever, rash at the site and the rash kept spreading. The affected area was warm to touch. She saw the doctor on April 17 when almost 3/4 th of her upper arm had rash and warmth. Doctor marked the area with a sharpie, started patient on Cephalexin for cellulitis. Pharmacy did a follow up with the patient on April 21 and 24th. Condition is improving, rash significantly reduced.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine was expired. No adverse effects noted.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired, no symptoms
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccines given was expired, no symptoms
Age: 0.42
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to patient, then it was realized that it is supposed to be given to ages 4 to 6.  No adverse effects noted.  Manufacturer called and they stated that it was still the same medication that this age group is supposed to have.
Age: 21.0
Sex: M
Vaccine: COVID19, IPV, JEV1, TDAP, TYP
Symptoms: Electrocardiogram normal, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Pt had syncopal episode after Vx. This nurse had Pt remain seated for several minutes after Vx administration d/t Pt stating that they have had dizziness/fainting spells w/ previous Vx. This nurse asked Pt if they felt safe to stand and walk to front desk, Pt responded in the affirmative. We walked to the desk with no deficit in Pt noted. After a few more minutes of looking at schedules Pt leaned over desk then fell backwards to the floor (this nurse was to the Lt. side of Pt talking to admin about Vx schedule). This nurse knelt to the floor to check Pt who was not immediately responsive. This nurse called for help and asked admin to call 911. 911 was called and assistance from other staff was started. Pt then began responding appropriately and stated that he was grateful for the help. VS, neuro check, pain assessment, injury assessment, found no deficit. Initial HR was low (48-56) while Pt was still laying on floor, HR was trending upward and Pt stated he was feeling okay by the time EMTs arrived. Care was handed off to EMTs and Pt was able to appropriately answer their questions. EMTs evaluation also found no deficits and they released Pt to his own care noting that he should follow-up with PCP. This nurse stayed w/ Pt till father arrived and Pt was able to leave safely at that time w/ his father. This nurse gave Pt and father instruction on how to monitor for concussion and when to seek medical care. Pt stated that he felt safe and comfortable to leave.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Large (6cm X 7cm) area of swelling and induration on left deltoid with pain and redness. Started day following vaccination and still present on day 5 with significant local induration and tenderness. Redness decreased by day 5 but residual ring of redness remains.
Age: 61.0
Sex: M
Vaccine: SMALL
Symptoms: Blood donor, Cerebrovascular accident
Clinical narrative: This donor was vaccinated on 11/01/2022 with the ACAM2000. Donor did not report any signs or symptoms after the vaccination was given and donated for a few months with no issues. He called the center and reported that he had a stroke on 04/07/2023. I asked the donor if it was related to his vaccination or to donating plasma and he stated that it wasn't.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction noted by patient.  Vaccine expired on 3-31-2024 but was administered on 4-22-24.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Incorrect dose administered, Pyrexia
Clinical narrative: 11-year-old patient was administered Covid 19 adult dose, instead of child dose.  Headache and fever started   2 days after vaccine was administered. Patient went to UC where he received acetaminophen 650 mg for headaches and Ibuprofen 400 for fever, and  was sent home. Patient Followed up with PCP , Mom stated patient felt better the night after being at urgent care and has not had any other symptoms since.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired. No adverse reactions noted.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine was expired. No adverse effects noted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine given was expired. No adverse effects noted.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine frozen instead of refrigerated
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Per FBE, ROTATEQ was inadvertently administered to a 15 day old patient.; No additional AE/PQC.; This spontaneous report was received from Company Representative on behalf of a nurse and refers to a 15-day-old patient of unknown gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was inadvertently vaccinated at age of 15 days with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Product administered to patient of inappropriate age). It was reported that the patient was healthy with no issue. No adverse event.   Lot number is being requested and will be submitted if received.
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: mild rash that looks like roseola; mild rash that looks like roseola; This spontaneous report was received from a healthcare professional via company representative and refers to an 1-year-old female patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 30-MAR-2024 (reported as "ten days ago"), the patient was vaccinated with with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), hepatitis b vaccine (recombinant) (RECOMBIVAX HB) and varicella virus vaccine live (oka/merck) (VARIVAX) (strengths, dose numbers, exact doses, lot #, expiration dates, sites and routes of administration were not provided) for prophylaxis at a routine appointment by a health professional.   On an unknown date in 2024 (reported as "now", exact date unknown by the reporter), the patient developed a mild rash that looks like roseola. It was unknown whether the patient received any treatment. At the reporting time, the patient had not recovered from the events.   The reporter considered the events to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (reported as "she believes the rash is due to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)"). The causality assessment between the events and other suspect vaccines was not reported.  Lot# is being requested and will be submitted if received.
Age: 7.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; a vaccine that was administered to a patient that should not have received combination and it should have been seperate; PEDVAX HIB was administered to 7 years old; This spontaneous report was received from a medical assistant and refers to a 7-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-MAR-2024, at the age of 7 years, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #u029144 with expiration date reported as and confirmed to be: 31-MAR-2024 (exact dose, route of administration and vaccination site were not provided) administered for prophylaxis (product administered to patient of inappropriate age). It was reported that the patient that should not have received combination and it should have been separate (product use issue). No additional adverse events (AEs) were reported (no adverse event). No further information was provided. No product quality complaint (PQC) was noted.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported. No PQC.; The caller said an expired dose of MMR II was administered to a patient; This spontaneous report was received from medical assistant and refers to a 49-year-old female patient.  The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 12-MAR-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) injection, lot #U009511, expiration date: 25-MAR-2023, administered for prophylaxis (strength, exact dose, dose number and route of administration were not provided) (Expired product administered) administered in combination with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (exact dose, lot #, expiry date, and route of administration were not provided). Operator of device was reported as Health professional. The consumer was provided with the case number because she was unsure if the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has ever had a temperature excursion. The medical assistant reporter that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) had two previous excursions. One excursion was 9.63 F for 26 minutes and 8 seconds, the other excursion was for 6 minutes 49 seconds at a high of 6.03 F, therefore measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was determined to be stored in recommended range. Additionally, the consumer stated the product was "labeled incorrectly", the vaccine's expiration date was "labeled incorrectly by a staff member in their facilities", however, documentation system and the company label was not incorrect and there were no quality issues with the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), so no Product quality complaint. No additional information provided to further clarify the details. No additional adverse event reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Dose administered to patient was considered "not supported" after temperature excursion evaluation; Dose administered to patient was considered "not supported" after temperature excursion evaluation; This spontaneous report was received from an office manager and refers to a patient of unknown age or gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-MAY-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W018824, expiration date reported as and confirmed to be 14-JUN-2024 (route of administration and vaccination site were not provided) administered for prophylaxis. The reporter noted a temperature excursion. The dose was administered to patient was considered "not supported" after temperature excursion evaluation. The time frame was as followed: -10 degree Celsius up to 8 degree Celsius (-6 C) for 360 hours (product storage error). No previous temperature excursion was noted.  On 21-JUN-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #W018824, expiration date reported as and confirmed to be 14-JUN-2024 (route of administration and vaccination site were not provided) administered for prophylaxis. The reporter noted a temperature excursion. The dose was administered to patient was considered "not supported" after temperature excursion evaluation. The time frame was as followed: -10 degree Celsius up to 8 degree Celsius (-6 C) for more than 999 hours (product storage error). No previous temperature excursion was noted. No additional adverse event (AE) and no product quality complaint (PQC) were noted (no adverse event). No additional information was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer called and reported that PROQUAD was administered following a temperature excursion. No additional AE reported. No PQC reported. No additional information provided.    ?    Names of vaccines involved (including lot/exp) PROQUAD X019557 1/1; This spontaneous report has been received from a nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 18-APR-2024, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, as a prophylaxis (lot number: X019557, which was determined to be valid, with an expiration date on 19-JAN-2025. Therapy type: rHA) (strength, dose, scheme, route and anatomical location of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of -10 degrees Celsius (C) for 1 hour and 9 minutes with a previous temperature excursion of 9.3 C for 2 hours and 2 minutes.   No additional adverse event nor information was reported.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A patients received PEDVAX HIB younger than recommended.  Patient received it at age 7 weeks 5 days old.; No adverse event; This spontaneous report was received from a medical student and refers to a 7-week-5-days-old patient of unknown gender.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On an unknown date, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). The reporter did not have additional information regarding the patient.  No adverse event reported.  Lot # is being requested and will be submitted if received.  This is one of several reports received from the same source; Sender's Comments:  US-009507513-2404USA006955:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2024 The reporter stated that the Shingles hit at any age after 16 year old, just getting over them despite the vaccine, but a mild case. The patient stated to get the vaccine. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Oral herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles/ have them on my lip right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ have them on my lip right now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-APR-2024 This case was reported the patient via interactive digital media. The patient had them (Shingles) on the lip right now (at the time of reporting) and got both shots. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/I got both shots. Two years later, I got the shingles; Shingles/ I got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/I got both shots. Two years later, I got the shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles/ I got the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2024 This case was reported by a consumer via interactive digital media. The patient got both shingles shots and two years later, he/she got the shingles.  The reporter stated that Shingles, he/she would not care. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.