chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Haemoglobin decreased, Hypoxia, Lung consolidation
Clinical narrative: Admit date: 2/2/2024  Discharge date: 2/6/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Patient is a 86 YO year old female with past medical history of interstitial lung disease with bronchiectasis, metastatic breast cancer on Faslodex and Ibrance, Atrial fibrillation not on anticoagulation, T2DM insulin dependent with diabetic retinopathy,  CKD4, alzheimer's dementia (reportedly nonverbal at baseline), HTN, HLD presenting to Hospital with fever, cough, difficulty breathing.  Patient unable to give significant history.  Most history gleaned from chart review.  Patient arrived via EMS from facility for complaint of fever, cough, difficulty breathing.  Facility noted that her symptoms started earlier today, presenting as a productive cough with a fever of 100.2.  She was reportedly hypoxic with 70% on room air which improved with 4 L nasal cannula.  On speaking to the patient, she can give yes or no answers, but otherwise simply mumbles.  This is apparently her baseline according to her facility, in report from ER resident.   ED Course:  In the emergency room, she presented with a heart rate of 102, respiratory rate 30, she was febrile at 102° F, blood pressure was stable, she was satting 93% on 2 L nasal cannula.  Lab work was significant for hemoglobin 9.1, white blood cell count was normal but she demonstrated a lymphopenia.  Creatinine is 2.5, baseline possibly 1.7.  Bicarb is 20.  ProBNP 2938, lactate was normal.  ABG was obtained demonstrated a well compensated metabolic acidosis with compensatory respiratory alkalosis.  UA demonstrated large leukocytes with greater than 100 WBCs and many casts.  Viral respiratory panel is pending, chest x-ray demonstrated a right upper lobe infiltrate concerning for pneumonia.  She will be admitted to inpatient status for sepsis secondary to community-acquired versus aspiration pneumonia  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  She was admitted for COVID 19 pneumonia with hypoxia. CXR showed consolidation suggestive of pneumonia and given this was possibly bacterial she was given Rocephin and Doxy, given procal was slightly high. . She was given Remdesevir and steroids. She had mild AKI which has resolved. She has chronic Afib which was controlled, she is not on AC.  Today she is doing well. Lungs are clear. Sats are good. Suspect COVID penumonia and not bacterial but will give short course of Doxy to empirically cover for bacterial PNA.  Of note, she was noted to have aspiration - SLP consulted and SLP recommends pt remain on current diet recommendations of NDD Level 2 (mechanically altered) (IDDSI 5) with nectar-thick liquids (IDDSI 2). Pt continues to demonstrate overt s/s of aspiration with thin liquid trials. Will need Op VFSS.  Discharged to Home.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Lung infiltration, Lymphopenia, Metabolic acidosis, Pneumonia, Pneumonia aspiration
Clinical narrative: Admit date: 2/2/2024  Discharge date: 2/6/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Patient is a 86 YO year old female with past medical history of interstitial lung disease with bronchiectasis, metastatic breast cancer on Faslodex and Ibrance, Atrial fibrillation not on anticoagulation, T2DM insulin dependent with diabetic retinopathy,  CKD4, alzheimer's dementia (reportedly nonverbal at baseline), HTN, HLD presenting to Hospital with fever, cough, difficulty breathing.  Patient unable to give significant history.  Most history gleaned from chart review.  Patient arrived via EMS from facility for complaint of fever, cough, difficulty breathing.  Facility noted that her symptoms started earlier today, presenting as a productive cough with a fever of 100.2.  She was reportedly hypoxic with 70% on room air which improved with 4 L nasal cannula.  On speaking to the patient, she can give yes or no answers, but otherwise simply mumbles.  This is apparently her baseline according to her facility, in report from ER resident.   ED Course:  In the emergency room, she presented with a heart rate of 102, respiratory rate 30, she was febrile at 102° F, blood pressure was stable, she was satting 93% on 2 L nasal cannula.  Lab work was significant for hemoglobin 9.1, white blood cell count was normal but she demonstrated a lymphopenia.  Creatinine is 2.5, baseline possibly 1.7.  Bicarb is 20.  ProBNP 2938, lactate was normal.  ABG was obtained demonstrated a well compensated metabolic acidosis with compensatory respiratory alkalosis.  UA demonstrated large leukocytes with greater than 100 WBCs and many casts.  Viral respiratory panel is pending, chest x-ray demonstrated a right upper lobe infiltrate concerning for pneumonia.  She will be admitted to inpatient status for sepsis secondary to community-acquired versus aspiration pneumonia  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  She was admitted for COVID 19 pneumonia with hypoxia. CXR showed consolidation suggestive of pneumonia and given this was possibly bacterial she was given Rocephin and Doxy, given procal was slightly high. . She was given Remdesevir and steroids. She had mild AKI which has resolved. She has chronic Afib which was controlled, she is not on AC.  Today she is doing well. Lungs are clear. Sats are good. Suspect COVID penumonia and not bacterial but will give short course of Doxy to empirically cover for bacterial PNA.  Of note, she was noted to have aspiration - SLP consulted and SLP recommends pt remain on current diet recommendations of NDD Level 2 (mechanically altered) (IDDSI 5) with nectar-thick liquids (IDDSI 2). Pt continues to demonstrate overt s/s of aspiration with thin liquid trials. Will need Op VFSS.  Discharged to Home.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Procalcitonin increased, Productive cough, Prohormone brain natriuretic peptide increased, Pyrexia, Respiratory alkalosis
Clinical narrative: Admit date: 2/2/2024  Discharge date: 2/6/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Patient is a 86 YO year old female with past medical history of interstitial lung disease with bronchiectasis, metastatic breast cancer on Faslodex and Ibrance, Atrial fibrillation not on anticoagulation, T2DM insulin dependent with diabetic retinopathy,  CKD4, alzheimer's dementia (reportedly nonverbal at baseline), HTN, HLD presenting to Hospital with fever, cough, difficulty breathing.  Patient unable to give significant history.  Most history gleaned from chart review.  Patient arrived via EMS from facility for complaint of fever, cough, difficulty breathing.  Facility noted that her symptoms started earlier today, presenting as a productive cough with a fever of 100.2.  She was reportedly hypoxic with 70% on room air which improved with 4 L nasal cannula.  On speaking to the patient, she can give yes or no answers, but otherwise simply mumbles.  This is apparently her baseline according to her facility, in report from ER resident.   ED Course:  In the emergency room, she presented with a heart rate of 102, respiratory rate 30, she was febrile at 102° F, blood pressure was stable, she was satting 93% on 2 L nasal cannula.  Lab work was significant for hemoglobin 9.1, white blood cell count was normal but she demonstrated a lymphopenia.  Creatinine is 2.5, baseline possibly 1.7.  Bicarb is 20.  ProBNP 2938, lactate was normal.  ABG was obtained demonstrated a well compensated metabolic acidosis with compensatory respiratory alkalosis.  UA demonstrated large leukocytes with greater than 100 WBCs and many casts.  Viral respiratory panel is pending, chest x-ray demonstrated a right upper lobe infiltrate concerning for pneumonia.  She will be admitted to inpatient status for sepsis secondary to community-acquired versus aspiration pneumonia  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  She was admitted for COVID 19 pneumonia with hypoxia. CXR showed consolidation suggestive of pneumonia and given this was possibly bacterial she was given Rocephin and Doxy, given procal was slightly high. . She was given Remdesevir and steroids. She had mild AKI which has resolved. She has chronic Afib which was controlled, she is not on AC.  Today she is doing well. Lungs are clear. Sats are good. Suspect COVID penumonia and not bacterial but will give short course of Doxy to empirically cover for bacterial PNA.  Of note, she was noted to have aspiration - SLP consulted and SLP recommends pt remain on current diet recommendations of NDD Level 2 (mechanically altered) (IDDSI 5) with nectar-thick liquids (IDDSI 2). Pt continues to demonstrate overt s/s of aspiration with thin liquid trials. Will need Op VFSS.  Discharged to Home.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory viral panel, Sepsis, Urinary casts present, White blood cell count decreased, White blood cells urine positive
Clinical narrative: Admit date: 2/2/2024  Discharge date: 2/6/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD Reason for Admission: Patient is a 86 YO year old female with past medical history of interstitial lung disease with bronchiectasis, metastatic breast cancer on Faslodex and Ibrance, Atrial fibrillation not on anticoagulation, T2DM insulin dependent with diabetic retinopathy,  CKD4, alzheimer's dementia (reportedly nonverbal at baseline), HTN, HLD presenting to Hospital with fever, cough, difficulty breathing.  Patient unable to give significant history.  Most history gleaned from chart review.  Patient arrived via EMS from facility for complaint of fever, cough, difficulty breathing.  Facility noted that her symptoms started earlier today, presenting as a productive cough with a fever of 100.2.  She was reportedly hypoxic with 70% on room air which improved with 4 L nasal cannula.  On speaking to the patient, she can give yes or no answers, but otherwise simply mumbles.  This is apparently her baseline according to her facility, in report from ER resident.   ED Course:  In the emergency room, she presented with a heart rate of 102, respiratory rate 30, she was febrile at 102° F, blood pressure was stable, she was satting 93% on 2 L nasal cannula.  Lab work was significant for hemoglobin 9.1, white blood cell count was normal but she demonstrated a lymphopenia.  Creatinine is 2.5, baseline possibly 1.7.  Bicarb is 20.  ProBNP 2938, lactate was normal.  ABG was obtained demonstrated a well compensated metabolic acidosis with compensatory respiratory alkalosis.  UA demonstrated large leukocytes with greater than 100 WBCs and many casts.  Viral respiratory panel is pending, chest x-ray demonstrated a right upper lobe infiltrate concerning for pneumonia.  She will be admitted to inpatient status for sepsis secondary to community-acquired versus aspiration pneumonia  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  She was admitted for COVID 19 pneumonia with hypoxia. CXR showed consolidation suggestive of pneumonia and given this was possibly bacterial she was given Rocephin and Doxy, given procal was slightly high. . She was given Remdesevir and steroids. She had mild AKI which has resolved. She has chronic Afib which was controlled, she is not on AC.  Today she is doing well. Lungs are clear. Sats are good. Suspect COVID penumonia and not bacterial but will give short course of Doxy to empirically cover for bacterial PNA.  Of note, she was noted to have aspiration - SLP consulted and SLP recommends pt remain on current diet recommendations of NDD Level 2 (mechanically altered) (IDDSI 5) with nectar-thick liquids (IDDSI 2). Pt continues to demonstrate overt s/s of aspiration with thin liquid trials. Will need Op VFSS.  Discharged to Home.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC20
Symptoms: Blood gases, Blood lactic acid, Crying, Differential white blood cell count, Full blood count
Clinical narrative: At 1/31 5:18 AM: Patient began to cry with her eyes wide open straightforward.  Not responsive.  Patient had shaking that started in her legs and began to march up her body involving her arms and legs, becoming t/c movements.  Mom reports that she was unresponsive during this time.  When the family went to get her she felt warm to touch, sweaty.  The violent episode lasted for approximately 9 to 10 minutes per the time stamps on the nursery camera and front door camera.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HIBV, PNC20
Symptoms: Hyperhidrosis, Skin warm, Tonic clonic movements, Tremor, Unresponsive to stimuli
Clinical narrative: At 1/31 5:18 AM: Patient began to cry with her eyes wide open straightforward.  Not responsive.  Patient had shaking that started in her legs and began to march up her body involving her arms and legs, becoming t/c movements.  Mom reports that she was unresponsive during this time.  When the family went to get her she felt warm to touch, sweaty.  The violent episode lasted for approximately 9 to 10 minutes per the time stamps on the nursery camera and front door camera.
Age: 57.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 57 year old female administered vaccine indicated only for individuals over the age of 60.  No adverse events or outcomes reported by recipient.
Age: 55.0
Sex: M
Vaccine: HEPAB
Symptoms: Antibody test negative
Clinical narrative: Patient completed full Twinrix accelerated series (Lot # 9RT94 administered on 1/9/20, 1/16/20, 2/8/20, and lot # DK23D administered on 2/22/21.) Clinic informed by patient on 2/2/24 that patient had titers drawn showing no immunity to Hepatitis A or B despite full series completed.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness and warmth at injection site the following day on 2/07/24.  Advised to apply cold compress,  monitor site mark around redness and scheduled in office visit with PCP for further evaluation on 2/09/24.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chest discomfort, Chills, Erythema, Fatigue
Clinical narrative: She got her vaccine, and did not feel quite right.  Her arm had swollen up and that was in the afternoon. By evening she had a headache.  She was just feeling worse and worse and by morning she woke up with real bad chills to the point that her body was shaking so hard she felt like she was in the process of dying.  It was such a horrible feeling and extremely tired.  She had nausea, did not throw up, her hands turned chalk white, and her feet and hands were so cold that she did not feel like they were her hands, they were like ice.  She thinks all of her blood was going to her core, does not believe she was getting a lot of blood to her extremities.  That lasted the full day.  After the chills passed she continued with the headache, and did have some cramping in her stomach that was brief.  She also had a heaviness in her chest, which she still gets off and on.  She did not take anything for her symptoms.  She did not call her doctor until last week and they did not call back.  She wanted to get an appointment with him earlier, but they suggested that she come in to see one of the interns and she refused.  She does have an appointment at the end of the month with him.   She still has the pink area the size of a golf ball on her arm, and her asthma is acting up a little bit, but that could be just normal, she is not sure.  Her headache has finally gone away, it was high up and high on her head.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Nausea, Pallor, Peripheral coldness
Clinical narrative: She got her vaccine, and did not feel quite right.  Her arm had swollen up and that was in the afternoon. By evening she had a headache.  She was just feeling worse and worse and by morning she woke up with real bad chills to the point that her body was shaking so hard she felt like she was in the process of dying.  It was such a horrible feeling and extremely tired.  She had nausea, did not throw up, her hands turned chalk white, and her feet and hands were so cold that she did not feel like they were her hands, they were like ice.  She thinks all of her blood was going to her core, does not believe she was getting a lot of blood to her extremities.  That lasted the full day.  After the chills passed she continued with the headache, and did have some cramping in her stomach that was brief.  She also had a heaviness in her chest, which she still gets off and on.  She did not take anything for her symptoms.  She did not call her doctor until last week and they did not call back.  She wanted to get an appointment with him earlier, but they suggested that she come in to see one of the interns and she refused.  She does have an appointment at the end of the month with him.   She still has the pink area the size of a golf ball on her arm, and her asthma is acting up a little bit, but that could be just normal, she is not sure.  Her headache has finally gone away, it was high up and high on her head.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Tremor
Clinical narrative: She got her vaccine, and did not feel quite right.  Her arm had swollen up and that was in the afternoon. By evening she had a headache.  She was just feeling worse and worse and by morning she woke up with real bad chills to the point that her body was shaking so hard she felt like she was in the process of dying.  It was such a horrible feeling and extremely tired.  She had nausea, did not throw up, her hands turned chalk white, and her feet and hands were so cold that she did not feel like they were her hands, they were like ice.  She thinks all of her blood was going to her core, does not believe she was getting a lot of blood to her extremities.  That lasted the full day.  After the chills passed she continued with the headache, and did have some cramping in her stomach that was brief.  She also had a heaviness in her chest, which she still gets off and on.  She did not take anything for her symptoms.  She did not call her doctor until last week and they did not call back.  She wanted to get an appointment with him earlier, but they suggested that she come in to see one of the interns and she refused.  She does have an appointment at the end of the month with him.   She still has the pink area the size of a golf ball on her arm, and her asthma is acting up a little bit, but that could be just normal, she is not sure.  Her headache has finally gone away, it was high up and high on her head.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Herpes zoster, Rash
Clinical narrative: Developed left sided chest rash which appear consistent with shingles, just started today
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: Patient received covid vaccine on 2/5 he has been having intense pain that comes and goes for the past couple days. The pain runs up and down his arm and then when the pain goes away he has cold feeling in his hands. He will be contacting  his MD.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Product substitution error
Clinical narrative: Gave patient correct vaccines but gave patient wrong funding source. Patient has private insurance. I drew up DTAP and MMR from fridge and realized by 2nd vaccine that I should have grabbed private vaccines.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Rash starting at left lateral upper thigh, near vaccine injection site, started 1 day after vaccines. Rash mostly collected at thigh. Subtle gradual rash to back, abdomen, upper and lower extremities
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event, medication error, administered outside 30 day refrigeration
Age: 49.0
Sex: F
Vaccine: HPV9
Symptoms: Anaphylactic shock, Feeling abnormal, Musculoskeletal stiffness, Skin tightness
Clinical narrative: patient waited in office after vaccine was given and then when she left started feeling abnormal while driving. She then called the and came back. She was having an anaphylactic shock, and we administered an Epi Pen and gave her 2 Benadryl . Kept monitoring her blood pressure and pulse.  Her arms and legs were tighten  up along with her face. As she laid on the exam table and things started to finally calm down and untighten her blood pressure and pulse came down, she was then able to sit up and drink some water. We continued to stay with her for at least an hour before she was able to fully function. Her husband came to pick her up so she would not drive. We called the patient and checked on her through the day to make sure she was still stable and she was.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, medication error, potential administration past 30 day refrigeration
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to the site.  Onset 2/8/24 worse on 2/9/24.  Advised to apply cool compress to site Tylenol and ibuprofen as needed.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient was given additional annual flu vaccine
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, medication error, potential administration past the 30 days refrigeration
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Came in for COVID vaccine on Jan 16th. Administered dose, no side effects. Was informed by our manager that COVID had expired on 01/04/2024 instead of 07/01/2024 as indicated on vial.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, vaccine may have been given outside 30 day refrigeration
Age: 1.83
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Came in for COVID vaccine on Jan 16th. Administered dose, no side effects. Was informed by our manager that COVID had expired on 01/04/2024 instead of 07/01/2024 as indicated on vial.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given the Covid Vaccine for children 12 years and older and should have be given the dose for children 5-11 years old.  No reaction occured.  Dad was called and made aware.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Came in for COVID vaccine on Jan 17th. Administered dose, no side effects. Was informed by our manager that COVID had expired on 01/04/2024 instead of 07/01/2024 as indicated on vial.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, potential administration past 30 days refrigeration
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine received in clinic past received by date which was discovered after vaccine administration.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine received in clinic past received by date which was discovered after vaccine administration.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have given vaccine outside 30 day refrigeration
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential med error, may have given vaccine outside 30 day refrigeration
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine received in clinic past received by date which was discovered after vaccine administration.
Age: 1.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reactions. Wrong vaccine ordered for pt and gave to pt. Pt was supposed to have MMRV and instead had this vaccine. Caregiver reports no side effects and spoke with provider in regard to this.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have given vaccine outside 30 day refrigeration
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have administered vaccine outside 30 day refrigeration
Age: 1.42
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC15, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine vaccine received in clinic past received by date which was discovered after vaccine administration.
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: DONOR CAME TO SEE FACILITY DUE TO REDNESS/SWELLING AND WARMTH TO RABIES VACCINE INJECTION SITE. 2 DAYS AFTER INJECTION. STATED REDNESS/SWELLING STARTED 2 HOURS AFTER SHE LEFT FACILITY.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have administered vaccine outside of 30 day refrigeration
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential vaccine error, may have administered vaccine outside of 30 day refrigeration
Age: 13.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Expired product administered
Clinical narrative: Vaccine received in clinic past received by date which was discovered after vaccine administration.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Asthma, Blood test normal, Dyspnoea, Electrocardiogram normal, Middle insomnia
Clinical narrative: Eight days after receiving the vaccine patient woke up in the middle of the night with a severe asthma attack, gasping for breath. Stated she has not had an asthma attack of any kind since age 11 (but does use a rescue inhaler for COPD). As the attack did not abate she went to the ER which ordered blood work and an ECG which, per the patient, returned as normal. She was given a Rx for albuterol nubulizer solution. The patient reported no swelling or other issues at any time and said all she experienced the day she received the shot was mild soreness on the arm.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Eight days after receiving the vaccine patient woke up in the middle of the night with a severe asthma attack, gasping for breath. Stated she has not had an asthma attack of any kind since age 11 (but does use a rescue inhaler for COPD). As the attack did not abate she went to the ER which ordered blood work and an ECG which, per the patient, returned as normal. She was given a Rx for albuterol nubulizer solution. The patient reported no swelling or other issues at any time and said all she experienced the day she received the shot was mild soreness on the arm.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential med error, may have administered vaccine outside 30 day refrigeration
Age: 55.0
Sex: M
Vaccine: HEP, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction and no side effects. Gave vaccine to 55yr old for second dose of MMR/Varicella that was meant for 12yrs and younger. Spoke with CDC and was informed that immunization would still be valid.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have administered vaccine outside 30 day refrigeration
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential administration error, may have given vaccine outside 30 day refrigeration
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event, potential medication error, may have administered vaccine outside 30 day refrigeration
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Product expiration was 1/28/24 which was missed when administering vaccine. Patient was administered expired vaccine. No adverse event was reported by patient. Vaccine was administered 2/1/24 and error discovered 2/9/24
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Ischaemic cardiomyopathy
Clinical narrative: Patient is deceased - cause of death is ischemic cardiomyopathy
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Dysstasia, Gait disturbance, Irritability, Pyrexia
Clinical narrative: Fever, refusing to stand/walk independently, irritability; tylenol/motrin
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt states that sx started at 8pm on same day of administration: joint pain, fever, chills, redness and swelling at injection site. Pt contacted office on 02/09/2024 at 0245PM stating that she was still continuing to have the same sx.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: None of the patients who received the vaccines reported any adverse issues or side effects; PROQUAD had a TE of (-2.0F) for 72 hours; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender.  The patient's medical history and concurrent conditions were not provided. The patient's concomitant therapies included sterile diluent (STERILE DILUENT).  On 09-JAN-2024, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 mL once, lot # X018577, expiration date: 05-JAN-2025 (route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine had a temperature excursion of -2.0 degrees Fahrenheit for 72 hours (product storage error). No prior temperature excursions had occurred. There were no additional adverse events reported (no adverse event).
Sex: M
Vaccine: HPV9, TD
Symptoms: Ill-defined disorder
Clinical narrative: An HCP was transferred by another MTM and the HCP reported an AE. The HCP reported that a patient received three different vaccines sometime last year, which included GARDASIL 9, an unspecified tetanus shot, and another unspecified vaccine. The calle; This spontaneous report was received from a nurse refers to a male patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided.  In 2023 (reported as "sometime last year") the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, dose number, route and site od administration, lot number and expiration date were not provided). Other suspect therapies included unspecified tetanus vaccine toxoid (TETANUS VACCIN) and another unspecified vaccine.  On an unknown date the the patient was "rather large" (ill-defined disorder) but did not provide additional information what she meant by this statement. The outcome of ill-defined disorder was unknown. Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding the event was not applicable.  The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the event was not provided.
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The HCP reported an 18 month old patient inadvertently received a dose of VARIVAX and PROQUAD, instead of receiving VARIVAX and MMR II.; The HCP reported an 18 month old patient inadvertently received a dose of VARIVAX and PROQUAD, instead of receiving VARIVAX and MMR II.; This spontaneous report has been received from a nurse, regarding an 18-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On an unspecified date, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, both as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) (Accidental overdose); instead of receiving varicella virus vaccine live (Oka/Merck) (VARIVAX) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (Wrong product administered).  No additional information was reported.   This case is one of two reports from the same reporter.  ; Sender's Comments:  US-009507513-2402USA001921:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: the patient was administered their first dose of PROQUAD in 2021/on 02-FEB-2024 administered second dose; No additional AE; Medical Assistant calling to report adverse event regarding PROQUAD.  Medical Assistant reporting that a 35 year old patient was seen for a routine appointment on 2/2/2024 in which they were due to have an MMR II vaccination, but the patient was admi; This spontaneous report was received from physican and refers to a 35-year-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2021, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 02-FEB-2024, the patient was vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, #lot X004369 and expiration date was 07-AUG-2024,  administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided), which was administered instead of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Product administered to patient of inappropriate age and wrong product administered). No additonal adverse event was reported.  Lot # is being requested and will be submitted if received (regarding first dose of Proquad).
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: just got diagnosed with HPV; This spontaneous report was received from patient's mother and refers to her daughter, a 30-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date in 2009 (also reported as 15 years ago), the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in February 2024, the patient just got diagnosed with human papillomavirus (HPV). At the time of reporting, the outcome of the event was unknown.   The causal relationship between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Age: 23.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; TE where product was administered to one patient; This spontaneous report was received from a registered nurse, referring to a 23-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in February 2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliters (lot #W025567 with an expiration date on 14-AUG-2024), administered for prophylaxis (route of administration was not provided) which experienced a temperature excursion (TE) of 66 degrees Fahrenheit (F) for 12 hours 0 minutes and 0 seconds on 06-FEB-2024.   No previous temperature excursions were reported.  No additional adverse events were reported.        no previous excursions   On an unknown date, the patient experienced No additional AE reported. On 06-FEB-2024, the patient experienced TE where product was administered to one patient. At the time of reporting, the outcome of the event TE where product was administered to one patient was not known, the outcome of the event No additional AE reported was not known. The action taken with M-M-R II regarding TE where product was administered to one patient was reported as Not Applicable. The action taken with M-M-R II regarding No additional AE reported was reported as Not Applicable.
Sex: F
Vaccine: RVX
Symptoms: Blindness transient, Blindness unilateral, Fear
Clinical narrative: very frightening to go completely blind in my right eye for 5 minutes; This serious case was reported by a consumer and described the occurrence of transient blindness in a 79-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 31-JAN-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced transient blindness (Verbatim: very frightening to go completely blind in my right eye for 5 minutes) (serious criteria GSK medically significant). The outcome of the transient blindness was resolved (duration 5 min).   It was unknown if the reporter considered the transient blindness to be related to RSV vaccine.     It was unknown if the company considered the transient blindness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 02-FEB-2024 This report was submitted via the online direct entry reporting system. It was very frightening to go completely blind in her right eye for 5 minutes.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: The pharmacist wanted to know if the patient could receive a second dose or if they needed to restart; This non-serious case was reported by a pharmacist via patient support programs and described the occurrence of incomplete course of vaccination in a patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 6th June 2023).   On 06-JUN-2023, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: The pharmacist wanted to know if the patient could receive a second dose or if they needed to restart). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-JAN-2024 The reporter was called for inquiring of dosing schedule for patient. The reporter wanted to know if the patient could receive second dose or if they needed to restart schedule. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received this vaccine a week prior to appointment. Checked and said she needed MCV4. Had not realized in EMR system, vaccine was entered in. Explained to patient what had happened and patient was okay with it. Will e coming back in August to get second dose .
Age: 72.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Patient experienced swelling and redness and some pain for a few days after the two vaccines. However, today (8 days after receiving vaccines) her pain intensified and was stinging and burning , especially when moving her arm.
Age: 23.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration, Injection site rash
Clinical narrative: 2nd vaccine was administered at 35 days vs vaccine schedule for Trumenba at 6 months. Patient also reports area surrounding injection site on deltoid developing a rash. Patient will either return for a 3rd dose of Trumenba at 6 months from initial dose OR due to rash will discuss instead doing 2 doses of Bexsero instead
Age: 41.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Gastrooesophageal reflux disease, Pyrexia
Clinical narrative: Mild diarrhea,  fatigue, mild GERD, abdominal bloating, low grade fever; still experiencing 5 days after dose
Age: 3.0
Sex: M
Vaccine: COVID19-2, DTAPIPV, FLU4, MMRV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: I injected a full vial of 3 doses of this medication without diluent.  One vial comes with 3 doses to be diluted; I did not use diluent and accidentally injected the undiluted vial to patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash consisting of small, red bumps that spread across patient's back, right below the shoulder blades. Patient says it lasted about five days and the only treatment she used on it was a topical steroid cream she purchased over the counter. She could not identify which brand.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Influenza like illness, Pain in extremity, Paraesthesia
Clinical narrative: Pt reports pain in arm s/p Shingrix vaccination that was administered on 5/27/23.  Pt states that she felt terrible after the shot explaining what sound to be flu-like symptoms at the time which did resolve.  The arm pain, however, has not resolved and continues.  It was described as soreness, redness, and warm to touch as well as some swelling initially.  It has continued since the time of vaccination but has changed over time and the soreness is now reported to be primarily from numbness and tingling.  Stating that while driving she often loses feeling in her hand on that arm while the other arm continues to be OK.  Patient did receive her second Shingrix vaccination in a timely manner on 10/27/2023 in the opposite arm and reports no issues with that administration.  Pt is seeking chiropractic care at this time to treat the numbness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Pt reports pain in arm s/p Shingrix vaccination that was administered on 5/27/23.  Pt states that she felt terrible after the shot explaining what sound to be flu-like symptoms at the time which did resolve.  The arm pain, however, has not resolved and continues.  It was described as soreness, redness, and warm to touch as well as some swelling initially.  It has continued since the time of vaccination but has changed over time and the soreness is now reported to be primarily from numbness and tingling.  Stating that while driving she often loses feeling in her hand on that arm while the other arm continues to be OK.  Patient did receive her second Shingrix vaccination in a timely manner on 10/27/2023 in the opposite arm and reports no issues with that administration.  Pt is seeking chiropractic care at this time to treat the numbness.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Injection site rash, Tremor
Clinical narrative: Injection site rash; Headache; Shaking; 50 to 75 BPM Heart Rate Increrase; This non-serious case was reported by a consumer and described the occurrence of injection site rash in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (previously had mild shingles several years ago). Concurrent medical conditions included hypertension. Concomitant products included amlodipine and olmesartan.   On 17-JAN-2024, the patient received the 1st dose of Shingrix. On 17-JAN-2024, less than a day after receiving Shingrix, the patient experienced injection site rash (Verbatim: Injection site rash), headache (Verbatim: Headache), tremor (Verbatim: Shaking) and heart rate increased (Verbatim: 50 to 75 BPM Heart Rate Increrase). On 17-JAN-2024, the outcome of the tremor and heart rate increased were resolved.  On 20-JAN-2024, the outcome of the headache was resolved.  On 24-JAN-2024, the outcome of the injection site rash was resolved.   It was unknown if the reporter considered the injection site rash, headache, tremor and heart rate increased to be related to Shingrix.     It was unknown if the company considered the injection site rash, headache, tremor and heart rate increased to be related to Shingrix.   Additional Information: GSK receipt date: 04-FEB-2024 The patient previously had mild shingles several years ago and received the older vaccine at the time.  They were trying to determine if it was safe to get the 2nd shot.  The reporter also wanted to know if there was benefit to getting the 2nd shot closer to the 2-month or 6-month interval. Again, the patient heart rate increased was from 50 to 75BPM. The reporter was requested for follow up.
Sex: F
Vaccine: FLUX, RSV, RSV
Symptoms: Fibromyalgia
Clinical narrative: fibromyalgia in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of fibromyalgia in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm) and Influenza vaccine (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fibromyalgia (Verbatim: fibromyalgia in arm). The outcome of the fibromyalgia was not reported.   It was unknown if the reporter considered the fibromyalgia to be related to Arexvy.     It was unknown if the company considered the fibromyalgia to be related to Arexvy.   Additional Information: GSK receipt date:30-JAN-2024 The patient was 60 plus in age. The reporter reported that a patient received Arexvy vaccine with flu vaccine both vaccine administered on different arm. The patient experienced claims of fibromyalgia in arm that Arexvy was given. It was unknown if the reporter considered the fibromyalgia to be related to influenza vaccine. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, RSV, RSV
Symptoms: Influenza, Injection site pain
Clinical narrative: fibromyalgia in arm; This non-serious case was reported by a physician via sales rep and described the occurrence of fibromyalgia in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   On an unknown date, the patient received Arexvy (unknown arm) and Influenza vaccine (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fibromyalgia (Verbatim: fibromyalgia in arm). The outcome of the fibromyalgia was not reported.   It was unknown if the reporter considered the fibromyalgia to be related to Arexvy.     It was unknown if the company considered the fibromyalgia to be related to Arexvy.   Additional Information: GSK receipt date:30-JAN-2024 The patient was 60 plus in age. The reporter reported that a patient received Arexvy vaccine with flu vaccine both vaccine administered on different arm. The patient experienced claims of fibromyalgia in arm that Arexvy was given. It was unknown if the reporter considered the fibromyalgia to be related to influenza vaccine. The reporter consented to follow up.