chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lung opacity, Pulmonary mass, Pyrexia, SARS-CoV-2 test positive, Sputum culture positive
Clinical narrative: Patient is a 72 y.o. male patient of, CNP with history of COPD, asthma, ataxia, hypertension, hypothyroidism, BPH, seizure disorder,  presented to Hospital with shortness of breath found to have pneumonia at outside facility and transferred for further work-up and management Covid Pneumonia Acute exacerbation Asthma  Acute hypoxic respiratory failure Covid-19 Virus Infection Leukocytosis  Date of onset of symptoms: 3/27/23 Symptoms present on admission: Fever, shortness of breath, cough  Date of covid positive test: 4/3/23 Vaccination status: vaccinated Imaging: Chest x-ray reveals ill-defined hazy nodular opacities, concern for bronchopneumonia Oxygen requirements on admission: 6 L Covid Pneumonia Acute exacerbation Asthma  Acute hypoxic respiratory failure Covid-19 Virus Infection Leukocytosis  Date of onset of symptoms: 3/27/23 Symptoms present on admission: Fever, shortness of breath, cough  Date of covid positive test: 4/3/23 Vaccination status: vaccinated Imaging: Chest x-ray reveals ill-defined hazy nodular opacities, concern for bronchopneumonia Oxygen requirements on admission: 6 L Current oxygen requirements: Room air  Medical therapy: steroids, Remdesivir  Consultants following: ID Anticipated special isolation end date: 4/13/23 Initial lactate was normal Respiratory panel positive for COVID  Chest CT showing diffuse patchy airspace disease throughout the left lung concerning for multifocal PNA  Oxygen per protocol, wean as appropriate, does not wear oxygen at home  S/p  IV Azithromycin, completed  Rocephin for 5 day course, s/p oral Azithromycin  Blood cultures showing Coagulase negative staph, likely contaminate, Repeat cultures negative  Continue on bronchodilators and DuoNebs Sputum Culture showing Yeast    Hypertension BNP was normal Continue Lasix 20 mg daily, Diamox  500 mg daily  S/P IV hydration  ECHO to be done outpatient-discussed with Cardiology who recommends outpatient  Blood pressure stable, elevated at times but appropriate for age, recommending close monitoring on discharge    Hyperlipidemia Hold statin for elevated liver enzymes    Hypothyroidism Continue Synthroid
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: Patient was seen in office for vaccines, along with other patients due for the same vaccines. After patient was seen, it was found that there had been a vaccine preparation error with a pentacel. A Pentacel vaccine had not been correctly reconstituted with the Hib component   Only the liquid component of the vaccine had been given. Due to the error being found after the fact, our office was not able to pinpoint which of the earlier patients had been affected.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was accidentally stored in the freezer.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: PHN mistakenly gave this 53 year old female an additional BV booster who is not immunocompromised or over 65
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Headache, Irritability, Malaise, Pyrexia, Rash
Clinical narrative: intermittent fever 100-102,  headache, malaise, irritability, some sort of rash on face (nose and cheeks), arms, hands, legs, feet, and a little on the back.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Anaemia of chronic disease, Anion gap, Bacterial disease carrier, Benign prostatic hyperplasia, Bladder catheterisation
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood glucose increased, Blood iron, Blood potassium increased, COVID-19
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cachexia, Chest X-ray abnormal, Computerised tomogram abdomen abnormal, Constipation, Dysphagia
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Faecaloma, Haemoglobin decreased, Hydronephrosis, Hydroureter
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperkalaemia, Hypoxia, Lung infiltration, Malnutrition, Neuropathy peripheral
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pneumonia bacterial, Prostatic obstruction, Pyrexia, Pyuria
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell transfusion, Rheumatoid arthritis, SARS-CoV-2 test positive, Sepsis, Social problem
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Staphylococcus test negative, Systemic inflammatory response syndrome, Urine analysis abnormal
Clinical narrative: Patient is a 91 y.o. male patient of, MD with PMH of Parkinson's Disease, DM, BPH, HTN, presented to the ED due to AMS.   Sepsis on POA Bacterial Pneumonia COVID infection SIRS on admit, lactate 2.1 Source includes COVID 19 and pneumonia Date of onset of symptoms: 4/5/23 Symptoms present on admission: fever, shortness of breath, hypoxia Date of covid positive test: 3/27/2023 Vaccination status: Unknown Imaging: CXR new RLL infiltrate/pneumonia Oxygen requirements on admission: RA Current oxygen requirements: 3LNC Medical therapy: remdesivir and steroids; cefepime switched to omnicef Blood cx, urine Ag; MRSA probe negative d/c vanco Consultants following: None Anticipated special isolation end date: 4/14/2023 Discharge on PO decadron to complete course   Anemia of chronic disease Hgb 6.4 from 7-8 baseline Checking iron panel, no active bleed Transfused 1 U PRBC and posttransfusion Hgb 7.5 Suspect increased destruction/consumption with sepsis' No active blood loss noted; Hgb stable 8.3   Hyperglycemia BG 200-300's due to decadron Treated with SSI while admitted Suspect will resolve once off decadron Plan for hospice care at facility   Fecal impaction Constipation High stool burden per CT A/P Started dulcolax, miralax, and senna Added one time glycerin suppository Has had 2 BM on  4/6   BPH with obstruction Suprapubic catheter Follows with Dr.   Has SPC placed 1/2023 CT showing mild to moderate left hydronephrosis and hydroureter to the level of prostate While UA appears pyuric suspect colonization rather than true infection Ucx proteus; switched to omnicef to complete outpatient treatment Dysphagia Protein calorie malnutrition with cachexia Evaluated by speech last admission, reg nectar thick high risk for aspiration recommended nectar thickened Unsure of what diet patient was on at ECF Restarted reg with nectar thickened liquids Added magic cup per last nutrition notes   Parkinson's disease Resume home Sinemet   Neuropathy Cymbalta   Hyperkalemia K 5.2, suspect hemolyzed sample Repeat 4.5 on 4/7   Goals of Care Per paperwork from ECF, patient is a DNRCCA Hospice to eval at facility once discharge
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Patient was seen in office for vaccines, along with other patients due for the same vaccines. After patient was seen, it was found that there had been a vaccine preparation error with a pentacel. A Pentacel vaccine had not been correctly reconstituted with the Hib component   Only the liquid component of the vaccine had been given. Due to the error being found after the fact, our office was not able to pinpoint which of the earlier patients had been affected.
Age: 0.67
Sex: M
Vaccine: COVID19-2
Symptoms: Wrong product administered
Clinical narrative: Patient received Moderna for first dose of Covid vaccine 4 weeks ago.  Today, Patient was given Pfizer in error for second dose.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid increased, COVID-19, COVID-19 pneumonia, Chest X-ray, Condition aggravated
Clinical narrative: Patient is a 47 y.o. male patient of, PA-C with history of relapsing remitting multiple sclerosis, seizure in the setting of MS, asthma, bipolar disorder, hypertension, hyperlipidemia, presented to Hospital with cough and shortness of breath over past few days.  While in the ER patient had chest x-ray concerning for multifocal pneumonia COVID-19 was positive, lactate was elevated concerning for sepsis.  Patient is being admitted for further management.   Sepsis likely in setting of viral pneumonia COVID-19 pneumonia Covid-19 Virus Infection Date of onset of symptoms: 3/31 Symptoms present on admission: Shortness of breath Date of covid positive test: 4/3 Vaccination status: vaccinated
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pneumonia viral, Relapsing-remitting multiple sclerosis, SARS-CoV-2 test positive
Clinical narrative: Patient is a 47 y.o. male patient of, PA-C with history of relapsing remitting multiple sclerosis, seizure in the setting of MS, asthma, bipolar disorder, hypertension, hyperlipidemia, presented to Hospital with cough and shortness of breath over past few days.  While in the ER patient had chest x-ray concerning for multifocal pneumonia COVID-19 was positive, lactate was elevated concerning for sepsis.  Patient is being admitted for further management.   Sepsis likely in setting of viral pneumonia COVID-19 pneumonia Covid-19 Virus Infection Date of onset of symptoms: 3/31 Symptoms present on admission: Shortness of breath Date of covid positive test: 4/3 Vaccination status: vaccinated
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Patient is a 47 y.o. male patient of, PA-C with history of relapsing remitting multiple sclerosis, seizure in the setting of MS, asthma, bipolar disorder, hypertension, hyperlipidemia, presented to Hospital with cough and shortness of breath over past few days.  While in the ER patient had chest x-ray concerning for multifocal pneumonia COVID-19 was positive, lactate was elevated concerning for sepsis.  Patient is being admitted for further management.   Sepsis likely in setting of viral pneumonia COVID-19 pneumonia Covid-19 Virus Infection Date of onset of symptoms: 3/31 Symptoms present on admission: Shortness of breath Date of covid positive test: 4/3 Vaccination status: vaccinated
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improper storage of product in use; This spontaneous report was received from a pharmacist referring to a 16-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      The varicella virus vaccine live (oka/merck)(VARIVAX) with lot number W025273, expiration date reported as 02-JUN-2023, but upon internal validation was confirmed as 10-AUG-2024  underwent a temperature excursion of 70 degrees Fahrenheit for 9 minutes on 02-MAR-2023, and on 09-JUN-2023, the patient was vaccinated with 0.5 milliliter (route of administration not reported) for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The office manager in the physician's office is reporting that a patient received improperly stored vaccine; This spontaneous report was received from an office manager in the physician's office, concerning to a patient of unspecified age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 14-JUN-2023, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) pre-filled syringe, 1 dose, lot #W023682, expiration date: 21-MAY-2025 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine underwent temperature excursions of -6.9 degree Celsius (C) for 27 hours 30 minutes and -6.9 C for 20 hours 30 minutes, with no previous temperature excursions.  No additional adverse events were reported (no adverse event). No further information provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Nurse calling to report an AAE regarding the RECOMBIVAX HB vaccine. Nurse reported that a patient was administered an expired dose of the vaccine. Permission to contact HCP was provided. No additional AE/PQC reported.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # U019139, expiration date: 11-JUN-2023 (strength, route of administration, anatomical location not provided) as prophylaxis. No additional adverse event was reported.  .
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; patient was given VARIVAX product that had been reconstituted with sodium chloride solution instead of sterile diluent.; This spontaneous report has been received from a pharmacist referring to a patient of unknown age or gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 23-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot# U039722, expiration date 15-DEC-2023, strength, dose, route and anatomical location were not reported) for prophylaxis, which was reconstituted with sodium chloride solution (strength, dose, frequency, lot#, expiration date, route and indication were not reported) instead of sterile diluent (product preparation error). No additional AE details available. No additional AE reported.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; HCP called to report TE of GARDASIL 9 in which the vaccine was administered to a patient; This spontaneous report has been received from a medical assistant referring to a 14-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 22-JUN-2023, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter, lot# W015188, expiration date 06-JAN-2025, strength, route and anatomical location were unknown) for prophylaxis. The vaccine was administered by the reporter as an experienced user. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) had multiple previous excursions (product storage error) and was not able to be evaluated during the call. No additional adverse event information could be provided.
Age: 0.17
Sex: U
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Email received in the mailbox on 23Jun2023 at 5:26 pm with possible AE from social media. Report verbatim: "message from social media "about to get @Merck 's MMRII vax for my 2 month old unless someone can convince me not to." See atta; This spontaneous report was received from a consumer referring to a 2-month-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, route of administration, lot number and expiration date not reported) for prophylaxis (product administered to patient of inappropriate age).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse outcomes or side effects were reported or observed by the patients who received the administered doses; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023; This spontaneous report has been received from a licensed practical nurse referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) (lot# W031813, expiration date 05-OCT-2024) experienced temperature excursions (TE). On 12-MAY-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 milliliter, lot# W031813, expiration date 05-OCT-2024, strength, route and anatomical location were unknown) for prophylaxis. The product was stored at 10.8 degree Fahrenheit (F) for 8 hours, 23 minutes, and 0 seconds with a supported TE stability evaluation (product storage error). There were not any previous excursions. No adverse outcomes or side effects were reported or observed by the patient who received the administered dose (no adverse event). No additional AE information was able to be provided. The reporter was not made aware of the TE until 26-JUN-2023 (also reported as today).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012560: US-009507513-2306USA012315: US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012362: US-009507513-2306USA012732: US-009507513-2306USA012753:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse outcomes or side effects were reported or observed by the patients who received the administered doses by an experienced HCP.; The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W031813, expiration date: 05-OCT-2024) was stored at 10.8 Fahrenheit for 8 hours, 23 minutes and 0 seconds with a supported temperature stability evaluation. There were not any previous excursions.  On 22-JUN-2023, the patient was vaccinated with that varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter via injection (strength, route of administration, and indication were not provided) (Product storage error). No adverse outcomes or side effects were reported or observed by the patient (No adverse event).; Sender's Comments:  US-009507513-2306USA012702: US-009507513-2306USA012560:
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Measles, Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia, Rash
Clinical narrative: PCR testing showed that she has the measles virus; This spontaneous report was received from a medical assistant referring to a 13-month-old female patient. The patient's concurrent condition included kabuki make-up syndrome, gastrostomy, milk allergy and food allergy. The patient's concomitant medication included diacoxide. The patient's historical medications and medical history were not reported.     On 21-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) lot number w028731, expiration date 06-APR-2024, 0.5 milliliter, subcutaneous for prophylaxis.         On 21-JUN-2023, the patient experienced fever of 101 degrees that continued on the next day. On 26-JUN-2023, the patient developed rash. The HCP did a throat swab that resulted positive for measles    The outcome of measles was reported as not resolved. The causal relationship between the event and the vaccine was not reported.
Age: 30.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No adverse event; HCP called to report that an adult patient was given GARDASIL 9 on 02/2022, 04/2022, and missed the dose scheduled for 08/2022. No additional AE/PQC.; This spontaneous report was received from a medical assistant refers to a 31-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown day in February 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis. On unknown day in April 2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  It was reported that the patient missed the dose scheduled for the third dose on September 2022 (vaccine dose omission). No additional adverse event reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: HCP reported administering GARDASIL 9 to a pregnant patient.; No additional AE; This spontaneous prospective pregnancy report was received from a nurse and refers to a female patient of unknown age. No information on patient's medical history, current conditions and concomitant medications was provided. On unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated due date (EDD) was not known. The pregnancy outcome was unknown.   On an unknown date the pregnant 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 of administration, lot# and expiration date were not provided) (exposure during pregnancy and no adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; Nurse calling with a medical information question. HCP states that 2 pediatric (twin) patients were given an extra dose of MMR-II and VARIVAX.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with extra dose (third dose) of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # W039697, expiration date: 13-DEC-2024, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Extra dose administered). No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA000029:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: No Additional AE; The PROQUAD also suffered from a non supported temperature excursion; HCP called to report that the patient was given PROQUAD instead of MMR II.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on patient medical history, current conditions and concomitant medications was provided.     On 26-JUN-2023 the patient vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W029552 and expiration date 14-MAR-2024, for prophylaxis (exact dose, dose number, route and site of administration were not provided) instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered, no adverse event and product storage error).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: No Adverse Event; HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; Improper storage of product; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-MAY-2023, the patient was vaccinated with the dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  Administered dose of vaccine was exposed to the temperature excursion of 8 degrees Celsius for 1200 hours (improper storage of product in use). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: HCP called to report that the patient was given PROQUAD instead of MMR II. The PROQUAD also suffered from a non supported temperature excursion. TE cases 02418202, 02418066.  HCP states they do not wish to be contacted about this and declines  any fo; Improper storage of product in use; No Adverse Event; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2023, the patient was vaccinated with the dose of improper storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin), (PROQUAD) lot #W029552, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (wrong product administered).  Administered dose of vaccine was exposed to the temperature excursion of 8 degrees Celsius for 2160 hours (improper storage of product in use). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-MAY-2023, the patient was vaccinated with the dose of improper storage PROQUAD lot #W029552, expiration date: 14-MAR-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis instead of M-M-R II (wrong product administered). Administered dose of vaccine was exposed to the temperature excursion of 8 degrees Celsius for 1440 hours (improper storage of product in use). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP reported that vaccine was administered after it experienced a temperature excursion.          ?    Names of vaccines involved (including lot/exp): VARIVAX (Lot: W031813, Expiration: 10/5/2024)        ?    Temperature: -7.93 C         ?    T; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 29-JUN-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W031813 and expiration date 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route and site of administration were not provided) (product storage error and no adverse event). The temperature excursion was -7.93 degrees Celsius, and the time frame was 0 hours, 15 minutes, 0 seconds. There were no previous temperature excursions.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Feeling hot, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: bad headache; runny nose; arm turned red from his shoulder to his elbow; arm feel hot; fever; has not been able to sleep; This spontaneous report was received from an consumer and refers to a 17-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023 at 9:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, right arm, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 28-JUN-2023 (also reported as shortly after receiving the vaccine), the patient had a bad headache and runny nose, his arm turned red from his shoulder to his elbow, his arm feel hot where it was red and he had a fever. The patient did also was not able to sleep since receiving the vaccine. The patient contacted a healthcare professional (HCP) and was advised to take Advil and put ice on his arm. At the time of the report, the patient did not recovered from the events.  The causal relationship between all adverse events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired dose of VARIVAX administered to patient; This spontaneous report was received from a medical assistantand refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JUN-2023, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/two dose series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient was asymptomatic. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; HCP calling to report AE related to Temp Excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; it was reported that on 25-MAY-2023, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024) administered as prophylaxis (dose, dose number, frequency, route of administration and anatomical location were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments: Keywords : US-009507513-2306USA011972:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP calling to report AE related to Temp Excursion; No additional AE.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not provided.   On an unspecified date, a call was received stating that a temperature excursion (Product storage error) had occurred; however, it was unknown the date of administration. It was reported that the patient had received either varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number valid, reported as W039294, expiration date 11-DEC-2024) or measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot number valid, reported as X002105, expiration date 18-JUL-2024); both administered for prophylaxis (doses, routes of administrations and anatomical locations, were not provided).  The vaccine presented a temperature excursion at -14.3 degrees Celsius (C) for a timeframe of 1 hour and 14 minutes. There were no product quality complaints and no adverse events reported.; Sender Comments: US-009507513-2306USA011972: