chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sepsis, Streptococcus test negative, Superinfection, Tachycardia
Clinical narrative: Patient is a 63 year-old female patient of, MD with history of hypothyroidism, and small fiber neuropathy/myelopathy who presented to Hospital on 7/2/23 with fatigue, weakness, and cough.   Patient was found to be positive for COVID-19 with additional concerns for superimposed bacterial CAP. CTPA showing peribronchiolar airspace opacities in the right upper and lower lobes consistent with bacterial pneumonia so IV ceftriaxone and azithromycin were started. Patient also started on decadron. Patient required oxygen supplementation and was able to wean down to room air prior to discharge. Patient found to have UTI, symptoms improved with antibiotics.   Acute hypoxemic respiratory failure COVID-19 viral pneumonia Suspected community acquired pneumonia Respiratory failure in setting of pneumonia, potentially combination of viral from COVID with bacterial superimposed given imaging findings Imaging: CTPA with peribronchiolar airspace opacities in the right upper and right lower lobes most confluent in the right upper lobe, no PE Medical therapy: IV Rocephin and Azithromycin, decadron. Transition to orals at discharge Urinary antigens negative for strep. pneumo and legionella Continue Mucinex and hycodan for cough Continue claritin for eustachian tube dysfunction Nasal Ocean Spray for congestion Sepsis Febrile and tachycardic on admission with normal lactate, likely due to pneumonia Blood cultures preliminary result showing no growth Continue COVID-19 treatment as above and antibiotics with ceftriaxone/azithromycin   UTI - improved Urinary cultures positive for Klebsiella pneumonia and E. coli, likely 2/2 patient intermittent self catheterization, POA  Patient already on rocephin therefore not starting new abx at this time, will continue to monitor   Hyperglycemia Elevated glucose in the setting of infection and decadron use Improving since starting SSI Continue SSI   Hyperkalemia Elevated potassium in the setting of potential dehydration, less likely medication induced Hold IVF in the setting of COVID infection Monitor K+, consider Lokelma if indicated   Hypothyroidism Continue home levothyroxine   Myelopathy Small fiber neuropathy Follows with neurology, chronically with lower extremity weakness and using walker Continue home pregabalin   Underweight Body mass index is 19.22 kg/m². In the setting of COVID and CAP Encourage PO intake
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underweight, Urinary tract infection, Urine analysis normal
Clinical narrative: Patient is a 63 year-old female patient of, MD with history of hypothyroidism, and small fiber neuropathy/myelopathy who presented to Hospital on 7/2/23 with fatigue, weakness, and cough.   Patient was found to be positive for COVID-19 with additional concerns for superimposed bacterial CAP. CTPA showing peribronchiolar airspace opacities in the right upper and lower lobes consistent with bacterial pneumonia so IV ceftriaxone and azithromycin were started. Patient also started on decadron. Patient required oxygen supplementation and was able to wean down to room air prior to discharge. Patient found to have UTI, symptoms improved with antibiotics.   Acute hypoxemic respiratory failure COVID-19 viral pneumonia Suspected community acquired pneumonia Respiratory failure in setting of pneumonia, potentially combination of viral from COVID with bacterial superimposed given imaging findings Imaging: CTPA with peribronchiolar airspace opacities in the right upper and right lower lobes most confluent in the right upper lobe, no PE Medical therapy: IV Rocephin and Azithromycin, decadron. Transition to orals at discharge Urinary antigens negative for strep. pneumo and legionella Continue Mucinex and hycodan for cough Continue claritin for eustachian tube dysfunction Nasal Ocean Spray for congestion Sepsis Febrile and tachycardic on admission with normal lactate, likely due to pneumonia Blood cultures preliminary result showing no growth Continue COVID-19 treatment as above and antibiotics with ceftriaxone/azithromycin   UTI - improved Urinary cultures positive for Klebsiella pneumonia and E. coli, likely 2/2 patient intermittent self catheterization, POA  Patient already on rocephin therefore not starting new abx at this time, will continue to monitor   Hyperglycemia Elevated glucose in the setting of infection and decadron use Improving since starting SSI Continue SSI   Hyperkalemia Elevated potassium in the setting of potential dehydration, less likely medication induced Hold IVF in the setting of COVID infection Monitor K+, consider Lokelma if indicated   Hypothyroidism Continue home levothyroxine   Myelopathy Small fiber neuropathy Follows with neurology, chronically with lower extremity weakness and using walker Continue home pregabalin   Underweight Body mass index is 19.22 kg/m². In the setting of COVID and CAP Encourage PO intake
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Atrial fibrillation, COVID-19, Cardiac monitoring, Chronic fatigue syndrome
Clinical narrative: Patient is a 86 y.o. female patient of, MD with history of anxiety, arthritis, A-fib, incontinence, hyperlipidemia, GERD, hypertension, ulcers, prediabetes, presented to Hospital with COVID and generalized weakness  COVID-19 infection Patient is vaccinated Continue Paxlovid ID is on board Patient is on room air, saturating well Will DC dexamethasone   Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitori  Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitoring Not on anticoagulant Continue her Toprol   UTI Urine culture sent, no growth  Was started on Macrobid, will DC at discharge
Age: 86.0
Sex: F
Vaccine: COVID19-2
Symptoms: Culture urine negative, Urinary incontinence, Urinary tract infection
Clinical narrative: Patient is a 86 y.o. female patient of, MD with history of anxiety, arthritis, A-fib, incontinence, hyperlipidemia, GERD, hypertension, ulcers, prediabetes, presented to Hospital with COVID and generalized weakness  COVID-19 infection Patient is vaccinated Continue Paxlovid ID is on board Patient is on room air, saturating well Will DC dexamethasone   Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitori  Generalized weakness Chronic fatigue disorder PT/OT evaluation Plan for PT at home    Hypertension Hyperlipidemia Continue Lipitor, Lasix,Potassium replaced,, metoprolol Cozaar  Dc iv fluid      Depression anxiety Continue Celexa   Urinary incontinence Patient requesting a pure wick   Paroxysmal atrial fibrillation Cardiac monitoring Not on anticoagulant Continue her Toprol   UTI Urine culture sent, no growth  Was started on Macrobid, will DC at discharge
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Arteriosclerosis, Atelectasis, Blood culture negative, Brain natriuretic peptide increased
Clinical narrative: Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiomegaly, Chest X-ray normal, Computerised tomogram thorax abnormal, Confusional state
Clinical narrative: Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Metabolic encephalopathy, Nausea, Oropharyngeal pain
Clinical narrative: Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Physical deconditioning, Pyrexia, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Patient is a 62 y.o. male patient of, MD with history of ischemic cardiomyopathy s/p ICD, coronary artery disease, severe MR, diabetes, hypertension, hepatitis B infection presented to Hospital with fever, nausea vomiting and diarrhea. Problem based management in the hospital is as follows:    Covid-19 Virus Infection Date of onset of symptoms: 06/28/2023 Symptoms present on admission: Fever, nausea vomiting and diarrhea, confusion and sore throat Date of covid positive test: 07/01/2023 Vaccination status: vaccinated. Two doses Imaging: CT chest showed mild cardiomegaly, trace pericardial effusion, atherosclerotic calcification.  Mild subsegmental dependent atelectasis and bilateral lower lobes were seen.  No acute pulmonary abnormality noted Oxygen requirements on admission: RA Current oxygen requirements: RA Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 7/10/2023   Acute metabolic encephalopathy, POA, resolved Likely due to sepsis and COVID infection Patient appears at baseline.   He is oriented X3 and able to provide history Monitor   Sepsis, POA, now resolved Likely secondary to above, presenting with fever of 103.2, heart rate 118, blood pressure 169/73.  Respiratory rate 8 Chest x-ray nonacute.  UA unremarkable Received 1 dose of cefepime and vancomycin in the ED Hold antibiotics for now Blood cultures NTD  Physical deconditioning Patient seen by PT/OT, recs consistent with home health care at discharge   Ischemic cardiomyopathy s/p ICD Coronary artery Hypertension Hyperlipidemia Continued home dose metoprolol, Imdur, atorvastatin, aspirin and Plavix BNP mildly elevated at 435 but chest x-ray nonacute/no evidence of pulmonary vascular congestion Continued home dose Lasix   Diabetes mellitus type II with insulin use Resumed Lantus and sliding scale insulin Dose insulin as needed   After 4 days of hospital stay, patient was doing well so he was discharged in stable condition. Advised to f/u with PCP. All questions and concerns were addressed before discharge.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Dysarthria, Hypoaesthesia, Injected limb mobility decreased, Muscular weakness
Clinical narrative: Patient presents to ED with left sided numbness started one hour ago. Pt states she has been having issues with nerve pain since the covid shot- March 16th. Unable to lift left arm and leg. Grip on left more weak. Slurred speech.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Musculoskeletal disorder, Neuralgia
Clinical narrative: Patient presents to ED with left sided numbness started one hour ago. Pt states she has been having issues with nerve pain since the covid shot- March 16th. Unable to lift left arm and leg. Grip on left more weak. Slurred speech.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Injection site warmth, Joint swelling
Clinical narrative: Swelling on injection site- pain, hot, red rash approximately 3 x 3 inches- 3 days after injection
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Swelling on injection site- pain, hot, red rash approximately 3 x 3 inches- 3 days after injection
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry throat, Dyspnoea, Hyperventilation, Seizure
Clinical narrative: Patient was given the first dose of Shingrix vaccine. Approximately 15 minutes later patient complains of very dry throat and potential tongue swelling. 5 minutes after that patient begins to hyperventilate saying that she could not breathe. At this time I administered the epipen (which patient had on her) and called emergency services. Patient was given 2 puffs of her albuterol since she was still hyperventilating. Immediately following the albuterol she was breathing normally. Patient was laid down on the ground and approximately 5 minutes later she started having seizures. The fire department arrived first and administered oxygen to patient. EMS arrives shortly after and takes patient away.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac failure, Death
Clinical narrative: Heart Failure leading to quick death
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Cerebral disorder, Condition aggravated, Eye disorder, Impaired driving ability
Clinical narrative: After I took the first vaccine shot at Facility I started having issues with my heat having PVC's after I took the second shot I got pneumonia and was out of work for several days.  Later I started having issues driving and found out that the shot has caused my eyes and brain not to connect so I am unable to drive up and down hills.  I have been under a doctor's care since July of 2022.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Pneumonia, Ventricular extrasystoles
Clinical narrative: After I took the first vaccine shot at Facility I started having issues with my heat having PVC's after I took the second shot I got pneumonia and was out of work for several days.  Later I started having issues driving and found out that the shot has caused my eyes and brain not to connect so I am unable to drive up and down hills.  I have been under a doctor's care since July of 2022.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Malaise, Nausea, Pain
Clinical narrative: She received her first shingrix vaccine in approx April or May of 2023 - she can't remember the date - at pharmacy. States she hasn't felt well since then (mostly fatigue, nausea, vomiting, and pain), and has had numerous shingles flare-ups to her left buttocks since receiving the vaccine. Tried valtrex and acyclovir with no improvement. Has an upcoming appt scheduled with GI to eval and treat ongoing nausea and vomiting. Most recent shingles rash flared up again 7/8/23. She is being referred to Internal Medicine for evaluation and treatment of her ongoing symptoms that started shortly after receiving her first shingles vaccine.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: She received her first shingrix vaccine in approx April or May of 2023 - she can't remember the date - at pharmacy. States she hasn't felt well since then (mostly fatigue, nausea, vomiting, and pain), and has had numerous shingles flare-ups to her left buttocks since receiving the vaccine. Tried valtrex and acyclovir with no improvement. Has an upcoming appt scheduled with GI to eval and treat ongoing nausea and vomiting. Most recent shingles rash flared up again 7/8/23. She is being referred to Internal Medicine for evaluation and treatment of her ongoing symptoms that started shortly after receiving her first shingles vaccine.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Sleep disorder
Clinical narrative: Patient complained of tingling sensation in the hands, uncomfortable enough that she had difficulty sleeping.  It started Wednesday night.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Fatigue, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Patient complained of tingling sensation in the hands, uncomfortable enough that she had difficulty sleeping.  It started Wednesday night.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vomiting
Clinical narrative: Patient complained of tingling sensation in the hands, uncomfortable enough that she had difficulty sleeping.  It started Wednesday night.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid contusion, Injection site erythema, Injection site swelling, Ocular hyperaemia
Clinical narrative: 1. swollen, red area on the left arm around 3 inches below the injection site. lasted 3 days 2. bruising at the inside corner of the left eye and the eye was bloodshot. vision was not impacted. lasted 3 to 4 days. *both began around 12 hours post vaccination *patient did not seek any medication attention for these effects. reported to the pharmacy on 7/30/23 (6 days following the vaccine). reports everything has resolved now.
Age: 59.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Fatigue, Hypersomnia, Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: PATIENT STATED SHE FELT VERY TIRED, FEVERISH, PAINFUL ARM, AND SLEPT A LOT  FOR A FEW DAYS. SHE NOTICED THE RASHES ON THE LEFT UPPER ARM THE MORNING AFTER VACCIEN GIVEN. SHE WENT TO THE EMERGENCY DEPARTMENT ON 07-30-2023  AND RECEIVED TREATMENT AND SENT HOME WITH SOME PRESCRIPTIONS. SHE IS NOW STATBLE AND RESTING.  SHE WILL BE FOLLOWING UP WITH HER PCP.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Infant nutritional formula, Resuscitation, Therapy non-responder, Unresponsive to stimuli
Clinical narrative: mom called me on the morning of 04/06/2023 , saying she fed the baby around 2-3 AM  and baby fed formula normally . when she came to her bed for feeding around 5-6 am . she was unresponsive . she called EMS , who found baby totally unresponsive with no favorable response to CPR  .
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Urticaria
Clinical narrative: Abdominal skin/under skin pain, started on July 28th, about 10 days after the Shingle vaccine. Singles-like rashes appeared last night on the front side of abdominal area. Five rashes within 1-2cm size were observed and pictures were taken. Pain last and spread to abdominal back side today (7/30). Purchased Advil for night usage.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient had arm turn red and associated with pain
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: Patient experienced double vision for 4-5 days
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Decreased appetite, Fatigue, Irritability, Myalgia
Clinical narrative: Day 1 - 7/3/23 3pm until Day 3 - 7/5/23 8pm:  nausea, extreme fatigue, soreness all over body, muscle aches & joint pain, fuzzy brain, loss of appetite, irritability
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Nausea, Pain
Clinical narrative: Day 1 - 7/3/23 3pm until Day 3 - 7/5/23 8pm:  nausea, extreme fatigue, soreness all over body, muscle aches & joint pain, fuzzy brain, loss of appetite, irritability
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Bedridden, Death, Fall, Gait disturbance
Clinical narrative: Started have problems walking  and had issues with left leg than would fall and couldn?t get up on own than dr said drop foot than left arm and hand turned unusable than a walker than on dec 22nd 2022 was told she had ALS and than in February bed ridden than in hospice and my wife passed on June 19th almost one year to the day of the vaccination
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Musculoskeletal disorder, Peroneal nerve palsy, Walking aid user
Clinical narrative: Started have problems walking  and had issues with left leg than would fall and couldn?t get up on own than dr said drop foot than left arm and hand turned unusable than a walker than on dec 22nd 2022 was told she had ALS and than in February bed ridden than in hospice and my wife passed on June 19th almost one year to the day of the vaccination
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Diarrhoea, Feeling cold, Myalgia
Clinical narrative: Chills  Muscle ache Diarrhea Severe abdominal cramps
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse reaction
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Gingivitis, Influenza like illness
Clinical narrative: Infection in gums where my right wisdom tooth was for a week, flu like symptoms for a day, knot in left breast for two weeks.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Crying, Feeling abnormal, Pyrexia, Rhinorrhoea, Sleep disorder
Clinical narrative: Inconsolable crying all night. Not sleeping. Next day, runny nose, fever off and on, fussing.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Abnormal behaviour, Anger
Clinical narrative: Behavior change (anger) , especially towards food
Age: 16.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Twinrix at 16 years of age.   Twinrix is for 18+ years
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine past BUD
Sex: U
Vaccine: MMRV
Symptoms: Product storage error, Wrong product administered
Clinical narrative: No additional AE/PQC reported; HCP called to report that the patient was given PROQUAD instead of MMR II; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from Pharmacist and refers to a patient of unknown gender or age. Information regarding the patient medical history, historical drug, current conditions or concomitant therapies was not provided.  On 05-MAY-2023, the patient was vaccinated by mistake (wrong product administered) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W029552 rHA, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) patient should received instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II.)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 8 degree celscius for 1032 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Additional AE/PQC reported; The patient was given PROQUAD instead of MMR II; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from Pharmacist and refers to a patient of unknown gender or age. Information regarding the patient medical history, historical drug, current conditions or concomitant therapies was not provided.  On 28-JUN-2023, the patient was vaccinated by mistake (wrong product administered) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W029552 rHA, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) patient should received instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II.)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 8 degree celscius for 2328 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error, Wrong product administered
Clinical narrative: No additional AE/PQC reported; HCP called to report that the patient was given PROQUAD instead of MMR II; The PROQUAD also suffered from a non supported temperature excursion; This spontaneous report was received from Pharmacist and refers to a patient of unknown gender or age. Information regarding the patient medical history, historical drug, current conditions or concomitant therapies was not provided.  On 26-JUN-2023, the patient was vaccinated by mistake (wrong product administered) with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #W029552 rHA, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) patient should received instead measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II.)  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 8 degree celscius for 2280 hours on an unknown date; no previous temperature excursions were reported.  No adverse symptoms were reported.
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE/no PQC; received improperly stored ROTATEQ, VAQTA, and GARDASIL 9 vaccinations; This spontaneous report was received from a nurse referring to an 18-month-old female patient. The patient's concurrent conditions and medical history were not reported.   Concomitant therapy included diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine, live, oral, pentavalent (ROTATEQ), varicella vaccine (manufacturer unknown), hepatitis b vaccine (manufacturer unknown), and measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN).     On 23-JUN-2023, the patient was vaccinated with an improperly stored dose of hepatitis A Vaccine, inactivated (VAQTA) lot# X003791 and expiration date 01-JUN-2024 in the left thigh as prophylaxis (strength, dose, route, and vaccination scheme frequency were not provided). It was reported that vaccine temperature excursion was not viable and occurred from a data logger alarm believed to be due to sensory issues. Monitoring temperature with back up logger. Temperature in range, new data logger was in use. It was also reported a storage in clinical practice. There was no adverse effect reported.  The action taken with the vaccine was reported as "returned, waste in progress".   This is one of several cases by the same reporter. ; Sender's Comments:  US-009507513-2307USA012178:
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first, second and third doses were administered to the patient on 10-DEC-2021, 08-FEB-2022 and 16-SEP-2022, respectively; the first, second and third doses were administered to the patient on 10-DEC-2021, 08-FEB-2022 and 16-SEP-2022, respectively; This spontaneous report was received from a nurse and refers to an 8-week-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported. Patient histyorical vaccination included: diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5),tetanus vaccine toxoid (PENTACEL); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13); rotavirus vaccine live reassort oral 5v (ROTATEQ).   On 10-DEC-2021, the patient was vaccinated with dose 1 of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection; then second and third doses were administered to the patient on 08-FEB-2022 (Inappropriate schedule of vaccine administered) and 16-SEP-2022 (Inappropriate schedule of vaccine administered) respectively administered for prophylaxis (strengths, exact doses, lot #s, expiry dates, and routes of administration were not provided)   Other vaccination included: measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown) and varicella vaccine (manufacturer unknown).  This is one of 2 cases of the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA011004: US-009507513-2306USA013096:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; Temperature excursion; This spontaneous report was received from a healthcare professional referring to a 4-month-old male patient. The patient's concurrent conditions included colecalciferol (Vitamin D), pneumococcal vaccine conj 7V (CRM197) (PREVENAR), Hepatitis B Vaccine, and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (PENTACEL). The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions were not reported.   On 27-APR-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (basic series; strength, dose, lot#, and expiration date were not provided) orally for prophylaxis. On 27-JUN-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (lot#: 1968386, expiration date: 23-MAY-2024; strength and dose were not reported) orally for prophylaxis. The vaccine administered experienced temperature excursion (product storage error). The alarm had some sensory issue and the vaccine was monitored with back up logger. No adverse effects (no adverse event).
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; temperature excursion; This spontaneous report was received from a healthcare professional referring to a 6-month-old male patient. The patient's historical vaccine included hepatitis B vaccine. The patient's concomitant vaccines included pneumococcal vaccine conj 7V (CRM197) (PREVENAR) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (PENTACEL). The patient's medical history, concurrent conditions, and past drug reactions or allergies were not reported.   On 12-JUN-2023, the patient was vaccinated with rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (lot#: 1968385, expiration date: 22-MAY-2024; strength and dose were not reported) orally for prophylaxis. The vaccine administered experienced temperature excursion (product storage error). The alarm had some sensory issue, and the vaccine was monitored with back up logger. No adverse effects (no adverse event).
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first, second and third doses were administered to the patient on 08-FEB-2012, 09-APR-2012 and 13-NOV-2012, respectively; the first, second and third doses were administered to the patient on 08-FEB-2012, 09-APR-2012 and 13-NOV-2012, respectively; This spontaneous report was received from a nurse and refers to an 8-week-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant vaccinations included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ) (manufacturer unknown), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).   On 08-FEB-2012, the patient was vaccinated with dose 1 of hepatitis b vaccine (recombinant) (manufacturer unknown) intramuscular injection, then, second and third doses were administered to the patient on  09-APR-2012 (Inappropriate schedule of vaccine administered) and 13-NOV-2012 (Inappropriate schedule of vaccine administered) administered as prophylaxis (strengths, lot #s, expiry dates, and routes of administration were not provided).  Other vaccination included: diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP); influenza vaccine; hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); hepatitis a vaccine inact (manufacturer unknown),  polio vaccine; measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA); and varicella vaccine (manufacturer unknown).   This is one of several cases of the same patient.; Sender's Comments:  US-009507513-2307USA010360:
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first, second doses were administered to the patient on 13-FEB-2014, and 05-SEP-2017 respectively (timeframe of 3years and 6 months); This spontaneous report was received from a nurse and refers to a 5-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported. Patient historical vaccines included: influenza vaccine; Hepatitis B Vaccine (Recombinant) (manufacturer unknown); polio vaccine; measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5),tetanus vaccine toxoid (PENTACEL); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), rotavirus vaccine live reassort oral 5v (ROTATEQ), and varicella vaccine inact (manufacturer unknown).  On 13-FEB-2014, the patient was vaccinated with dose 1 of hepatitis a vaccine, inactivated (manufacturer unknown) intramuscular injection, then on 05-SEP-2017, was vaccinated with the second dose (Inappropriate schedule of vaccine administered), both doses administered for prophylaxis (strengths, lot #s, expiry dates, anatomical locations, and routes of administration were not provided).  Other vaccination included: hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).    This is one of several cases of the same patient.; Sender's Comments:  US-009507513-2307USA010345: US-009507513-2307USA009835:
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Rotateq was given to the patient on 05-APR-2022 and the third one on 24-JUN-2022 (timeframe: 10 weeks + 10 days); This spontaneous report was received from a nurse and refers to a 6-month-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Historical vaccines include: diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13); and Hepatitis B Vaccine (Recombinant) (manufacturer unknown).   On 08-FEB-2022, the patient was vaccinated with dose 1 of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, then, on 05-APR-2022 and 24-JUN-2022 (Inappropriate schedule of vaccine administered) second and third doses were administered to the patient respectively administered orally for prophylaxis (strengths, lot #s, and expiry dates were not provided).  Other vaccines included: diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); hepatitis a vaccine inact (manufacturer unknown); measles vaccine, mumps vaccine, rubella vaccine (manufacturer unknown); and varicella vaccine (manufacturer unknown).  This is one of 2 cases of the same patient.; Sender's Comments:  US-009507513-2306USA013096: US-009507513-2307USA009456:
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; two patients received expired MMR II vaccine; two patients received expired MMR II vaccine when they were supposed to receive a dose of PROQUAD; This spontaneous report was received from a registered nurse referring to an unknown age and gender patient.  The patient's concurrent conditions, medical history, drug reaction or allergies and concomitant therapies were not provided.  On 20-JUL-2023, the patient was administered 1 dose of expired vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA)(M-M-R II) (albumin status rHA) injection, 1 dose, (lot number U022316 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date reported and established as 15-JUL-2023) (strength, and route of administration were not provided), this vaccine was administered instead of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (wrong product administered). No adverse event was reported.   This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2307USA011531:
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hepatitis B vaccine 12/12/2021,02/04/2022, 09/12/2022; This spontaneous report was received from a Nurse referring to a 18-months-old female patient. The patient's pertinent medical history, drug reactions or allergies were not provided.   Concomitant vaccines included Hepatitis A Vaccine, inactivated (manufacturer unknown), rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR VACCIN), varicella vaccine (manufacturer unknown), and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).  On 12-DEC-2021, 04-FEB-2022, and 12-SEP-2022, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, route of administration, exact dose, lot number and expiration date were not provided) for prophylaxis, respectively (inappropriate schedule of product administration for the second and third doses).   This is one of several reports from the same reporter. This is one of two reports for the same patient.; Sender's Comments:  US-009507513-2307USA009244:
Sex: U
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse event was reported; TE for ROTATEQ and VAXNEUANCE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 26-JUL-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection (0.5 ml/once, lot#: X005583, expiration date: 10-DEC-2024; strength and route of administration were not provided); and Rotavirus vaccine live, pentavalent (ROTATEQ) oral liquid (2 ml/once, lot#: 1933911, expiration date: 18-APR-2024; strength was not provided) orally, both for prophylaxis. The vaccines administered experienced temperature excursion (TE) at 9.6 degree Celsius for 16 minutes (product storage error). No adverse event (AE) was reported (no adverse event).