chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Haemodialysis, Hyperkalaemia, Hypoxic-ischaemic encephalopathy, Lung infiltration, Magnetic resonance imaging head abnormal
Clinical narrative: Assessment and Plan:  45 year old female (pronouns he/him) with a history of ESRD secondary to Alport syndrome, HTN, HLD, chronic pain, and chronic ulcer who presents with cardiac arrest in setting of hyperkalemia.  Hospital course complicated by COVID and cdiff.  Currently on minimal vent settings but mental status precludes extubation.  Neurology following for evaluation of anoxic brain injury with poor prognosis.       Acute Respiratory Failure Secondary to cardiac arrest, now also with COVID and pulmonary infiltrates, further plan as below Continue vent support Pulm/CC consulted and continue care per critical care team Palliative care following Transitioned to DNRCC and compassionate extubation on 1/20 and patient expired   Anoxic Encephalopathy Anoxic Brain injury Refractory Status Epilepticus  Secondary to cardiac arrest as below CT head non-acute EEG consistent with global cerebral dysfunction Non-epileptiform seizures well controlled on propofol and versed gtt Elevated neuron specific enolase indicative of significant neurologic injury Neurology followed: continue Keppra, cEEG MRI 1/6: diffuse anoxic brain injury without evidence of significant mass effect, midline shift or acute intracranial hemorrhage Poor prognosis for neurological recovery.   Palliative care follows, DNR CCA DNI Transition to comfort care only   Cardiac Arrest Low suspicion for primary cardiac event Admission EKG sinus w/ 1st degree AV block, prolonged Qtc Echo: EF 53%, mild AS, mild TR Cardiology signed off, no further recommendations Telemetry Pulmonary Infiltrates Fevers Noted on imaging: chronic fibrosis vs infectious infiltrates Urine antigens negative Completed rocephin, on ancef for chronic wound infection Further recs per critical care   COVID Vent management as above S/p IV decadron for 10 day course Now out of isolation   Cdiff Completed Vanc through tube Remains on contact precautions    UTI E. Coli +1/2 Continue antibiotics  Was on ancef   ESRD  Alport Syndrome Hyperkalemia Cr 4.2, at baseline, K 6.4 on admission, now improved Secondary to Alports syndrome MWF dialysis, started on midodrine, initiate epogen with HD sessions Neph continued to follow
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical ventilation, Nervous system disorder, Neurone-specific enolase increased, Pyrexia, Seizure
Clinical narrative: Assessment and Plan:  45 year old female (pronouns he/him) with a history of ESRD secondary to Alport syndrome, HTN, HLD, chronic pain, and chronic ulcer who presents with cardiac arrest in setting of hyperkalemia.  Hospital course complicated by COVID and cdiff.  Currently on minimal vent settings but mental status precludes extubation.  Neurology following for evaluation of anoxic brain injury with poor prognosis.       Acute Respiratory Failure Secondary to cardiac arrest, now also with COVID and pulmonary infiltrates, further plan as below Continue vent support Pulm/CC consulted and continue care per critical care team Palliative care following Transitioned to DNRCC and compassionate extubation on 1/20 and patient expired   Anoxic Encephalopathy Anoxic Brain injury Refractory Status Epilepticus  Secondary to cardiac arrest as below CT head non-acute EEG consistent with global cerebral dysfunction Non-epileptiform seizures well controlled on propofol and versed gtt Elevated neuron specific enolase indicative of significant neurologic injury Neurology followed: continue Keppra, cEEG MRI 1/6: diffuse anoxic brain injury without evidence of significant mass effect, midline shift or acute intracranial hemorrhage Poor prognosis for neurological recovery.   Palliative care follows, DNR CCA DNI Transition to comfort care only   Cardiac Arrest Low suspicion for primary cardiac event Admission EKG sinus w/ 1st degree AV block, prolonged Qtc Echo: EF 53%, mild AS, mild TR Cardiology signed off, no further recommendations Telemetry Pulmonary Infiltrates Fevers Noted on imaging: chronic fibrosis vs infectious infiltrates Urine antigens negative Completed rocephin, on ancef for chronic wound infection Further recs per critical care   COVID Vent management as above S/p IV decadron for 10 day course Now out of isolation   Cdiff Completed Vanc through tube Remains on contact precautions    UTI E. Coli +1/2 Continue antibiotics  Was on ancef   ESRD  Alport Syndrome Hyperkalemia Cr 4.2, at baseline, K 6.4 on admission, now improved Secondary to Alports syndrome MWF dialysis, started on midodrine, initiate epogen with HD sessions Neph continued to follow
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Status epilepticus, Tricuspid valve incompetence, Urinary tract infection, Urine antigen test, Wound infection
Clinical narrative: Assessment and Plan:  45 year old female (pronouns he/him) with a history of ESRD secondary to Alport syndrome, HTN, HLD, chronic pain, and chronic ulcer who presents with cardiac arrest in setting of hyperkalemia.  Hospital course complicated by COVID and cdiff.  Currently on minimal vent settings but mental status precludes extubation.  Neurology following for evaluation of anoxic brain injury with poor prognosis.       Acute Respiratory Failure Secondary to cardiac arrest, now also with COVID and pulmonary infiltrates, further plan as below Continue vent support Pulm/CC consulted and continue care per critical care team Palliative care following Transitioned to DNRCC and compassionate extubation on 1/20 and patient expired   Anoxic Encephalopathy Anoxic Brain injury Refractory Status Epilepticus  Secondary to cardiac arrest as below CT head non-acute EEG consistent with global cerebral dysfunction Non-epileptiform seizures well controlled on propofol and versed gtt Elevated neuron specific enolase indicative of significant neurologic injury Neurology followed: continue Keppra, cEEG MRI 1/6: diffuse anoxic brain injury without evidence of significant mass effect, midline shift or acute intracranial hemorrhage Poor prognosis for neurological recovery.   Palliative care follows, DNR CCA DNI Transition to comfort care only   Cardiac Arrest Low suspicion for primary cardiac event Admission EKG sinus w/ 1st degree AV block, prolonged Qtc Echo: EF 53%, mild AS, mild TR Cardiology signed off, no further recommendations Telemetry Pulmonary Infiltrates Fevers Noted on imaging: chronic fibrosis vs infectious infiltrates Urine antigens negative Completed rocephin, on ancef for chronic wound infection Further recs per critical care   COVID Vent management as above S/p IV decadron for 10 day course Now out of isolation   Cdiff Completed Vanc through tube Remains on contact precautions    UTI E. Coli +1/2 Continue antibiotics  Was on ancef   ESRD  Alport Syndrome Hyperkalemia Cr 4.2, at baseline, K 6.4 on admission, now improved Secondary to Alports syndrome MWF dialysis, started on midodrine, initiate epogen with HD sessions Neph continued to follow
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary, COVID-19, COVID-19 pneumonia, Chest X-ray
Clinical narrative: Report on admission: Patient is a 65 y.o. year-old male, who presented with SOB to the ED yesterday (1/16). Patient has had cough, rhinorrhea, and congestion for 3wks. On 1/16 he presented to his PCP and was found to have low O2, which prompted him to come to the ED. His initial O2 saturation upon arrival to the ED was 80% with RR of 17. Patient denies SOB, chest pain, loss of taste/smell, numbness or tingling. Patient states he has been able to hear himself wheezing occassionally while breathing. With his cough he has been occassionally spitting up small amounts of "gray" colored sputum. Patient was a previous smoker but stopped 10-12 years ago. Since then he has been cycling and improving his diet. He has a history of hypertension which is controlled with amlodipine and losartan.     Hospital course as below.  Pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged home in stable condition.     1. COVID pneumonia .Covid-19 Virus Infection Date of onset of symptoms:  3 weeks ago Symptoms present on admission: Hypoxemia/cough Date of covid positive test:  1/16/23 Vaccination status:  vaccinated x3 Imaging:   CTPA and CXR reviewed. Oxygen requirements on admission:   15 L NC Medical therapy: decadron, not a candidate for remdesivir Consultants following:  pulmonology Anticipated special isolation end date: 10 days from diagnosis as long as clinically improving.   2. Acute respiratory failure             - Continue to wean as able             - Incentive spirometer while awake.   3. Community acquired pneumonia             - Continue with antibiotic.             - Cultures pending             - Pulmonology following  -Repeat imaging outpatient in March   4. Hypertensive heart disease             - continue to monitor.             - continue home meds
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Culture, Dyspnoea, Hypertensive heart disease, Hypoxia
Clinical narrative: Report on admission: Patient is a 65 y.o. year-old male, who presented with SOB to the ED yesterday (1/16). Patient has had cough, rhinorrhea, and congestion for 3wks. On 1/16 he presented to his PCP and was found to have low O2, which prompted him to come to the ED. His initial O2 saturation upon arrival to the ED was 80% with RR of 17. Patient denies SOB, chest pain, loss of taste/smell, numbness or tingling. Patient states he has been able to hear himself wheezing occassionally while breathing. With his cough he has been occassionally spitting up small amounts of "gray" colored sputum. Patient was a previous smoker but stopped 10-12 years ago. Since then he has been cycling and improving his diet. He has a history of hypertension which is controlled with amlodipine and losartan.     Hospital course as below.  Pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged home in stable condition.     1. COVID pneumonia .Covid-19 Virus Infection Date of onset of symptoms:  3 weeks ago Symptoms present on admission: Hypoxemia/cough Date of covid positive test:  1/16/23 Vaccination status:  vaccinated x3 Imaging:   CTPA and CXR reviewed. Oxygen requirements on admission:   15 L NC Medical therapy: decadron, not a candidate for remdesivir Consultants following:  pulmonology Anticipated special isolation end date: 10 days from diagnosis as long as clinically improving.   2. Acute respiratory failure             - Continue to wean as able             - Incentive spirometer while awake.   3. Community acquired pneumonia             - Continue with antibiotic.             - Cultures pending             - Pulmonology following  -Repeat imaging outpatient in March   4. Hypertensive heart disease             - continue to monitor.             - continue home meds
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Incentive spirometry, Oxygen saturation decreased, Pneumonia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Report on admission: Patient is a 65 y.o. year-old male, who presented with SOB to the ED yesterday (1/16). Patient has had cough, rhinorrhea, and congestion for 3wks. On 1/16 he presented to his PCP and was found to have low O2, which prompted him to come to the ED. His initial O2 saturation upon arrival to the ED was 80% with RR of 17. Patient denies SOB, chest pain, loss of taste/smell, numbness or tingling. Patient states he has been able to hear himself wheezing occassionally while breathing. With his cough he has been occassionally spitting up small amounts of "gray" colored sputum. Patient was a previous smoker but stopped 10-12 years ago. Since then he has been cycling and improving his diet. He has a history of hypertension which is controlled with amlodipine and losartan.     Hospital course as below.  Pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged home in stable condition.     1. COVID pneumonia .Covid-19 Virus Infection Date of onset of symptoms:  3 weeks ago Symptoms present on admission: Hypoxemia/cough Date of covid positive test:  1/16/23 Vaccination status:  vaccinated x3 Imaging:   CTPA and CXR reviewed. Oxygen requirements on admission:   15 L NC Medical therapy: decadron, not a candidate for remdesivir Consultants following:  pulmonology Anticipated special isolation end date: 10 days from diagnosis as long as clinically improving.   2. Acute respiratory failure             - Continue to wean as able             - Incentive spirometer while awake.   3. Community acquired pneumonia             - Continue with antibiotic.             - Cultures pending             - Pulmonology following  -Repeat imaging outpatient in March   4. Hypertensive heart disease             - continue to monitor.             - continue home meds
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sputum discoloured, Wheezing
Clinical narrative: Report on admission: Patient is a 65 y.o. year-old male, who presented with SOB to the ED yesterday (1/16). Patient has had cough, rhinorrhea, and congestion for 3wks. On 1/16 he presented to his PCP and was found to have low O2, which prompted him to come to the ED. His initial O2 saturation upon arrival to the ED was 80% with RR of 17. Patient denies SOB, chest pain, loss of taste/smell, numbness or tingling. Patient states he has been able to hear himself wheezing occassionally while breathing. With his cough he has been occassionally spitting up small amounts of "gray" colored sputum. Patient was a previous smoker but stopped 10-12 years ago. Since then he has been cycling and improving his diet. He has a history of hypertension which is controlled with amlodipine and losartan.     Hospital course as below.  Pulmonology followed patient during stay.  Patient improved with medical treatment.  Patient discharged home in stable condition.     1. COVID pneumonia .Covid-19 Virus Infection Date of onset of symptoms:  3 weeks ago Symptoms present on admission: Hypoxemia/cough Date of covid positive test:  1/16/23 Vaccination status:  vaccinated x3 Imaging:   CTPA and CXR reviewed. Oxygen requirements on admission:   15 L NC Medical therapy: decadron, not a candidate for remdesivir Consultants following:  pulmonology Anticipated special isolation end date: 10 days from diagnosis as long as clinically improving.   2. Acute respiratory failure             - Continue to wean as able             - Incentive spirometer while awake.   3. Community acquired pneumonia             - Continue with antibiotic.             - Cultures pending             - Pulmonology following  -Repeat imaging outpatient in March   4. Hypertensive heart disease             - continue to monitor.             - continue home meds
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic stenosis, COVID-19, Cardiac failure, Cardiac failure congestive
Clinical narrative: Acute Hypoxic Respiratory Failure, resolved - Secondary to decompensated CHF with possible component of Covid - Required supplemental oxygen with Bipap on admission s/p diuretics and treatment for Covid as below   Covid-19 - Vaccinated with Moderna x3  - Symptom onset 1/23, positive test 1/23  - S/p 3 days of 6 mg decadron and Remdesivir   Acute, Decompensated HFpEF - Appeared fluid overloaded on admission with JVD - ProBNP 6395 & CXR with new diffuse coarsening of the interstitial markings  - Echo 8/20/19 with EF 65%, Severe AS, mild MR/TR. Repeat TTE on 1/24/2023 with severe aortic stenosis, LVEF 61% - Heart failure followed, s/p IV diuresis. Recommended Lasix 20 mg daily on discharge and repeat BMP in 1 week. Follow-up with HF outpatient    Severe Aortic Stenosis - Echo as above - Structural Heart followed, recommended TAVR evaluation outpatient after resolution of covid infection     Hypertensive Urgency, Resolved  - Secondary to acute decompensated heart failure - BP 230s/130s on admission - Not on home antihypertensives. Resolved with treatment of heart failure exacerbation as above    Paroxysmal Afib - CHADs2VAC 7 - Home medications including Xarelto and Sotalol 120 mg BID continued
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Condition aggravated, Echocardiogram abnormal, Hypertensive urgency, Hypervolaemia
Clinical narrative: Acute Hypoxic Respiratory Failure, resolved - Secondary to decompensated CHF with possible component of Covid - Required supplemental oxygen with Bipap on admission s/p diuretics and treatment for Covid as below   Covid-19 - Vaccinated with Moderna x3  - Symptom onset 1/23, positive test 1/23  - S/p 3 days of 6 mg decadron and Remdesivir   Acute, Decompensated HFpEF - Appeared fluid overloaded on admission with JVD - ProBNP 6395 & CXR with new diffuse coarsening of the interstitial markings  - Echo 8/20/19 with EF 65%, Severe AS, mild MR/TR. Repeat TTE on 1/24/2023 with severe aortic stenosis, LVEF 61% - Heart failure followed, s/p IV diuresis. Recommended Lasix 20 mg daily on discharge and repeat BMP in 1 week. Follow-up with HF outpatient    Severe Aortic Stenosis - Echo as above - Structural Heart followed, recommended TAVR evaluation outpatient after resolution of covid infection     Hypertensive Urgency, Resolved  - Secondary to acute decompensated heart failure - BP 230s/130s on admission - Not on home antihypertensives. Resolved with treatment of heart failure exacerbation as above    Paroxysmal Afib - CHADs2VAC 7 - Home medications including Xarelto and Sotalol 120 mg BID continued
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy, Prohormone brain natriuretic peptide increased, SARS-CoV-2 test positive
Clinical narrative: Acute Hypoxic Respiratory Failure, resolved - Secondary to decompensated CHF with possible component of Covid - Required supplemental oxygen with Bipap on admission s/p diuretics and treatment for Covid as below   Covid-19 - Vaccinated with Moderna x3  - Symptom onset 1/23, positive test 1/23  - S/p 3 days of 6 mg decadron and Remdesivir   Acute, Decompensated HFpEF - Appeared fluid overloaded on admission with JVD - ProBNP 6395 & CXR with new diffuse coarsening of the interstitial markings  - Echo 8/20/19 with EF 65%, Severe AS, mild MR/TR. Repeat TTE on 1/24/2023 with severe aortic stenosis, LVEF 61% - Heart failure followed, s/p IV diuresis. Recommended Lasix 20 mg daily on discharge and repeat BMP in 1 week. Follow-up with HF outpatient    Severe Aortic Stenosis - Echo as above - Structural Heart followed, recommended TAVR evaluation outpatient after resolution of covid infection     Hypertensive Urgency, Resolved  - Secondary to acute decompensated heart failure - BP 230s/130s on admission - Not on home antihypertensives. Resolved with treatment of heart failure exacerbation as above    Paroxysmal Afib - CHADs2VAC 7 - Home medications including Xarelto and Sotalol 120 mg BID continued
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral, Computerised tomogram head, Intraocular pressure test, Laboratory test, Lumbar puncture
Clinical narrative: Received second Moderna June 2021,  acute vision loss Left eye  August 2021.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Skull X-ray
Clinical narrative: Received second Moderna June 2021,  acute vision loss Left eye  August 2021.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest X-ray normal
Clinical narrative: Patient is a 73 y.o. male 72 y.o. male with a past medical history significant for atypical AVN RT, atypical atrial flutter, HFpEF, pituitary adenoma s/p resection, CVA, secondary adrenal insufficiency, prostate cancer and Alzheimer's dementia . Presented to hospital 01/26/2023 with COVID pneumonia. Initially required BiPAP but aggressively improved to room air at time of discharge   Comments/Problems to be Addressed After Discharge General follow up with PCP   Discharge Diagnosis and Associated Hospital Course   Acute Hypoxemic Respiratory Failure, improved - in the setting of COVID infection, less likely superimposed bacterial infection - on room air at time of discharge   Covid-19 Pneumonia - Symptoms 01/24, diagnosis 01/26, vaccinated x 5 - CXR without acute abnormality, mild leukocytosis, CRP 87.2 - discontinued Decadron and Remdesivir 3 days total   Atypical Atrial Flutter - Failed previous ablation, home regimen Eliquis, Toprol XL 50 mg daily   Secondary Adrenal Insufficiency - Etiology due to previous pituitary tumor. Home regimen Cortef 10 mg in am, Cortef 5 mg in evening.  -continue home regimen   Hypothyroidism - home regimen Synthroid 137 mcg x 6 days a week, Synthroid 205.5 mcg 1x per week.   Alzheimer's Dementia  - home regimen Namenda 10 mg BID   Hx of CVA
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Leukocytosis, Malaise, Positive airway pressure therapy
Clinical narrative: Patient is a 73 y.o. male 72 y.o. male with a past medical history significant for atypical AVN RT, atypical atrial flutter, HFpEF, pituitary adenoma s/p resection, CVA, secondary adrenal insufficiency, prostate cancer and Alzheimer's dementia . Presented to hospital 01/26/2023 with COVID pneumonia. Initially required BiPAP but aggressively improved to room air at time of discharge   Comments/Problems to be Addressed After Discharge General follow up with PCP   Discharge Diagnosis and Associated Hospital Course   Acute Hypoxemic Respiratory Failure, improved - in the setting of COVID infection, less likely superimposed bacterial infection - on room air at time of discharge   Covid-19 Pneumonia - Symptoms 01/24, diagnosis 01/26, vaccinated x 5 - CXR without acute abnormality, mild leukocytosis, CRP 87.2 - discontinued Decadron and Remdesivir 3 days total   Atypical Atrial Flutter - Failed previous ablation, home regimen Eliquis, Toprol XL 50 mg daily   Secondary Adrenal Insufficiency - Etiology due to previous pituitary tumor. Home regimen Cortef 10 mg in am, Cortef 5 mg in evening.  -continue home regimen   Hypothyroidism - home regimen Synthroid 137 mcg x 6 days a week, Synthroid 205.5 mcg 1x per week.   Alzheimer's Dementia  - home regimen Namenda 10 mg BID   Hx of CVA
Age: 0.92
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Early vaccination before 12 months, no reactions  or symptoms
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Back pain, Diarrhoea, Nausea, Sciatica
Clinical narrative: Nausea, stomach pain, diarrhea lasting 30 hours. Severe sciatic nerve pain and back pain continuing through the weekend that still hasn't resolved.
Age: 18.0
Sex: U
Vaccine: UNK
Symptoms: Panic attack
Clinical narrative: Was given HPV vaccine dose 1 and had a panic attack, in 2016
Age: 43.0
Sex: F
Vaccine: COVID19-2, FLUC4
Symptoms: Joint range of motion decreased, Muscle atrophy, Pain in extremity, Tenderness, X-ray normal
Clinical narrative: Arm was sore, tender then limited range of motion and pain, therefore, not using arm. Arm muscle became atrophy. X-ray taken without injuries but still has limited range of motion.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Dizziness, Electrocardiogram, Epistaxis
Clinical narrative: 1 hour after administration, patient reported headache, dizziness, visual changes, nausea, vomiting.  His symptoms progressed with nosebleeds, urinary frequency, and ongoing high blood pressure.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Nausea, Pollakiuria, SARS-CoV-2 test
Clinical narrative: 1 hour after administration, patient reported headache, dizziness, visual changes, nausea, vomiting.  His symptoms progressed with nosebleeds, urinary frequency, and ongoing high blood pressure.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: 1 hour after administration, patient reported headache, dizziness, visual changes, nausea, vomiting.  His symptoms progressed with nosebleeds, urinary frequency, and ongoing high blood pressure.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza virus test negative, Loss of consciousness, Rhinorrhoea, Road traffic accident
Clinical narrative: After receiving my third dose, I passed out and had to wait there until I was comfortable walking and then I was driven home. They also checked my vitals and I had to wait until they were normal before I was able to leave. I tested positive for COVID-19 on 8/26/22. I had a runny nose about a month before I tested positive. It started to concern me because it was running constantly. It was a lot too. I took MUCINEX, and SUDAFED to try to get it to stop and that did not work. I had to go to the doctor, because I was in a car accident previously and I had to do a follow-up. I let them know that my nose had been running for about a month and they decided to give me a COVID-19 test and that is when I tested positive. They prescribed FLONASE. No other medications were prescribed. It took about 24 weeks for my nose to stop running after starting FLONASE. I took another COVID-19 test on 9/27/22 because my nose was still running, and I tested negative at that time.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: After receiving my third dose, I passed out and had to wait there until I was comfortable walking and then I was driven home. They also checked my vitals and I had to wait until they were normal before I was able to leave. I tested positive for COVID-19 on 8/26/22. I had a runny nose about a month before I tested positive. It started to concern me because it was running constantly. It was a lot too. I took MUCINEX, and SUDAFED to try to get it to stop and that did not work. I had to go to the doctor, because I was in a car accident previously and I had to do a follow-up. I let them know that my nose had been running for about a month and they decided to give me a COVID-19 test and that is when I tested positive. They prescribed FLONASE. No other medications were prescribed. It took about 24 weeks for my nose to stop running after starting FLONASE. I took another COVID-19 test on 9/27/22 because my nose was still running, and I tested negative at that time.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse event, vaccine may have been expired.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; she administered a dose of PNEUMOVAX 23 that was expired.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information of the patient's medical history, drug reaction/allergy, concurrent condition and concomitant therapy was not reported.  On 30-JAN-2023, the patient was administrated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml (lot #U026796, expiration date: 28-JAN-2023, strength, anatomical location and route of administration were not provided) for prophylaxis (expired product administered). The product had not undergone any temperature excursions. No additional adverse event (AE).
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; M-M-R II administered after temperature excursion; This spontaneous report as received from a from a medical assistant refers to a 15 month old male patient. The patient's concurrent conditions included eczema. The patient had one sister. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # W023072 exp date 05-APR-2024) subcutaneously in the right thigh at a private hospital. The patient had ear infection at time of vaccination. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040: US-009507513-2301USA001095:
Age: 0.92
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; VARIVAX was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to an 11 month old female patient with one sister. The patient's historical vaccine included quadrivalent flu vaccine. On 02-JAN-2023, the patient was vaccinated with the first improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # W021740 exp date 10-JUL-2024) (dose not reported) subcutaneously in the left leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001037: US-009507513-2302USA001038: US-009507513-2302USA001039: US-009507513-2302USA001040: US-009507513-2301USA001095:
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; M-M-R II was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 12 month old male patient with no illness at time of vaccination. The patient had no siblings. On 30-DEC-2022, the patient was vaccinated with the first improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA (lot # W023072 exp date 05-APR-2024) (dose not reported) subcutaneously in the left leg at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2302USA001034: US-009507513-2302USA001035: US-009507513-2302USA001036: US-009507513-2302USA001037: US-009507513-2302USA001039: US-009507513-2302USA001040: US-009507513-2301USA001095:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs or PQC reported; PROQUAD was administered after temperature excursion; This spontaneous report as received from a medical assistant refers to a 4 year old male patient with no illness at time of vaccination or pertinent medical history.  The patient had 2 siblings. On 02-JAN-2023, the patient was vaccinated with the second improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA (lot # W026316 exp date 18-FEB-2024) (dose not reported) subcutaneously in the right arm at a private hospital. The medical assistant reported that the freezer door was left ajar.  This is one of several reports received from the same source. .
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; Medical assistant reports patient was accidently administered an expired dose of VAQTA on Nov 15, 2022. Product expired on Nov 11, 2022. Product had no prior temperature excursions. No further information provided. No additional AE reported. No PQC r; This spontaneous report was received from an other health professional (Medical assistant) and referred to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 15-NOV-2022, the patient was accidently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (once, lot #U031911, expiration date: 11-NOV-2022, dose, strength, anatomical location and route of administration were not provided) administered for prophylaxis (Expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event (AE) reported (No adverse event).
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patients being administered expired ACTHIB with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA046771.  This case involves a 15 months old male patient who being administered expired haemophilus type B (HIB) vaccine (ACT-HIB) HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Influenza  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Immunisation.  On 01-Nov-2022, the patient received a dose 4 at dosage 0.5 mL of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection, (lot number: UJ594AAA and expiry date: 26-Oct-2022 via intramuscular route in the left vastus lateralis for immunization with no reported adverse event (expired product administered) (latency: same day).  No lab data was reporte.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACTHIB that expired on 26OCT2022 (with no reported adverse event); Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA046834, 2023SA046778, 2023SA046763, 2023SA046745, 2023SA045388 and 2023SA045123.  This case involves a 16 month old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that expired on 26oct2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Immunisation.  On 10-Jan-2023, the patient received an expired 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot: UJ594AAA; expiry date: 26-Oct-2022) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered acthib that expired on 26oct2022 (with no reported adverse event).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: administered ACTHIB that expired with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from health professional and Physician. GMI number: 01481508.  This case involves 16 months old female patient to whom expired HIB (PRP/T) VACCINE [ACT-HIB] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to seven patient cases 2023SA046771, 2023SA046778, 2023SA046763, 2023SA046745, 2023SA045388 and 2023SA045123.  Concomitant medications included Pneumococcal Vaccine CONJ 7V (CRM197) (Prevnar) for Immunization.  On 10-Jan-2023, the patient received expired vaccine fourth dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at dose 0.5 ml once (lot: UJ594AAA, expiry date: 10-Oct-2022) via intramuscular route in the right deltoid for Immunization with no reported adverse event (expired product administered) at same day latency.  It was reported that they inquired about next steps to take and what information to tell the parents. This situation is reported as a medication error due to seven patients being administered expired ACTHIB.   Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event expired product administered.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired ADACEL was given to a 16-year-old male patient with no reported adverse event; Initial information received  on 09-Feb-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 16 years old male patient who was administered expired diphtheria-2/ tetanus/ 5 AC pertussis vaccine [Adacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (dip tox) (Menactra) for Immunisation; and polio vaccine INACT 3V (vero) (Ipol) for Immunisation.  On 08-Feb-2023, the patient received an expired 0.5 mL dose 4 of suspect diphtheria-2/ tetanus/5 AC pertussis vaccine, suspension for injection (lot: U6922AA; expiry date: 22-Jan-2023) via intramuscular route in the right deltoid for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired adacel was given to a 16-year-old male patient with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Platelet count decreased
Clinical narrative: No adverse effects until September 2022
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death
Clinical narrative: Death by Cardiac Arrest
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Cough, Fatigue, Laboratory test normal, Malaise
Clinical narrative: I developed cold like symptoms with a  cough sore throat and severe fatigue 1 month after this vaccine. The fatigue improved after 1 6 weeks but the cough, sore throat and feeling of malaise have persisted for over 2 months.  Lateral flow tests were negative.  I have consulted and am continuing to consult my GP about these prolonged symptoms which I am still experiencing. The cough is entirely in the upper respiratory tract. Although I cannot be sure that this is a mRNA induced set of symptoms I have never had any experience like this before and as such will not be willing to have further mRNA vaccination.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I developed cold like symptoms with a  cough sore throat and severe fatigue 1 month after this vaccine. The fatigue improved after 1 6 weeks but the cough, sore throat and feeling of malaise have persisted for over 2 months.  Lateral flow tests were negative.  I have consulted and am continuing to consult my GP about these prolonged symptoms which I am still experiencing. The cough is entirely in the upper respiratory tract. Although I cannot be sure that this is a mRNA induced set of symptoms I have never had any experience like this before and as such will not be willing to have further mRNA vaccination.
Sex: F
Vaccine: HEPA
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received HAV (Havrix 720 adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included meniere's disease. Previously administered products included Flu vaccine (20 plus years ago) and Pneumonia vaccine (20 plus years ago).   On an unknown date, the patient received the 1st dose of Havrix 720 adult and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 720 adult and Havrix Pre-Filled Syringe Device, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Havrix 720 adult and Havrix Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The reporter was the patient. The reporter also stated that 20 plus years ago she had the flu vaccine (unknown name and manufacturer) and the pneumonia vaccine (unknown name and manufacturer) and was diagnosed with Meniere's disease. Patient refused to give consent or provide demographic details.   All elements of the flu and pneumonia vaccine are unknown due to time period that has elapsed. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: The first one made me sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be possibly related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR018248   Additional Information: GSK receipt date: 03-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the first shot of shingles vaccine. After the first shot, the patient was sick. The consumer reported skip the shot. The reporter think that the event might have been related to the product/device. Additional Supportive Information: The follow up would not possible, as no contact, details were available. For tolerance of 2nd dose refer case US2023AMR018248.; Sender's Comments:  US-GSK-US2023AMR018248:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Pyrexia
Clinical narrative: Redness; Headache; Fever; This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema, headache and fever. On an unknown date, the outcome of the erythema and headache were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the erythema, headache and fever to be related to Shingrix.     Additional Information: GSK receipt date: 07-FEB-2023 Reporter comment: The medical assistant shared her own experience after having gotten the 2nd dose of Shingrix.  She mentioned she experienced redness, headache, and fever (1 day). The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/source case
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/Source case