chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Metabolic function test, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Next day, arm aching 10/22/22.  Then upper back aching on left.  Over the next few days pain began to radiate to front of chest wall predominantly on left.  Face and head on left hurting. Tingling on side of left breast.  Raised red bumps in clusters starting near spine moving in a horizontal line towards left breast.  Malaise. Went to ER 11/1/22.  XR CHEST 2 VW, BASIC METABOLIC PANEL, TROPONIN I, CBC W/ AUTO DIFFERENTIAL, ECG 12-LEAD, various tests.  Given zofran for nausea, torodol by iv. Prescribed ibruprofen for pain and methocarbamol.  Zofran did not help.  Torodol did very little to alleviate pain.  Methocarbamol prescription caused anxiety, no relief and was disposed of.
Age: 64.0
Sex: F
Vaccine: COVID19-2, UNK
Symptoms: Rash erythematous, Rash papular, Troponin I normal
Clinical narrative: Next day, arm aching 10/22/22.  Then upper back aching on left.  Over the next few days pain began to radiate to front of chest wall predominantly on left.  Face and head on left hurting. Tingling on side of left breast.  Raised red bumps in clusters starting near spine moving in a horizontal line towards left breast.  Malaise. Went to ER 11/1/22.  XR CHEST 2 VW, BASIC METABOLIC PANEL, TROPONIN I, CBC W/ AUTO DIFFERENTIAL, ECG 12-LEAD, various tests.  Given zofran for nausea, torodol by iv. Prescribed ibruprofen for pain and methocarbamol.  Zofran did not help.  Torodol did very little to alleviate pain.  Methocarbamol prescription caused anxiety, no relief and was disposed of.
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Decreased appetite, Nausea, Pyrexia
Clinical narrative: Fever starting 18 hours after injection (approx 100 degrees). Lasting 36 hours.  Lack of appitite starting 18 hours after injection. Still ongoing after 72 hours. Nausea starting 24 hours after injection. Still ongoing after 64 hours.
Age: 40.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Skin discolouration, Throat tightness
Clinical narrative: Patient complained of burning and skin color change on bilateral arms following vaccination. Patient evaluation completed and complained of throat tightness.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Diarrhoea, Erythema, Pain, Pruritus
Clinical narrative: Patient developed big red bump/spot on arm which itches and diarrhea which started within a few hours along with achiness. The spot was still big and red several days later as well as upset stomach.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Swelling
Clinical narrative: Patient developed big red bump/spot on arm which itches and diarrhea which started within a few hours along with achiness. The spot was still big and red several days later as well as upset stomach.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Tremor
Clinical narrative: Severe shaking for approximately 45 minutes (about 12 hours after injection)
Age: 42.0
Sex: M
Vaccine: UNK
Symptoms: Cold sweat, Dizziness, Face injury, Loss of consciousness
Clinical narrative: Patient was administered his 1st Jynneos (MPX) vaccine, after the vaccine was administered the patient sat down in our post vaccination area. Within 10 minutes of sitting in post vaccination area the patient passed out and hit the floor face foward. When we flipped the patient over and he regained consciousness he was able to answer all questions asked. Patient was A&O x4. All vitals were in range patient did state he was dizzy, and patient looked pale and clammy. Patient stated he always passes out when getting his blood drawn and doesn't like needles. Paramedics were called and arrived on seen, when told he would be transported to hospital he denied and left AMA.
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received dose of flu vaccine 11/6/2022 after receiving a flu vaccine on 8/2/22
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: Swelling left foot
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Dyspnoea, Dyspnoea exertional, Lung opacity, Oxygen saturation decreased
Clinical narrative: Shortness of breath, pulse oxygen dropped below 75, hospitalization for 7 days, given prednisone for 3 months to raise pulse oxygen, 100% gro7nd glass found in CT scan high res, still shortness of breath with any exertion or climbing stairs. 60% lung capacity left.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test, Total lung capacity decreased
Clinical narrative: Shortness of breath, pulse oxygen dropped below 75, hospitalization for 7 days, given prednisone for 3 months to raise pulse oxygen, 100% gro7nd glass found in CT scan high res, still shortness of breath with any exertion or climbing stairs. 60% lung capacity left.
Age: 72.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Afib episode 8 hours later  Episode lasted 12 hours  Second episode 14 days later (Patient has chronic afib, does not normally have isolayed episodes )
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administered the wrong amount of vaccine in the route it was given. Patient recieved 0.1ML Sub-Q. Patient was re-dosed immediately with the proper amount for the proper route.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site, including redness and swelling.  Pain in left shoulder, left side of neck and left shoulder blade down to but cheek.  Headaches, nausea since receiving injection.  Pain level has remained at 8 or higher.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain
Clinical narrative: Pain at injection site, including redness and swelling.  Pain in left shoulder, left side of neck and left shoulder blade down to but cheek.  Headaches, nausea since receiving injection.  Pain level has remained at 8 or higher.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Differential white blood cell count, Full blood count, Immune thrombocytopenia, Laboratory test, Platelet count increased
Clinical narrative: secondary immune thrombocytopenia (ITP)
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system lesion, Gait disturbance, Headache, Myelitis transverse, Optic neuritis
Clinical narrative: I developed transverse myelitis and optic neuritis . I?m having trouble walking. Headaches. I have lesions on my brain and spinal cord.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal cord injury
Clinical narrative: I developed transverse myelitis and optic neuritis . I?m having trouble walking. Headaches. I have lesions on my brain and spinal cord.
Age: 51.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Bell's palsy, Computerised tomogram head, Headache, Laboratory test, Magnetic resonance imaging
Clinical narrative: Hospitalized with Bell's Palsy diagnosis on Sunday October 16th, 2022 after stroke like symptoms following headache for two days.
Age: 51.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Neurological symptom
Clinical narrative: Hospitalized with Bell's Palsy diagnosis on Sunday October 16th, 2022 after stroke like symptoms following headache for two days.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Loss of consciousness, Seizure
Clinical narrative: pt did check the box saying she has a seizure disorder. However, pt stated that she was due to for one per her drs recommendation and that she has had it before in the past with no issues. Pt did lose consciousness + had a seizure for at lesat 30 seconds. The pt's partner was there to assist and he was able to get her out of the seizure. I did call EMS but the pt declined emergency care. I had the pt stay for monitoring and gave her some water. Pt left of her own free will with her husband. I did call her at the end of my shift just to make sure she was ok and it seems she is doing fine and will follow up with her neurologist
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Mechanical urticaria, Metabolic function test normal, Pruritus, Rash erythematous
Clinical narrative: While asleep the night of 11/21/2021, I woke up with extreme itching on my torso.  Over the next 24-48 hours welts developed all over my abdomen/torso.  It took me a while to realize these were hives.  I thought it was due to the Aleve I had been taking for shoulder pain, so I stopped taking the Aleve.  I developed dermatographia.  After showering I would have red marks all over my back and torso.  After dish washing I would have large red areas on my forearms.  I took over-the-counter antihistamines.  On 11/30/2021 I had a visit with the PA at my PCP's office.  She confirmed that I had hives and prescribed a steroid pack and told me to continue with the OTC antihistamines.  She ordered a comprehensive metabolic panel, both of which came back normal.  I felt much better after taking the steroid pack.  The itching was less severe but I would still get dermatographia and it appeared on more parts of my body, including my neck, face, legs.  I later saw a dermatologist who diagnosed chronic urticaria after it lasted for 6 weeks.  She also did some lab work which came back negative.  The dermatologist prescribed Xyzal, and once I begain taking that, my symptoms were better controlled.  I took 5 mg Xyzal once daily and it controlled my symptoms for months.  I stopped taking the Xyzal periodically, and symptoms would resume within 48 hours.  I weaned myself off of Xyzal in Aug/Sept 2022 and have not experienced any additional urticaria.  Note that I did get a 4th Moderna vaccine in April 2022, and had no skin reaction.  I was taking daily Xyzal at the time of the 4th vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Urine analysis normal, Urticaria, Urticaria chronic
Clinical narrative: While asleep the night of 11/21/2021, I woke up with extreme itching on my torso.  Over the next 24-48 hours welts developed all over my abdomen/torso.  It took me a while to realize these were hives.  I thought it was due to the Aleve I had been taking for shoulder pain, so I stopped taking the Aleve.  I developed dermatographia.  After showering I would have red marks all over my back and torso.  After dish washing I would have large red areas on my forearms.  I took over-the-counter antihistamines.  On 11/30/2021 I had a visit with the PA at my PCP's office.  She confirmed that I had hives and prescribed a steroid pack and told me to continue with the OTC antihistamines.  She ordered a comprehensive metabolic panel, both of which came back normal.  I felt much better after taking the steroid pack.  The itching was less severe but I would still get dermatographia and it appeared on more parts of my body, including my neck, face, legs.  I later saw a dermatologist who diagnosed chronic urticaria after it lasted for 6 weeks.  She also did some lab work which came back negative.  The dermatologist prescribed Xyzal, and once I begain taking that, my symptoms were better controlled.  I took 5 mg Xyzal once daily and it controlled my symptoms for months.  I stopped taking the Xyzal periodically, and symptoms would resume within 48 hours.  I weaned myself off of Xyzal in Aug/Sept 2022 and have not experienced any additional urticaria.  Note that I did get a 4th Moderna vaccine in April 2022, and had no skin reaction.  I was taking daily Xyzal at the time of the 4th vaccine.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chills, Rash
Clinical narrative: Violent Shivering, body rash
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess, Acoustic stimulation tests normal, Hypoacusis, Tinnitus
Clinical narrative: Between 2-3 weeks after my Covid-19 booster shot, my tinnitus got noticeably worse.  I have had tinnitus since I was about 10, following an abscess in my ear.  My tinnitus worsened after my 2nd dose of Covid-19 vaccine on March 25, 2021.  (My doctor reported that to VAERS.)  So this booster on March 10, 2022 was the second time that a Covid shot worsened my tinnitus.  Historically, my tinnitus sounded like a hissing in my ears.  It got louder with each shot.  Now it is much harder to ignore during the day.  I cannot hear music nearly as well as before, since I hear my tinnitus instead.  The pitch seemed to be a bit higher after my booster shot.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Lacrimation increased, Nasal congestion, Nausea
Clinical narrative: Very stuffy nose, shortness of breath-needed an inhaler.  (Wheezing.) Nausea, vertigo, runny nose, cough, watery eyes.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vertigo, Wheezing
Clinical narrative: Very stuffy nose, shortness of breath-needed an inhaler.  (Wheezing.) Nausea, vertigo, runny nose, cough, watery eyes.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chest X-ray normal, Dyspnoea exertional, Productive cough, Troponin normal
Clinical narrative: Patient arrives with a chief complaint of shortness of breath.  Patient has been having exertional shortness of breath in his house patient has significant medical history and he does use home O2.  Patient's home O2 has been titrated up.  Patient has no chest pain.  Patient has no nausea vomiting.  Patient has been having a persistent cough with phlegm.  Patient has past medical history of O2 dependence, with COPD CHF, hypertension, hypothyroid, dyslipidemia A. fib for which she is on Eliquis and diabetes Patient has past surgical history of quadruple bypass, cardiac stents, and adrenal gland removed Patient is a former smoker nondrinker ,, Associated Symptoms: cough, shortness of breath, sputum
Age: 1.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Seizure
Clinical narrative: restlessness, vomiting, fever, seizure subsequently taken to ER by ambulance and appeared sleepy after event
Age: 1.33
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Restlessness, Seizure, Somnolence, Vomiting
Clinical narrative: restlessness, vomiting, fever, seizure subsequently taken to ER by ambulance and appeared sleepy after event
Age: 59.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Anaphylactic reaction, Loss of consciousness, Swollen tongue
Clinical narrative: Within 2 minutes anaphylactic shock. Required hospital stay overnight. Life treatening, throat closed. 6 EpiPen's, two Benadryl injections and steroid IV
Age: 59.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Anaphylactic shock, Throat tightness
Clinical narrative: Within 2 minutes anaphylactic shock. Required hospital stay overnight. Life treatening, throat closed. 6 EpiPen's, two Benadryl injections and steroid IV
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Agitation, Asthenia, Bacterial infection, Blood creatinine increased
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Chronic kidney disease, Computerised tomogram head abnormal, Condition aggravated
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Decreased appetite, Delirium, Fatigue, Full blood count normal
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertransaminasaemia, Hypophagia, Mental status changes, Metabolic encephalopathy, Metabolic function test abnormal
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Respiratory symptom, SARS-CoV-2 test positive, Superinfection
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Cough, Decreased appetite, Delirium, Eye discharge
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Hypophagia, Malaise, Mental status changes
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test abnormal, Pneumonia, Pulmonary congestion, Respiratory symptom, Rhinorrhoea
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Superinfection
Clinical narrative: Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 10/25/2022 Discharge Date: 10/27/22 HOSPITAL COURSE: Patient is a 78 y.o. male presented to the emergency department on 10/25 with 6 days of progressive weakness and fatigue and new onset altered mental status.  He noted upper respiratory infection signs symptoms at home and do a COVID test which resulted as positive. PCP started him on molnupiravir.  He had a 1 week history of decreased oral intake and poor appetite.  He and his wife were initially managing symptoms at home, however, wife states that he became agitated and confused with possible hallucinations prompting presentation to the emergency department.    September presentation to the emergency department his vitals stable.  Workup obtained to evaluate for etiology of his symptoms, evidence of pneumonia, superimposed bacterial infection, or source of his fatigue.  Complete blood count largely noncontributory.  His CMP noting increased creatinine from his baseline at 2.05 with baseline of 1.5.  COVID-19 test was positive.  Chest x-ray noting possible left lower lobe infiltrate concerning for possible pneumonia.  Suspect this is related to his COVID-19 infection.  CT head noting multiple chronic findings but no acute process that would explain his altered mental status.  Changes in mental status for suspected to be due to delirium versus antiviral medication.  He was admitted for observation to general medicine service due to AKI on chronic kidney disease stage 3.    He received supportive care with initiation of IV fluids on admission.  His mental status improved to baseline.  He was not a candidate for remdesivir or Decadron, and remained on room air.  Over the course of the next 36 hours his creatinine decreased to baseline.  He was had adequate oral intake.  Vitals remained stable.  He was discharged on 10/27 in stable improved condition.
Age: 10.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Moderna Bivalent 6-11 years 0.5 ml administered
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The physician reported that a patient received improperly stored vaccine.; No adverse event; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Patient's medical history, other concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On 07-OCT-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, ((strength, dose, frequency, route of administration and site of vaccination were not provided; lot number W012163 had been verified to be a valid number; expiration date was reported and established as 12-APR-2024) for prophylaxis (improper storage of product in use). Administered dose of the vaccine experienced temperature excursion of 10.1 Fahrenheit (F) for 51 hours. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The physician reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a physician referring to a patient of unknown age and gender. Patient's medical history, other concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not provided.  On 07-OCT-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, one dose, ((strength, dose, frequency, route of administration and site of vaccination were not provided; lot number W012163 had been verified to be a valid number; expiration date was reported and established as 12-APR-2024) for prophylaxis (improper storage of product in use). Administered dose of the vaccine experienced temperature excursion of 10.1 Fahrenheit (F) for 51 hours. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No addtional AEs; CMA called to report administration of expired MMR II vaccine.; This spontaneous report was received from a medical assistant and refers to a 13-month-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reactions were not reported.  On 13-OCT-2022, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) at a dose of  0.5ml/once, first dose, lot #T033815, expiration date: 05-OCT-2022, administered for prophylaxis (route of administration was not provided). No additional adverse event were reported (Expired vaccine used).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient had no known side effects; An expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a pharmacist referring to an adult under the age of 65 years old.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.    On 31-OCT-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #T030667, for prophylaxis (dose, route and site of administration were not reported)  which had expired on 28-SEP-2022 (expired product administered).  Administered vaccine had no known temperature excursions prior to administration and patient had no known side effects.   Lot number T030667 is an invalid lot number for pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). Lot number T030667 is a valid lot number for Rocuronium Bromide (ESMERON).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: The shot don't work/Suspected vaccination failure; The shot don't work; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that the shot did not work just like Covid shot, more bull and more bull and so on. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Shingles, Shots don't always work/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Had as a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that after received Shingles vaccine he/she experienced shingles a bad case of them. The patient stated that shots always not works. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: muscle aches; pain; This case was reported by a pharmacist via sales rep and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced muscle pain and pain. On an unknown date, the outcome of the muscle pain and pain were recovered/resolved.   It was unknown if the reporter considered the muscle pain and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The reporter mentioned that, she experienced muscle aches and pain for several days week after having received a Shingrix dose. The reporter did not agrees to follow up from GlaxoSmithKline Additional supportive information: The reporter did not agree to follow up from GlaxoSmithKline
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain in extremity
Clinical narrative: Arm pain; Redness; Heat; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, erythema and feeling hot. On an unknown date, the outcome of the pain in arm, erythema and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema and feeling hot to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and asked how long did arm pain, redness and heat last. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix shots on 6/23/22 and 3/10/21; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th March 2021).   On 23rd June 2022, the patient received the 2nd dose of Shingrix. On 23rd June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had a both Shingrix shots. The interval between shots was over a year. The reporter wanted to know do he/she need another injection. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swollen armpit; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's comment:  This case was reported by patient's via interactive digital media. The patient experienced swollen armpit after receiving Shingles shot. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was recovered/resolved.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK receipt date: 28-OCT-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. After getting his/her flu shot and shingle shot he/she was dizzy for 3 days. The patient asked as what should he/she did. Additional supportive information: Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's comment:  This case was reported by patient's via interactive digital media. The patient said could he/she find out why he/she was dizzy after having shingle shot. Additional Supportive Information:  The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Chest pain, Pain, Pain in extremity
Clinical narrative: Chest started hurting; Hurt under his arm; It was moving around and stomach and everything; It was moving around and stomach and everything; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (Chest started hurting), PAIN IN EXTREMITY (Hurt under his arm), ABDOMINAL PAIN UPPER (It was moving around and stomach and everything) and PAIN (It was moving around and stomach and everything) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022, the patient experienced CHEST PAIN (Chest started hurting), PAIN IN EXTREMITY (Hurt under his arm), ABDOMINAL PAIN UPPER (It was moving around and stomach and everything) and PAIN (It was moving around and stomach and everything). At the time of the report, CHEST PAIN (Chest started hurting), PAIN IN EXTREMITY (Hurt under his arm), ABDOMINAL PAIN UPPER (It was moving around and stomach and everything) and PAIN (It was moving around and stomach and everything) outcome was unknown.            No concomitant medications were reported. On 02-Nov-2022, patient had received Moderna booster dose. The reporter wanted to know if they need to take patient to the hospital. No treatment details were reported.