chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Cardiac valve disease, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Computerised tomogram thorax abnormal, Condition aggravated, Death, Dyspnoea at rest
Clinical narrative: Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Emphysema, Essential hypertension, Hyperlipidaemia, Left ventricular failure
Clinical narrative: Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Lung adenocarcinoma, Lung consolidation, Lung opacity, Pleural effusion, Productive cough
Clinical narrative: Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Radiation pneumonitis, SARS-CoV-2 test positive
Clinical narrative: Admitted 10/30/2022 with chief complaint SOB. Onset of symptoms was gradual starting several days ago with been gradually worsening course since that time. Reports SOB at rest and exertion, associated productive cough, weakness.  Active Problems: Essential hypertension, benign Centrilobular emphysema (CMS/HCC) Diastolic CHF (CMS/HCC) COPD, moderate (CMS/HCC) Adenocarcinoma of left lung (CMS/HCC) Other hyperlipidemia  Acute hypoxic respiratory failure, Acute on chronic diastolic heart failure,  COVID-19 infection pneumonia, Acute systolic heart failure, Hypoxia is multifactorial, DDX, radiation pneumonitis, HF, COVID or a combination of these.  Pulmonology consulted. Patient clearly expressed that he does not want to be intubated. Inpatient hospice. Continue Lasix 40 mg IV b.i.d. and spironolactone. Continue atorvastatin, Coreg. Continue PPI Dexamethasone 6 mg iv daily  11/6/2022: Cause of death: Acute hypoxemic respiratory failure due to COVID-19 infection and acute combined congestive heart failure. Confounding factors include left lung adenocarcinoma, valvular heart disease and acute kidney injury.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administration error, Product preparation error
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg. Patient/caregiver did not report any adverse event.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bronchial secretion retention, Cardiac arrest, Colostomy, Deep vein thrombosis
Clinical narrative: Continued mechanical ventilatory support. Consulted Nephrology for dialysis.  Continued tube feedings with Nepro.  Occupational Therapy, Physical Therapy, and Speech Therapy consultations were requested.  Nutrition consult was requested.  Continued IV Avycaz for multidrug-resistant Pseudomonas pneumonia and consulted ID.  Wound Care consult was requested. Colostomy care was ordered.  Continued Protonix. Bilateral lower extremity venous Doppler ultrasound was been ordered and showed new left lower extremity DVT. IVC filter placement was performed by Interventional Radiology. The patient appeaeds to have developed significant debilitation due to his prolonged illness and severe injuries following his motor vehicle accident and episodes of cardiac arrest due to mucus plugging on the 8th August 2022 and another episode of cardiac arrest on the 6th September 2022. He was also diagnosed with severe ventilator associated pneumonia which was treated with a full course of IV antibiotics.  Sputum cultures showed increasingly resistant Pseudomonas species.  Patient had difficulty tolerating weaning trials.  He continues to require mechanical ventilatory support without much progress.  Patient's family were contacted and have brought forward a copy of patient's living well.  They have requested discontinuation of life support measures and focusing on comfort measures only
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal tube insertion, Illness, Mechanical ventilation, Multiple injuries, Multiple-drug resistance
Clinical narrative: Continued mechanical ventilatory support. Consulted Nephrology for dialysis.  Continued tube feedings with Nepro.  Occupational Therapy, Physical Therapy, and Speech Therapy consultations were requested.  Nutrition consult was requested.  Continued IV Avycaz for multidrug-resistant Pseudomonas pneumonia and consulted ID.  Wound Care consult was requested. Colostomy care was ordered.  Continued Protonix. Bilateral lower extremity venous Doppler ultrasound was been ordered and showed new left lower extremity DVT. IVC filter placement was performed by Interventional Radiology. The patient appeaeds to have developed significant debilitation due to his prolonged illness and severe injuries following his motor vehicle accident and episodes of cardiac arrest due to mucus plugging on the 8th August 2022 and another episode of cardiac arrest on the 6th September 2022. He was also diagnosed with severe ventilator associated pneumonia which was treated with a full course of IV antibiotics.  Sputum cultures showed increasingly resistant Pseudomonas species.  Patient had difficulty tolerating weaning trials.  He continues to require mechanical ventilatory support without much progress.  Patient's family were contacted and have brought forward a copy of patient's living well.  They have requested discontinuation of life support measures and focusing on comfort measures only
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Pneumonia pseudomonal, Pseudomonas test positive, Road traffic accident, Sputum culture positive
Clinical narrative: Continued mechanical ventilatory support. Consulted Nephrology for dialysis.  Continued tube feedings with Nepro.  Occupational Therapy, Physical Therapy, and Speech Therapy consultations were requested.  Nutrition consult was requested.  Continued IV Avycaz for multidrug-resistant Pseudomonas pneumonia and consulted ID.  Wound Care consult was requested. Colostomy care was ordered.  Continued Protonix. Bilateral lower extremity venous Doppler ultrasound was been ordered and showed new left lower extremity DVT. IVC filter placement was performed by Interventional Radiology. The patient appeaeds to have developed significant debilitation due to his prolonged illness and severe injuries following his motor vehicle accident and episodes of cardiac arrest due to mucus plugging on the 8th August 2022 and another episode of cardiac arrest on the 6th September 2022. He was also diagnosed with severe ventilator associated pneumonia which was treated with a full course of IV antibiotics.  Sputum cultures showed increasingly resistant Pseudomonas species.  Patient had difficulty tolerating weaning trials.  He continues to require mechanical ventilatory support without much progress.  Patient's family were contacted and have brought forward a copy of patient's living well.  They have requested discontinuation of life support measures and focusing on comfort measures only
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler abnormal, Vena cava filter insertion, Weaning failure
Clinical narrative: Continued mechanical ventilatory support. Consulted Nephrology for dialysis.  Continued tube feedings with Nepro.  Occupational Therapy, Physical Therapy, and Speech Therapy consultations were requested.  Nutrition consult was requested.  Continued IV Avycaz for multidrug-resistant Pseudomonas pneumonia and consulted ID.  Wound Care consult was requested. Colostomy care was ordered.  Continued Protonix. Bilateral lower extremity venous Doppler ultrasound was been ordered and showed new left lower extremity DVT. IVC filter placement was performed by Interventional Radiology. The patient appeaeds to have developed significant debilitation due to his prolonged illness and severe injuries following his motor vehicle accident and episodes of cardiac arrest due to mucus plugging on the 8th August 2022 and another episode of cardiac arrest on the 6th September 2022. He was also diagnosed with severe ventilator associated pneumonia which was treated with a full course of IV antibiotics.  Sputum cultures showed increasingly resistant Pseudomonas species.  Patient had difficulty tolerating weaning trials.  He continues to require mechanical ventilatory support without much progress.  Patient's family were contacted and have brought forward a copy of patient's living well.  They have requested discontinuation of life support measures and focusing on comfort measures only
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Nervousness, Vertigo
Clinical narrative: A day after the injection experienced 6 episodes of dizziness/vertigo over a period of 8-9 hours. No more occurrences after that but felt shaky for the next 2-3 days. Had experienced incidents of this early in 2022 but only very short duration events and very sporadically over a 6-month period.  Had been diagnosed with benign positional vertigo and given exercises to prevent/treat this.  In the 5 months prior to vaccination had only 2 twenty second incidents. My previous Covid vaccinations were from Moderna.  The only reaction I had to those were a significant uncomfortable rash on my arm which lasted about 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: body rash
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no side effect
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Cold sweat, Dizziness, Dyskinesia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Immediately after vaccine patient started to feel clammy and dizzy. Patient then passed out while sitting upright. Mom and RN supported patient's upper body so he did not fall.  While passed out the patient's legs extended straight and head/arms made jerking motion. Pt quickly woke up within one minute of passing out. The patient asked where he was but quickly became aware of his surroundings. The patient still appeared pale. He then vomited and his legs were shaking mildly. Once the patient was stable the RN alerted doctor of the incident and asked for her to evaluate the patient. Mom stayed with patient while RN out of room. Vitals were done and the patient rested in room. Ice pack, snack and water were given to help him recover. Doctor evaluated the patient. Per doctor's judgement the patient was able to leave the office once he felt able to safely leave. The patient was able to walk out of office after about 30 minutes. His color had returned to normal in his face and he was no longer clammy when he left the office. Mom was to stay with patient to monitor him throughout the day.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Tremor, Vomiting
Clinical narrative: Immediately after vaccine patient started to feel clammy and dizzy. Patient then passed out while sitting upright. Mom and RN supported patient's upper body so he did not fall.  While passed out the patient's legs extended straight and head/arms made jerking motion. Pt quickly woke up within one minute of passing out. The patient asked where he was but quickly became aware of his surroundings. The patient still appeared pale. He then vomited and his legs were shaking mildly. Once the patient was stable the RN alerted doctor of the incident and asked for her to evaluate the patient. Mom stayed with patient while RN out of room. Vitals were done and the patient rested in room. Ice pack, snack and water were given to help him recover. Doctor evaluated the patient. Per doctor's judgement the patient was able to leave the office once he felt able to safely leave. The patient was able to walk out of office after about 30 minutes. His color had returned to normal in his face and he was no longer clammy when he left the office. Mom was to stay with patient to monitor him throughout the day.
Age: 10.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Incorrect product formulation administered
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient complains of left arm pain post influenza vaccine. Seen in UC on 11/15/22
Age: 74.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Feeling hot, Hyperhidrosis, Visual impairment
Clinical narrative: Patient said he was feeling hot and sweaty. and said he was also losing eyesight 5 to 10 minutes after getting covid 19 booster and fluzone hd. Patient was asked to lay on his back and elevate his feet. Pt started feeling better after few minutes. After 10 minutes, patient left pharmacy as he was no longer experiencing symptoms.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administration error, Product preparation error
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg. Patient/caregiver did not report any adverse event.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling of eyelid, Urticaria chronic
Clinical narrative: I have been having chronic hives starting may 5th 2022 all over my body, swollen eye lid, lips. I went to the emergency room at hospital and was told they were chronic hives and was given prednisone and when I left then gave me a prescription for prednisone for 5days with 1 refill. I still have these chronic hives till this day  11/18/2022 and I have tried other medications like Allegra, ibuprofen  and Claritin and Zyrtec and the work and then started to not work as much
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Patient called 2 hrs. later with complaint of "severe headache," that is like a migraine. Vaccine given at 1220 and patient called at 1500 stating headache started 20 mins ago. Advised patient to take Tylenol and if it does not get better to come to urgent care or the emergency room. Patient denies history of stroke or chest pain or any palpitations. With patients' history of heart palpitations vaccine coordinator contacted and VAERS was implemented.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Patient received Fluarix vaccine at 5:00pm and at 5:02pm patient started experiencing dizziness, sweating. This was almost immediately followed by the patient starting to fall who was caught by her friend who lowered patient to the ground without injury. I examined patient at 5:04pm, and at this time she was sweating and pale. The patient did not lose consciousness, and did not experience chest pain, SOB, N/V/D, loss of bowel or bladder control, changes in vision or hearing. The patient was alert and oriented times three shortly after the near syncope event. Patient stated she had not eaten since early in the morning.  Patient laid down flat with feet elevated for 15 minutes, then sat up for 15 minutes (her color returned, and other symptoms resolved during this time), which was followed by standing for 10-15 minutes all while under supervision. Patient tolerated snacks and drink without issue.  Patient vitally stable throughout event other than her HR went up to 101 at time of event: BP 100-114/67-83, HR 101->74, SpO2 97-99%. Plan: suspect patient experienced vasovagal episode and near syncopal event. Recommended patient drink plenty of fluid and eat well for next 24 hours. Recommended patient receive future vaccinations with PCP and to always eat meals about an hour before future vaccinations. Patient stable and advised she could go home with her friend who took the bus home. Advised patient against driving that night or if symptoms returned.
Age: 7.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Syringe issue, Underdose
Clinical narrative: Syringe malfunction and dose spilled out of the barrel during administration.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure immeasurable, Death, Dyspnoea, Positive airway pressure therapy, Pulse absent
Clinical narrative: They both agree that they want to stop all life saving or sustaining efforts at this time including fluids and would like to remove the Bipap. They agreed to using a HFNC for patient comfort and to reduce air hunger. Notified by RN that patient was unresponsive. Patient was found to be breathless, pulseless and without a BP. RN had already attempted to call her children and was unable to reach them. He was able to reach her granddaughter to notify her of the patient's passing. Patient was pronounced dead at 0154 11/17/22. Health officials and ME to be contacted by house supervisor.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: They both agree that they want to stop all life saving or sustaining efforts at this time including fluids and would like to remove the Bipap. They agreed to using a HFNC for patient comfort and to reduce air hunger. Notified by RN that patient was unresponsive. Patient was found to be breathless, pulseless and without a BP. RN had already attempted to call her children and was unable to reach them. He was able to reach her granddaughter to notify her of the patient's passing. Patient was pronounced dead at 0154 11/17/22. Health officials and ME to be contacted by house supervisor.
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: no side effect
Age: 1.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I incorrectly administer Kinrix to my pt who was 1 year and 6 months old.  I grabbed the Kinrix instead of the Infanrix.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Patient started feeling dizzy, then complained of Shortness of breath (on observation, shortness of breath was very severe). Patient was taken to ER department by EMT
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no side effect
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given incorrect vaccines.   No adverse outcome noted.
Age: 63.0
Sex: M
Vaccine: FLUR4
Symptoms: Paraesthesia
Clinical narrative: Patient came to pharmacy on 11/17/2022 reported tingling sensation going down his arm for 2 of days. Called patient on 11/18/2022 to follow-up, patient said he is feeling a slight improvement - advised patient to see his healthcare provider.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no side effect
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Incorrect dose administered, Malaise, Product preparation issue, Pyrexia
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient experienced a high fever, headache, and malaise 3 days after immunization that prompted ED visit at hospital.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: "Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event."
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: pt signed up for a flu shot today at this pharmacy 11-18-22, pt was brought into vaccine area and confirmed we were giving a flu shot to which she replied yes. because at pharmacy, we batch/process the vaccines at the end of the day, it wasnt realized that she received a flu shot at this location just a month ago. pt was notified and on call dr was notified to which the on call dr said it was ok
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, No adverse event, Product administration error, Product preparation error
Clinical narrative: "Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver did not report any adverse event."
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient did not remember getting a flu shot already this year, and received a 2nd flu shot 1 month after the first.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Error occurred when administering a dose of Pediatric Pfizer Bivalent vaccine. Clinic staff did not dilute vaccine vial prior to administration and so patient received concentrated vaccine. Estimated dose administered ~28 mcg rather than intended 10 mcg.  Patient/caregiver unable to be reached for follow-up. Not known if any ADR occurred.
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A nurse called stating that a patient received an extra dose of VARIVAX. No additional AE's and no PQC's were reported.; A nurse called stating that a patient received an extra dose of VARIVAX. No additional AE's and no PQC's were reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 22-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, quantity: 1, use as directed to prevent varicella infection, administered for prophylaxis (dose, anatomical location, and route of administration were not provided), lot# U010744 is not valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as: 03-OCT-2022. The reporter stated that the patient received an extra dose of varicella virus vaccine live (oka/merck) (VARIVAX) (extra dose administered).  There were no adverse events reported (no adverse event).
Age: 1.67
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; an improperly stored vaccine was administered to a patient / freezer out of temp range; This spontaneous report was received from a registered nurse and refers to a 20-month-old (reported as 19-month-old) female patient. She was a premature baby (36 weeks, 3118 grams birth weight). The patient had no medications, allergies, medical or surgical history. She had no siblings.  On 18-OCT-2022, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) 0.5 milliliter via subcutaneous route in right vastus lateralis, lot #W005206, expiration date 14-FEB-2024, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (first dose) via subcutaneous route in left vastus lateralis, lot #U022983, expiration date 22-JUL-2023 (exact dose was not reported), hib vaccine (HIB) (fourth dose) via intramuscular route in left vastus lateralis, lot #335N9, expiration date 25-MAY-2023 (exact dose was not reported), diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) (fourth dose) via intramuscular route in right vastus lateralis, lot #LS444, expiration date 16-SEP-2023 (exact dose was not reported) and pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (fourth dose) lot #FMS700, expiration date 31-JUL-2024 (exact dose, injection site, route of administration were not reported) for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of 10.8 degrees Fahrenheit (F) for 18 hours 30 minutes. Freezer failed, the vaccines were moved to the back up location. Temperatures out of range multiple times due to odd cycle. The reporter was not aware of excursions until 21-OCT-2022. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There was no adverse event reported. No prescription drug treatment for the experience was required. The medication error occurred during storage in clinical practice. After excursion found, no further doses were given. The vaccines were not available for evaluation. The single use vaccines were used according to the instruction leaflet and were administered by trained healthcare professional in the private doctor's office/ hospital; purchased with private funds.  This is one of several reports received from the same reporter.
Age: 34.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired dose of VAQTA. Admin on 10/31/2022; This spontaneous report was received from a physician and refers to a 34-year-old patient of unknown gender. The patient's medical history, concomitant therapies, and concurrent conditions were not provided.  On 13-OCT-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U024378, expiration date 22-OCT-2022 (strength, route and site of administration were not provided) for prophylaxis (expired product administered).
Age: 1.33
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administration error
Clinical narrative: no adverse event; patient inadvertently received HAVRIX, MMR II and VARIVAX on 11/4/2022. The same vaccines- HAVRIX, MMR Iand VARIVAX had been administered on 6/30/2022; This spontaneous report was received from a nurse and refers to a 16-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 30-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant Human albumin (rHa), dose 0.5 ml, lot #T029550, expiration date: 01-SEP-2022, administered subcutaneously (anatomical location was not provided), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 ml, lot #U002397, expiration date: 22-JAN-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) and hepatitis a vaccine inactivated (HAVRIX), administered for prophylaxis (dose, route of administration, lot #, expiry date, and anatomical location were not provided). On 04-NOV-2022, the patient inadvertently received (product administration error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant Human albumin (rHa), dose 0.5 ml, lot #U029619, expiration date: 22-SEP-2023, administered subcutaneously (anatomical location was not provided), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 ml, lot #U008182, expiration date: 04-NOV-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) and hepatitis a vaccine inactivated (HAVRIX), administered for prophylaxis (dose, route of administration, lot #, expiry date, and anatomical location were not provided). No additional adverse events reported.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of product administration
Clinical narrative: the patient's Hep B titer came back as "undetectable immunity."; patient that received the Hep B vaccine at the usual scheduled time: 3 1/2 weeks, 8 months and 21 months; patient that received the Hep B vaccine at the usual scheduled time: 3 1/2 weeks, 8 months and 21 months; This spontaneous report was received from a Registered Nurse (RN) and referring to a currently 18-year-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  In December 2003, July 2004 and August 2005 (reported as in 3 1/2 weeks, 8 months and 21 months), the patient received Hepatitis B Vaccine (Recombinant) (manufacturer unknown) at the usual scheduled time(all dose, route, lot# and expiration date were not reported; first series) for prophylaxis (inappropriate schedule of product administration). On 23-MAY-2022, physician drew many different titers for unknown reason and the results showed the patient's Hep B titer came back as "undetectable immunity" (Hepatitis B surface antibody negative). As a treatment, the patient had another Hep B series with the 1st dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) on 03-JUN-2022, and the 2nd dose on 06-JUL-2022. (both strength, dose, frequency, lot #, expiry date, and route of administration were not provided) for prophylaxis. And the 3rd dose was scheduled for 5 months and some days. The nurse was asking if the third dose can be given at less than 6 months (5 months +days). It was reported the therapy was continued. The patient had sought medical attention. Outcome of the event Hepatitis B surface antibody negative was not reported.  The causality between the suspect product and the event Hepatitis B surface antibody negative was not reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE information provided.; HCP states that MMR II was accidentally administered to a patient via the intramuscular route instead of subcutaneously into the deltoid area.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter, accidentally via the intramuscular route instead of subcutaneously (Incorrect route of product administration) into the deltoid area, valid lot #U013035, expiration date: 23-APR-2023, administered for prophylaxis (strength was not provided). No additional information or adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 14-NOV-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W024548, expiration date: 31-JAN-2024, administered once for prophylaxis (strength, and route of administration were not provided) after a temperature excursion of 9.7 Fahrenheit for 15 minutes (product storage error). No previous temperature excursions were reported. No additional adverse events details or product quality complaints were reported (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that a patient received an expired RECOMBIVAX.  No additional AEs were reported.  No further information provided.; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 14-NOV-2022, the patient was vaccinated with expired dose of hepatitis b vaccine (recombinant) (thiomersal free) (RECOMBIVAX HB) intramuscular injection, 1 dose, lot #T036814, expiration date: 12-NOV-2022 (strength, exact dose, site and route of administration were not provided) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza, Influenza virus test positive, Malaise
Clinical narrative: TESTED POSITIVE FOR FLU; NOT FEELING SO WELL; "Not feeling so well"; A spontaneous report has been received from a health professional. The report concerns a child of unknown gender of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on 21-OCT-2022. The patient received 1 dose(s).     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 23-OCT-2022, the patient experienced not feeling so well (preferred term: Malaise). On 25-OCT-2022, the patient experienced tested positive for flu (preferred term: Influenza).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of not feeling so well and tested positive for flu was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got vaccine on 8/28, 3 days ago got Shingles; Shingles/ 3days ago got shingles; 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 (Shingrix) for prophylaxis.   On 28th August 2022, the patient received Shingrix. On 8th November 2022, 72 days after receiving Shingrix, 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 Shingrix.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case  was received from the patient via interactive digital media. The patient had received the Shingrix vaccine and 3 days ago from the reporting date, got shingles. The patient was getting ready to do. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The vaccination date year was captured as 2022, conservatively considered that the patient got the vaccine on 28th August 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: got GBS as side affect; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received both the Shingrix shot. A week after the second shot, the patient experienced Guillain Barre syndrome (GBS) the side effect from hell. The Guillain Barre syndrome was over year ago from reporting but the patient still dealing with it. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I took the vaccine and still got shingles/suspected vaccination failure; shingles/ Still got shingles; severe pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient took the vaccine and still got the shingles. The patient mentioned severe pain for sure. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine doesn't work,  wife has shingles/Suspected vaccination failure; Has Shingles right now; 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.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: The case was received from the patient's husband via  interactive digital media. The patient's husband reported that nice try, the vaccine did not worked, the patient has had shingles right now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Friend had shingles 4x even with the shot/Suspected vaccination failure; Had shingles 4x even with the shot; 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.   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Nov-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient's knew that the patient who has had shingles 4 times even with the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the Shingles vaccine and I still got them/Suspected vaccination failure; Still got them (shingles); 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.   The patient's past medical history included chickenpox.   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. The patient was treated with valaciclovir hydrochloride (Valtrex). 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: 13-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got them. The patient stated that fortunately, no pain and Valtrex took care of them. The patient stated that ugly. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.