chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 1/13/21 lot# EK4176;  Pfizer 2/3/21 lot# EL9265;  Pfizer 10/26/21 lot# FF2590
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 2/20/21 lot# 023M20A;  Moderna 3/20/21 Lot#  007B21A
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 3/4/21 lot# EN6206;  Pfizer 3/5/21 lot# EN6206;  Pfizer 10/29/21 lot # 32030BD;  Pfizer 7/29/22 lot# FP7150
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 9/3/21 lot# FC3180;  Pfizer 10/14/21 lot# FC3180;  Moderna 6/22/22 lot# 049L21A
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Pfizer 4/16/21 lot# Ew0169;  Pfizer 5/7/21 lot# EW0179;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Symptom recurrence
Clinical narrative: PERIPHERAL NEUROPATHY 3/17/2023  &  3/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 2/13/21 lot# 015M20A;  Moderna 3/13/21 lot# 032M20A
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring, Echocardiogram
Clinical narrative: Atrial fibrillation developed shortly after vaccination
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Acute respiratory failure, Angiogram pulmonary normal, Aphasia, Blood creatinine
Clinical narrative: Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood folate, Blood thyroid stimulating hormone, COVID-19, Cerebrovascular accident, Chills
Clinical narrative: Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Diabetic diet, Dyspnoea, Echocardiogram normal, Encephalopathy
Clinical narrative: Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Glycosylated haemoglobin increased, Hypoxia, Lacunar stroke, Lipids, Lung hypoinflation
Clinical narrative: Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging head abnormal, Mental status changes, Pyrexia, SARS-CoV-2 test positive, Vitamin B12
Clinical narrative: Patient is a 84 y.o. female patient of, MD with history of Diabetes, hypertension, hyperlipidemia presented to Hospital with altered mental status.  Patient was found to be hypoxic and COVID-positive and was treated initially with steroids and remdesivir.  Due to CTPA being unremarkable pulmonology recommended cessation of steroids and continuation of remdesivir while inpatient.  She was weaned to room air and did not require any oxygen on home O2 evaluation.  Due to some word finding difficulty patient obtained an MRI brain which showed an acute CVA.  Neurology recommended medication change meds and close outpatient follow-up with stroke neurology or Center.  Patient is otherwise back to baseline and doing well with no acute complaints.  She is otherwise stable this time for discharge home and outpatient follow-up as above.  All questions and concerns answered at bedside.   Acute Respiratory Failure with Hypoxia Covid-19 Virus Infection Date of onset of symptoms: 6/13/23 Symptoms present on admission: fever, chills, cough, SOB Date of covid positive test: 06/14/23  Vaccination status: unable to verify at this time Imaging: Hypoinflation of lungs Oxygen requirements on admission: 3 L Current oxygen requirements: RA, no oxygen needs on home O2 evaluation Medical therapy: remdesivir and steroids initially but now stop steroids Consultants following: Pulmonology Anticipated special isolation end date: 6/24/2023 Acute stroke Acute Encephalopathy, resolved Thought to be secondary to COVID and hypoxia The patient does have an accent, though she states that she speaks language, and is able to answer some of her questions Neuro consulted, MRI brain with small right parietal lacunar stroke Echo with no PFO MR cow carotid brain with no extracranial carotid stenosis, slightly hypoplastic vertebral artery and short segment significant irregularity in the M1 segment of the left cerebral artery but flow is preserved Obtain MRA head neck and obtain echo Placed on aspirin and Plavix for 21 days then aspirin alone. Continue atorvastatin Outpatient stroke neurology follow-up Center referral placed B12/Folate, TSH not low   AKI Serum creatinine of 1.32, appears baseline is between 1 and 1.1 but no previous labs for definitive.  SCr down to 1.18 Give gentle IV fluid hydration Stop home losartanHCTZ, continue losartan on discharge   Hypertension Continue Lopressor, nifedipine Stop home losartanHCTZ, continue losartan on discharge   Hyperlipidemia Continue statin therapy Lipid panel pending   Diabetes Type 2 Holding Metformin, Amaryl 2 mg BID, Steglatro 15 mg daily, Januvia 25 mg daily and Ozempic 0.5 mg weekly therapy at this time A1c of 8.5 We will continue with sliding scale insulin coverage and lantus increased to 18 units.  Glucose control should be improving since steroids have been discontinued Continue Januvia Diabetic diet Continue to monitor
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Immunisation reaction, Pallor
Clinical narrative: Vasovagal reaction to vaccine, patient had a near fainting experience, a few seconds after receiving her vaccine. We had the patient lie supine on the table and drink juice. The patient stated she felt better so we had her sit up on the table, she then felt faint again and her skin was pale and clammy, we had her lie back down on the table and continued to give her fluids of juice and water while monitoring her blood pressure and pulse. Patient was monitored for 1.5 hours and given 50 oz of water to drink while in the office. Patient was released to leave our office after her vital signs stabled and she was feeling better.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Presyncope
Clinical narrative: Vasovagal reaction to vaccine, patient had a near fainting experience, a few seconds after receiving her vaccine. We had the patient lie supine on the table and drink juice. The patient stated she felt better so we had her sit up on the table, she then felt faint again and her skin was pale and clammy, we had her lie back down on the table and continued to give her fluids of juice and water while monitoring her blood pressure and pulse. Patient was monitored for 1.5 hours and given 50 oz of water to drink while in the office. Patient was released to leave our office after her vital signs stabled and she was feeling better.
Age: 70.0
Sex: M
Vaccine: COVID19-2, TDAP
Symptoms: Needle issue
Clinical narrative: Tdap vial was attached to a faulty needle. The injection leaked out through the vial/needle junction site. It appeared as though all of the vaccine dripped out from the junction site, however the patient may have received some of the Tdap vaccine through the tip of the needle. An additional Tdap vaccine was given 2 inches above the previous insertion site on the right deltoid.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: given booster dose for primary series
Age: 2.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: none
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: given booster dose instead of primary dose
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 0.83
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given booster dose instead of primary dose
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: None: No signs or symptoms noted or reported.  vaccine was left out overnight and a dose was given the next morning
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sarcoma metastatic
Clinical narrative: Started having arm pain in Dec '21. Diagnosed with metastatic sarcoma cancer
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Rash, Rash erythematous
Clinical narrative: Client showed Case Manager photos of red circular rash spots covering client's arm which were reportedly taken approximately 3 days after the MPOX injection was administered by the Department of Health and Environment nurse.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: patient given booster dose instead of primary dose
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia
Clinical narrative: auto immune hemolytic anemia requiring steroids onset 7/18/23
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given booster dose instead of primary dose
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given vaccine after BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given vaccine after BUD
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 17 y/o female patient received extra Men B vaccine. No adverse reactions were reported or noted.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given booster dose instead of primary dose
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Decreased appetite, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Mother relates patient began with swelling, redness on left upper arm after DTAP vaccination on 7/24. Since that time, redness/swelling has increased, having pain, and subjective fever. Taking acetaminophen regularly, last dose 10AM on 7/26. Afebrile during visit on 7/26. Mother relates pt. has decreased appetite, denies SOB/difficulty swallowing.  Mother denies similar reaction to any vaccinations in the past.  Referred to urgent care for evaluation due to no PCP.
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: given booster dose instead of primary dose
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Sensory disturbance
Clinical narrative: Patient was given vaccinated with Adacel. During the monitoring period, she informed that she was feeling week and felt that her blood sugar was going down. Her daughter who was assisting her was giving her candy as I was speaking to her. She noted once she was given the vaccine, she felt a rush in her head. Patient was given water and monitored longer prior to leaving pharmacy. There was no sign of rash or injection site reaction  she denied any trouble breathing or throat swelling.  After monitoring patient felt ok and stated she felt fine to go home.
Age: 1.17
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: given booster dose instead of primary dose
Age: 66.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chills, Pyrexia, Visual impairment
Clinical narrative: Pt reported a 103 degree F fever for 2 days along with chills and visual disturbances (seeing shadows in the dimly lit bedroom during the night)
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose (1ml) of Engerix was administered to patient <19 years of age. Nursing supervisor and onsite NP notified of error. Legal guardian of pediatric patient also notified.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No specific adverse event, however second bivalent Moderna COVID-19 vaccine was erroneously administered at 64 years old (patient is not yet 65 years old and is not immunocompromised) which is outside of current authorization.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No specific adverse event, however second bivalent Moderna COVID-19 vaccine was erroneously administered at 62 years old (patient is not yet 65 years old and is not immunocompromised) which is outside of current authorization.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after BUD
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Patient received vaccine after BUD
Sex: U
Vaccine: MMRV
Symptoms: Product expiration date issue, Product storage error
Clinical narrative: She states that the products were labeled but still accidentally administered after the new short dated expiration date; Caller reports that they had 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 medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAR-2023, measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) underwent temperature excursion in 6°F up to 14°F 4 hours 0 minutes; 14°F up to 46°F 4 hours 0 minutes ; 47°F to 77°F (50 F) 3 hours 57 minutes (product storage error). On 05-JUL-2023, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot #W035470, expiration date: 06-MAY-2024 (also reported as 30-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided).Due to temperature excurion the expiration date was estimeted as "short dated" (Product expiration date issue).
Sex: U
Vaccine: HEP, HEPA
Symptoms: Product storage error
Clinical narrative: No additional AE; HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2023, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #X004814, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided); and  hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #W008704, expiration date: 18-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse events were reported.
Sex: M
Vaccine: PPV
Symptoms: Injection site discomfort, Swelling
Clinical narrative: the patient noticed that his lower back was a bit swollen. The patient does not have any pain, just swelling which seems to be going down.; He experienced some discomfort at the injection site following the vaccination.; This spontaneous report as received from a consumer reporting on himself, a 83 year old male patient. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies were provided.      On 17-JUL-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported).    On 17-JUL-2023, following the vaccination the patient experienced some discomfort at the injection site  (vaccination site discomfort).  On 19-JUL-2023, the patient noticed that his lower back was a bit swollen. The patient did not have any pain, just swelling (swelling). No treatment was given for the adverse events and the patient did not seek medical attention.  At the reporting time, the outcome of vaccination site discomfort was unknown, while the outcome of swelling was reported as recovering as the swelling seemed to be going down. The causality assessment between the adverse events and the suspect vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC reported; improperly stored and administered VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concomitant medications and concurrent conditions were not reported.  On 21-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) injection 0.5 mL (two dose series) as prophylaxis (lot # W032507 and expiration date was 11-OCT-2024; strength, route of administration, and frequency were unknown) (product storage error), the single patient involved had not reported any symptoms related to this adverse event. No additional adverse event (AE) reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No other AE; HBP calling to report an administration of the GARDASIL 9 vaccine to a 2 month old patient on 03/29/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 29-MAR-2023 the patient that was too young to receive vaccine was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W010663 and expiration date 11-MAR-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule; This spontaneous report was received from Other Health Professional and refers to a 4-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications were not reported.  On 02-FEB-2023, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 31-MAR-2023, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration).  This one of several reports received from the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient had the shots and had shingles right now. This case was considered as suspected vaccination failure as details regarding complete vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: now have shingles/ dealing with shingles right now; Suspected vaccination failure/ now have shingles; This serious 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. In JUL-2023, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/ now have shingles) (serious criteria GSK medically significant). On an unknown date, the patient experienced shingles (Verbatim: now have shingles/ dealing with shingles right now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-JUL-2023 The case was received from the patient via interactive digital media. The patient have had the shots one year ago and was dealing with shingles right now. The patient stated that they told him that they only help 50 percent (only 50 percent works from the shots) . The patient stated good luck. 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: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; got them again/ it was less severe than the first time; was less severe than the first time, but itched just the same; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pruritus.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got them again/ it was less severe than the first time) and pruritus (Verbatim: was less severe than the first time, but itched just the same). The outcome of the vaccination failure was unknown and the outcome of the shingles and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 24-Jul-2023 The case was received from the patient via interactive digital media. The patient had them previous to getting the first shot, then got them again between the first and second dose. There was a supply problem with the second dose, it was less severe than the first time, but itched just the same. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Trigeminal neuralgia
Clinical narrative: vaccine caused Trigeminal Neuralgia; vaccine caused Bells Palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bell's palsy (Verbatim: vaccine caused Trigeminal Neuralgia) (serious criteria GSK medically significant) and trigeminal neuralgia (Verbatim: vaccine caused Bells Palsy). The outcome of the bell's palsy and trigeminal neuralgia were not reported.   The reporter considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine.     The company considered the bell's palsy and trigeminal neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 The case was received from the consumer interactive digital media. The reporter stated that vaccine caused Trigeminal Neuralgia and Bells Palsy The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: had the shingles vaccine in 2021 and in 2022 I got the shingles; had the shingles vaccine in 2021 and in 2022 I got the shingles; had the shingles vaccine in 2021 and in 2022 I got the shingles; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shingles vaccine in 2021 and in 2022 I got the shingles) (serious criteria GSK medically significant), shingles (Verbatim: had the shingles vaccine in 2021 and in 2022 I got the shingles) and drug dose administration interval too long (Verbatim: had the shingles vaccine in 2021 and in 2022 I got the shingles). The outcome of the vaccination failure and drug dose administration interval too long were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 The case was received from the patient interactive digital media. The patient had the Shingles vaccine in 2021 and in 2022 and got the shingles. The patient stated that he/she was done with vaccines period.  This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I still got shingles; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 22-Jul-2023 This case was reported the patient via interactive digital media. The patient had both the shingles shots and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Inappropriate schedule of product administration, Rash, Rash pruritic
Clinical narrative: extremely itchy rash all over her body from the neck down to her  feet; feels heat internally; received her second Shingrix vaccine on 2-20-2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2020 in unknown arm).   On 20-FEB-2023, the patient received the 2nd dose of Shingrix (unknown arm). On 20-FEB-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: received her second Shingrix vaccine on 2-20-2023). On an unknown date, the patient experienced itchy rash (Verbatim: extremely itchy rash all over her body from the neck down to her  feet) and feeling hot (Verbatim: feels heat internally). The outcome of the itchy rash was not resolved and the outcome of the feeling hot was not reported and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the itchy rash and feeling hot to be related to Shingrix.     It was unknown if the company considered the itchy rash and feeling hot to be related to Shingrix.   Additional Information: GSK receipt date 21 Jul 2023:  The reporter was niece of the patient. The patient was 82 years at the time of reporting.  The reporter stated her great aunt received her first Shingrix vaccine in April 2020, unknown arm.  Her great aunt received her second Shingrix vaccine and about 1 week after receiving the second Shingrix vaccine her great aunt developed an extremely itchy rash all over her body from the neck down to her feet. To date, the reporter stated that the rash seems to be getting worse with no relief from the itching. The patient had been to her doctor, a dermatologist, a rheumatologist and an allergist and no one knows what the rash was. The patient feels heat internally.  The reporter gave permission to contact both her primary doctor and her Dermatologist.  It was reported that rash was continue until 24 Jul 2023.  The patient received 2nd dose late than recommendation which led to drug dose interval too long.
Sex: U
Vaccine: VARZOS
Symptoms: Cold sweat, Emotional disorder, Hot flush, Nasopharyngitis
Clinical narrative: hot flashes; cold; clammy; up and down emotions; This non-serious case was reported by a consumer via call center representative and described the occurrence of hot flashes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hot flashes (Verbatim: hot flashes), cold (Verbatim: cold), clamminess (Verbatim: clammy) and emotional disorder (Verbatim: up and down emotions). The outcome of the hot flashes, cold, clamminess and emotional disorder were not resolved.   It was unknown if the reporter considered the hot flashes, cold, clamminess and emotional disorder to be related to Shingrix.     It was unknown if the company considered the hot flashes, cold, clamminess and emotional disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUL-2023 The patient self-reported this case. The reporter asked for Information about medication side effects as the patient had uncommon side effects. The patient was currently had up and down emotions and hot flashes, cold and clammy. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Scratch, Urticaria
Clinical narrative: had chronic hives that seem to get worse with time; Scratching; This non-serious case was reported by a consumer and described the occurrence of hives in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced hives (Verbatim: had chronic hives that seem to get worse with time) and scratch (Verbatim: Scratching). The patient was treated with benadryl (nos) (Benadryl). The outcome of the hives and scratch were not resolved.   It was unknown if the reporter considered the hives and scratch to be related to Shingles vaccine.     It was unknown if the company considered the hives and scratch to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20 Jul 2023 The patient stated that ever since he/she received shingles vaccine the patient had chronic hives that seems to be got worst with time. The patient had to take benadryl every night just to make it through the night without scratching himself/herself to death. The patient need help and would like to cure to this symptom.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt all over; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Hurt all over). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     It was unknown if the company considered the general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd dose of Shingles vaccine and hurt all over. Follow up was not possible as no contact details were available.