chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Brain natriuretic peptide increased, Bundle branch block right, COVID-19, Chest X-ray normal
Clinical narrative: Patient is a 86 y.o. male with past medical history significant for HFrEF, CKD3b, HTN, HLD, mild Alzheimer's who presented from assisted living facility with shortness of breath and was found to have positive COVID test. Required 2L O2 upon admission and started on dexamethasone 6 mg with planned 10 day course. Patient weaned down to room air.    Acute COVID-19 infection Acute Respiratory Failure, resolved Upon admission, patient with productive cough for 2 days and one episode of emesis. COVID+ test at assisted living facility. First day of symptoms 10/2/23. - On arrival, patient hypoxic 88-89% O2 and placed on 2L nasal canula, afebrile, non-tachycardic - CXR without infiltrates or edema - Given oxygen requirement on admission, patient started on dexamethasone 6 mg daily  - supplemental oxygen as needed - Continue dexamethasone, consider adding Paxlovid upon discharge   Chronic heart failure, mildly reduced ejection fraction Patient with history of CABGx4 in late 90's. Home medications include Lisinopril, Coreg, Plavix. Most recent echo 08/2022 showing EF 50% with grade I diastolic dysfunction. Likely demand ischemia given presentation and above COVID infection. Less likely acute heart failure exacerbation.  - Upon admission, troponin 53, BNP 1,687, baseline unclear; EKG with RBBB without ST changes, similar to prior - Patient denies chest pain or other anginal symptoms or signs of fluid overload - troponin down trending 53->71->69 - continue home medications - Continue to monitor and treat as appropriate.    Thrombocytopenia Likely secondary to COVID infection - upon admission platelets 124 (baseline 150) - platelets stable, continue to trend   PVCs Known history of PVCs. - EKG showing sinus rhythm with occasional PVCs. - Patient assymptomatic at time of admission. - Patient placed on cardiac monitoring while admitted. Continue home Coreg 12.5 mg BID.   Left lower extremity wound, POA - Old, non-healing wound with LLE edema. - Patient recently finished course of Ancef - Wound care consult placed.    Alzheimer's - Continue home Sinemet 1 tablet at night   Hypertension - Mildly hypertensive on admission. Continue home medications: Coreg 12.5 mg BID, Pletal 100 mg BID, lisinopril 10 mg daily   DVT Prophylaxis: Lovenox
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Condition aggravated, Dyspnoea, Electrocardiogram abnormal, Hypertension, Hypoxia
Clinical narrative: Patient is a 86 y.o. male with past medical history significant for HFrEF, CKD3b, HTN, HLD, mild Alzheimer's who presented from assisted living facility with shortness of breath and was found to have positive COVID test. Required 2L O2 upon admission and started on dexamethasone 6 mg with planned 10 day course. Patient weaned down to room air.    Acute COVID-19 infection Acute Respiratory Failure, resolved Upon admission, patient with productive cough for 2 days and one episode of emesis. COVID+ test at assisted living facility. First day of symptoms 10/2/23. - On arrival, patient hypoxic 88-89% O2 and placed on 2L nasal canula, afebrile, non-tachycardic - CXR without infiltrates or edema - Given oxygen requirement on admission, patient started on dexamethasone 6 mg daily  - supplemental oxygen as needed - Continue dexamethasone, consider adding Paxlovid upon discharge   Chronic heart failure, mildly reduced ejection fraction Patient with history of CABGx4 in late 90's. Home medications include Lisinopril, Coreg, Plavix. Most recent echo 08/2022 showing EF 50% with grade I diastolic dysfunction. Likely demand ischemia given presentation and above COVID infection. Less likely acute heart failure exacerbation.  - Upon admission, troponin 53, BNP 1,687, baseline unclear; EKG with RBBB without ST changes, similar to prior - Patient denies chest pain or other anginal symptoms or signs of fluid overload - troponin down trending 53->71->69 - continue home medications - Continue to monitor and treat as appropriate.    Thrombocytopenia Likely secondary to COVID infection - upon admission platelets 124 (baseline 150) - platelets stable, continue to trend   PVCs Known history of PVCs. - EKG showing sinus rhythm with occasional PVCs. - Patient assymptomatic at time of admission. - Patient placed on cardiac monitoring while admitted. Continue home Coreg 12.5 mg BID.   Left lower extremity wound, POA - Old, non-healing wound with LLE edema. - Patient recently finished course of Ancef - Wound care consult placed.    Alzheimer's - Continue home Sinemet 1 tablet at night   Hypertension - Mildly hypertensive on admission. Continue home medications: Coreg 12.5 mg BID, Pletal 100 mg BID, lisinopril 10 mg daily   DVT Prophylaxis: Lovenox
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Platelet count decreased, Productive cough, SARS-CoV-2 test positive, Thrombocytopenia, Troponin increased
Clinical narrative: Patient is a 86 y.o. male with past medical history significant for HFrEF, CKD3b, HTN, HLD, mild Alzheimer's who presented from assisted living facility with shortness of breath and was found to have positive COVID test. Required 2L O2 upon admission and started on dexamethasone 6 mg with planned 10 day course. Patient weaned down to room air.    Acute COVID-19 infection Acute Respiratory Failure, resolved Upon admission, patient with productive cough for 2 days and one episode of emesis. COVID+ test at assisted living facility. First day of symptoms 10/2/23. - On arrival, patient hypoxic 88-89% O2 and placed on 2L nasal canula, afebrile, non-tachycardic - CXR without infiltrates or edema - Given oxygen requirement on admission, patient started on dexamethasone 6 mg daily  - supplemental oxygen as needed - Continue dexamethasone, consider adding Paxlovid upon discharge   Chronic heart failure, mildly reduced ejection fraction Patient with history of CABGx4 in late 90's. Home medications include Lisinopril, Coreg, Plavix. Most recent echo 08/2022 showing EF 50% with grade I diastolic dysfunction. Likely demand ischemia given presentation and above COVID infection. Less likely acute heart failure exacerbation.  - Upon admission, troponin 53, BNP 1,687, baseline unclear; EKG with RBBB without ST changes, similar to prior - Patient denies chest pain or other anginal symptoms or signs of fluid overload - troponin down trending 53->71->69 - continue home medications - Continue to monitor and treat as appropriate.    Thrombocytopenia Likely secondary to COVID infection - upon admission platelets 124 (baseline 150) - platelets stable, continue to trend   PVCs Known history of PVCs. - EKG showing sinus rhythm with occasional PVCs. - Patient assymptomatic at time of admission. - Patient placed on cardiac monitoring while admitted. Continue home Coreg 12.5 mg BID.   Left lower extremity wound, POA - Old, non-healing wound with LLE edema. - Patient recently finished course of Ancef - Wound care consult placed.    Alzheimer's - Continue home Sinemet 1 tablet at night   Hypertension - Mildly hypertensive on admission. Continue home medications: Coreg 12.5 mg BID, Pletal 100 mg BID, lisinopril 10 mg daily   DVT Prophylaxis: Lovenox
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ventricular extrasystoles, Vomiting
Clinical narrative: Patient is a 86 y.o. male with past medical history significant for HFrEF, CKD3b, HTN, HLD, mild Alzheimer's who presented from assisted living facility with shortness of breath and was found to have positive COVID test. Required 2L O2 upon admission and started on dexamethasone 6 mg with planned 10 day course. Patient weaned down to room air.    Acute COVID-19 infection Acute Respiratory Failure, resolved Upon admission, patient with productive cough for 2 days and one episode of emesis. COVID+ test at assisted living facility. First day of symptoms 10/2/23. - On arrival, patient hypoxic 88-89% O2 and placed on 2L nasal canula, afebrile, non-tachycardic - CXR without infiltrates or edema - Given oxygen requirement on admission, patient started on dexamethasone 6 mg daily  - supplemental oxygen as needed - Continue dexamethasone, consider adding Paxlovid upon discharge   Chronic heart failure, mildly reduced ejection fraction Patient with history of CABGx4 in late 90's. Home medications include Lisinopril, Coreg, Plavix. Most recent echo 08/2022 showing EF 50% with grade I diastolic dysfunction. Likely demand ischemia given presentation and above COVID infection. Less likely acute heart failure exacerbation.  - Upon admission, troponin 53, BNP 1,687, baseline unclear; EKG with RBBB without ST changes, similar to prior - Patient denies chest pain or other anginal symptoms or signs of fluid overload - troponin down trending 53->71->69 - continue home medications - Continue to monitor and treat as appropriate.    Thrombocytopenia Likely secondary to COVID infection - upon admission platelets 124 (baseline 150) - platelets stable, continue to trend   PVCs Known history of PVCs. - EKG showing sinus rhythm with occasional PVCs. - Patient assymptomatic at time of admission. - Patient placed on cardiac monitoring while admitted. Continue home Coreg 12.5 mg BID.   Left lower extremity wound, POA - Old, non-healing wound with LLE edema. - Patient recently finished course of Ancef - Wound care consult placed.    Alzheimer's - Continue home Sinemet 1 tablet at night   Hypertension - Mildly hypertensive on admission. Continue home medications: Coreg 12.5 mg BID, Pletal 100 mg BID, lisinopril 10 mg daily   DVT Prophylaxis: Lovenox
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute kidney injury, Acute respiratory failure, Atrial fibrillation, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is a 82 y.o. female patient of DO with a history of COPD, chronic respiratory failure on home oxygen (3L) presented to Hospital on 9/23 with acute on chronic respiratory failure. She became unresponsive on the evening of 9/24 with worsening hypercapnia requiring BiPAP and transfer to ICU for closer monitoring. She had been dependent on AVAPs and was intubated 9/30. She experienced seizure like activity on 10/1 overnight, which resolved with 1 mg of versed. EEG showed no signs of a seizure. Bloody secretions were noted in ETT and OG on 10/1 so heparin infusion switched to heparin subcutaneous and a PPI was started. For COVID, she received a course of remdesivir and 10 days of decadron. She also completed a course of cefepime and vancomycin to cover pneumonia and a UTI. Her urine culture was positive for candida tropicalis and fluconazole was initiated. She was found to have atrial fibrillation during this hospitalization, therefore was medically cardioverted with amiodarone x 2 and was synchronized cardioverted on 10/10/2023.   Discharge Diagnoses: Acute on chronic respiratory failure with hypoxia and hypercapnia COVID pneumonia COPD exacerbation  Ileus Acute UTI Seizure like activity, resolved  AKI on CKD III Paroxsymal Atrial fibrillation with RVR  Normocytic Anemia Hypernatremia, resolved   Chronic Conditions  Crohn's disease Essential Hypertension
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Candida infection, Chronic kidney disease, Chronic obstructive pulmonary disease, Condition aggravated, Crohn's disease
Clinical narrative: Patient is a 82 y.o. female patient of DO with a history of COPD, chronic respiratory failure on home oxygen (3L) presented to Hospital on 9/23 with acute on chronic respiratory failure. She became unresponsive on the evening of 9/24 with worsening hypercapnia requiring BiPAP and transfer to ICU for closer monitoring. She had been dependent on AVAPs and was intubated 9/30. She experienced seizure like activity on 10/1 overnight, which resolved with 1 mg of versed. EEG showed no signs of a seizure. Bloody secretions were noted in ETT and OG on 10/1 so heparin infusion switched to heparin subcutaneous and a PPI was started. For COVID, she received a course of remdesivir and 10 days of decadron. She also completed a course of cefepime and vancomycin to cover pneumonia and a UTI. Her urine culture was positive for candida tropicalis and fluconazole was initiated. She was found to have atrial fibrillation during this hospitalization, therefore was medically cardioverted with amiodarone x 2 and was synchronized cardioverted on 10/10/2023.   Discharge Diagnoses: Acute on chronic respiratory failure with hypoxia and hypercapnia COVID pneumonia COPD exacerbation  Ileus Acute UTI Seizure like activity, resolved  AKI on CKD III Paroxsymal Atrial fibrillation with RVR  Normocytic Anemia Hypernatremia, resolved   Chronic Conditions  Crohn's disease Essential Hypertension
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Culture urine positive, Electroencephalogram normal, Endotracheal intubation, Essential hypertension, Hypercapnia
Clinical narrative: Patient is a 82 y.o. female patient of DO with a history of COPD, chronic respiratory failure on home oxygen (3L) presented to Hospital on 9/23 with acute on chronic respiratory failure. She became unresponsive on the evening of 9/24 with worsening hypercapnia requiring BiPAP and transfer to ICU for closer monitoring. She had been dependent on AVAPs and was intubated 9/30. She experienced seizure like activity on 10/1 overnight, which resolved with 1 mg of versed. EEG showed no signs of a seizure. Bloody secretions were noted in ETT and OG on 10/1 so heparin infusion switched to heparin subcutaneous and a PPI was started. For COVID, she received a course of remdesivir and 10 days of decadron. She also completed a course of cefepime and vancomycin to cover pneumonia and a UTI. Her urine culture was positive for candida tropicalis and fluconazole was initiated. She was found to have atrial fibrillation during this hospitalization, therefore was medically cardioverted with amiodarone x 2 and was synchronized cardioverted on 10/10/2023.   Discharge Diagnoses: Acute on chronic respiratory failure with hypoxia and hypercapnia COVID pneumonia COPD exacerbation  Ileus Acute UTI Seizure like activity, resolved  AKI on CKD III Paroxsymal Atrial fibrillation with RVR  Normocytic Anemia Hypernatremia, resolved   Chronic Conditions  Crohn's disease Essential Hypertension
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypernatraemia, Hypoxia, Ileus, Intensive care, Normocytic anaemia
Clinical narrative: Patient is a 82 y.o. female patient of DO with a history of COPD, chronic respiratory failure on home oxygen (3L) presented to Hospital on 9/23 with acute on chronic respiratory failure. She became unresponsive on the evening of 9/24 with worsening hypercapnia requiring BiPAP and transfer to ICU for closer monitoring. She had been dependent on AVAPs and was intubated 9/30. She experienced seizure like activity on 10/1 overnight, which resolved with 1 mg of versed. EEG showed no signs of a seizure. Bloody secretions were noted in ETT and OG on 10/1 so heparin infusion switched to heparin subcutaneous and a PPI was started. For COVID, she received a course of remdesivir and 10 days of decadron. She also completed a course of cefepime and vancomycin to cover pneumonia and a UTI. Her urine culture was positive for candida tropicalis and fluconazole was initiated. She was found to have atrial fibrillation during this hospitalization, therefore was medically cardioverted with amiodarone x 2 and was synchronized cardioverted on 10/10/2023.   Discharge Diagnoses: Acute on chronic respiratory failure with hypoxia and hypercapnia COVID pneumonia COPD exacerbation  Ileus Acute UTI Seizure like activity, resolved  AKI on CKD III Paroxsymal Atrial fibrillation with RVR  Normocytic Anemia Hypernatremia, resolved   Chronic Conditions  Crohn's disease Essential Hypertension
Age: 81.0
Sex: F
Vaccine: COVID19-2
Symptoms: Positive airway pressure therapy, Secretion discharge, Seizure like phenomena, Unresponsive to stimuli, Urinary tract infection
Clinical narrative: Patient is a 82 y.o. female patient of DO with a history of COPD, chronic respiratory failure on home oxygen (3L) presented to Hospital on 9/23 with acute on chronic respiratory failure. She became unresponsive on the evening of 9/24 with worsening hypercapnia requiring BiPAP and transfer to ICU for closer monitoring. She had been dependent on AVAPs and was intubated 9/30. She experienced seizure like activity on 10/1 overnight, which resolved with 1 mg of versed. EEG showed no signs of a seizure. Bloody secretions were noted in ETT and OG on 10/1 so heparin infusion switched to heparin subcutaneous and a PPI was started. For COVID, she received a course of remdesivir and 10 days of decadron. She also completed a course of cefepime and vancomycin to cover pneumonia and a UTI. Her urine culture was positive for candida tropicalis and fluconazole was initiated. She was found to have atrial fibrillation during this hospitalization, therefore was medically cardioverted with amiodarone x 2 and was synchronized cardioverted on 10/10/2023.   Discharge Diagnoses: Acute on chronic respiratory failure with hypoxia and hypercapnia COVID pneumonia COPD exacerbation  Ileus Acute UTI Seizure like activity, resolved  AKI on CKD III Paroxsymal Atrial fibrillation with RVR  Normocytic Anemia Hypernatremia, resolved   Chronic Conditions  Crohn's disease Essential Hypertension
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Influenza like illness, Injection site pain, Injection site warmth, Lymphadenopathy
Clinical narrative: Significant arm soreness, body aches, subjective fever, swollen lymph nodes in the armpit, and soreness with warmth around the area of the injection. Nausea with diarrhea. Provided Zofran on 11/27/2023. As of 12/19/2023 patient has arm soreness at the injection site and lymph nodes continue to be about 10% swollen. No longer has flu-like symptoms.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Significant arm soreness, body aches, subjective fever, swollen lymph nodes in the armpit, and soreness with warmth around the area of the injection. Nausea with diarrhea. Provided Zofran on 11/27/2023. As of 12/19/2023 patient has arm soreness at the injection site and lymph nodes continue to be about 10% swollen. No longer has flu-like symptoms.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: lingering pain and weakness at injection site
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Adverse reaction, Posture abnormal, Syncope
Clinical narrative: Patient Came in at 8: 58AM for Well Child Check and Vaccines. Today the patient received HEP A and HPV9 vaccines, after HPV9 was administered. Patient begin to start leaning forward and fainted. Patient was unconscious for 2 minutes. Immediately doctor came in room and assessed the patient. She was observed for 30 minutes and patient recovered from adverse reaction.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Rash
Clinical narrative: rash on arm, tingling feeling in head
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD REFRIGERATED
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Disorientation, Dizziness
Clinical narrative: Patient start feeling lightheaded and stiff also disoriented for few seconds. Observed and gave him snack and juice because he did not have breakfast. assesses by medical provider
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Hep A Vaccine was administered to patient. No known reactions at this time.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE WAS FROZEN INSTEAD OF REFRIGERATED
Age: 52.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received the RSV Abrexy vaccine when he was not suppose to.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: A medical assistant in our office drew up two dilutents, combined them and administered them to the patient.  The patient has been notified of the error.  The patient has no symptoms or signs of any symptoms at this time.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Severe muscle and joint pain, severe shakes, nausea, fever and chills,  headache,  fatigue.  I couldn't believe a vaccination could make me so ill.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Tremor
Clinical narrative: Severe muscle and joint pain, severe shakes, nausea, fever and chills,  headache,  fatigue.  I couldn't believe a vaccination could make me so ill.
Age: 2.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Pyrexia, Wrong product administered
Clinical narrative: Patient was inadvertently administered Boostrix (Tdap) instead of Infanrix (DTaP) on 12/11/23. Patient tolerated administration well. Patient experienced a fever x1 episode that responded to Tylenol after leaving the office. The error was caught on 12/19 when documenting vaccine administrations for the county immunization record program. The provider then reached out to the parents who stated patient is doing well without any lingering side effects. Provider explained to the parents that the child will need a replacement dose of DTaP as soon as possible to get her up to date on her immunizations.
Age: 72.0
Sex: M
Vaccine: COVID19-2, FLU4, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse event. Patient requested a Flu and RSV vaccine and was given a Moderna Spikevax (Covid ) and RSV vaccine. Store contacted patient post immunization and patient returned to store on same day to receive flu vaccine.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Client received Tdap 12/19/23 after searches under maiden and married name indicated no Tdap given within ten years and following education and discussion with client. Client returned to this clinic on the same day with paper documentation stating received Tdap and flu vaccination 12/13/23 and that she required polio booster. Client advised of duplicate Tdap vaccination, voiced understanding.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction reported
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect product formulation administered, Product administered to patient of inappropriate age
Clinical narrative: Pt received the 12+ formulation at the appropriate dose (0.25 ml) rather than the 6 month-11 year formulation
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Client was administered a dose of 2023-2024 Moderna 6m-11Y instead of a dose of Spikevax 2023-2024 12+ covid vaccine.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Computerised tomogram, Scan with contrast, Urine analysis
Clinical narrative: Severe abdominal pain. Had to go to ER in pain - they took extensive testing. Saw surgeon today. Encouraged me to report
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Headache, Myalgia, Pain, Paraesthesia
Clinical narrative: tingling, mental confusion, headaches, muscle pain, soreness
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Nausea, Vomiting
Clinical narrative: Shortness of breath, feels heaviness in her chest, diarrhea, vomiting,,  nausea
Age: 7.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: NO ADVERSE EVENT, PATIENT WAS GIVEN VACCINE EARLY. NO ADVERSE OUTCOME TO DATE
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Myalgia
Clinical narrative: right arm bursitis and muscle pain
Age: 67.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Cerebellar stroke, Ischaemic stroke, Occipital lobe stroke, Visual field defect
Clinical narrative: Peripheral vision loss 10 days after vaccine - 12/14/2023.   Acute/Subacute Ischemic Left occipital/Left cerebellar stroke - 12/18/2023
Age: 0.5
Sex: F
Vaccine: FLU4
Symptoms: Cyanosis, Sleep apnoea syndrome
Clinical narrative: Received flu vaccine 3/21/23. That night had episodes where she stopped breathing. Mother noted her lip turning blue. Mother had to shake her to help her recover. These episodes occurred x 3 that day. Mother stayed up the entire night with the baby.
Age: 2.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Expired product administered
Clinical narrative: THE HAVRIX VACCINE (HEPATITIS A) THAT WAS GIVEN ON 12/12/2023 HAD EXPIRED ON 12/07/2023.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: AT CHECK IN MOM INITIALLY REGISTERED CHILD WITH INCORRECT YEAR OF BIRTH AS 2018 INSTEAD OF 2019, WHEN CONFIRMED IN CHECK IN .  WHEN THIS NURSE CHECK DATABASE AFTER VACCINE GIVEN NOTED BIRTHDAY AS 2019.  6MO-4Y PFIZER DOSE GIVEN INSTEAD OF 5-11Y DOSE.  CALLED MOM X3, WAS UNABLE TO LEAVE VOICE MAIL.  EMAILED MOM, AWAITING RESPONSE.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Throat clearing, Tic
Clinical narrative: same night started to have facial tics (blinking) and verbal tics (clearing throat) frequently. persistent until now (10 months now)
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Pain in extremity
Clinical narrative: muscle pain traveling across her arm for more than 2 months .
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: gave patient extra does of Covid vaccine- no reaction
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-related death on 5/10/23
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Hypoaesthesia, Myalgia, Pain, Paraesthesia
Clinical narrative: headache, muscle ache, pain with numbness and tingling
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: significant redness, swelling and pain at injection site
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, HEPA, PNC15
Symptoms: Excessive eye blinking
Clinical narrative: Two days after last visit pt started blinking a lot.   Blinking appears to be getting worse.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was given 4 days past the Must Use Before Date, Dec 13, 2023
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient reported redness at the injection site that was hot to the touch and itchy. She reported the reaction initially to her PCP 12/18/2023. She advised her to keep monitoring the area, and if it spread to let her know. Patient didn't take anything for the reaction.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Covid-related death on 12/4/23
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: After injection patient complained of swelling, redness and bruising at inejction site.  Pt also had itching at injection site after vaccination. Patient said that the redness and itching has subsided but patient still has a dull ache at inejction site in arm and now over a month later patient said that she is experiencing numbness and tingling in left hand that sometimes extends up the arm towards the injection site. Patient did recently go to urgent care on friday 10/15 to adress numbness and tingling in hand and arm, but patient was referred back to PCP.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Paraesthesia
Clinical narrative: After injection patient complained of swelling, redness and bruising at inejction site.  Pt also had itching at injection site after vaccination. Patient said that the redness and itching has subsided but patient still has a dull ache at inejction site in arm and now over a month later patient said that she is experiencing numbness and tingling in left hand that sometimes extends up the arm towards the injection site. Patient did recently go to urgent care on friday 10/15 to adress numbness and tingling in hand and arm, but patient was referred back to PCP.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: Consumer did not receive third dose of GARDASIL 9 because she became pregnant.; No additional AE; This spontaneous prospective pregnancy report was received from a consumer and refers to a pregnant, female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with the first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact doses, formulations, lot #, expiration dates, sites and routes of administration were not provided) for prophylaxis. The patient did not receive third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as on an unknown date, she became pregnant (exposure during pregnancy). The patient's last menstrual period (LMP) and due date were not provided. At the time of report, pregnancy outcome was lost to F/U (as there was no contact details provided and no consent for contact) and fetal outcome was unknown. There was no additional information given and no additional adverse event reported (no adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Rash vesicular, Respiratory tract congestion
Clinical narrative: Reporter calling on behalf of Physician to report adverse event regarding VARIVAX.  Reporter reporting that the Physician stated a 1 year old female patient was administered their first dose of VARIVAX on 11/20/2023, and began to develop symptoms of "a Varicel; lesions greater than 50 but less than 200, cough, congestion, and the patient did not record a fever."; lesions greater than 50 but less than 200, cough, congestion, and the patient did not record a fever."; Information has been received from a physician via a company representative, referring to a 1 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-NOV-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, intramuscularly, 0.5 ml / two dose series, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 27-NOV-2023, the patient began to develop symptoms of "a Varicella like rash, lesions greater than 50 but less than 200 (units not provided)". On an unknown date in 2023, she also developed cough and congestion; it was also confirmed that the patient did not record a fever.  The reporting physician stated that the location of the "varicella like rash" was not provided. Additional, the physician saw the patient in their office on 01-DEC-2023 and reported that the patient has not resolved from their symptoms.    The causal relationship between Varicella like rash (lesions greater than 50 but less than 200 (units not provided)), cough and congestion and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; HCP calling to report T/E for PROQUAD that was administered.; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not provided.  On 14-DEC-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) (valid lot number X009731, expiration date 30-SEP-2024), administered for prophylaxis (dose number, frequency, and route of administration were not provided), after a temperature excursion of 14 degrees Fahrenheit (F) to 46 degrees F (36.57 degrees F) for 3 hours 0 minutes 0 seconds. The product did not have any prior excursions. The excursion occurred on 14-DEC-2023 (product storage error), the call was not because of a data logger. No adverse additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical assistant called to report MMR II inadvertently administered on 12/14/2023 which was caller states was expired on 12/04/2023.  Provided information per attached article.  No additional AE/no PQC.; This spontaneous report was received from 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-DEC-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHa) (M-M-R II) injection, unk, lot #W009105, expiration date: 04-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Pancreatic disorder, Unresponsive to stimuli
Clinical narrative: Patient was found unresponsive; severe anaphylactic reaction that led to pancreatic complications; severe anaphylactic reaction that led to pancreatic complications; This serious case was reported by a nurse via sales rep and described the occurrence of unresponsive to stimuli in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of shingrix vaccine on unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 hrs after receiving Shingrix, the patient experienced unresponsive to stimuli (Verbatim: Patient was found unresponsive) (serious criteria GSK medically significant), anaphylactic reaction (Verbatim: severe anaphylactic reaction that led to pancreatic complications) (serious criteria GSK medically significant) and pancreatic disorder (Verbatim: severe anaphylactic reaction that led to pancreatic complications). The outcome of the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder were not resolved.   It was unknown if the reporter considered the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder to be related to Shingrix.     It was unknown if the company considered the unresponsive to stimuli, anaphylactic reaction and pancreatic disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-DEC-2023 Patient was the mother of nurse practitioner. The reporter reported that the patient received 2nd dose of Shingrix vaccine. After 3 hours after 2nd dose patient found unresponsive. Patient had severe anaphylactic reaction that led to pancreatic complications. Issues were not resolved. The reporter agrees to follow up from GlaxoSmithKline.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: needle leaked; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 9MB95, expiry date 06-DEC-2025) for prophylaxis.   On 04-DEC-2023, the patient received Shingrix. On 04-DEC-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: needle leaked). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 4-DEC-2023 A nurse practitioner had an issue with administering Shingrix.  There was an error with the needle and syringe.  The syringe separated from the needle and needle leaked, and the vaccine was not fully administered, which led to accidental under dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Injection site rash
Clinical narrative: Received Shingrix on November 6th 2023 and the 2nd dose was administered on December 6th; Pain in the injection site after administration of 2nd dose; Rash in the injection site after administration of 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 557PZ, expiry date 30-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX).   On 06-DEC-2023, the patient received the 2nd dose of Shingrix. On 06-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Received Shingrix on November 6th 2023 and the 2nd dose was administered on December 6th). In DEC-2023, the patient experienced injection site pain (Verbatim: Pain in the injection site after administration of 2nd dose) and injection site rash (Verbatim: Rash in the injection site after administration of 2nd dose). The outcome of the injection site pain and injection site rash were not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain and injection site rash to be related to Shingrix.   It was unknown if the company considered the injection site pain and injection site rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-DEC-2023 The reporter reported that patient received a dose of Shingrix. The patient was not immunocompromised according to the pharmacy records.  After the administration of the 2nd dose of Shingrix, the patient developed rash and pain in the injection site that last until the day of reporting. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 40.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: the administration of Arexvy in pregnant patients; 40 year old patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number C9GB5, expiry date 30-MAY-2025) for prophylaxis.   On 12-DEC-2023, the patient received the 1st dose of Arexvy. On 12-DEC-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 40 year old patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: the administration of Arexvy in pregnant patients). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-DEC-2023 Pharmacist inquired about Arexvy and what information was available about the administration of Arexvy in pregnant patients. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient below recommended age received Arexvy, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On 12-Dec/-023, a nurse called to inform that earlier that day, a patient had received the 2nd dose of the Twinrix series; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old male patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis.   Previously administered products included Twinrix (on APR-2023, the patient received 1st dose of Twinrix).   On 12-DEC-2023, the patient received the 2nd dose of Twinrix. On 12-DEC-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: On 12-Dec/-023, a nurse called to inform that earlier that day, a patient had received the 2nd dose of the Twinrix series). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-DEC-2023 On 12-Dec-2023, a nurse called to inform that earlier that day, a patient had received the 2nd dose of the Twinrix series. The patient's1st dose had been administered on APR-2023, which led to lengthening of vaccination schedule.  The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Manger reported that an expired dose of Menveo (one vial) 0.5 ml was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number L542P, expiry date 31-OCT-2023) for prophylaxis.   On 11-DEC-2023, the patient received Menveo .5 ml. On 11-DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Manger reported that an expired dose of Menveo (one vial) 0.5 ml was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 13-DEC-2023 The reporter reported that an expired dose of Menveo (one vial) was administered to a patient, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Developed atrial fibrillation; This serious case was reported by a physician via sales rep and described the occurrence of atrial fibrillation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (intramuscular). On an unknown date, an unknown time after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Developed atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation to be related to Arexvy.   Additional Information: GSK receipt date: 13-DEC-2023 The physician reported that the patient was a normal electrocardiography the week before Arexvy vaccination. Following the vaccination, the patient had developed atrial fibrillation.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He received his first Shingrix dose in 2021 and his second in October 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received his first dose in 2021).   In OCT-2023, the patient received the 2nd dose of Shingrix. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: He received his first Shingrix dose in 2021 and his second in October 2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-DEC-2023 The patient self-reported this case. The reason for delay was unknown. Nothing else was reported. The reporter did not consent to follow-up. The patient received the 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Caller mentioned she felt mostly miserable with previous Moderna vaccines (did not specified what vaccines); she felt fevers, with the first one it was difficult she was driving her husband back and forth to the cancer hospital; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Caller mentioned she felt mostly miserable with previous Moderna vaccines (did not specified what vaccines)) and PYREXIA (she felt fevers, with the first one it was difficult she was driving her husband back and forth to the cancer hospital) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Cold and Sigmoidectomy (colon sigmoid partially removed for diverticulitis.). Previously administered products included for Arthritis: Cortisone shot (on the knees because of arthritis) in May 2023. Past adverse reactions to the above products included No adverse event with Cortisone shot. Concurrent medical conditions included Skin cancer (on the arm) since 2020, Breast cancer since 2017, Colon cancer since 1995 and Diverticulitis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Caller mentioned she felt mostly miserable with previous Moderna vaccines (did not specified what vaccines)) and PYREXIA (she felt fevers, with the first one it was difficult she was driving her husband back and forth to the cancer hospital). At the time of the report, FEELING ABNORMAL (Caller mentioned she felt mostly miserable with previous Moderna vaccines (did not specified what vaccines)) and PYREXIA (she felt fevers, with the first one it was difficult she was driving her husband back and forth to the cancer hospital) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. She got allergy shots, her allergist tested her in Jun-2023 or Apr-2023 for food or environmental allergens, but she was not allergic to anything. Patient stated that already received 5 or 6 doses of the Moderna COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-753406 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753406:Case for dose Spikevax 2023-2024