chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events; receiving the vaccines post-temperature excursion with no adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old female patient who received the HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 18-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) vaccine (lot: U026802; exp: 03-Nov-2023) via intramuscular route in left arm for prophylactic vaccination post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events (product storage error) (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events and was Unknown for the event receiving the vaccines post-temperature excursion with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion of pentacel vaccine as temperature reached to negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; patient received pentacel post-temperature excursion with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA137908, 2023SA138048 and 2023SA136956.  This case involves an unknown age male patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] post-temperature excursion with temperature reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included Rototec.  On 18-Apr-2023, the patient received a 0.5 ml dose (frequency: once) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot: UJ753ABA; expiry date: 16-Sep-2023; strength: standard) via intramuscular route in the left thigh for Immunization.  On 18-Apr-2023 the temperature excursion of pentacel reached to negative -40F degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and patient received pentacel post-temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  It was reported, "Human Error: UNKNOWN Does extended stability data cover the excursion? No PRODUCT UNOPENED Caller wanted to know if products were given to a patient would they need to call and revaccinate. The caller reported that since the excursion 3-patients received doses of the vaccines; that 2-of the 3-patients received both DAPTACEL and ACTHIB post excursion; and 1-patient received PENTACEL post excursion."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired menactra was administered to a patient, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old female patient who had an expired menactra was administered to a patient, with no reported adverse event after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-May-2023, the patient received 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U7273BA , Expiration Date: 24-Apr-2023 via intramuscular route in unknown administration site, strength for Immunization.  On 01-May-2023 the patient developed a non-serious event an expired menactra was administered to a patient, with no reported adverse event (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome:  Unknown for the event an expired menactra was administered to a patient, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events; patient given an expired quadracel with no reported adverse events; Initial information received on 02-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient and Is reported patient given an expired diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] and patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR VACCIN) for Immunisation.  On 26-Apr-2023, the patient received a DOSE 1 dose 0.5 ml of suspect Diphtheria-15/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5) Vaccine Suspension for injection expiry date: 01-Apr-2023 lot C5862BA via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  On 26-APR-2023 at 9:55 the patient developed a non-serious patient given an expired quadracel with no reported adverse events (expired product administered) and at 11:24 patient given an expired quadracel / after giving the expired product, they repeated the dose with no reported adverse events (extra dose administered) latency on the same day.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered ACTHIB vaccine that was expired to a patient with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown age and gender who was administered HIB (PRP/T) vaccine [ACT-HIB] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, HIB (PRP/T) vaccine [ACT-HIB] vaccine Powder and solvent for solution for injection (batch/lot number: UJ677AAA; expiry date: 07-Apr-2023; strength, dose, route: unknown) that was expired was administered to a patient in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day)  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 66.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Erythema, Infection, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient called on 5/4/23 to let us know he had experienced an adverse reaction to the prevnar vaccine. He states he went home after he was vaccinated and felt soreness and saw redness on his arm. He was not too worried about it. Second day he still had soreness, swelling, and red and warm, continued to third day. After third day he went to doctor who told him it was an infection and prescribed him an antibiotic (amoxicillin). It has been 8 days patient is still experiencing symptoms although he states it has lessened today (8th day).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Bladder cancer, Chills, Neoplasm malignant, Pyrexia
Clinical narrative: Chills, fever, arythmias
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose of Shingrix administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 08-APR-2023) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. In APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Shingrix administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-APR-2023 The pharmacist called to inform that it was possible that earlier that day, an expired dose of Shingrix had been administered to a patient. The Vaccine Administration Facility was the same as primary reporter. Consented to follow up. The patient received expired dose of Shingrix vaccine, which led to expired vaccine used.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Injection site rash, Injection site urticaria, Oxygen saturation decreased, Pyrexia
Clinical narrative: Oxygen dropped into the mid to upper 80's, fever, rash and hives at injection site, extremely heavy menstrual cycles beginning a little over a month after the first dose of the vaccine. Menstrual cycles are the worst they have ever been since getting the vaccine and the extreme bleeding has not resolved over a year later.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came in on 5-1-23 she went to the doctor and doctor said she has a hematoma due to site of injection being low
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient came in on 5-1-23 she went to the doctor and doctor said she has a hematoma due to site of injection being low
Age: 93.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 74.0
Sex: F
Vaccine: TDAP
Symptoms: Arthropathy, Asthenia, Fall, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: PT FELL UPON LEAVING IMMUNIZATION ROOM BUT STATES IT HAD NOTHING TO DO WITH IMMUNIZATIONS.HER KNEE GAVE OUT, WHICH IT IS PRONE TO DOING ACCORDING TO THE PATIENT AND HER SISTER-IN-LAW, WHO CAME TO PICK HER UP. THIS FORM REQUIRED REACTION TYPE:CHOSE REDNESS-Mild, Systemic: Weakness-Mild
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Weakness-Medium, Additional Details: pt came to pharmacy on 5/1/2023. on her left upper arm has 1 big red rash at the injection side and two small rashes under. She complaint the rash just appeared today 5/1/2023 despite she had her prevnar 20 vaccine on 4/26/2023. Instructed her to do cold compress and see a doctor. Also, instructed her to call back to let us know about dx from her dr.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Lethargy, Pyrexia, Rash, Rash erythematous, Syncope
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Weakness-Medium, Additional Details: pt came to pharmacy on 5/1/2023. on her left upper arm has 1 big red rash at the injection side and two small rashes under. She complaint the rash just appeared today 5/1/2023 despite she had her prevnar 20 vaccine on 4/26/2023. Instructed her to do cold compress and see a doctor. Also, instructed her to call back to let us know about dx from her dr.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Weakness-Medium, Additional Details: pt came to pharmacy on 5/1/2023. on her left upper arm has 1 big red rash at the injection side and two small rashes under. She complaint the rash just appeared today 5/1/2023 despite she had her prevnar 20 vaccine on 4/26/2023. Instructed her to do cold compress and see a doctor. Also, instructed her to call back to let us know about dx from her dr.
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, Vaccination error
Clinical narrative: Error: Expired Product Administered-
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Erythema, Fall, Fatigue, Malaise
Clinical narrative: On Tuesday, April 25, 2023, I went to my doctor for my annual physical. Even though I had previously had PCV 13, she recommended that I get Prevnar 20. Of course my arm hurt. The next day I was very tired. Thursday morning I was still very tired. Seemed to feel better that afternoon, but then I felt ill. I was sitting at my kitchen table. I decided to go lie down. I stood up a few steps and felt woozy. My vision blurred and I saw flashes of light. I fell to my knees. After a few seconds, it was over. I felt fine except I did notice that my arm was slightly swollen, red and itchy. By May 1st, the redness and swelling were gone. The itching has not gone away completely, but has mostly subsided.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Peripheral swelling, Photopsia, Pruritus, Vision blurred
Clinical narrative: On Tuesday, April 25, 2023, I went to my doctor for my annual physical. Even though I had previously had PCV 13, she recommended that I get Prevnar 20. Of course my arm hurt. The next day I was very tired. Thursday morning I was still very tired. Seemed to feel better that afternoon, but then I felt ill. I was sitting at my kitchen table. I decided to go lie down. I stood up a few steps and felt woozy. My vision blurred and I saw flashes of light. I fell to my knees. After a few seconds, it was over. I felt fine except I did notice that my arm was slightly swollen, red and itchy. By May 1st, the redness and swelling were gone. The itching has not gone away completely, but has mostly subsided.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine Hep B was given to pt. All but one vaccine in the bag of Engerix Hep B expired in 2024 one given to pt expired 12/2022. Pt and provider was informed. Patient later deferred to health department to receive proper vaccinations, unknown follow up.
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient came in for Hep A and Hep B Vaccines. Patient was given both vaccines at time of visit. Patient was given Adult Hep A and accidently given Peds Hep B which is a half of dose less than the adult dose. Patient notified and will be back in 4 weeks his next dose.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was given expired Hep A vaccine expired on 2/6/23. Provider notified and he stated that he would notify the patient's parents of error once he reviewed the CDC recommendations.
Sex: U
Vaccine: COVID19
Symptoms: Acute pulmonary oedema, Acute respiratory failure, Blood creatinine increased, Blood urea normal, Central venous catheterisation
Clinical narrative: flash pulmonary edema / acute hypoxic respiratory failure patient enrolled in the Janssen study. Patient received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022 patient presented to site via hospital transfer with a chief complaint of shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that patient woke from their sleep and complained of severe shortness of breath on 4/30/2023, it was at that time the patient called 911 and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient remained intubated and was transferred to clinic for ongoing management of his conditions on 5/1/2023. The patient's spouse reported that prior to his episode of shortness of breath for the last few weeks patient has been feeling well. Spouse denies any recent fever, chills, nausea, vomiting, diarrhea, or night sweats. Spouse reports that the patient was in their usual state of mind for the past few days as well. Patient was intubated and sedated at facility 4/30/2023. Sedated: will d/c Propofol and fentanyl - Inotropes/Pressor infusions: Levophed - 0.03 currently - IJ triple-lumen catheter placed 05/01/2023. Pulmonary: X-ray 5/1/2023 showed bilateral pleural effusions left worse than right. Patient's O2 sats remained at 100% on lowest ventilator setting. Therapy. Patient's MRSA nares were positive. - Will trial extubation once patient wakes up - propofol and fentanyl has been discontinued. - Continue vancomycin and Zosyn for respiratory infection as source for sepsis. Gastrointestinal: - Place OG tube while patient intubated - All meds IV or through tube - Protonix 40 mg IV BID Renal: Patient has a history of renal transplant in 2013. He was started on HD during last hospitalization and was discharged on 3x weekly HD scheduled. - Consult TXP nephrology - Will likely Continue 3x weekly HD Schedule with additional sessions as needed to optimize volume status. - monitor daily RFP - f/u UA as urine cultures DVT Prophylaxis: Heparin Disposition: Admitted to ICU
Sex: U
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Dyspnoea, Endotracheal intubation, Gastrointestinal tube insertion, Haemodialysis
Clinical narrative: flash pulmonary edema / acute hypoxic respiratory failure patient enrolled in the Janssen study. Patient received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022 patient presented to site via hospital transfer with a chief complaint of shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that patient woke from their sleep and complained of severe shortness of breath on 4/30/2023, it was at that time the patient called 911 and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient remained intubated and was transferred to clinic for ongoing management of his conditions on 5/1/2023. The patient's spouse reported that prior to his episode of shortness of breath for the last few weeks patient has been feeling well. Spouse denies any recent fever, chills, nausea, vomiting, diarrhea, or night sweats. Spouse reports that the patient was in their usual state of mind for the past few days as well. Patient was intubated and sedated at facility 4/30/2023. Sedated: will d/c Propofol and fentanyl - Inotropes/Pressor infusions: Levophed - 0.03 currently - IJ triple-lumen catheter placed 05/01/2023. Pulmonary: X-ray 5/1/2023 showed bilateral pleural effusions left worse than right. Patient's O2 sats remained at 100% on lowest ventilator setting. Therapy. Patient's MRSA nares were positive. - Will trial extubation once patient wakes up - propofol and fentanyl has been discontinued. - Continue vancomycin and Zosyn for respiratory infection as source for sepsis. Gastrointestinal: - Place OG tube while patient intubated - All meds IV or through tube - Protonix 40 mg IV BID Renal: Patient has a history of renal transplant in 2013. He was started on HD during last hospitalization and was discharged on 3x weekly HD scheduled. - Consult TXP nephrology - Will likely Continue 3x weekly HD Schedule with additional sessions as needed to optimize volume status. - monitor daily RFP - f/u UA as urine cultures DVT Prophylaxis: Heparin Disposition: Admitted to ICU
Sex: U
Vaccine: COVID19
Symptoms: Intensive care, Mechanical ventilation, Pleural effusion, Respiratory tract infection, Sepsis
Clinical narrative: flash pulmonary edema / acute hypoxic respiratory failure patient enrolled in the Janssen study. Patient received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022 patient presented to site via hospital transfer with a chief complaint of shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that patient woke from their sleep and complained of severe shortness of breath on 4/30/2023, it was at that time the patient called 911 and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient remained intubated and was transferred to clinic for ongoing management of his conditions on 5/1/2023. The patient's spouse reported that prior to his episode of shortness of breath for the last few weeks patient has been feeling well. Spouse denies any recent fever, chills, nausea, vomiting, diarrhea, or night sweats. Spouse reports that the patient was in their usual state of mind for the past few days as well. Patient was intubated and sedated at facility 4/30/2023. Sedated: will d/c Propofol and fentanyl - Inotropes/Pressor infusions: Levophed - 0.03 currently - IJ triple-lumen catheter placed 05/01/2023. Pulmonary: X-ray 5/1/2023 showed bilateral pleural effusions left worse than right. Patient's O2 sats remained at 100% on lowest ventilator setting. Therapy. Patient's MRSA nares were positive. - Will trial extubation once patient wakes up - propofol and fentanyl has been discontinued. - Continue vancomycin and Zosyn for respiratory infection as source for sepsis. Gastrointestinal: - Place OG tube while patient intubated - All meds IV or through tube - Protonix 40 mg IV BID Renal: Patient has a history of renal transplant in 2013. He was started on HD during last hospitalization and was discharged on 3x weekly HD scheduled. - Consult TXP nephrology - Will likely Continue 3x weekly HD Schedule with additional sessions as needed to optimize volume status. - monitor daily RFP - f/u UA as urine cultures DVT Prophylaxis: Heparin Disposition: Admitted to ICU
Sex: U
Vaccine: COVID19
Symptoms: Staphylococcus test positive, White blood cell count increased
Clinical narrative: flash pulmonary edema / acute hypoxic respiratory failure patient enrolled in the Janssen study. Patient received study medication (Janssen ad26.CoV2.vaccine) on 10/17/2022 patient presented to site via hospital transfer with a chief complaint of shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that patient woke from their sleep and complained of severe shortness of breath on 4/30/2023, it was at that time the patient called 911 and ambulance took the patient to Medical Center, patient was admitted there with flash pulmonary edema was subsequently intubated and sedated for acute hypoxic respiratory failure on 4/30/2023. Patient remained intubated and was transferred to clinic for ongoing management of his conditions on 5/1/2023. The patient's spouse reported that prior to his episode of shortness of breath for the last few weeks patient has been feeling well. Spouse denies any recent fever, chills, nausea, vomiting, diarrhea, or night sweats. Spouse reports that the patient was in their usual state of mind for the past few days as well. Patient was intubated and sedated at facility 4/30/2023. Sedated: will d/c Propofol and fentanyl - Inotropes/Pressor infusions: Levophed - 0.03 currently - IJ triple-lumen catheter placed 05/01/2023. Pulmonary: X-ray 5/1/2023 showed bilateral pleural effusions left worse than right. Patient's O2 sats remained at 100% on lowest ventilator setting. Therapy. Patient's MRSA nares were positive. - Will trial extubation once patient wakes up - propofol and fentanyl has been discontinued. - Continue vancomycin and Zosyn for respiratory infection as source for sepsis. Gastrointestinal: - Place OG tube while patient intubated - All meds IV or through tube - Protonix 40 mg IV BID Renal: Patient has a history of renal transplant in 2013. He was started on HD during last hospitalization and was discharged on 3x weekly HD scheduled. - Consult TXP nephrology - Will likely Continue 3x weekly HD Schedule with additional sessions as needed to optimize volume status. - monitor daily RFP - f/u UA as urine cultures DVT Prophylaxis: Heparin Disposition: Admitted to ICU
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix given during 12mo well child visit instead of prevnar.
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE PULMONARY EMBOLISM
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Hypotension, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT FEMORAL VEIN HYPOTENSION 10/23/2022 &  11/5/2022  -- RECURRENCE OF SAME SYMPTOMS
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  NEUROPATHY
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypotension, Hypoxia, Pulmonary embolism
Clinical narrative: HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE HYPOXIA 9/4/2022,  9/28/2022,  12/9/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory failure, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM ACUTE HYPERCAPNIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE HYPOXIA 9/4/2022,  9/28/2022,  12/9/2022  --  RECURRENCE OF SAME SYMPTOMS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Fatigue, Headache
Clinical narrative: 12/15/22  I had bad head cold symptoms. I had a headache, sinus stuffiness, high fever and coughing. I was taking Claritin D, cough syrup, cough drops, Advil, Nyquil, and sinus medication. I took an at home COVID test which was positive. This went on for a week or week and a half.  I have been tired and have trouble getting my energy, still.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: 12/15/22  I had bad head cold symptoms. I had a headache, sinus stuffiness, high fever and coughing. I was taking Claritin D, cough syrup, cough drops, Advil, Nyquil, and sinus medication. I took an at home COVID test which was positive. This went on for a week or week and a half.  I have been tired and have trouble getting my energy, still.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Chronic respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: CHRONIC HYPERCAPNIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient did not mix the ActHIB component with the DTaP-IPV component prior to administration. Patient  was only given the DTap-IPV components of the vaccine
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE ST ELEVATION MI, RIGHT CORONARY ARTERY
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Muscular weakness, Nausea
Clinical narrative: Staff reports that around 6PM the child experienced weakness in the legs, dizziness, nausea and headache.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: throat hurts, P med
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: 3RD DOSE MODERNA COVID VACCINE GIVEN 11/11/21, #076C21A; 4TH DOSE MODERNA COVID VACCINE GIVEN 7/11/22, #049L21A.  pt resides in a SNF; positive COVID test 10/4/22; given molupirovir, eliquis, zinc, mucinex, ABX, vitamin C; pt feels well, no complaints, no SOB; DNR/DNI; pt passed away in the facility
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Blood iron decreased, Blood test abnormal, Blood thyroid stimulating hormone, Chest discomfort, Electrocardiogram normal
Clinical narrative: She was super shaky, she said it felt like her heart felt like it had butterflies in it, she went from hot to cold. We went it to the emergency room, where they ran a CBC blood test, a TSH blood test gave her fluids, ran an EKG. The blood test did reveal that she had low iron, the EKG came back normal. We were advised to follow up with her primary care physician, we have an appointment next week to see her.
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Feeling of body temperature change, Full blood count abnormal, Tremor
Clinical narrative: She was super shaky, she said it felt like her heart felt like it had butterflies in it, she went from hot to cold. We went it to the emergency room, where they ran a CBC blood test, a TSH blood test gave her fluids, ran an EKG. The blood test did reveal that she had low iron, the EKG came back normal. We were advised to follow up with her primary care physician, we have an appointment next week to see her.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring abnormal, Cardiac stress test normal, Chest discomfort, Dyspnoea, Echocardiogram
Clinical narrative: I experienced shortness of breath, pressure changes in my chest and I would feel like my heart was skipping beats. My heart would pause then start pounding real fast, I would wake up in the night due to the rhythm of my heartbeat, I have no cardiac history so this is a first for me. I saw a Cardiologist and he advised a two week monitor and once I was done with that and turned it in, I did a stress tread mill and came back to see the Cardiologist and it showed no blockages and everything was normal, but he said we need to check the two week monitor and it showed I was having irregular heart rates and PAT, the monitor showed I was having pauses in my heart and it was skipping beats.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Extrasystoles, Heart rate irregular, Sleep disorder
Clinical narrative: I experienced shortness of breath, pressure changes in my chest and I would feel like my heart was skipping beats. My heart would pause then start pounding real fast, I would wake up in the night due to the rhythm of my heartbeat, I have no cardiac history so this is a first for me. I saw a Cardiologist and he advised a two week monitor and once I was done with that and turned it in, I did a stress tread mill and came back to see the Cardiologist and it showed no blockages and everything was normal, but he said we need to check the two week monitor and it showed I was having irregular heart rates and PAT, the monitor showed I was having pauses in my heart and it was skipping beats.
Age: 73.0
Sex: F
Vaccine: PNC20, VARCEL
Symptoms: Oropharyngeal pain, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: Patient's daughter called to clinic on 5/5/23 at around 9am, reports patient is having a possible reaction from the vaccine. Fever started the morning of 5/3/23, Temperature on 5/5/23 was 103.F Starting vomiting  5/4/23 sore throat present denies shortness of breath or difficulty breathing Able to verbalize symptoms, no difficulty with speech Left arm is not swollen but is tender to touch Patient was sent to Local ED  no outcome at this time
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Respiratory failure, SARS-CoV-2 test positive, Troponin increased
Clinical narrative: 3RD MODERNA COVID VACCINE GIVEN 9/24/21, #045C21A; pt brought from facility to ED via EMS with unresponsiveness and respiratory failure; NRB; was positive for COVID; O2 supplementation; IV steroids; DNR with limited therapies; high troponin level; pt found deceased in the hospital
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: 3RD MODERNA COVID VACCINE GIVEN 9/24/21, #045C21A; pt brought from facility to ED via EMS with unresponsiveness and respiratory failure; NRB; was positive for COVID; O2 supplementation; IV steroids; DNR with limited therapies; high troponin level; pt found deceased in the hospital
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: COVID-RELATED DEATH, BREAKTHROUGH CASE
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis bacterial, Cardiac arrest, Septic shock
Clinical narrative: complicated by septic arthritis- septic shock- Cardiac Arrest 5/4
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Epilepsy
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, UNSPECIFIED
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There are two names with same birthday system. At the time of healthcheck, the child in our office was in our office for a 5 yr HC and information that was printed was the wrong child and our office didn't realize it until after the vaccine were given. So the child in our office received a 3rd dose of Kinrix, MMR, and Varicella after the 2nd dose was given on 9/8/22. I have called and spoke with CDC about any potential reactions, and they assured there are likely no adverse reactions to occur.
Age: 68.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: COVID-19, Chills, Nasal congestion, Oropharyngeal pain, Pain
Clinical narrative: 4/23/23 I had a very bad sore throat , aches, pains, chills and heavy chest and nasal congestion. I took an at home COVID test and it was negative. 4/25/23 I still tested negative, and symptoms were continuing. I went to the clinic and had a positive PCR COVID test. I did an at home COVID test on 4/30/23 and it was positive.  This morning, I took an At Home COVID test and it was negative.  I still have some of the symptoms, but they are better.
Age: 68.0
Sex: M
Vaccine: COVID19-2, UNK
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: 4/23/23 I had a very bad sore throat , aches, pains, chills and heavy chest and nasal congestion. I took an at home COVID test and it was negative. 4/25/23 I still tested negative, and symptoms were continuing. I went to the clinic and had a positive PCR COVID test. I did an at home COVID test on 4/30/23 and it was positive.  This morning, I took an At Home COVID test and it was negative.  I still have some of the symptoms, but they are better.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, COVID-19, Deafness unilateral, Dizziness, Magnetic resonance imaging
Clinical narrative: I had a breakthrough case of Covid-19 where I had nausea dizziness loss of hearing in right ear.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Nausea, SARS-CoV-2 test positive, Ultrasound scan, Vaccine breakthrough infection
Clinical narrative: I had a breakthrough case of Covid-19 where I had nausea dizziness loss of hearing in right ear.
Age: 23.0
Sex: F
Vaccine: COVID19-2, HEPA, TDAP
Symptoms: Chest discomfort, Chest pain, Painful respiration
Clinical narrative: Patient called on 5/5/23 stating she has an aching pain in her chest, especially at the end of an exhale.  Described and discomfort and ache in her chest.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Migraine, Photopsia, Pyrexia
Clinical narrative: I had a fever after receiving the vaccine for about day. I have a history of migraine headaches, but they do not happen very often. On 11/08/2022, I developed a migraine headache with seeing flashing lights. To relieve my discomfort, I took ADVIL. I had this migraine for three days. I have not had another migraine since then.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: 3RD MODERNA COVID VACCINE GIVEN 12/30/21, #066H21A; pt had a positive COVID test on 10/27/22; brought to ED 11/1/2022 with worsening SOB and productive cough; AHRF; during admission pt started to have dark tarry stools;   consult; ICU; vasopressors; pt's status worsened requiring intubation; multiple blood transfusions; worsening renal failure; transitioned to comfort measures and he passed away in the hospital
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured, General physical health deterioration, Intensive care, Melaena, Productive cough
Clinical narrative: 3RD MODERNA COVID VACCINE GIVEN 12/30/21, #066H21A; pt had a positive COVID test on 10/27/22; brought to ED 11/1/2022 with worsening SOB and productive cough; AHRF; during admission pt started to have dark tarry stools;   consult; ICU; vasopressors; pt's status worsened requiring intubation; multiple blood transfusions; worsening renal failure; transitioned to comfort measures and he passed away in the hospital
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Renal failure, SARS-CoV-2 test positive, Transfusion
Clinical narrative: 3RD MODERNA COVID VACCINE GIVEN 12/30/21, #066H21A; pt had a positive COVID test on 10/27/22; brought to ED 11/1/2022 with worsening SOB and productive cough; AHRF; during admission pt started to have dark tarry stools;   consult; ICU; vasopressors; pt's status worsened requiring intubation; multiple blood transfusions; worsening renal failure; transitioned to comfort measures and he passed away in the hospital
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired vaccine administered to the patient no reaction at this time
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine had expired from being pulled from the ultra freezer just the day before the vaccine was given.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Neuropathy peripheral, Symptom recurrence
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE GUILLAIN BARRE SYNDROME PERIPHERAL NEUROPATHY 1/20/23 -- RECURRENCE OF SAME SYMPTOMS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Lichen sclerosus, Melanocytic naevus
Clinical narrative: I was just going in to get a mole check and there was an area on my body that the skin looked different so she performed a biopsy where I was diagnosed with Lichen Sclerosus. I was prescribed Clobetasol Proprionate Ointment.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Abdominal pain upper, Fatigue, Oropharyngeal pain, Pharyngitis streptococcal, Pyrexia
Clinical narrative: On 02/2023 in the morning my son had sore throat, fever, stomach aches, and fatigued. I took him to the urgent care right way. At the urgent care they did a Strep Throat test which was positive. They prescribed him with amoxycillin for 10 days.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Streptococcus test positive
Clinical narrative: On 02/2023 in the morning my son had sore throat, fever, stomach aches, and fatigued. I took him to the urgent care right way. At the urgent care they did a Strep Throat test which was positive. They prescribed him with amoxycillin for 10 days.
Age: 81.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood pressure increased, Hypertension
Clinical narrative: Since the second vaccine my wife and I have noticed that our blood pressure has steadily been increasing. Our doctor has asked us to monitor our blood pressure every day so that we will know what it is and if it is increasing, staying steady or decreasing. I have noticed that my blood pressure stays consistent 140 to 150 but it has been spiking as high as in the 154 to the 180's.  My wife and I never had a problen with our blood pressure before the vaccines it was always 118 to 122, now it stays high.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, COVID-19 pneumonia, Condition aggravated, Death
Clinical narrative: pt had a positive COVID test 10/28/22; brought to hospital 11/4/22 with SOB; treated for septic shock, acute hypoxemic, hypercapnic respiratory failure secondary to COVID pneumonia, AFib with RVR; cardiology txmt; BiPAP, bronchodilators, mucolytics, steroids, ABX, Remdesivir; pt's condition worsened; uncontrolled A Fib; DNR with comfort measures only; transitioned to hospice and passed away in the hospital
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, General physical health deterioration, Hypoxia, Positive airway pressure therapy, Respiratory failure
Clinical narrative: pt had a positive COVID test 10/28/22; brought to hospital 11/4/22 with SOB; treated for septic shock, acute hypoxemic, hypercapnic respiratory failure secondary to COVID pneumonia, AFib with RVR; cardiology txmt; BiPAP, bronchodilators, mucolytics, steroids, ABX, Remdesivir; pt's condition worsened; uncontrolled A Fib; DNR with comfort measures only; transitioned to hospice and passed away in the hospital
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Septic shock
Clinical narrative: pt had a positive COVID test 10/28/22; brought to hospital 11/4/22 with SOB; treated for septic shock, acute hypoxemic, hypercapnic respiratory failure secondary to COVID pneumonia, AFib with RVR; cardiology txmt; BiPAP, bronchodilators, mucolytics, steroids, ABX, Remdesivir; pt's condition worsened; uncontrolled A Fib; DNR with comfort measures only; transitioned to hospice and passed away in the hospital
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, No adverse event, SARS-CoV-2 test positive, Thyroid function test
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 12/03/2022. I checked my provider website, and it was recommended to wait before seeking treatment. I went to my doctor due to extreme fatigue and they are checking my thyroid levels.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalized with covid; fully vaccinated
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Adjustment disorder with anxiety
Clinical narrative: Moderna vaccine was administered outside of office- reported by patient ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/19/2022 ADJUSTMENT DISORDER W ANXIETY