chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-B was administered 4 days after the expiration date; 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 5-day-old female patient who received HBV (Engerix B) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   On 22-MAY-2023, the patient received the 1st dose of Engerix B. On 22-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B was administered 4 days after the expiration date). The outcome of the expired vaccine used 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: 22-MAY-2023 Medical Assistant Supervisor stated that Engerix-B was administered 4 days after the expiration date. Consented to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: need to restart the regimen or is ok to get a second dose now; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a first Shingrix injection over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: need to restart the regimen or is ok to get a second dose now). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 Sales rep submitted the following for a physician. Physician wanted to know if a patient received a first Shingrix injection over a year ago, do they need to restart the regimen or is ok to get a second dose now. The reporter was unsure what the recommendation should be.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Expired dose 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 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 A medical assistant called to inform that on, an expired dose of Menveo was inadvertently administered to a patient, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo was inadvertently 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA677A, expiry date 30-APR-2023) for prophylaxis.   On 16-MAY-2023, the patient received Menveo. On 16-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo was inadvertently administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 The reporter was a medical assistant. The reporter did not consent to follow-up. The reporter informed that an expired dose of Menveo was inadvertently administered to a patient, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shorter than recommended interval; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) (batch number 2Y29Z, expiry date 12-JUL-2023) for prophylaxis.   Previously administered products included Havrix (1st dose received on an unknown date).   On 22-MAY-2023, the patient received the 2nd dose of Havrix. On 22-MAY-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Shorter than recommended interval). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 A public health nurse called in to report that a patient accidentally received a dose of Havrix before 6 months had elapsed since the first dose, which led to shortening of vaccinations schedule. Call was escalated to second line. Information about patient, vaccine and event were collected. The reporter consented to follow up. the vaccine administration facility is the same as primary reporter. The second line agent did not answer call.
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; pediatric dose of Engerix-B was given to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 66-year-old male patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 22-MAY-2023, the patient received Engerix B pediatric. On 22-MAY-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: pediatric dose of Engerix-B was given to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 22-MAY-2023 Nurse calls to report a pediatric dose of Engerix-B was given to an adult patient, which led to underdose and adult use of a child product. The reporter consented to follow up. Follow up via email agreed.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received the Shingrix liquid adjuvant only (unreconstituted dose); patient received the Shingrix liquid adjuvant only (unreconstituted dose); This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number L4472, expiry date 08-OCT-2023) for prophylaxis.   On 10-MAY-2023, the patient received the 1st dose of Shingrix. On 10-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received the Shingrix liquid adjuvant only (unreconstituted dose)) and inappropriate dose of vaccine administered (Verbatim: patient received the Shingrix liquid adjuvant only (unreconstituted dose)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Shingrix liquid adjuvant only (unreconstituted dose), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 86.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: patient who received a pediatric dose of Engerix-B back in January 17th 2023; Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 86-year-old patient who received HBV (Engerix B pediatric) (batch number 9PG49, expiry date 28-DEC-2024) for prophylaxis.   On 17-JAN-2023, the patient received Engerix B pediatric. On 17-JAN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: patient who received a pediatric dose of Engerix-B back in January 17th 2023) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter did not provide patient initials and gender.  The reporter asked for recommendations on this situation. The reporter declined permission to store her contact information in our database. The reporter asked for information about a patient who received a pediatric dose of Engerix-B, which led to underdose and inappropriate age at vaccine administration.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administration of an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 22-MAY-2023, the patient received Engerix B. On 22-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2023 The reporter asked for recommendations on this situation. The reporter consented to follow up. The patient administered expired dose of Engerix-B, which led to expired vaccine used.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Arthritis, Chronic respiratory failure, Hypotension, Hypoxia
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 ARTHRITIS OF LEFT KNEE  PERIPHERAL NEUROPATHY 11/16/2022 ARTHRITIS OF LEFT KNEE  HYPOTENSION 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE RESPIRATORY FAILURE 2/21/2023 ARTHRITIS OF LEFT KNEE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 ARTHRITIS OF LEFT KNEE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 ARTHRITIS OF LEFT KNEE  HYPOXIA 8/1/2022 ARTHRITIS OF LEFT KNEE  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 CANCER METASTATIC TO BONE  PERIPHERAL NEUROPATHY 11/16/2022 CANCER METASTATIC TO BONE  HYPOTENSION 1/5/2023 CANCER METASTATIC TO BONE  ACUTE RESPIRATORY FAILURE 2/21/2023 CANCER METASTATIC TO BONE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 CANCER METASTATIC TO BONE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 CANCER METASTATIC TO BONE  HYPOXIA 8/1/2022 CANCER METASTATIC TO BONE
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Metastases to bone, Neoplasm malignant, Neuropathy peripheral, Respiratory failure
Clinical narrative: Moderna vaccine was administered outside of clinic- reported by patient ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 ARTHRITIS OF LEFT KNEE  PERIPHERAL NEUROPATHY 11/16/2022 ARTHRITIS OF LEFT KNEE  HYPOTENSION 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE RESPIRATORY FAILURE 2/21/2023 ARTHRITIS OF LEFT KNEE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 ARTHRITIS OF LEFT KNEE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 ARTHRITIS OF LEFT KNEE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 ARTHRITIS OF LEFT KNEE  HYPOXIA 8/1/2022 ARTHRITIS OF LEFT KNEE  IDIOPATHIC PERIPHERAL NEUROPATHY 12/6/2022 CANCER METASTATIC TO BONE  PERIPHERAL NEUROPATHY 11/16/2022 CANCER METASTATIC TO BONE  HYPOTENSION 1/5/2023 CANCER METASTATIC TO BONE  ACUTE RESPIRATORY FAILURE 2/21/2023 CANCER METASTATIC TO BONE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE 1/5/2023 CANCER METASTATIC TO BONE  RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/24/2023 CANCER METASTATIC TO BONE  HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/7/2023 CANCER METASTATIC TO BONE  HYPOXIA 8/1/2022 CANCER METASTATIC TO BONE
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pt received dose on 5/6/23.  Presented back to pharmacy 5/24/23, complaining of swelling and tenderness in arm below immunization site as well as redness and rash that has persisted since immunization occurred.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Dyspnoea, Influenza like illness, Sluggishness
Clinical narrative: Patient called Wednesday stating on Tuesday was having trouble breathing, very weak and no energy. Felt sluggish and flu like symptoms. Did not eat anything all day.
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Speech disorder
Clinical narrative: Patient called Wednesday stating on Tuesday was having trouble breathing, very weak and no energy. Felt sluggish and flu like symptoms. Did not eat anything all day.
Age: 69.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Expired product administered
Clinical narrative: no symptoms from patient. dose of twinrix expired 05/20/2023. provider informed. incident report made. patient informed.
Age: 5.0
Sex: M
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Twinrix
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Discontinued product administered, Fatigue
Clinical narrative: Patient came in for Covid Booster on 4/27/2023 and received Comirnaty (mono-valent) injection rather than Bi-Valent injection that was due. Patient had previously received Moderna products for original series and boosters in past with no issues. Patient did report feeling more fatigued for 1 to 2 weeks after administration of Comirnaty. No other issues reported. Patient will be re-vaccinated with Moderna Bi-Valent product per vaccine schedule.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: headache, naseau, light headedness
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient came in for 1st COVID vaccine on 5/15/2023 and given Moderna 0.25 mL (6 mos to < 6 y/o)(Bivalent Formulation)(PINK CAP). After administration it was determined pt should have been given Moderna 0.25 mL  from the vial with blue cap..
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall, Head injury
Clinical narrative: Within 5 minutes after the vaccine administration, the patient fell dizzy and slipped from the exam table to the floor, landed on her bottom and her head hit the floor.  Her dad was the only one in the room other than the patient.  I went in immediately,  and saw the patient lying on the floor. She was able to open her eyes.  Her radial pulse was well felt.  BP 100/70 mm Hg.  Oxygen saturation was 99%.  She was responding well to questions.  She was observed for 2 hours and sent home.  Her exam was normal.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anaemia, Arthralgia, Blood thyroid stimulating hormone, Differential white blood cell count, Fatigue
Clinical narrative: Onset of arthralgia within 5 days of vaccine, fatigue and mild anemia noted on ER visit 9/21/2022
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count, Metabolic function test, Microscopy, Thyroxine free, Troponin I
Clinical narrative: Onset of arthralgia within 5 days of vaccine, fatigue and mild anemia noted on ER visit 9/21/2022
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urine analysis
Clinical narrative: Onset of arthralgia within 5 days of vaccine, fatigue and mild anemia noted on ER visit 9/21/2022
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Biopsy breast abnormal, Breast cancer female, Breast cancer stage I, Breast conserving surgery, Breast disorder female
Clinical narrative: On 11/7/2022, I had a routine mammogram. An anomaly was found in the right breast, so I was scheduled for a follow-up mammogram on 11/14/2022. The presence of an anomaly in the right breast was confirmed, and I underwent a biopsy of the right breast on 11/21/2022. On 11/22/2022, I was informed that I had stage I breast cancer. On 12/8/2022, I underwent an MRI of both breasts. On 12/15/2022, I underwent a SAVI SCOUT procedure. I then underwent a lumpectomy on 12/29/2022. Between 3/6/2023 and 3/27/2023, I underwent radiation treatment. Sometime in mid-April 2023, I began undergoing letrozole treatment, which I ended on 5/17/2023. The letrozole treatment was ended, because I didn't like the side effects. I plan to take a break from any breast cancer therapies for a month, and then I plan to start taking anastrozole on 6/16/2023.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging breast, Mammogram abnormal, Radiotherapy
Clinical narrative: On 11/7/2022, I had a routine mammogram. An anomaly was found in the right breast, so I was scheduled for a follow-up mammogram on 11/14/2022. The presence of an anomaly in the right breast was confirmed, and I underwent a biopsy of the right breast on 11/21/2022. On 11/22/2022, I was informed that I had stage I breast cancer. On 12/8/2022, I underwent an MRI of both breasts. On 12/15/2022, I underwent a SAVI SCOUT procedure. I then underwent a lumpectomy on 12/29/2022. Between 3/6/2023 and 3/27/2023, I underwent radiation treatment. Sometime in mid-April 2023, I began undergoing letrozole treatment, which I ended on 5/17/2023. The letrozole treatment was ended, because I didn't like the side effects. I plan to take a break from any breast cancer therapies for a month, and then I plan to start taking anastrozole on 6/16/2023.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported, this is a report to inform patient received a vaccine that was adminstered beyond the use date. Vial was adminstered after the 30 days under refrigeration.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported. This report is to inform patient received the vaccine beyond its use date. Patient received the vaccine after the 30 days stored under refrigeration. Vial moved to fridge on 4/3/23 and patient received vaccine on 5/9/23.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported. This is inform that patient received a second booster of the moderna bivalent after its beyond use date. Vial was moved to fridge on 4/3/2023 and patient received vaccine on 5/10/23
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event reported. This is inform that patient received a first booster of the moderna bivalent after its beyond use date. Vial was moved to fridge on 4/3/2023 and patient received vaccine on 5/12/23
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Felt like I had the flu for a day: achy, feverish
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Mom reports inflammation at vaccine injection site x few days. Examined 5/24/2023 nothing R erythema, swelling and tenderness at R anterior thigh (~quarter sized). Rx for Cefdinir and advised warm compresses and ibuprofen PRN.
Age: 2.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Wrong product administered
Clinical narrative: DTAP-IPV, MMRV WERE ADMINISTERED INADVERTEDLY.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthma, Blood pressure increased, Condition aggravated
Clinical narrative: I have had blood pressure spikes and terrible arthritis ever sincemy Moderna booster..my Cardiologist keeps trying to find a script that will help with the spikes therse are the 5 I hve been on in the llast six months and my reactions 10/22 Cardevol 6.25 mg=pretty bad asthma attack almost had to go to emergency but I toughed it out,...11/22Verapamil. 40 mg.my legs swelled up like telephone poles and took me 6 week  or so of diruetics to get them back down. 2/23,Chlorathidone50 mg  4 days and my stools were pale yellow Obviously killing my liver...4/23. Doazosin mesylate.4 mg.so dizzy I couldnt walk down the  hall without  hands on the walls.5/23 Isosorbide Dinitrite 10 mg ONE dose gave me a horrid headache and doubled my arthritis pain..still dealing with  the arthritis 2 weeks later.  While I am sensative to  drugs I take several with NO side effects including Losartin Metoprolos Clonodine, Ventolin inhaler, no labs but you should be aware of my responses.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diuretic therapy, Dizziness, Faeces discoloured, Gait disturbance, Headache
Clinical narrative: I have had blood pressure spikes and terrible arthritis ever sincemy Moderna booster..my Cardiologist keeps trying to find a script that will help with the spikes therse are the 5 I hve been on in the llast six months and my reactions 10/22 Cardevol 6.25 mg=pretty bad asthma attack almost had to go to emergency but I toughed it out,...11/22Verapamil. 40 mg.my legs swelled up like telephone poles and took me 6 week  or so of diruetics to get them back down. 2/23,Chlorathidone50 mg  4 days and my stools were pale yellow Obviously killing my liver...4/23. Doazosin mesylate.4 mg.so dizzy I couldnt walk down the  hall without  hands on the walls.5/23 Isosorbide Dinitrite 10 mg ONE dose gave me a horrid headache and doubled my arthritis pain..still dealing with  the arthritis 2 weeks later.  While I am sensative to  drugs I take several with NO side effects including Losartin Metoprolos Clonodine, Ventolin inhaler, no labs but you should be aware of my responses.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I have had blood pressure spikes and terrible arthritis ever sincemy Moderna booster..my Cardiologist keeps trying to find a script that will help with the spikes therse are the 5 I hve been on in the llast six months and my reactions 10/22 Cardevol 6.25 mg=pretty bad asthma attack almost had to go to emergency but I toughed it out,...11/22Verapamil. 40 mg.my legs swelled up like telephone poles and took me 6 week  or so of diruetics to get them back down. 2/23,Chlorathidone50 mg  4 days and my stools were pale yellow Obviously killing my liver...4/23. Doazosin mesylate.4 mg.so dizzy I couldnt walk down the  hall without  hands on the walls.5/23 Isosorbide Dinitrite 10 mg ONE dose gave me a horrid headache and doubled my arthritis pain..still dealing with  the arthritis 2 weeks later.  While I am sensative to  drugs I take several with NO side effects including Losartin Metoprolos Clonodine, Ventolin inhaler, no labs but you should be aware of my responses.
Sex: U
Vaccine: COVID19
Symptoms: Acute pulmonary oedema, Acute respiratory failure, Aortic valve stenosis, Condition aggravated, Dialysis
Clinical narrative: Follow up Report: acute hypoxic respiratory failure / flash pulmonary edema Admission Date: 5/1/2023 Discharge Date: 5/12/2023 Patient enrolled in the Janssen study. Subject received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 Patient presented to study site via hospital transfer with a chief complaint of Shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that subject woke from their sleep and complained of severe shortness of breath on 4/30/2023, It was at that time the patient called EMS 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 was admitted to ICU for shock and he was transiently on pressors.  Both the pressors and ventilator have been weaned off and the patient transferred to the PCU. Given his echocardiogram was concerning for a vegetation, infectious disease was consulted for management of endocarditis. Patient was started on ceftriaxone and Vancomycin and will continue to take IV abx at home for 6 weeks.  On 5/3/2023 TEE confirmed a large highly mobile echodensity attached to the non coronary cusp of the aortic valve.  Additional findings support moderate to severe aortic valve stenosis.  Blood cultures have been negative to date.  Inflammatory markers are elevated including CRP and procalcitonin. 5/5/20203: Cardiology was consulted and patient received interventional cardiology aspiration procedure and a CT head angiogram to rule out bleeding prior to the cardiac procedure. Patient was also found to have bilateral pleural effusion with partial collapse of the right lower on CT abdomen which correlates to his increase oxygen demand 5/4. US thoracentesis drained 1.7L from the left lung. Patient respiratory status improved and no longer require oxygen after the left thoracentesis.  The patient will be sent home with ceftriaxone daily and vancomycin Tuesday Thursday and Saturday after dialysis. Patient will follow up with the Infectious Disease team and their office upon discharge. Patient will be set up with outpatient home health for education on home infusions for his antibiotics. I updated the patient's daughter and patient's wife at the bedside prior to discharge. All medications were reconciled prior to discharge patient is in agreement with the current plan.  Outpatient referral for Urology for his renal lesions that were found incidentally on CT scan. This was communicated to the renal transplant team as well. Patient was assessed as severely malnourished during this hospitalization based upon the ASPEN criteria. Outpatient follow-up: Discharged 5/12/2023 to home health care service. Staff has given causality / relationship assessment as not study related
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Endocarditis, Endotracheal intubation, Intensive care, Malnutrition
Clinical narrative: Follow up Report: acute hypoxic respiratory failure / flash pulmonary edema Admission Date: 5/1/2023 Discharge Date: 5/12/2023 Patient enrolled in the Janssen study. Subject received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 Patient presented to study site via hospital transfer with a chief complaint of Shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that subject woke from their sleep and complained of severe shortness of breath on 4/30/2023, It was at that time the patient called EMS 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 was admitted to ICU for shock and he was transiently on pressors.  Both the pressors and ventilator have been weaned off and the patient transferred to the PCU. Given his echocardiogram was concerning for a vegetation, infectious disease was consulted for management of endocarditis. Patient was started on ceftriaxone and Vancomycin and will continue to take IV abx at home for 6 weeks.  On 5/3/2023 TEE confirmed a large highly mobile echodensity attached to the non coronary cusp of the aortic valve.  Additional findings support moderate to severe aortic valve stenosis.  Blood cultures have been negative to date.  Inflammatory markers are elevated including CRP and procalcitonin. 5/5/20203: Cardiology was consulted and patient received interventional cardiology aspiration procedure and a CT head angiogram to rule out bleeding prior to the cardiac procedure. Patient was also found to have bilateral pleural effusion with partial collapse of the right lower on CT abdomen which correlates to his increase oxygen demand 5/4. US thoracentesis drained 1.7L from the left lung. Patient respiratory status improved and no longer require oxygen after the left thoracentesis.  The patient will be sent home with ceftriaxone daily and vancomycin Tuesday Thursday and Saturday after dialysis. Patient will follow up with the Infectious Disease team and their office upon discharge. Patient will be set up with outpatient home health for education on home infusions for his antibiotics. I updated the patient's daughter and patient's wife at the bedside prior to discharge. All medications were reconciled prior to discharge patient is in agreement with the current plan.  Outpatient referral for Urology for his renal lesions that were found incidentally on CT scan. This was communicated to the renal transplant team as well. Patient was assessed as severely malnourished during this hospitalization based upon the ASPEN criteria. Outpatient follow-up: Discharged 5/12/2023 to home health care service. Staff has given causality / relationship assessment as not study related
Sex: U
Vaccine: COVID19
Symptoms: Mechanical ventilation, Platelet count, Pleural effusion, Pneumothorax, Renal disorder
Clinical narrative: Follow up Report: acute hypoxic respiratory failure / flash pulmonary edema Admission Date: 5/1/2023 Discharge Date: 5/12/2023 Patient enrolled in the Janssen study. Subject received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 Patient presented to study site via hospital transfer with a chief complaint of Shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that subject woke from their sleep and complained of severe shortness of breath on 4/30/2023, It was at that time the patient called EMS 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 was admitted to ICU for shock and he was transiently on pressors.  Both the pressors and ventilator have been weaned off and the patient transferred to the PCU. Given his echocardiogram was concerning for a vegetation, infectious disease was consulted for management of endocarditis. Patient was started on ceftriaxone and Vancomycin and will continue to take IV abx at home for 6 weeks.  On 5/3/2023 TEE confirmed a large highly mobile echodensity attached to the non coronary cusp of the aortic valve.  Additional findings support moderate to severe aortic valve stenosis.  Blood cultures have been negative to date.  Inflammatory markers are elevated including CRP and procalcitonin. 5/5/20203: Cardiology was consulted and patient received interventional cardiology aspiration procedure and a CT head angiogram to rule out bleeding prior to the cardiac procedure. Patient was also found to have bilateral pleural effusion with partial collapse of the right lower on CT abdomen which correlates to his increase oxygen demand 5/4. US thoracentesis drained 1.7L from the left lung. Patient respiratory status improved and no longer require oxygen after the left thoracentesis.  The patient will be sent home with ceftriaxone daily and vancomycin Tuesday Thursday and Saturday after dialysis. Patient will follow up with the Infectious Disease team and their office upon discharge. Patient will be set up with outpatient home health for education on home infusions for his antibiotics. I updated the patient's daughter and patient's wife at the bedside prior to discharge. All medications were reconciled prior to discharge patient is in agreement with the current plan.  Outpatient referral for Urology for his renal lesions that were found incidentally on CT scan. This was communicated to the renal transplant team as well. Patient was assessed as severely malnourished during this hospitalization based upon the ASPEN criteria. Outpatient follow-up: Discharged 5/12/2023 to home health care service. Staff has given causality / relationship assessment as not study related
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder, Shock, Sleep disorder, Therapeutic aspiration
Clinical narrative: Follow up Report: acute hypoxic respiratory failure / flash pulmonary edema Admission Date: 5/1/2023 Discharge Date: 5/12/2023 Patient enrolled in the Janssen study. Subject received study medication (Janssen ad26.CoV2. vaccine) on 10/17/2022 Patient presented to study site via hospital transfer with a chief complaint of Shortness of breath of acute hypoxic respiratory failure Patient's spouse reported that subject woke from their sleep and complained of severe shortness of breath on 4/30/2023, It was at that time the patient called EMS 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 was admitted to ICU for shock and he was transiently on pressors.  Both the pressors and ventilator have been weaned off and the patient transferred to the PCU. Given his echocardiogram was concerning for a vegetation, infectious disease was consulted for management of endocarditis. Patient was started on ceftriaxone and Vancomycin and will continue to take IV abx at home for 6 weeks.  On 5/3/2023 TEE confirmed a large highly mobile echodensity attached to the non coronary cusp of the aortic valve.  Additional findings support moderate to severe aortic valve stenosis.  Blood cultures have been negative to date.  Inflammatory markers are elevated including CRP and procalcitonin. 5/5/20203: Cardiology was consulted and patient received interventional cardiology aspiration procedure and a CT head angiogram to rule out bleeding prior to the cardiac procedure. Patient was also found to have bilateral pleural effusion with partial collapse of the right lower on CT abdomen which correlates to his increase oxygen demand 5/4. US thoracentesis drained 1.7L from the left lung. Patient respiratory status improved and no longer require oxygen after the left thoracentesis.  The patient will be sent home with ceftriaxone daily and vancomycin Tuesday Thursday and Saturday after dialysis. Patient will follow up with the Infectious Disease team and their office upon discharge. Patient will be set up with outpatient home health for education on home infusions for his antibiotics. I updated the patient's daughter and patient's wife at the bedside prior to discharge. All medications were reconciled prior to discharge patient is in agreement with the current plan.  Outpatient referral for Urology for his renal lesions that were found incidentally on CT scan. This was communicated to the renal transplant team as well. Patient was assessed as severely malnourished during this hospitalization based upon the ASPEN criteria. Outpatient follow-up: Discharged 5/12/2023 to home health care service. Staff has given causality / relationship assessment as not study related
Sex: U
Vaccine: COVID19
Symptoms: Acute kidney injury, Aspergillus test negative, Atypical pneumonia, Bacterial test negative, Blood creatinine increased
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Sex: U
Vaccine: COVID19
Symptoms: Blood culture negative, Bronchoscopy, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Sex: U
Vaccine: COVID19
Symptoms: Culture negative, Cytomegalovirus test negative, Dyspnoea, Fungal test negative, Influenza virus test
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Sex: U
Vaccine: COVID19
Symptoms: Laboratory test normal, Legionella test, Lung consolidation, Lung opacity, Mycobacterium test negative
Clinical narrative: Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.