chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Superinfection
Clinical narrative: Patient was recently admitted to the hospital for acute decompensated heart failure and discharged and then subsequent to home.   On 12/28/22, patient was brought to the ED by EMS as family was concerned about patient's progressive fatigue. She was also found to be hypoxic on room air to the 80s, and so EMS administered supplemental O2. Patient reported she has been feeling short of breath. Notably, she had tested positive for COVID approximately a week prior. Repeat COVID PCR test performed on that day also resulted positive. Patient was admitted 12/28/22 - 1/4/23 for acute hypoxic respiratory failure secondary to COVID-19 pneumonia with superimposed bacterial pneumonia and acute on chronic diastolic heart failure. She initially required 2L O2, but was able to be weaned to room air.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Exposure to SARS-CoV-2, Malaise, SARS-CoV-2 test positive
Clinical narrative: Was around others who tested positive for COVID-19. Started feeling a cold come on, took a home COVID-19 test and it was positive. After reaching out to Telehealth doctor was prescribed PAXLOVID. Felt better after 5 days, then a week later I started feeling sick and tested positive for COVID-19 again.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Acute respiratory failure, Aortic arteriosclerosis, Asthma
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 11/18/2021 ATHEROSCLEROSIS OF AORTA J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 ATHEROSCLEROSIS OF AORTA I21.4 ACUTE NON ST ELEVATION MI 11/18/2021 ASTHMA, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 12/22/2021 ASTHMA, UNSPECIFIED
Age: 36.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: After vaccine forearm began to swell, egg shaped raised skin, warm to the touch and redness. Swelling measurements are 7in in length and 5 inches wide. Continuing to swell outside these dimensions.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site inflammation, Injection site pain
Clinical narrative: 100.5° fever for 36 hours Nausea Chills Tiredness Headache Pain at injection site  Inflammation at injection site Sore injection arm
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: 100.5° fever for 36 hours Nausea Chills Tiredness Headache Pain at injection site  Inflammation at injection site Sore injection arm
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine on moderna on 04/03/2023 that expired 04/01/2023. Patient was notified and is feeling well, advise patient to return in 4 weeks to restart covid vaccine primary series.
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: I experienced COVID-19 after my vaccine. My symptoms began in December 2022. I also had a telehealth call with a nurse practitioner who prescribed PAXLOVID which was very beneficial that minimized my symptoms. I took a COVID test but do not remember the date. I have fully recovered from my symptoms.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, Breast cancer female, Hypoxia, Respiratory failure
Clinical narrative: J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST R09.02 HYPOXIA 5/26/2022 FEMALE BREAST CANCER, UNSPECIFIED SITE OF LEFT BREAST J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 NONTRAUMATIC ACUTE KIDNEY INJURY R09.02 HYPOXIA 5/26/2022 NONTRAUMATIC ACUTE KIDNEY INJURY J96.00 ACUTE RESPIRATORY FAILURE 7/6/2022 HX OF LEFT BREAST CANCER J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/26/2022 HX OF LEFT BREAST CANCER J96.02 ACUTE HYPERCAPNIC RESPIRATORY FAILURE 7/6/2022 HX OF LEFT BREAST CANCER R09.02 HYPOXIA 5/26/2022 HX OF LEFT BREAST CANCER
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, SARS-CoV-2 test positive, Sneezing
Clinical narrative: I thought I a sinus infection. I had chills on my body. I had four days of consistent sneezing. After 10 days I went to see my doctor and he wanted to make sure I had no lung problems.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Cardiac failure congestive, Condition aggravated, Hypoxia
Clinical narrative: Janssen vaccine was administered outside of facility- reported by patient  HYPOXIA 11/2/2021 COVID-19 PNEUMONIA HYPOXIA 11/2/2021 CHF EXACERBATION, UNSPECIFIED
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Headache, Malaise, Pain
Clinical narrative: It started Sunday evening about 09:30PM. It lasted about 12 hours. I had chills and wasn't feeling well. I went to bed and got terrific body aches. I also had a very severe headache. The next morning, I started feeling much better. I called my doctor and told him I tested positive for COVID-19. He prescribed antibiotics and another medication. After I took the medication, I was completely normal after about two days.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: It started Sunday evening about 09:30PM. It lasted about 12 hours. I had chills and wasn't feeling well. I went to bed and got terrific body aches. I also had a very severe headache. The next morning, I started feeling much better. I called my doctor and told him I tested positive for COVID-19. He prescribed antibiotics and another medication. After I took the medication, I was completely normal after about two days.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination error, Wrong product administered
Clinical narrative: An error occurred. Pt was given Pfizer gray top 12+ Bivalent as first dose. Pt informed of error. will come back to complete series.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF RIGHT FEMORAL VEIN 5/20/2021 HX OF DVT
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Nausea, Vomiting
Clinical narrative: HYPOXIA     9/29/2022 NAUSEA AND VOMITING
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood creatinine normal, Blood glucose increased, Blood test abnormal, Cardiac stress test abnormal, Chest X-ray normal
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Echocardiogram abnormal, Electrocardiogram normal, Extrasystoles, Flushing
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Full blood count normal, Glomerular filtration rate normal, Headache, Heart rate irregular, Hypertension
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Laboratory test normal, Left ventricular hypertrophy, Liver function test normal, Metabolic function test normal
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: PCO2 decreased, PO2 decreased, Pain in extremity, Platelet count normal, Stress
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Troponin normal, Ultrasound Doppler normal, Ventricular extrasystoles
Clinical narrative: On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: brain seizure
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Cardiac failure congestive, Hypoxia, Pulmonary embolism
Clinical narrative: Pfizer vaccine was administered outside of entity - reported by patient  I21.4 ACUTE NON ST ELEVATION MI 2/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 2/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 2/27/2021 ACUTE NON ST ELEVATION MI I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/17/2021 ACUTE NON ST ELEVATION MI J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/17/2021 ACUTE NON ST ELEVATION MI R09.02 HYPOXIA 2/27/2021 ACUTE NON ST ELEVATION MI
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Expired product administered, No adverse event, SARS-CoV-2 test positive
Clinical narrative: Vaccine was put in refrigerator 74 day prior to being administered making it expired by 4 days.  Patient did not have any adverse effects from vaccine but did test positive for covid 3/25.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Chills, Cough, Pain, Pyrexia
Clinical narrative: I tested positive for Covid 19 on Jan 22, 2023 - home test.  +fever, +chills, cough, sinus congestion, +body aches,  I was treated with Lageviro capsules.  48 hours after starting the Lageviro - I started feeling markedly improved.  I am back to my health base line.  But, I still have decreased sense of taste/smell from the first time I had Covid 19 in November of 2020.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: I tested positive for Covid 19 on Jan 22, 2023 - home test.  +fever, +chills, cough, sinus congestion, +body aches,  I was treated with Lageviro capsules.  48 hours after starting the Lageviro - I started feeling markedly improved.  I am back to my health base line.  But, I still have decreased sense of taste/smell from the first time I had Covid 19 in November of 2020.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nasal congestion, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Low fever, headache, nasal and chest congestion
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Obstruction gastric, Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM 3/22/2022 GASTRIC OUTLET OBSTRUCTION
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test positive
Clinical narrative: Vaccine was in refrigerator for 74 days prior to administration making it expired by 4 days.  Patient did test positive for Covid 03/25/23.  Recommended re-vaccination 3 months after recovery from Covid.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine expired 4/1/23, was given 4/5/23
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: Shortly after I got my vaccine, I felt tired. I thought it was due to the vaccine, but then I developed sneezing, runny nose, and a cough. On 11/21/2022, I had body aches, sore throat, cough, and nasal congestion. That morning, I took a home antigen test and got a positive result. I called the number for my medical provider and reported that I had just tested positive for COVID-19. On 11/22/2022, I was prescribed Paxlovid. I immediately started the medication. By 11/25/2022, I tested negative and felt fine. I completed the course of Paxlovid and felt fine afterwards.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Shortly after I got my vaccine, I felt tired. I thought it was due to the vaccine, but then I developed sneezing, runny nose, and a cough. On 11/21/2022, I had body aches, sore throat, cough, and nasal congestion. That morning, I took a home antigen test and got a positive result. I called the number for my medical provider and reported that I had just tested positive for COVID-19. On 11/22/2022, I was prescribed Paxlovid. I immediately started the medication. By 11/25/2022, I tested negative and felt fine. I completed the course of Paxlovid and felt fine afterwards.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Malaise, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I had a runny nose, was achy and feverish. I was generally achy and just wanted to sleep. I reached to my doctor after testing positive for COVID-19. He prescribed PAXLOVID for my symptoms. I was already taking MOTRIN for the symptoms. I started taking the medication and my symptom improved. I was sleepy for several days. The head congestion and the fever did go away after a few days. I took about 9 days to completely recover from all my symptoms.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Somnolence
Clinical narrative: I had a runny nose, was achy and feverish. I was generally achy and just wanted to sleep. I reached to my doctor after testing positive for COVID-19. He prescribed PAXLOVID for my symptoms. I was already taking MOTRIN for the symptoms. I started taking the medication and my symptom improved. I was sleepy for several days. The head congestion and the fever did go away after a few days. I took about 9 days to completely recover from all my symptoms.
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute left ventricular failure, Blood sodium decreased, COVID-19, Cardiac failure congestive, Chest X-ray abnormal
Clinical narrative: 2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Dyspnoea, Electrocardiogram, Fatigue, Full blood count
Clinical narrative: 2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Haemoglobin decreased, Hyponatraemia, Metabolic function test, Oedema peripheral, Prohormone brain natriuretic peptide increased
Clinical narrative: 2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 RNA, SARS-CoV-2 test positive, Tachypnoea, Viral test negative
Clinical narrative: 2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
Age: 92.0
Sex: F
Vaccine: COVID19-2
Symptoms: White blood cell count normal
Clinical narrative: 2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Got Covid 12/26/2022 tested positive. Started PAXLOVID 12/30/2023. Really bad sinus congestion.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, PNC15
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Pentacel was not reconstituted. No adverse reaction just did not receive complete dose. Will repeat vaccination for full protection.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray abnormal, Fatigue, Headache, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had a sore throat, cold, headache, and fatigue. I went to a walk-in clinic, and they prescribed amoxicillin. After a week I still wasn't better, so I went back to the doctor and told me I needed to go the ER. I went to the ER, and they took and X-ray, and diagnosed me with Pneumonia. I was prescribed an antibiotic and a couple other things, but I am unable to recall the names of them. I went back for a checkup, and they did another X-Ray, and they found something on my lung that shouldn't have been there. For some reason I had developed this. I had to have another X-Ray 3 weeks later and this was still there, and they determined it is scar tissue from Pneumonia.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pneumonia, Pulmonary fibrosis
Clinical narrative: I had a sore throat, cold, headache, and fatigue. I went to a walk-in clinic, and they prescribed amoxicillin. After a week I still wasn't better, so I went back to the doctor and told me I needed to go the ER. I went to the ER, and they took and X-ray, and diagnosed me with Pneumonia. I was prescribed an antibiotic and a couple other things, but I am unable to recall the names of them. I went back for a checkup, and they did another X-Ray, and they found something on my lung that shouldn't have been there. For some reason I had developed this. I had to have another X-Ray 3 weeks later and this was still there, and they determined it is scar tissue from Pneumonia.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chest X-ray, Chest discomfort, Electrocardiogram T wave abnormal, Electrocardiogram abnormal
Clinical narrative: 3/1/2023 Started to feel like I was coming down with something. This became full sinus pressure in the face with headache, and runny nose. Tested with an At Home COVID-19 test, positive. Tele-visit with doctor who proscribed Paxlovid and to treat symptomatically. Treated with Nyquil and Dayquil. Symptoms stays the same until 3/4/23 and then symptoms gradually got better. Symptoms got much worse on 3/13/23 with a visit to Urgent care on 3/15 due to tightness of chest. Doctors there performed an EKG and a chest X-ray. Doctors noted some T-Wave abnormalities and referred to the Cardiologist. Cardiologist follow up has not happened yet at time of reporting. Participant reports symptoms getting better very gradually until 4/1/23.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Facial discomfort, Headache, Malaise, Paranasal sinus discomfort, Rhinorrhoea
Clinical narrative: 3/1/2023 Started to feel like I was coming down with something. This became full sinus pressure in the face with headache, and runny nose. Tested with an At Home COVID-19 test, positive. Tele-visit with doctor who proscribed Paxlovid and to treat symptomatically. Treated with Nyquil and Dayquil. Symptoms stays the same until 3/4/23 and then symptoms gradually got better. Symptoms got much worse on 3/13/23 with a visit to Urgent care on 3/15 due to tightness of chest. Doctors there performed an EKG and a chest X-ray. Doctors noted some T-Wave abnormalities and referred to the Cardiologist. Cardiologist follow up has not happened yet at time of reporting. Participant reports symptoms getting better very gradually until 4/1/23.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: 3/1/2023 Started to feel like I was coming down with something. This became full sinus pressure in the face with headache, and runny nose. Tested with an At Home COVID-19 test, positive. Tele-visit with doctor who proscribed Paxlovid and to treat symptomatically. Treated with Nyquil and Dayquil. Symptoms stays the same until 3/4/23 and then symptoms gradually got better. Symptoms got much worse on 3/13/23 with a visit to Urgent care on 3/15 due to tightness of chest. Doctors there performed an EKG and a chest X-ray. Doctors noted some T-Wave abnormalities and referred to the Cardiologist. Cardiologist follow up has not happened yet at time of reporting. Participant reports symptoms getting better very gradually until 4/1/23.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Myocarditis
Clinical narrative: myocarditis
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Injection site pain, Neck pain, Pain in jaw
Clinical narrative: Neck sharp, debilitating pain right side Jaw pain right side Shoulder pain right side Memory loss
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash erythematous
Clinical narrative: Red, painful arm, rash - lasted approximately 1.5 days. Patient took OTC pain relievers for treatment.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Aortic valve incompetence, Metastases to the mediastinum, Neoplasm malignant, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 AORTIC VALVE REGURGITATION ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/28/2021 CANCER METASTATIC TO MEDIASTINUM
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Myalgia
Clinical narrative: Menstruation is irregular; Unbearable muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0175) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EW0151), administration date: 07Apr2021, for COVID-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "not recovered", described as "Menstruation is irregular"; MYALGIA (non-serious), outcome "not recovered", described as "Unbearable muscle aches". The events "menstruation is irregular" and "unbearable muscle aches" required physician office visit. Therapeutic measures were taken as a result of menstruation irregular, myalgia.  Additional information: Patient reported she did not received other vaccine in four weeks. She stated that her menstruation was irregular since she got the vaccine. Additionally she had unbearable muscle aches. She worked in medical office. The adverse events resulted her to visit a doctor's office or other healthcare professional. Gynaecologist gave her treatment. It was unknown if she tested positive for COVID post vaccination.
Age: 31.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: patient received a dose of MMR II that was reconstituted with "sodium chloride or sterile water" instead of the Merck supplied diluent.; No adverse effects were reported; This spontaneous report has been received from pharmacist referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant human albumin (rHA)(M-M-R II) subcutaneous injection, lot number U031359 that had been verified to be a valid number with expiration date 07-OCT-2023, administered for prophylaxis (strength, specific dosage, vaccination scheme, route of administration and anatomical site of application were not provided) that was reconstituted with an unspecified brand of "sodium chloride or sterile water" instead of the Merck supplied diluent (product preparation error). No adverse effects were reported  This case was classified as non-valid due to lack of patient identifiers.  Follow-up information has been received from the pharmacist on 30-MAR-2023 referring an approximately 31-year-old male patient.  On 12-FEB-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant human albumin (rHA)(M-M-R II) subcutaneous injection, lot number U031359 that had been verified to be a valid number with expiration date 07-OCT-2023 (also reported as 6024220), administered subcutaneously in a left limb (strength, specific dosage, and vaccination scheme, were not provided). The patient was contacted several times and no answer was received.    This case was considered valid as patient identifiers were provided.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that a dose of PROQUAD expired on 2/2/2023 and was administered to a patient on 3/3/2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not reported.  On 03-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) recombinant human albumin (PROQUAD) subcutaneous injection, lot #W029554, expiration date reported as 02-FEB-2023 but upon internal validation discrepantly established as 14-MAR-2024 (dose, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered).  The suspect vaccine underwent no temperature excursions. No additional adverse event was reported. No additional information provided.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Nurse reports administration of ROTATEQ to a 9 month male patient; This spontaneous report was received from a nurse referring to a 9-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 09-MAR-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W026137, expiration date: 05-FEB-2024, administered orally for prophylaxis (strength was not provided) at the age of 9-month-old (Product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's were reported; The HCP reports that a patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a registered medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-APR-2023, the was vaccinated with expired vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1837117, expiration date: 24-MAR-2023 (strength was not provided) administered for prophylaxis (expired product administered). No additional clarifying statements or adverse event (AE) details were provided and no additional adverse events (AE's) were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; expired dose of VARIVAX was administered to a patient on 4/1/2023; This spontaneous report was received from a pharmacist and refers to a 57-year-old patient (gender unknown).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-APR-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T035401, expiration date:16-OCT-2022 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse events were provided (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; An expired dose of VARIVAX was administered to a patient; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. No information on patient current condition, medical history and concomitant medications was provided.     On 03-APR-2023 the patient was vaccinated with one dose of expired varicella virus vaccine live (oka/merck) (VARIVAX) lot# U010399 and expiration date 01-APR-2023, for prophylaxis (exact dose and route of administration was not provided) (expired product administered and no adverse event).
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: A year after 2nd shot, got shingles/suspected vaccination failure; shingles on arm - 2nd outbreak; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (refer link case US2023047361 for first outbreaks of Shingles). Additional patient notes included No prior history of a shingles outbreak.   On 24-FEB-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: A year after 2nd shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles on arm - 2nd outbreak). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023047361   Additional Information: GSK receipt date: 29-MAR-2023 The reporter was the patients husband. She had both Shingrix dose.  Shot number 2 was given on 24-Feb-2022.  The reporter did not have the exact date of Shingrix shot 1.  The reporter provided the pharmacy name and phone number where the shots were administered as the pharmacy would have the date of administration on file as well as the lot number, site, and route of administration.  After that now, like a year into (after) the (second) shots, it (shingles) came out on her other arm. The reporter confirmed that this was his wife's second shingles outbreak. The wife was in the room and did not object to her husband giving her MD contact information. The reporter was consented to follow up. This case was considered as vaccination failure as details regarding laboratory test confirming influenza were unknown at the time of reporting.; Sender's Comments:  US-GSK-US2023047361:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had both shingles vaccines, still developed shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had both shingles vaccines, still developed shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.   The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-MAR-2023  This case was reported by a patient via  interactive digital media. The patient had both shingles vaccines. However, she still developed shingles after. The reporter stated that just because you got the shingles vaccines, it would not prevent you from getting shingles. The reporter thought that the event might had been related to the drug. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot but he got shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot but he got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that the patient got the shingles shot which was 90 percent effective but he got shingles within 6 months.  The reporter further stated that she believed this was rare, fortunately. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Face paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of facial paralysis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced facial paralysis (Verbatim: Face paralyzed) (serious criteria GSK medically significant). The outcome of the facial paralysis was not reported.   It was unknown if the reporter considered the facial paralysis to be related to Shingles vaccine.     It was unknown if the company considered the facial paralysis to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by patient's cousin via interactive digital media. The reporter stated that it was very common, so be careful of vaccine. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR049000 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR049000:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Died; got Guilaine Barre Syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: Died) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: got Guilaine Barre Syndrome) (serious criteria GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reported cause of death was unknown cause of death.  It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine.  It was unknown if the company considered the unknown cause of death and guillain barre syndrome to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 01-APR-2023 This case was reported by the patient's child friend via interactive digital media.  The reporter stated that the patient got that vaccine and got Guillain Barr Syndrome and died. The reporter had asked to do your research properly. Make sure you were willing to take the risks. The reporter had stated that, he/she would not risk it.  Follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: Site injection soreness; General malaise; Tiredness; This non-serious case was reported by a physician and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site injection soreness), general malaise (Verbatim: General malaise) and tiredness (Verbatim: Tiredness). The outcome of the injection site pain, general malaise and tiredness were resolved.   It was unknown if the reporter considered the injection site pain, general malaise and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, general malaise and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 This report was submitted via the online direct entry reporting system by gsk site. This case was reported by a doctor, who was giving a speaker program on behalf of GSK/Shingrix and mentioned that when got the shot that he some tiredness and injection site soreness. At the program the PI (patient information) was provided. The reporter stated general malaise and site injection soreness as not serious. The reporter did not consent to follow up.