chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac stress test normal, Constipation, Diarrhoea, Echocardiogram normal
Clinical narrative: On the 12-03-2021 I got COVID-19 symptoms lasted till 12-13-2021, with symptoms for fever and headaches, body aches. I lost sense of smell. Right after Christmas, I started to feel agitated, pain in my left shoulder radiating to my heart. Went to see my PCP and she checked my vitals, said everything was okay, lungs were clear. I also had an EKG which shoed I had a heart attack, lower myocardia-infarction.  I went to see a cardiologist on 01-06-2022 and another EKG was done with same results. The cardiologist sent me for an echocardiogram and nuclear stress test and these exams were normal.  I was told my symptoms were viral and was dismissed on 04-07-2022 and myocarditis had disappeared. In mid march 2022, I started to have pain in my joints, hair was falling and my right ankle was swollen and pain in every joint in my body. I also had diarrhea and constipation. I went to my PCP again and my vitamin D was low. My liver enzymes were high as well. I am now also going to see a rheumatologist to check in the joints. I do not know if my symptoms are related to the vaccine or due to COVID-19. They also gave me a prescription for Pantoprazole 20mg from my gastroenterologist. I had also some pain in my left arm after my vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Headache, Hepatic enzyme increased, Injection site pain, Joint swelling
Clinical narrative: On the 12-03-2021 I got COVID-19 symptoms lasted till 12-13-2021, with symptoms for fever and headaches, body aches. I lost sense of smell. Right after Christmas, I started to feel agitated, pain in my left shoulder radiating to my heart. Went to see my PCP and she checked my vitals, said everything was okay, lungs were clear. I also had an EKG which shoed I had a heart attack, lower myocardia-infarction.  I went to see a cardiologist on 01-06-2022 and another EKG was done with same results. The cardiologist sent me for an echocardiogram and nuclear stress test and these exams were normal.  I was told my symptoms were viral and was dismissed on 04-07-2022 and myocarditis had disappeared. In mid march 2022, I started to have pain in my joints, hair was falling and my right ankle was swollen and pain in every joint in my body. I also had diarrhea and constipation. I went to my PCP again and my vitamin D was low. My liver enzymes were high as well. I am now also going to see a rheumatologist to check in the joints. I do not know if my symptoms are related to the vaccine or due to COVID-19. They also gave me a prescription for Pantoprazole 20mg from my gastroenterologist. I had also some pain in my left arm after my vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Myocardial infarction, Myocarditis, Pain
Clinical narrative: On the 12-03-2021 I got COVID-19 symptoms lasted till 12-13-2021, with symptoms for fever and headaches, body aches. I lost sense of smell. Right after Christmas, I started to feel agitated, pain in my left shoulder radiating to my heart. Went to see my PCP and she checked my vitals, said everything was okay, lungs were clear. I also had an EKG which shoed I had a heart attack, lower myocardia-infarction.  I went to see a cardiologist on 01-06-2022 and another EKG was done with same results. The cardiologist sent me for an echocardiogram and nuclear stress test and these exams were normal.  I was told my symptoms were viral and was dismissed on 04-07-2022 and myocarditis had disappeared. In mid march 2022, I started to have pain in my joints, hair was falling and my right ankle was swollen and pain in every joint in my body. I also had diarrhea and constipation. I went to my PCP again and my vitamin D was low. My liver enzymes were high as well. I am now also going to see a rheumatologist to check in the joints. I do not know if my symptoms are related to the vaccine or due to COVID-19. They also gave me a prescription for Pantoprazole 20mg from my gastroenterologist. I had also some pain in my left arm after my vaccine.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Viral infection, Vitamin D decreased
Clinical narrative: On the 12-03-2021 I got COVID-19 symptoms lasted till 12-13-2021, with symptoms for fever and headaches, body aches. I lost sense of smell. Right after Christmas, I started to feel agitated, pain in my left shoulder radiating to my heart. Went to see my PCP and she checked my vitals, said everything was okay, lungs were clear. I also had an EKG which shoed I had a heart attack, lower myocardia-infarction.  I went to see a cardiologist on 01-06-2022 and another EKG was done with same results. The cardiologist sent me for an echocardiogram and nuclear stress test and these exams were normal.  I was told my symptoms were viral and was dismissed on 04-07-2022 and myocarditis had disappeared. In mid march 2022, I started to have pain in my joints, hair was falling and my right ankle was swollen and pain in every joint in my body. I also had diarrhea and constipation. I went to my PCP again and my vitamin D was low. My liver enzymes were high as well. I am now also going to see a rheumatologist to check in the joints. I do not know if my symptoms are related to the vaccine or due to COVID-19. They also gave me a prescription for Pantoprazole 20mg from my gastroenterologist. I had also some pain in my left arm after my vaccine.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: It started about May or June of 2021. It hasn't gone away. I have insomnia, so some nights I can't fall asleep. My doctor prescribed Trazadone. At first it 50mg tablets and now its been increased to 100 mg.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: My heart is pounding every morning. You can see it pounding outside my body. I need to get up in the middle of the night and walk around, breathe deep and sip water. Laying down exacerbates it.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: red, itchy, swelling and bump at injection site
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: Sore arm & mild rash after injection, headache, fever, tinnitus, aches. All resolved within 36 hours, except tinnitus, which has persisted.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sore arm & mild rash after injection, headache, fever, tinnitus, aches. All resolved within 36 hours, except tinnitus, which has persisted.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Tinnitus in both that continues to this day.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Formication, Hypersensitivity, Magnetic resonance imaging, X-ray
Clinical narrative: Within a month or so started to have hypersensitivity in both legs to vibrations wherever I am, the feeling of vibrations of items running being transferred up through my feet and legs. Shortly after that I started having  spider crawling feelings in both legs, like my muscles in my legs are moving, this has continued up to this date.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache
Clinical narrative: headache
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests normal, Deafness neurosensory, Headache, Hypoacusis, Sudden hearing loss
Clinical narrative: Noticed painful headache on Saturday 4/23/22 and thought I had a migraine. Hearing was ok in the am. By the afternoon hearing was decreasing and I thought I had an ear infection. Sunday AM I still had a headache and hearing was worse. Sound was muffled and sounded like I was hearing under water. Monday morning I called my ENT provider and had a hearing test after the ear exam came back clear. Tuesday I started on a course of Prednisone. Diagnosis of Sudden Neurosensory Hearing Loss - right ear
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Tachycardia, Urticaria
Clinical narrative: All over body rash and redness with some welts, tachycardia. Given epinephrine injection and a script for a steroid taper as well as antihistamine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin mass, Swelling
Clinical narrative: PATIENT CALLED IN AT AROUND 10AM 05/02/2022 COMPLAING ABOUT ARM SORNESS, SWELLING, AND A LUMP ON HER ARM RADIATING TO HER CHEST. RECOMENDED PT TO CONTINUE TAKING IBUPROFEN PRN. AT AROUND 2PM PATIENT STATES THEY WENT TO URGENT CARE DUE TO PAIN AND WERE PRESCRIBED NAPROXEN.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Neuralgia
Clinical narrative: Patient received COVID19 (Moderna) vaccine and reported nerve pain in injection arm following the injection. Patient stated that she was seen by a physician. Patient's physician will monitor for changes in condition and refer to a neurologist if symptoms worsen or do not improve.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus in right ear
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Acute herpes zoster eruption over the Rt. thoracic region.
Age: 51.0
Sex: M
Vaccine: PNC20
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Patient received Prevnar 20 on 4/16/22 here in the pharmacy in his left deltoid. On 4/30/22, he noticed facial drooping on his right side.  He presented to his physician on 5/2/22 where they diagnosed it as Bells Palsy and started him on a course of Prednisone in hopes to resolve it
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: PT CALLED COMPLAINING OF EXCRUCIATING PAIN THROUGHOUT HER BODY FROM HER HEAD TO THE BOTTOM OF HER FEET REQUIRING HER TO STAY IN BED FOR THE LAST 5 DAYS
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Vision blurred, Visual impairment
Clinical narrative: Pt had initial slight blurriness in Left eye on the initial day of vaccination. The day following vaccination patient reports sight was dim and blurry. By Saturday 4/30, pt reports no sight in left eye but sight returned later that evening. Sunday May 1, patient reports complete loss of vision in left eye. Patient daughter says he is going to doctor today.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Confusional state, Dysarthria, Pyrexia, Tremor
Clinical narrative: Confusion, slurred speech, fever, both hands with tremor
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myocardial infarction, Nausea, Sudden death
Clinical narrative: Patient had felt different since the vaccine.  Tired and occasional nausea.  He died suddenly March 30th, 2022 from a heart attack.  He had never had blood pressure issues or heart problems.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Electromyogram, Injection site pain, Pain in extremity, Paraesthesia, Ultrasound Doppler
Clinical narrative: Within 24 hrs of injection, I had extreme pain in my left shoulder that lasted a couple of days.  Over the last few months, the pain has traveled down my left arm, my fingers have tingled.  Currently, my arm aches constantly and the pain is mostly in my elbow.
Age: 53.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: X-ray
Clinical narrative: Within 24 hrs of injection, I had extreme pain in my left shoulder that lasted a couple of days.  Over the last few months, the pain has traveled down my left arm, my fingers have tingled.  Currently, my arm aches constantly and the pain is mostly in my elbow.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: BRUISING AT INJECTION SITE       BRUISE ON CALF
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hearing aid user, Hypoacusis, Tinnitus
Clinical narrative: I always have had mild tetanus, but a about a week after the shot my left ear started to get more sensitive to loud noise.  On the 27th of March I woke up with a very loud constant lower tone in my left ear.  It continued until today, April 2 when about 10 a.m. it started to fade.  I still have it but not as bad.  Hearing still seems to be a little sensitive, especially to loud noise.  I wear hearing aids in both ears.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Brain oedema, Dizziness, Headache, Inappropriate schedule of product administration
Clinical narrative: Vertigo, dizziness, nystagmus, cerebellum swelling, headache Treatment Neurometabolic Brain-Based Rehabiitation Program Outcome:  Over the course of 6 months of treatment, the symptoms have slowly diminished, but have not subsided,  and have now returned
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nystagmus, SARS-CoV-2 antibody test negative, Vertigo
Clinical narrative: Vertigo, dizziness, nystagmus, cerebellum swelling, headache Treatment Neurometabolic Brain-Based Rehabiitation Program Outcome:  Over the course of 6 months of treatment, the symptoms have slowly diminished, but have not subsided,  and have now returned
Age: 65.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Furuncle, Rash
Clinical narrative: Genital boils occurred 6-weeks after injections.  Self-care with tea tree tincture (100% oil) & neosporin for 90+ days. Visited physician after multiple boils.  The problem was not going away.  The self-care treatment dried up the boils, however, more boils continued to appear.  Physician prescribed Amoxicillin to be taken twice daily for 10 days on April 20, 2022.  Boils reduced in size and started disappearing.  However, there are now small bumps occurring.  Which appear to be the beginning of new boils, if not treated with the tea tree oil & neosporin.  Planning another visit to the physician, if the tea tree oil & neosporin do not clear up the problem.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Oropharyngeal pain
Clinical narrative: temperature, sore throat, slight chest tightening, shivering, fatigue for 2 days until 5/2/2022.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Grandmother called this evening saying patient was having a headache and she had not experienced that after the 1st vaccine
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriogram coronary normal, Atrial fibrillation, Body temperature increased, Cardiac arrest, Cardiac failure
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiogenic shock, Cardioversion, Catheterisation cardiac normal, Computerised tomogram pelvis abnormal, Congestive cardiomyopathy
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Echocardiogram abnormal, Emotional distress, Endotracheal intubation
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Extravasation, Intensive care, Intra-aortic balloon placement, Laboratory test, Malaise
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral artery thrombosis, Peripheral ischaemia, Peripheral pulse decreased, Respiratory arrest
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Resuscitation, Stress cardiomyopathy, Thrombectomy, Thromboembolectomy, Vascular pseudoaneurysm
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular hypokinesia
Clinical narrative: Patient was seen for symptoms of urinary tract infection possible kidney stone but looks to be quite ill.  3 days later presented in florid heart failure and had a respiratory arrest.  She was intubated.  Echocardiogram showed dilated cardiomyopathy consistent with Takotsubo's cardiomyopathy. She had a heart catheterization which was negative. She was diagnosed with Takotsubo's cardiomyopathy. Extremely complicated course which included intra-aortic balloon pump. Arterial clot around the intra-aortic balloon pump. Emergent embolectomy. Followed by a slow recovery. Patient recovered intact. Patient was anxious about getting a booster for COVID based on the timing of her shot and the severity of her illness. I discussed what happened to her was a rare outcome and could not completely rule out it could be related.  And suggested I would report her case  From discharge summary: history of COPD who was admitted to the hospital on 5/8/2021 with dyspnea.   She had been complaining of this along with a low-grade temp as well as nausea for 1 to 2 days prior to the admission.  She had also been dealing with severe emotional stressors at home prior to the hospitalization which she did not elaborate about.   In the ED she was noted to have atrial fibrillation with RVR and a cardioversion attempt was performed.  This resulted in a brief cardiac arrest and approximately 1 minute of CPR with return of spontaneous circulation.   TTE was performed shortly thereafter and showed a severely hypokinetic left ventricle with findings compatible with Takotsubo cardiomyopathy.  Cardiology was consulted urgently and took the patient to Cath Lab and placed an intra-aortic balloon pump.  Angiogram showed no coronary disease.  It was overall thought that her cardiogenic shock was secondary to Takotsubo cardiomyopathy brought about by severe emotional stressors.   She did require vasopressor support in the ICU and was on balloon pump until 5/12.  She was found to have a pseudoaneurysm of the left groin by CT with active extravasation.  Bleeding resolved; however, on the day the pump was removed there was difficulty finding pulse in the left leg.  Vascular surgery was consulted emergently and she went to the OR which found a left iliofemoral arterial thrombosis with acute limb ischemia and she underwent thrombectomy.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Arteriogram carotid abnormal, Blood test, COVID-19, Cardiac stress test abnormal
Clinical narrative: From 1/21/22 onwards I had headaches and tiredness . By 3/22 I felt twinges occasionally in my chest. 3/25/22 I was not I BLT rubbing my chest and had Drs appointment on 3/27/22. It got worse daily. By 3/31/22 around midnight I had a lot of pain and pressure and 4/1/22 shortness of breath and major pain. Went to urgent care and EKG was fine, chest X-ray was fine and troponen levels were elevated. Sent to Medical Center E.R. Was admitted and given blood thinner shots to stomach and a pill for heart inflammation in case it was pleuritus. More EKG and bloodwork done . Normal held for heart ultrasound and stress test. Heart ultrasound normal stress test positive. Did angiogram and was told by cardiologist it was beautiful no blocks, plaque nothing until he got to my LAD?Widow MAKER? are teary it was over 95%blocked with a clot. Stent put in.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carditis, Chest X-ray, Chest discomfort, Coronary arterial stent insertion, Coronary artery occlusion
Clinical narrative: From 1/21/22 onwards I had headaches and tiredness . By 3/22 I felt twinges occasionally in my chest. 3/25/22 I was not I BLT rubbing my chest and had Drs appointment on 3/27/22. It got worse daily. By 3/31/22 around midnight I had a lot of pain and pressure and 4/1/22 shortness of breath and major pain. Went to urgent care and EKG was fine, chest X-ray was fine and troponen levels were elevated. Sent to Medical Center E.R. Was admitted and given blood thinner shots to stomach and a pill for heart inflammation in case it was pleuritus. More EKG and bloodwork done . Normal held for heart ultrasound and stress test. Heart ultrasound normal stress test positive. Did angiogram and was told by cardiologist it was beautiful no blocks, plaque nothing until he got to my LAD?Widow MAKER? are teary it was over 95%blocked with a clot. Stent put in.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Fatigue
Clinical narrative: From 1/21/22 onwards I had headaches and tiredness . By 3/22 I felt twinges occasionally in my chest. 3/25/22 I was not I BLT rubbing my chest and had Drs appointment on 3/27/22. It got worse daily. By 3/31/22 around midnight I had a lot of pain and pressure and 4/1/22 shortness of breath and major pain. Went to urgent care and EKG was fine, chest X-ray was fine and troponen levels were elevated. Sent to Medical Center E.R. Was admitted and given blood thinner shots to stomach and a pill for heart inflammation in case it was pleuritus. More EKG and bloodwork done . Normal held for heart ultrasound and stress test. Heart ultrasound normal stress test positive. Did angiogram and was told by cardiologist it was beautiful no blocks, plaque nothing until he got to my LAD?Widow MAKER? are teary it was over 95%blocked with a clot. Stent put in.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pleurisy, Troponin increased
Clinical narrative: From 1/21/22 onwards I had headaches and tiredness . By 3/22 I felt twinges occasionally in my chest. 3/25/22 I was not I BLT rubbing my chest and had Drs appointment on 3/27/22. It got worse daily. By 3/31/22 around midnight I had a lot of pain and pressure and 4/1/22 shortness of breath and major pain. Went to urgent care and EKG was fine, chest X-ray was fine and troponen levels were elevated. Sent to Medical Center E.R. Was admitted and given blood thinner shots to stomach and a pill for heart inflammation in case it was pleuritus. More EKG and bloodwork done . Normal held for heart ultrasound and stress test. Heart ultrasound normal stress test positive. Did angiogram and was told by cardiologist it was beautiful no blocks, plaque nothing until he got to my LAD?Widow MAKER? are teary it was over 95%blocked with a clot. Stent put in.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen left armpit probably lymph node.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Asthenia, Blood test, Chest discomfort, Death
Clinical narrative: A day later patient had reported to me that he was feeling tension on both sides of his chest, shoulder and back. Patient said he was not experiencing any pain but commented that he felt completely different than he has ever felt after receiving his third dose covid booster.  He discuss with me that he was scared that this shot did something to him. He discussed his concerns and then we started making appointments for him to get in to see the doctor for the tension he was having in his chest, back and shoulders. Patient also said he was feeling more tired and weak after receiving that third booster shot. Patient passed away March 19th, he suffered a heart attack at home.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Fear, Laboratory test abnormal, Musculoskeletal discomfort, Myocardial infarction
Clinical narrative: A day later patient had reported to me that he was feeling tension on both sides of his chest, shoulder and back. Patient said he was not experiencing any pain but commented that he felt completely different than he has ever felt after receiving his third dose covid booster.  He discuss with me that he was scared that this shot did something to him. He discussed his concerns and then we started making appointments for him to get in to see the doctor for the tension he was having in his chest, back and shoulders. Patient also said he was feeling more tired and weak after receiving that third booster shot. Patient passed away March 19th, he suffered a heart attack at home.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tension
Clinical narrative: A day later patient had reported to me that he was feeling tension on both sides of his chest, shoulder and back. Patient said he was not experiencing any pain but commented that he felt completely different than he has ever felt after receiving his third dose covid booster.  He discuss with me that he was scared that this shot did something to him. He discussed his concerns and then we started making appointments for him to get in to see the doctor for the tension he was having in his chest, back and shoulders. Patient also said he was feeling more tired and weak after receiving that third booster shot. Patient passed away March 19th, he suffered a heart attack at home.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Joint pain and stiffness in fingers, wrists, ankles, elbow, toes, and hips. No treatment as of yet, but symptoms not improving only worsening 12 days post COVID injection number 2.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: On April 1, 2022 - I got the Booster.  Only now - on May 2nd - does it not look like I have a bruise at the injection site.  A bruise is one thing - which I expected to fade after a couple of days and be totally gone in a week.    I may be out of shape but otherwise in good health.  I am reporting this - as anonymously as possible - because a bruise lasting for 4 weeks is not what I would consider "normal".
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Our new medical assistant gave a DTAP-IPV combo shot that expired on XX/XX/2022. Kinrix was the manufacturer and 0.5ml was the injection dose. She gave the shots to two siblings on XX/XX/2022. We will be checking our vaccine inventory daily to make sure we do not have any expired vaccine in the fridge. We will be double checking expirations date as we are preparing injections. If we have ant doubt or questions, we will be sure to speak up immediately.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face, Urticaria
Clinical narrative: Our daughter took Pfizer booster shot and ended up with hives, swollen lips, and face. The hives are now everyday routine. We are very worried about or child. Allergists have tried everything and it is not helping. It has been damaging our child physically and mentally. Please help.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Malaise, Vagus nerve disorder
Clinical narrative: Patient reported being sick due to having a adverse reaction to the fourth Covid-19 vaccine and vagus nerve issues. No further information provided. Patient does not consent to be contacted.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient reported pain in the arm after COVID 19 booster shot. Patient believes this was an administration error & that is why she is having pain in her arm. Patient does not believe the pain is from the medication itself. This was a subcutaneous injection & her Pharmacist believes the injection did not go deep enough.
Sex: U
Vaccine: MMRV
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: We usually only carry Varicella and MMR Vaccines for kids. Did not realize that you could order MMR & Varicella in one shot. However the last time MMR was ordered we ordered the combo dose not even realizing. Went to give child their MMR and Varicella and the child actually received the Varicella and the MMR/Varicella combo. Had immunization Monitoring review and realized that this was what happened. Add new immunizations storage bin with correct labeling for the new MMR/Varicella that is not in stock
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac infection, Laboratory test abnormal, Product administered to patient of inappropriate age
Clinical narrative: Heart infection from Moderna covid vaccine Do not approve Moderna covid vaccine young ages emergency use.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Reporter of adverse event: Patient: Summary of adverse event: went to emergency room due to side effects of coronavirus booster vaccine. had difficulty walking and was released to a long term care facility for 3 weeks; date of occurrence 01/2022. no further information was provided; MD aware and drug therapy continues unchanged
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Menstrual disorder, Pain
Clinical narrative: She got the shot and has not had a period since. She's in a lot of pain. Her periods were normal for the past two years til she got this shot.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Undiluted COVID vaccine administered. Error was not noted until about 2 hours after patient had left clinic. Nurse manager, notified provider and then mother of the error. Per my discussion with mom, patient was doing well and experiencing no side effects at the time of my call (~4:30pm on 4/26). Advised to notify our office and/or seek care immediately for significant side effects. No reports of adverse events since error.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram thorax abnormal, Deep vein thrombosis, Fibrin D dimer, Pulmonary embolism, Troponin increased
Clinical narrative: I suffered 2 (L) legt DVT and massive pulmonary embolism 1 week after my second Covid booster.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bedridden, Bladder dysfunction, Loss of personal independence in daily activities, Muscle disorder
Clinical narrative: lost muscle control; couldn't get up; loss of bladder control slowly; i still have considerable weakness in the core; have not been able to resume my normal activities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 at 08:30 as dose 2, single (Lot number: EN6201) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN; PEPCID [FAMOTIDINE]. Past drug history included: Tegretol, reaction(s): "known allergies: Tegretol"; Dylantin, reaction(s): "known allergies: Dylantin". Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=PFIZER, prev dose brand unknown=False, prev dose lot number=EL1223, prev dose lot unknown=False, prev dose administration date=30Jan2021, prev dose administration time=09:30 AM, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 30Jan2021, when the patient was 81-year-old, for COVID-19 immunization.  The following information was reported: BEDRIDDEN (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "couldn't get up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "have not been able to resume my normal activities"; ASTHENIA (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "i still have considerable weakness in the core"; BLADDER DYSFUNCTION (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "loss of bladder control slowly"; MUSCLE DISORDER (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "lost muscle control". The events "lost muscle control", "couldn't get up", "loss of bladder control slowly", "i still have considerable weakness in the core" and "have not been able to resume my normal activities" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle disorder, bedridden, bladder dysfunction, asthenia, loss of personal independence in daily activities.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: lost muscle control; couldn't get up; loss of bladder control slowly; i still have considerable weakness in the core; have not been able to resume my normal activities; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 20Feb2021 at 08:30 as dose 2, single (Lot number: EN6201) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN; PEPCID [FAMOTIDINE]. Past drug history included: Tegretol, reaction(s): "known allergies: Tegretol"; Dylantin, reaction(s): "known allergies: Dylantin". Vaccination history included: BNT162b2 (prev dose product=COVID 19, prev dose brand=PFIZER, prev dose brand unknown=False, prev dose lot number=EL1223, prev dose lot unknown=False, prev dose administration date=30Jan2021, prev dose administration time=09:30 AM, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 30Jan2021, when the patient was 81-year-old, for COVID-19 immunization.  The following information was reported: BEDRIDDEN (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "couldn't get up"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "have not been able to resume my normal activities"; ASTHENIA (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "i still have considerable weakness in the core"; BLADDER DYSFUNCTION (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "loss of bladder control slowly"; MUSCLE DISORDER (non-serious) with onset 24Feb2021 at 04:00, outcome "not recovered", described as "lost muscle control". The events "lost muscle control", "couldn't get up", "loss of bladder control slowly", "i still have considerable weakness in the core" and "have not been able to resume my normal activities" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle disorder, bedridden, bladder dysfunction, asthenia, loss of personal independence in daily activities.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Electrocardiogram, Heart rate increased
Clinical narrative: Heart beating fast and bad anxiety.