chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: PO2 decreased, Palpitations, Periarthritis, Pulse abnormal, Resuscitation
Clinical narrative: Unexpected, spontaneous cardiac arrest 16 days following Moderna COVID shot 1. Witnessed by myself (spouse), called 911, performed CPR until police and EMS arrived. Shocked 3 times, intubated, placed on maximum pressors with BP no higher than 50/30 for nearly a day. Resulted in subsequent multi-organ anoxic injury - many GI issues, 3 brain bleeds, multiple mini-strokes, acidosis, acute kidney failure, among the many issues. Cardiac arrest cause never determined. Prognosis for survival initially poor. One month in ICU followed by 2 weeks in specialty care hospital, then 2 weeks in inpatient rehab hospital. Slowly continues to recover. Still treated for low iron, extreme fatigue, two frozen shoulders and anoxic neurologic issues in right arm/hand and right lower leg and both feet.  Has a large, scarred over injury on scalp that was a "bed sore" injury that will never heal as the hair follicles are now scarred over. On multiple medications including carvedilol, Entresto, spironolactone, iron, multivitamins, B12, calcium/vit D, metformin, sitagliptan, empagliflozin, glimiperimide, rosuvastatin, probiotics, fexofenadine, mometasone, folic acid, gabapentin. DVT of right thigh occurred while in the hospital requiring an ICT filter (subsequently removed).  Pt now has an implantable defibrillator.  After much consultation, she received a second COVID vaccine shot - this time Pfizer lot 320308D - on November 11, 2021.  Pt experienced racing and thudding heart on November 12 for about "5 seconds", then pulse when back to normal feeling.  Cardiologist later revealed her defibrillator registered a 10 second ventricular tachycardia on that day that resolved on it's own without any pacing intervention of the defibrillator device.  On April 10 and 11, 2021, Pt had three shockable ventricular fibrillation episodes.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Scar, Transient ischaemic attack, Ventricular tachycardia
Clinical narrative: Unexpected, spontaneous cardiac arrest 16 days following Moderna COVID shot 1. Witnessed by myself (spouse), called 911, performed CPR until police and EMS arrived. Shocked 3 times, intubated, placed on maximum pressors with BP no higher than 50/30 for nearly a day. Resulted in subsequent multi-organ anoxic injury - many GI issues, 3 brain bleeds, multiple mini-strokes, acidosis, acute kidney failure, among the many issues. Cardiac arrest cause never determined. Prognosis for survival initially poor. One month in ICU followed by 2 weeks in specialty care hospital, then 2 weeks in inpatient rehab hospital. Slowly continues to recover. Still treated for low iron, extreme fatigue, two frozen shoulders and anoxic neurologic issues in right arm/hand and right lower leg and both feet.  Has a large, scarred over injury on scalp that was a "bed sore" injury that will never heal as the hair follicles are now scarred over. On multiple medications including carvedilol, Entresto, spironolactone, iron, multivitamins, B12, calcium/vit D, metformin, sitagliptan, empagliflozin, glimiperimide, rosuvastatin, probiotics, fexofenadine, mometasone, folic acid, gabapentin. DVT of right thigh occurred while in the hospital requiring an ICT filter (subsequently removed).  Pt now has an implantable defibrillator.  After much consultation, she received a second COVID vaccine shot - this time Pfizer lot 320308D - on November 11, 2021.  Pt experienced racing and thudding heart on November 12 for about "5 seconds", then pulse when back to normal feeling.  Cardiologist later revealed her defibrillator registered a 10 second ventricular tachycardia on that day that resolved on it's own without any pacing intervention of the defibrillator device.  On April 10 and 11, 2021, Pt had three shockable ventricular fibrillation episodes.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Throat irritation, Vomiting, Wheelchair user
Clinical narrative: At 07:02pm patient complaints of throat itchiness, hoarse voice and vomiting. Patient received 1st Dose Vaccine @06:51pm. Transported to gurney via wheelchair. Vital signs were taken @ 07:05 BP of 159/78 HR:78 RR:22 SpO2: 100 T:97.4. Assessment was done, patient allergic to Norco, taking omeprazole at home as verbalized.  Patient's status remains, complaints of dizziness, EMS was called @ 07:14pm and arrived @ 07:27pm. No medication was given. Report given to EMS personnel. Patient was transported to a local Hospital.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry throat, Dysphonia, Flushing, Hyperhidrosis
Clinical narrative: At 07:02pm patient complaints of throat itchiness, hoarse voice and vomiting. Patient received 1st Dose Vaccine @06:51pm. Transported to gurney via wheelchair. Vital signs were taken @ 07:05 BP of 159/78 HR:78 RR:22 SpO2: 100 T:97.4. Assessment was done, patient allergic to Norco, taking omeprazole at home as verbalized.  Patient's status remains, complaints of dizziness, EMS was called @ 07:14pm and arrived @ 07:27pm. No medication was given. Report given to EMS personnel. Patient was transported to a local Hospital.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Pharyngeal hypoaesthesia, Rash, Throat irritation
Clinical narrative: At 07:02pm patient complaints of throat itchiness, hoarse voice and vomiting. Patient received 1st Dose Vaccine @06:51pm. Transported to gurney via wheelchair. Vital signs were taken @ 07:05 BP of 159/78 HR:78 RR:22 SpO2: 100 T:97.4. Assessment was done, patient allergic to Norco, taking omeprazole at home as verbalized.  Patient's status remains, complaints of dizziness, EMS was called @ 07:14pm and arrived @ 07:27pm. No medication was given. Report given to EMS personnel. Patient was transported to a local Hospital.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: At 07:02pm patient complaints of throat itchiness, hoarse voice and vomiting. Patient received 1st Dose Vaccine @06:51pm. Transported to gurney via wheelchair. Vital signs were taken @ 07:05 BP of 159/78 HR:78 RR:22 SpO2: 100 T:97.4. Assessment was done, patient allergic to Norco, taking omeprazole at home as verbalized.  Patient's status remains, complaints of dizziness, EMS was called @ 07:14pm and arrived @ 07:27pm. No medication was given. Report given to EMS personnel. Patient was transported to a local Hospital.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis, patient is getting hospitalized
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Myocardial infarction, Organ failure, Sepsis
Clinical narrative: My grandson suffered a massive heart attack, septic, organ failure and passed March 10th 2022 leaving 2 babies fatherless
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Haemoglobin decreased, Haemolytic anaemia
Clinical narrative: hemolytic anemia requiring prednisone; resolution of anemia; persistent frail state
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dysgeusia, Face and mouth X-ray normal, Parosmia, Taste disorder
Clinical narrative: Prior to vaccinations I had COVID-19 in 11/2020. After my second dose I started to have a lack of appetite and certain foods did not taste good. It started with beef and then to vegetables. Food was tasting metallic. The inability to taste food gradually had gotten worse. I noticed it was now even pork. After about 2-3 months I decided to see a doctor. They weren't sure what was the cause. They referred me to an ENT. I saw the ENT and they did a sinus x-ray to see if there was any growths or blockage. The x-rays came back normal. I was told to take Flonase and zinc. I followed his direction and it did not help. I did some of my own research and I found that I have Parosmia. To date I have now lost a total of 32 pounds. After I got my booster the symptoms have gotten worse. If I eat a food and it taste metallic I do vomit. I can't eat chicken in a large amount, I can't eat potatoes. I can stomach fish, mushrooms and cheese. The green vegetables that I can stomach is zucchini and sometimes asparagus.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight decreased
Clinical narrative: Prior to vaccinations I had COVID-19 in 11/2020. After my second dose I started to have a lack of appetite and certain foods did not taste good. It started with beef and then to vegetables. Food was tasting metallic. The inability to taste food gradually had gotten worse. I noticed it was now even pork. After about 2-3 months I decided to see a doctor. They weren't sure what was the cause. They referred me to an ENT. I saw the ENT and they did a sinus x-ray to see if there was any growths or blockage. The x-rays came back normal. I was told to take Flonase and zinc. I followed his direction and it did not help. I did some of my own research and I found that I have Parosmia. To date I have now lost a total of 32 pounds. After I got my booster the symptoms have gotten worse. If I eat a food and it taste metallic I do vomit. I can't eat chicken in a large amount, I can't eat potatoes. I can stomach fish, mushrooms and cheese. The green vegetables that I can stomach is zucchini and sometimes asparagus.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Mother brought her child in and wanted her son to have the COVID vaccine and wanted him to have Moderna, that is what she had and did well. Injection was given and he should have had the Pfizer vaccine. Called the mother and let her know, no adverse reactions, supervisor also called and no adverse reactions.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Body temperature increased, COVID-19, Chest X-ray normal, Lethargy, Malaise
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mental status changes, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea, Exposure to SARS-CoV-2, Intensive care
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test normal, Positive airway pressure therapy, Respiratory distress, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Coronavirus test positive, Dyspnoea, Exposure to SARS-CoV-2, Influenza virus test positive
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID BREAKTHROUGH: 79 year-old male a PMH of COPD, A-fib, HTN, DM , pituitary tumor resection (remote) who presented to the ER this evening via EMS for complaints of SOB with a COVID-19 exposure.  Upon EMS arrival the patient had an SpO2 of 88% so he was given albuterol and atrovent treatments.  On arrival to the ER his O2 sats were 94% 3L NC.  His respiratory distress became progressively worse per ER MD report so he was initiated on BiPAP therapy.  His initial laboratory studies were mostly unremarkable except for a COVID-19 positive PCR.  Critical care was contacted for admission to the ICU for further work and management of his acute respiratory failure. 2ND DOSE 2/27/21.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Electrocardiogram normal, Hypotonia, Throat tightness
Clinical narrative: Pt at the vaccine clinic arrived today for their second Pfizer COVID-19 vaccine. The Pt proceeded through the vaccine clinic system. The Pt was given the vaccine in a booth, the Pt waited in a chair in the observing area for 15 minutes. After the 15 minutes, the Pt proceeded towards the exit. While walking out the Pt sat down in the entryway, staff noticed the Pt sit down and went to her side. More staff were called to help. A bystander on scene was able to translate with the Pt, the Pt spoke limited. The Pt complained of tightness in her throat, dizziness and heaviness in the chest, the Pt did not complain of any pain. The Pt did not fall, the Pt did not hit her head, the Pt did not lose consciousness. Staff called 911. Staff utilized language translation after the bystander helped with the initial translation. Staff at the clinic gave adult Epi-pen x1 IM Right leg, Staff then gave 50mg diphenhydramine x1 IM right deltoid.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Throat tightness
Clinical narrative: Pt at the vaccine clinic arrived today for their second Pfizer COVID-19 vaccine. The Pt proceeded through the vaccine clinic system. The Pt was given the vaccine in a booth, the Pt waited in a chair in the observing area for 15 minutes. After the 15 minutes, the Pt proceeded towards the exit. While walking out the Pt sat down in the entryway, staff noticed the Pt sit down and went to her side. More staff were called to help. A bystander on scene was able to translate with the Pt, the Pt spoke limited. The Pt complained of tightness in her throat, dizziness and heaviness in the chest, the Pt did not complain of any pain. The Pt did not fall, the Pt did not hit her head, the Pt did not lose consciousness. Staff called 911. Staff utilized language translation after the bystander helped with the initial translation. Staff at the clinic gave adult Epi-pen x1 IM Right leg, Staff then gave 50mg diphenhydramine x1 IM right deltoid.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: 4/26 62y.o. male who presents to the ED for evaluation of shortness of breath, generalized weakness, and abdominal pain. Pt's wife states that pt tested positive for COVID last week Monday.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Asthenia, COVID-19, Dyspnoea, Influenza virus test positive
Clinical narrative: 4/26 62y.o. male who presents to the ED for evaluation of shortness of breath, generalized weakness, and abdominal pain. Pt's wife states that pt tested positive for COVID last week Monday.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory syncytial virus test positive, SARS-CoV-2 test positive
Clinical narrative: 4/26 62y.o. male who presents to the ED for evaluation of shortness of breath, generalized weakness, and abdominal pain. Pt's wife states that pt tested positive for COVID last week Monday.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Blister, Blood test, Candida infection, Cardiac function test
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Mobility decreased
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oral discomfort, Pain, Palpitations, Rash
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase normal, Blood iron normal, C-reactive protein normal, Cardiac monitoring normal
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Dehydration, Diarrhoea, Dyspnoea
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Fatigue, Fibrin D dimer normal, HIV test negative, Headache
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C test negative, Herpes simplex test positive, Lip blister, Muscle spasms, Myocardial necrosis marker normal
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oral candidiasis, Oral mucosal blistering, Palpitations, Pyrexia
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Restlessness, Salivary hypersecretion, Tachycardia, Thyroid function test normal
Clinical narrative: within 4 hours of vaccine, headache, nausea, excessive salivation and fatigue then diarrhea and weakness  12 hours after vaccine outbreak of blisters on lips and mouth - past history of HSV1 was on prophylaxis persistent nausea diarrhea headache and fatigue , fever to 100.2 one week after vaccine to ER with palpitations and tachycardia - persistent nausea diarrhea, dehydration rx with ondansetron/ IV fluids healing sores on lips noted, no oral lesions. two weeks after vaccine oral thrush diagnosed in office, rx nystatin, persistent nausea and diarrhea fatigue, no fever  26 days after vaccine palpitations tachycardia, recurrent HSV inside mouth and nose, persistent fatigue and nausea with cramping and diarrhea requiring imodium. she reported she was sick after colonoscopy prep and anesthesia and wondered if she could be sensitive to PEG.   48 days after vaccine back in ER with chest pain, palpitations, SOB abd tachycardia to 120-140. sinus tachy diagnosed treated with ondansetron and iv fluids, cardiac monitor and echocardiogram were normal  11 weeks after vaccine improving but not well, fatigued and needing to rest during normal activity, sleeping restless but 12 hours a day, still with recurrent HSV 1, culture pos hsv 1 palpitations are improved.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Sleep disorder, Trigger finger
Clinical narrative: My right hand and wrist were painful before the vaccine, but not that bad.  About a month after the vaccine, my right hand started getting more painful, especially in the finger joints.  A month later, it spread to my left hand.  It hurts so much, I sometimes cannot sleep at night.  It is especially painful in the morning.  I can barely, and only with significant pain, make a fist.  I'm no medical doctor, but it feels like aggressive arthritis.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia, Somnolence
Clinical narrative: Severe headache,  aching joints, severe chills, "groggy" feeling, fever
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral abnormal, Aortic dilatation, Aortic valve incompetence, Aortic valve stenosis, Aphasia
Clinical narrative: The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriosclerosis, Brain natriuretic peptide normal, Carotid artery stenosis, Cerebral artery thrombosis, Cerebral infarction
Clinical narrative: The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Depressed level of consciousness, Echocardiogram abnormal, Ejection fraction
Clinical narrative: The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, International normalised ratio normal, Magnetic resonance imaging head abnormal, Metabolic function test normal
Clinical narrative: The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count normal, SARS-CoV-2 test negative, Troponin normal, White blood cell count decreased
Clinical narrative: The day after his vaccination (I think in the evening but I'm not certain) his wife noted that he was less interactive while watching TV together, and he had some trouble finding words. Of note, despite his age he still works as a judge. The next morning he was no better so he went to the emergency room where he was found to have an acute stroke.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac function test normal, Colonoscopy normal, Diarrhoea, Fat tissue increased, Gastrointestinal disorder
Clinical narrative: Developed severe gastro symptoms.  Had diarhhea multiple times a day for several months.  Doctor recommended a colonoscopy that showed nothing wrong.  However, I  had extremely high Blood Pressure - 180ish/90ish.  I've always had LOW blood pressure.  I'm currently taking blood pressure medicine, but my BP continues to spike with no explanation.   The symptoms have continued, but are less severe at this time.  After the 3rd vaccine I developed a bump on the front right side of my collarbone -- it's not a tumor or cyst - doctor had no explanation.  It is painful and has not improved.  Then I developed a fat pocket below my bottom lip - the doctor has never seen anything like this and doesn't know how to treat it.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Laboratory test normal, Pain, Swelling, Ultrasound abdomen normal
Clinical narrative: Developed severe gastro symptoms.  Had diarhhea multiple times a day for several months.  Doctor recommended a colonoscopy that showed nothing wrong.  However, I  had extremely high Blood Pressure - 180ish/90ish.  I've always had LOW blood pressure.  I'm currently taking blood pressure medicine, but my BP continues to spike with no explanation.   The symptoms have continued, but are less severe at this time.  After the 3rd vaccine I developed a bump on the front right side of my collarbone -- it's not a tumor or cyst - doctor had no explanation.  It is painful and has not improved.  Then I developed a fat pocket below my bottom lip - the doctor has never seen anything like this and doesn't know how to treat it.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Headache, dizziness and nausea right after vaccine and worsen until vomiting 5-10 hours after vaccine. Milk headache and nausea has sustained daily since first time getting vaccine and worsen after 3rd dose.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Weird patchy hair loss began all over head. I know this is not a "severe" symptom but it is becoming increasingly common and this NEEDS to be known. Seems like it kind of stabilized, and then this issue then WORSENED about 2 weeks after receiving my booster.
Age: 1.83
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller did not provide any additional AE details; HCP reports that VAQTA that expired on 03-DEC-2021, was accidentally administered to a patient today, 20-APR-2022.; This spontaneous report has been received from a medical assistant referring to a 22-month-old male patient. The patient's pertinent medical history, and previous drugs reactions or allergies.Concomitant medications and historical vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR).   On 20-APR-2022, the patient was accidentally vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection,  at a dose of 0.5 milliliter for prophylaxis lot number T013204, expiration date: 03-DEC-2021 (route of administration  and anatomical location were not provided) . The reporter confirmed the product had been stored appropriately with no temperature excursions and did not provide any additional adverse event details(no adverse event).  The patient's mom was notified about the expired vaccine and a re-vaccination was offered, nonetheless, the patient's mom did not want another vaccination.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reports patient received both VARIVAX and PROQUAD on the same day.; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of an unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-MAY-2022, the patient was vaccinated on the same day with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, subcutaneously, 0.5 milliliter, lot #U025791 was confirmed to be valid, expiration date: 19-AUG-2023 (strength not provided), administered for prophylaxis and with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, subcutaneously, 0.5 milliliter, lot #U022726, expiration date: 16-JAN-2023, (strength not provided), administered for prophylaxis (Overdose).  No adverse effect was reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; expired dose of VAQTA was administered to a patient; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-APR-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot #T035720, expiration date: 15-APR-2022 (expired product administered)(route of administration and injection site were not provided) for prophylaxis. Dose was properly stored up through time of administration. No other adverse events reported (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller explained a patient was administered MMR II after the expiration date.; This spontaneous report was received from pharmacist and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status recombinant Human albumin (rHA) lot #T000892, expiration date: 08-JAN-2022 (expired product administered) (dose, route of administration and injection site were not provided) for prophylaxis.Caller confirmed the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) has not had any temperature excursions. No additional AE was reported (No adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller is a Merck employee who reports one of her offices told her that there was an expired dose of VAQTA that was given to a patient. They refused to provide any further information to the employee and said they would report the AE on their own. No; No other AE/no PQC.; This spontaneous report was received from a company Representative and referred to a patient of unspecified age (reported as child) and gender.  The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided)(Expired product administered). No other adverse events were reported. They wanted to know immediately whether the child would need to be revaccinated. The office manager was not satisfied with the instruction to call for revaccination information.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at the injection site; Heat at the injection site; Pain at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 10 years before the date of reporting).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient got the original shingles shot almost 10 years ago. It turned out only about 30 percent effective. The patient got the Shingrix shots, it was 2 shot deal and had a higher rate of effectiveness. After vaccination, the patient had swelling, heat and pain at the injection site. The patient hope that he/she feel better soon and would check with doctor about whether or not other should get the newer vaccine. Additional Supportive Information: This case was linked with case US2022AMR076126, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076126:Same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at the injection site; Heat at the injection site; Pain at the injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's comments:  This case was reported by the patient's wife via interactive digital media.  The patient got the Shingrix shots, it was 2 shot deal and had a higher rate of effectiveness. After vaccination, the patient had swelling, heat and pain at the injection site. The reporter hope that you feel better soon and asked to check with your doctor about whether or not you should get the newer vaccine. Additional Supportive Information: The follow-up would not possible as no contact details were available. This case was linked with case US2022AMR076122, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076122:Same reporter.