chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Dyskinesia, Electrocardiogram normal, Electroencephalogram, Laboratory test normal
Clinical narrative: On Jan. 27, 2021 was scheduled to have my 2nd dose of the Moderna Covid-19 Vaccine at 4:40pm at Health Clinic. The vaccine was injected on my right arm at around 4:50pm. I was then told to wait in the waiting room for 15 mins. When I walked in to the waiting room the nurse announced that there were donuts and hot chocolate for everyone. I pulled a chair from on the tables to set my coat and purse down then I went to serve myself hot chocolate and a donut. I had then went to sit down and while I was talking to my co-worker I began to feel my blood rushing to my head and felt dizzy, my eyes began to close involuntary, and then I began to start twitching and lost control of my body. My eyes and mouth shut completely but I could hear everything that was going on. Everyone at the office began to panic and someone injected me with an epipen. I was then taken by an ambulance to the nearest hospital. At the hospital I had about 5 seizure episodes, had slurred speech and was unable to move much. All they kept telling me was that I was fine. I was then discharged after running a few tests and was told that I had an anxiety attack. When I arrived home I had 3 more seizures and my husband took me to the hospital.  I was then hospitalized for 4 days. There at the hospital I continued to have the same symptoms and after doing more tests everyday the doctors said that all the tests resulted normal and that they were unable to figure out what was the actual cause of all this. I was told to follow up  with my PCP and with a Neurologists.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Mobility decreased, Movement disorder, Muscle twitching, Seizure
Clinical narrative: On Jan. 27, 2021 was scheduled to have my 2nd dose of the Moderna Covid-19 Vaccine at 4:40pm at Health Clinic. The vaccine was injected on my right arm at around 4:50pm. I was then told to wait in the waiting room for 15 mins. When I walked in to the waiting room the nurse announced that there were donuts and hot chocolate for everyone. I pulled a chair from on the tables to set my coat and purse down then I went to serve myself hot chocolate and a donut. I had then went to sit down and while I was talking to my co-worker I began to feel my blood rushing to my head and felt dizzy, my eyes began to close involuntary, and then I began to start twitching and lost control of my body. My eyes and mouth shut completely but I could hear everything that was going on. Everyone at the office began to panic and someone injected me with an epipen. I was then taken by an ambulance to the nearest hospital. At the hospital I had about 5 seizure episodes, had slurred speech and was unable to move much. All they kept telling me was that I was fine. I was then discharged after running a few tests and was told that I had an anxiety attack. When I arrived home I had 3 more seizures and my husband took me to the hospital.  I was then hospitalized for 4 days. There at the hospital I continued to have the same symptoms and after doing more tests everyday the doctors said that all the tests resulted normal and that they were unable to figure out what was the actual cause of all this. I was told to follow up  with my PCP and with a Neurologists.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Left ventricular dysfunction, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Myocarditis, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Troponin T increased, Troponin increased
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chills, Headache, Influenza like illness, Magnetic resonance imaging
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pyrexia, SARS-CoV-2 test, Serology test, Troponin
Clinical narrative: Flu-like symptoms; fever; chills; headaches; myocarditis; A spontaneous report was received from a physician concerning a middle-aged, male patient, who received Moderna's COVID-19 Vaccine, and who experienced myocarditis, flu-like symptoms, fever, chills and headache.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 26 Jan 2021, approximately three days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced flu-like symptoms, fever, chills and headache.  On 29 Jan 2021, the patient developed substernal chest pain and came to the ED for evaluation. His troponins were elevated, but his cardiac catheterization was negative for acute coronary occlusion. Cardiac MRI findings were consistent with myocarditis and evaluation for covid 19 disease by PCR and serology were negative. Additional workup for other causes of myocarditis is still pending. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome of the events myocarditis, flu-like symptoms, fever, chills and headache was not provided.; Reporter's Comments: This case concerns a male patient, with prior cardiac risk factors, who experienced a serious event of myocarditis along with other non-serious events after receiving second dose of mRNA-1273 (Lot# unknown). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Herpes zoster
Clinical narrative: JAN 21 received moderna vaccine and he stated his ear was hurting - went to ENT, was later dx with shingles by dermatalogist.  Was prescribed anitvirals - completed within 7 days , Feb 5th.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Autopsy, Cyanosis, Death, Dental discomfort, Diarrhoea haemorrhagic
Clinical narrative: After the first vaccination on 01/03/2021, the decedent experienced no side effects.  On 01/31/2021, she received second vaccine.  Later she complained of tiredness, vomiting, diarrehea, and severe jaw pain.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dizziness, Nausea, Resuscitation, Toothache, Unresponsive to stimuli
Clinical narrative: After the first vaccination on 01/03/2021, the decedent experienced no side effects.  On 01/31/2021, she received second vaccine.  Later she complained of tiredness, vomiting, diarrehea, and severe jaw pain.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Pain in jaw, Vomiting
Clinical narrative: After the first vaccination on 01/03/2021, the decedent experienced no side effects.  On 01/31/2021, she received second vaccine.  Later she complained of tiredness, vomiting, diarrehea, and severe jaw pain.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Fatigue, Pain in jaw, Unresponsive to stimuli, Vomiting
Clinical narrative: After the first vaccination on 01/03/2021, the decedent experienced no side effects.  On 01/31/2021, she received second vaccine.  Later she complained of tiredness, vomiting, diarrehea, and severe jaw pain.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Asthenia, Blood test, Computerised tomogram, Condition aggravated
Clinical narrative: Patient deceased, may not be related but thought we would report
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Death, Hypotension, Urinary tract infection
Clinical narrative: Patient deceased, may not be related but thought we would report
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient deceased, may not be related but thought we would report
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Fatigue
Clinical narrative: Fatigue for 5 days, died in sleep on fifth day after vaccine
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood test, Chest discomfort, Chills, Dizziness
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Electrocardiogram, Heart rate increased, Myalgia
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pharyngeal swelling, Pyrexia, Tinnitus
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Defaecation urgency, Dizziness, Dyspnoea
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Headache, Laboratory test, Paraesthesia
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Pyrexia, Tachycardia
Clinical narrative: pt c/o fatigue, SOB, weakness, presyncope, fever, chills, bowel urgency, tingling, HA dizziness, tachycardia
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away on 2/4/21 the day after receiving the 2nd dose of the covid19 moderna vaccine on 2/3/21.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Hypertension
Clinical narrative: After receiving the Covid vaccine, the decedent had complaints of insomnia, tiredlness and dizziness.  Her symptoms worsened and included nausea and labored breathing.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dizziness, Dyspnoea, Fatigue, Insomnia
Clinical narrative: After receiving the Covid vaccine, the decedent had complaints of insomnia, tiredlness and dizziness.  Her symptoms worsened and included nausea and labored breathing.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Syncope
Clinical narrative: After receiving the Covid vaccine, the decedent had complaints of insomnia, tiredlness and dizziness.  Her symptoms worsened and included nausea and labored breathing.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Insomnia, Nausea
Clinical narrative: After receiving the Covid vaccine, the decedent had complaints of insomnia, tiredlness and dizziness.  Her symptoms worsened and included nausea and labored breathing.
Age: 86.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Angiogram, Echocardiogram, Myocardial infarction, Tremor
Clinical narrative: Patient received Moderna Covid-19 vaccine #1 morning of 2/7/2021.  Had been feeling fine until about 8 hours later, when she started to have epigastric /chest pain, full body shaking.  EMS activated and patient was brought to ER.  Upon arrival, found to have elevated troponin of 141 and peak level of 490;    diagnosed with NSTEMI.   Patient was taken to cath lab:  patent L main; normal circumflex and RCA;   50% proximal LAD steonsis (mod).   Echocardiogram showed preserved LV function w/o wall motion abnormalities.  Treated w/ Plavix, metoprolol, ASA.  Patient hospitalized from 2/7/2021 - 2/9/2021. Patient has done well post-discharge w/o recurrence of chest pain.
Age: 86.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Abdominal pain upper, Acute myocardial infarction, Catheterisation cardiac abnormal, Chest pain, Coronary artery stenosis
Clinical narrative: Patient received Moderna Covid-19 vaccine #1 morning of 2/7/2021.  Had been feeling fine until about 8 hours later, when she started to have epigastric /chest pain, full body shaking.  EMS activated and patient was brought to ER.  Upon arrival, found to have elevated troponin of 141 and peak level of 490;    diagnosed with NSTEMI.   Patient was taken to cath lab:  patent L main; normal circumflex and RCA;   50% proximal LAD steonsis (mod).   Echocardiogram showed preserved LV function w/o wall motion abnormalities.  Treated w/ Plavix, metoprolol, ASA.  Patient hospitalized from 2/7/2021 - 2/9/2021. Patient has done well post-discharge w/o recurrence of chest pain.
Age: 86.0
Sex: F
Vaccine: UNK, COVID19
Symptoms: Echocardiogram normal, Tremor, Troponin, Troponin increased
Clinical narrative: Patient received Moderna Covid-19 vaccine #1 morning of 2/7/2021.  Had been feeling fine until about 8 hours later, when she started to have epigastric /chest pain, full body shaking.  EMS activated and patient was brought to ER.  Upon arrival, found to have elevated troponin of 141 and peak level of 490;    diagnosed with NSTEMI.   Patient was taken to cath lab:  patent L main; normal circumflex and RCA;   50% proximal LAD steonsis (mod).   Echocardiogram showed preserved LV function w/o wall motion abnormalities.  Treated w/ Plavix, metoprolol, ASA.  Patient hospitalized from 2/7/2021 - 2/9/2021. Patient has done well post-discharge w/o recurrence of chest pain.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging, Neck pain, Pain in extremity
Clinical narrative: immediate shoulder pain at the injection site after vaccination with parasthesias of the ulnar aspect of forearm and hand/fingers.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Paraesthesia
Clinical narrative: immediate shoulder pain at the injection site after vaccination with parasthesias of the ulnar aspect of forearm and hand/fingers.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dry mouth, Dysgeusia, Paraesthesia oral
Clinical narrative: Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue.  About 5 minutes after that, I had a metallic taste in my mouth.  I was monitored and my blood pressure was elevated. My pulse was normal.  They monitored me for 1 hour and then let me go home.  The tingling continued through the night.  Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue.  Two days after the vaccine, my heart began to race.  My blood pressure remained high for approx. 2 1/2 weeks.  My heart beat continues to race at times.  I followed up with my PCP and cardiologist who both took EKGs which were normal.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dysgeusia, Electrocardiogram normal, Laboratory test normal, Palpitations
Clinical narrative: Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue.  About 5 minutes after that, I had a metallic taste in my mouth.  I was monitored and my blood pressure was elevated. My pulse was normal.  They monitored me for 1 hour and then let me go home.  The tingling continued through the night.  Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue.  Two days after the vaccine, my heart began to race.  My blood pressure remained high for approx. 2 1/2 weeks.  My heart beat continues to race at times.  I followed up with my PCP and cardiologist who both took EKGs which were normal.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Ten minutes after getting the vaccine I experienced tingling on both sides of my mouth and my tongue.  About 5 minutes after that, I had a metallic taste in my mouth.  I was monitored and my blood pressure was elevated. My pulse was normal.  They monitored me for 1 hour and then let me go home.  The tingling continued through the night.  Around 8 hours after the vaccine, the tingling was only on the left side of my mouth and tongue.  Two days after the vaccine, my heart began to race.  My blood pressure remained high for approx. 2 1/2 weeks.  My heart beat continues to race at times.  I followed up with my PCP and cardiologist who both took EKGs which were normal.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Productive cough, Rash, SARS-CoV-2 test
Clinical narrative: The rash started on the feet on 02-07-2021 - progressed to cover all limbs, upper and lower back, neck to the hairline. I took Benadryl when I first noticed the rash as well as Zyrtec. When the rash started to become more pronounced and inflamed I called my regular clinic and was advised to go to urgent care since I also had an occasional cough (to get air) and a headache. I was seen by APN who advised a Covid test (both PCR & Antigen) both ended up negative she also advised me to continue with Benadryl and Zyrtec and follow up with my regular doctor if symptoms continue - On Friday 02-12-2021 my throat began to feel "full" and the rash more pronounced my doctor then prescribed Prednisone 20 mg tablets for five days along with the other two meds. Rash has started to fade over the course of three days.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Rash, SARS-CoV-2 test negative, Throat tightness
Clinical narrative: The rash started on the feet on 02-07-2021 - progressed to cover all limbs, upper and lower back, neck to the hairline. I took Benadryl when I first noticed the rash as well as Zyrtec. When the rash started to become more pronounced and inflamed I called my regular clinic and was advised to go to urgent care since I also had an occasional cough (to get air) and a headache. I was seen by APN who advised a Covid test (both PCR & Antigen) both ended up negative she also advised me to continue with Benadryl and Zyrtec and follow up with my regular doctor if symptoms continue - On Friday 02-12-2021 my throat began to feel "full" and the rash more pronounced my doctor then prescribed Prednisone 20 mg tablets for five days along with the other two meds. Rash has started to fade over the course of three days.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Injection site pain
Clinical narrative: I received a double dose, 1 milliliter instead of 1/2 milliliter. No adverse effects except pharmacist said I wouldn?t need a second injection in a month and I?m concerned about this.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: I received a double dose, 1 milliliter instead of 1/2 milliliter. No adverse effects except pharmacist said I wouldn?t need a second injection in a month and I?m concerned about this.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose decreased, Glassy eyes, Heart rate increased, Injection site pain, Tremor
Clinical narrative: Patient had post vaccine tachycardia, tremor, hypertension requiring phone call to 911 + prolonged observation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Tremor
Clinical narrative: Patient had post vaccine tachycardia, tremor, hypertension requiring phone call to 911 + prolonged observation
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Hypertension, Tachycardia, Tremor
Clinical narrative: Patient had post vaccine tachycardia, tremor, hypertension requiring phone call to 911 + prolonged observation
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Death, Fatigue, Hypersomnia, Somnolence
Clinical narrative: Nurse out to see Member on 2/12 at 1530 due to "weakness", member states "probably feeling sick because of the vaccine".  Nurse noted that she was lethargic but oriented and responding.  VSS T 98.6, P 74, O2 96%, Res 18, BP 138/60, BS 235.  Son notified.  He stated that he was on the way and would stay with her to monitor her.  She refused hospital evaluation, nurse recommended she go to outpatient clinic for f/u.  Nurse called at 2/13, 4:20am.  Son found Member unresponsive.  Nurse noted  Member to be pulseless, not breathing, non responsive to tactile stimulation.  EMS and police notified.  Member was DNR.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Lethargy, Malaise, Pulse absent, Respiratory arrest
Clinical narrative: Nurse out to see Member on 2/12 at 1530 due to "weakness", member states "probably feeling sick because of the vaccine".  Nurse noted that she was lethargic but oriented and responding.  VSS T 98.6, P 74, O2 96%, Res 18, BP 138/60, BS 235.  Son notified.  He stated that he was on the way and would stay with her to monitor her.  She refused hospital evaluation, nurse recommended she go to outpatient clinic for f/u.  Nurse called at 2/13, 4:20am.  Son found Member unresponsive.  Nurse noted  Member to be pulseless, not breathing, non responsive to tactile stimulation.  EMS and police notified.  Member was DNR.
Age: 94.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Nurse out to see Member on 2/12 at 1530 due to "weakness", member states "probably feeling sick because of the vaccine".  Nurse noted that she was lethargic but oriented and responding.  VSS T 98.6, P 74, O2 96%, Res 18, BP 138/60, BS 235.  Son notified.  He stated that he was on the way and would stay with her to monitor her.  She refused hospital evaluation, nurse recommended she go to outpatient clinic for f/u.  Nurse called at 2/13, 4:20am.  Son found Member unresponsive.  Nurse noted  Member to be pulseless, not breathing, non responsive to tactile stimulation.  EMS and police notified.  Member was DNR.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain
Clinical narrative: Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104.  Brought in for observation.  Pt stated being nervous about the vaccine.  @1210 HR 80 per Dr.  @ 1251 BP 122/70, HR 72, Pt stating feeling better.   Dr.  walked her to her husband.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104.  Brought in for observation.  Pt stated being nervous about the vaccine.  @1210 HR 80 per Dr.  @ 1251 BP 122/70, HR 72, Pt stating feeling better.   Dr.  walked her to her husband.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Nervousness, Palpitations
Clinical narrative: Pt c/o shaky, dizziness, heart racing, @ 1204 BP 138/80, O2 99, HR 104.  Brought in for observation.  Pt stated being nervous about the vaccine.  @1210 HR 80 per Dr.  @ 1251 BP 122/70, HR 72, Pt stating feeling better.   Dr.  walked her to her husband.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Lots of arm burning with rash and painful to touch at area of injection site (2/11 am) - up to 5x5"; some improvement 2/13 - now mostly resolved - light pruritus only; axillary fullness 2/11, but enlarged through 2/14 and somewhat better today.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site rash, Oedema peripheral, Pruritus
Clinical narrative: Lots of arm burning with rash and painful to touch at area of injection site (2/11 am) - up to 5x5"; some improvement 2/13 - now mostly resolved - light pruritus only; axillary fullness 2/11, but enlarged through 2/14 and somewhat better today.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Headache, chills, muscle ache, fatigue, no appetite
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, muscle ache, fatigue, no appetite
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Influenza like illness, Myalgia, Pain
Clinical narrative: Your evaluation in the ER was consistent with a viral GI infection.  Specifically, you tested negative for Coronavirus and Influenza.  Use Zofran provided to help with nausea and vomiting to facilitate drinking 3-4 liters of water daily. Return to the ER for increasing or localizing abdominal pain, blood in stool or fevers. Otherwise, please follow up with your Primary Care provider.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Your evaluation in the ER was consistent with a viral GI infection.  Specifically, you tested negative for Coronavirus and Influenza.  Use Zofran provided to help with nausea and vomiting to facilitate drinking 3-4 liters of water daily. Return to the ER for increasing or localizing abdominal pain, blood in stool or fevers. Otherwise, please follow up with your Primary Care provider.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gastrointestinal infection, Influenza virus test negative, Nausea, SARS-CoV-2 test negative, Viral infection
Clinical narrative: Your evaluation in the ER was consistent with a viral GI infection.  Specifically, you tested negative for Coronavirus and Influenza.  Use Zofran provided to help with nausea and vomiting to facilitate drinking 3-4 liters of water daily. Return to the ER for increasing or localizing abdominal pain, blood in stool or fevers. Otherwise, please follow up with your Primary Care provider.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Your evaluation in the ER was consistent with a viral GI infection.  Specifically, you tested negative for Coronavirus and Influenza.  Use Zofran provided to help with nausea and vomiting to facilitate drinking 3-4 liters of water daily. Return to the ER for increasing or localizing abdominal pain, blood in stool or fevers. Otherwise, please follow up with your Primary Care provider.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: The patient had her second COVID vaccine on 2/13/2021 around 1130 a.m. At 1145 she stated her lips were tingling. We placed her with the crew. Around 12noon she She said she started feeling like her tongue felt different. 1210 she said her tongue swelling sensation. We continued to monitor closely. at 1215 she reported that her throat felt like there was a pill stuck. 911 was called she stated herthroat  felt funny, some nausea and a slight rash and her tongue started to feel like it was swellingworst and therefore sheinjected herself with her EpiPen at  1230. She was started feeling better and was brought in by EMS for medical eval. Denies  short of breath and is having no trouble breathing or swallowing.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Nausea, Paraesthesia oral, Pharyngeal swelling, Rash
Clinical narrative: The patient had her second COVID vaccine on 2/13/2021 around 1130 a.m. At 1145 she stated her lips were tingling. We placed her with the crew. Around 12noon she She said she started feeling like her tongue felt different. 1210 she said her tongue swelling sensation. We continued to monitor closely. at 1215 she reported that her throat felt like there was a pill stuck. 911 was called she stated herthroat  felt funny, some nausea and a slight rash and her tongue started to feel like it was swellingworst and therefore sheinjected herself with her EpiPen at  1230. She was started feeling better and was brought in by EMS for medical eval. Denies  short of breath and is having no trouble breathing or swallowing.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: The patient had her second COVID vaccine on 2/13/2021 around 1130 a.m. At 1145 she stated her lips were tingling. We placed her with the crew. Around 12noon she She said she started feeling like her tongue felt different. 1210 she said her tongue swelling sensation. We continued to monitor closely. at 1215 she reported that her throat felt like there was a pill stuck. 911 was called she stated herthroat  felt funny, some nausea and a slight rash and her tongue started to feel like it was swellingworst and therefore sheinjected herself with her EpiPen at  1230. She was started feeling better and was brought in by EMS for medical eval. Denies  short of breath and is having no trouble breathing or swallowing.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood electrolytes, Computerised tomogram, Eyelid disorder, Facial paralysis, Facial paresis
Clinical narrative: None stated.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Full blood count, Hypoaesthesia oral, Lacrimation increased, Oropharyngeal discomfort
Clinical narrative: None stated.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: I wanted to report that the pharmacist that administered the vaccine gave my mother the 1st dose of the vaccine 2 times in under a minute while being distracted.  This was a horrifying and careless mistake.  My mother is experiencing a headache that has been intense for 48 hours now, a very large visible lump at the injection site along with a red rash.  She has had  dizziness and lightheadedness.  She also has ringing in her ears.  The main reason for filing this report is because of the error made and the concern of what other effects getting a double dose of the 1st shot will cause her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Incorrect dose administered, Injection site mass
Clinical narrative: I wanted to report that the pharmacist that administered the vaccine gave my mother the 1st dose of the vaccine 2 times in under a minute while being distracted.  This was a horrifying and careless mistake.  My mother is experiencing a headache that has been intense for 48 hours now, a very large visible lump at the injection site along with a red rash.  She has had  dizziness and lightheadedness.  She also has ringing in her ears.  The main reason for filing this report is because of the error made and the concern of what other effects getting a double dose of the 1st shot will cause her.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Rash erythematous, Tinnitus
Clinical narrative: I wanted to report that the pharmacist that administered the vaccine gave my mother the 1st dose of the vaccine 2 times in under a minute while being distracted.  This was a horrifying and careless mistake.  My mother is experiencing a headache that has been intense for 48 hours now, a very large visible lump at the injection site along with a red rash.  She has had  dizziness and lightheadedness.  She also has ringing in her ears.  The main reason for filing this report is because of the error made and the concern of what other effects getting a double dose of the 1st shot will cause her.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Nurse calling to report a temperature excursion involving PROQUAD and VARlVAX.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 27-JAN-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, 0.5 milliliter (ml) (lot number T025510 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (vaccination scheme, route of administration, and anatomical site of injection were not reported), and varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) both administered as prophylaxis. The administered doses of the vaccines were stored at a temperature of 8.3 degrees Fahrenheit (F); 8.1 F, during a time frame of 5 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA013552: US-009507513-2101USA013563: US-009507513-2101USA013565:
Age: 11.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; Temperature -7.9 for 53 minutes and -10.5C for 52 minutes; Information has been received from the vaccine coordinator and a nurse, referring to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 29-JAN-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1637651, expiration date on 09-JUN-2022 (also reported on 09-SEP-2022) (anatomical location and administration route were not reported) as prophylaxis. No adverse effects were reported.  The reporting vaccine coordinator was unsure about the lot number used, however the nurse confirmed the lot number administered to the patient. The vaccine had two temperature excursions of -7.9 Celsius degrees (C) during 53 minutes and -10.5 C during 52 minutes. It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. This is one of several reports received from the same source. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA001188: US-009507513-2102USA001280: US-009507513-2102USA001367:
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: the patient is not exhibiting any adverse symptoms.; Caller is a nurse practitioner reporting that a patient received a dose of MMR II on 29JAN2021 after having had a previous admistration l 1SEP2020.; Information has been received from a nurse practitioner, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 11-SEP-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (anatomical location, administration route, lot # and expiration date were not reported) for prophylaxis.  Later, on 29-JAN-2021, the patient was vaccinated with an additional dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037502 and expiration date on 20-NOV-2021 (anatomical location and administration route were not reported) for prophylaxis.  Per caller, the patient was not exhibiting any adverse symptoms.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: no additional AE; temperature excursion involving Pneumovax 23 was administrated to 2 patients; Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no information regarding to the patient's pertinent medical history, concomitant medications, or drug reactions/allergies provided.  On 02-FEB-2021, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T031820, expiration date 10-MAY-2022 for prophylaxis; dose and route were not provided), which involved a temperature excursion. The vaccine was stored at temperature of 47.7 Fahrenheit degree for 30 minutes. There was no previous temperature excursion. The call was because of digital data logger. No other adverse effect was reported. There was no product quality complaint involved in this case. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T031820; expirationdate: 10-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Office manager calling to report a temperature excursion involving VARlVAX. Caller, "some of the vaccines were administered."; No other AE reported.; This spontaneous report was received from a office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, for prophylaxis (lot # T010311 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 24-MAR-2022) (strength, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were -9.51° Celsius (C) for 56 minutes respectively.  A digital data logger was involved, and there was not previous temperature excursion.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Manager report a temperature excursion for PROQUAD and VARIVAX and were administered to patients prior to having them evaluated; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, for prophylaxis (lot # T003707 has been verified to be a valid lot number virus vaccine live (oka/merck), expiration date reported and establish as 30-JAN-2022) (strength, route of administration and anatomical location were not provided) and with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, route of administration and anatomical location, lot number and expiration date were not provided).   The temperature of storage and time frame of the excursion were unknown. Also, if a digital data logger was involved, and if there was a previous temperature excursion were not provided.