chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Throat tightness
Clinical narrative: My daughter is experiencing periodically nose bleeds, brain fog and bit distracted and losing herself in her thoughts after her first dose  Pfizer vaccine. This is new from the initial report. Her mother also states she feels fatigue and not active for a few days now.  At this time I have not been able to get an appointment to see her doctor and I am very concerned about her symptoms.   I would like more research or documentation to be released about this type of group to figure out why this happened to her. Also, I would like to see if they are going to be monitored after her vaccine. I do not know what other side effects will be coming after her vaccine and I am concerned.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Epistaxis, Fatigue, Feeling abnormal
Clinical narrative: My daughter is experiencing periodically nose bleeds, brain fog and bit distracted and losing herself in her thoughts after her first dose  Pfizer vaccine. This is new from the initial report. Her mother also states she feels fatigue and not active for a few days now.  At this time I have not been able to get an appointment to see her doctor and I am very concerned about her symptoms.   I would like more research or documentation to be released about this type of group to figure out why this happened to her. Also, I would like to see if they are going to be monitored after her vaccine. I do not know what other side effects will be coming after her vaccine and I am concerned.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Uterine dilation and curettage
Clinical narrative: miscarriage; Pregnancy at the time of vaccination: Yes; Pregnancy at the time of vaccination: Yes; This is a spontaneous report from a contactable consumer (patient). A 32-year-old pregnant female patient received BNT162B2 (brand: Pfizer), dose 1 on 17Mar2021 13:30 and dose 2 on 07Apr2021 13:30, via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a workplace clinic. Medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified prenatal vitamin, iron supplement, and sertraline hydrochloride (ZOLOFT). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. The fetus she was pregnant with stopped growing at 5.5 weeks which happened to be the same time she had the vaccine. She ended up with a miscarriage. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Treatment was received: took medicine to complete the miscarriage process. Since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: miscarriage; Pregnancy at the time of vaccination: Yes; Pregnancy at the time of vaccination: Yes; This is a spontaneous report from a contactable consumer (patient). A 32-year-old pregnant female patient received BNT162B2 (brand: Pfizer), dose 1 on 17Mar2021 13:30 and dose 2 on 07Apr2021 13:30, via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a workplace clinic. Medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included unspecified prenatal vitamin, iron supplement, and sertraline hydrochloride (ZOLOFT). No other vaccines within 4 weeks prior to the COVID vaccine. The patient was pregnant at the time of vaccination. The fetus she was pregnant with stopped growing at 5.5 weeks which happened to be the same time she had the vaccine. She ended up with a miscarriage. The adverse events resulted to doctor or other healthcare professional office/clinic visit. Treatment was received: took medicine to complete the miscarriage process. Since the vaccination, she has not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oral pruritus, Throat tightness
Clinical narrative: throat was closing; throat was itching; This is a spontaneous report received from a contactable consumer (patient). This 12-year-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 18:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient previously took penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced throat was itching on 14May2021 18:05 and throat was closing on 14May2021 18:08. Within 5 min of shot throat was itching, at 8 minutes throat was closing and 911 was called. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included Oxygen treatment, epinephrine, diphenhydramine hydrochloride (BENADRYL). The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information about Lot/Batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: throat was closing; throat was itching; This is a spontaneous report received from a contactable consumer (patient). This 12-year-old male patient received the first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left on 14May2021 18:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no medical history or concomitant medications. The patient previously took penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced throat was itching on 14May2021 18:05 and throat was closing on 14May2021 18:08. Within 5 min of shot throat was itching, at 8 minutes throat was closing and 911 was called. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event included Oxygen treatment, epinephrine, diphenhydramine hydrochloride (BENADRYL). The outcome of the events was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information about Lot/Batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Vision blurred
Clinical narrative: I got the vaccine and I experienced very slightly blurry vision 15 minutes after. My vision detororated very bad so I couldn't read my phone or laptop in a weeks time. I contacted my primary care 2 days after this happened and she referred me to a Ophthalmologist, and then the Ophthalmologist referred me to a Retinal Specialist who said nothing seems wrong and to use reading glasses temporarily. And so after that I contacted the Optometrist to get the proper glasses because over the counter glasses werent working well. There has been reddness in my eyes so I;ve been using eye drops for more than a month.  I"m nursing and also had the Lasik done 5 years ago because childhood distance vision problem.  I used glasses when I was younger and did surgery to stop using them. Since vaccination my near and distance vision got really bad, now the distance is a little better but near is still very bad.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Ocular hyperaemia, Vision blurred, Visual impairment
Clinical narrative: I got the vaccine and I experienced very slightly blurry vision 15 minutes after. My vision detororated very bad so I couldn't read my phone or laptop in a weeks time. I contacted my primary care 2 days after this happened and she referred me to a Ophthalmologist, and then the Ophthalmologist referred me to a Retinal Specialist who said nothing seems wrong and to use reading glasses temporarily. And so after that I contacted the Optometrist to get the proper glasses because over the counter glasses werent working well. There has been reddness in my eyes so I;ve been using eye drops for more than a month.  I"m nursing and also had the Lasik done 5 years ago because childhood distance vision problem.  I used glasses when I was younger and did surgery to stop using them. Since vaccination my near and distance vision got really bad, now the distance is a little better but near is still very bad.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: The day of the vaccine his throat started to feel like it was closing.  He was starting to have trouble breathing. His parent gave him some Benadryl and we waited to be observed for an hour before we left. He has not had any other problems since the vaccine and we have been advised to pre-medicate before the next dose.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: The day of the vaccine his throat started to feel like it was closing.  He was starting to have trouble breathing. His parent gave him some Benadryl and we waited to be observed for an hour before we left. He has not had any other problems since the vaccine and we have been advised to pre-medicate before the next dose.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Malaise, Nervousness, Pallor, Unresponsive to stimuli
Clinical narrative: C/O "not feeling well today" became unresponsive for less than 1 second, became  pale was given juice, color improved and he stated he was 'stressed out prior to vaccine
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pallor, Unresponsive to stimuli
Clinical narrative: C/O "not feeling well today" became unresponsive for less than 1 second, became  pale was given juice, color improved and he stated he was 'stressed out prior to vaccine
Age: 15.0
Sex: M
Vaccine: COVID19, HPV9, COVID19
Symptoms: C-reactive protein increased, Chest pain, Chills, Electrocardiogram ST segment abnormal, Electrocardiogram abnormal
Clinical narrative: AT THE TIME OF VACCINE, NO ADVERSE EVENT REPORTED DUE TO PATIENT AGE
Age: 15.0
Sex: M
Vaccine: COVID19, HPV9, COVID19
Symptoms: Fatigue, Intensive care, Myocarditis, Respiratory viral panel, SARS-CoV-2 antibody test positive
Clinical narrative: AT THE TIME OF VACCINE, NO ADVERSE EVENT REPORTED DUE TO PATIENT AGE
Age: 15.0
Sex: M
Vaccine: COVID19, HPV9, COVID19
Symptoms: SARS-CoV-2 test negative, Tachycardia, Troponin increased
Clinical narrative: AT THE TIME OF VACCINE, NO ADVERSE EVENT REPORTED DUE TO PATIENT AGE
Age: 15.0
Sex: M
Vaccine: COVID19, HPV9, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: AT THE TIME OF VACCINE, NO ADVERSE EVENT REPORTED DUE TO PATIENT AGE
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 5/19/2021 Symptom Onset - cough, wheezing, no fever, no other symptoms noted per patient    5/24/2021 Treated with Casirivimab, Indevimab 2400 mg IV once at 240 ml/hr + epinephrine + diphenhydramine + famotidine 5/24/2021 productive cough, SOB with exertion, wheezing (on steroid) 5/26/2021 H/A, taking Ibuprofen, cough, SOB with exertion on stairs.   Tussionex 5/26/2021 Z PAck
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Cough, Dyspnoea exertional, Productive cough
Clinical narrative: 5/19/2021 Symptom Onset - cough, wheezing, no fever, no other symptoms noted per patient    5/24/2021 Treated with Casirivimab, Indevimab 2400 mg IV once at 240 ml/hr + epinephrine + diphenhydramine + famotidine 5/24/2021 productive cough, SOB with exertion, wheezing (on steroid) 5/26/2021 H/A, taking Ibuprofen, cough, SOB with exertion on stairs.   Tussionex 5/26/2021 Z PAck
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sinusitis bacterial, Wheezing
Clinical narrative: 5/19/2021 Symptom Onset - cough, wheezing, no fever, no other symptoms noted per patient    5/24/2021 Treated with Casirivimab, Indevimab 2400 mg IV once at 240 ml/hr + epinephrine + diphenhydramine + famotidine 5/24/2021 productive cough, SOB with exertion, wheezing (on steroid) 5/26/2021 H/A, taking Ibuprofen, cough, SOB with exertion on stairs.   Tussionex 5/26/2021 Z PAck
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyspnoea, Echocardiogram
Clinical narrative: bilateral pulmonary embolism; legs were checked and they could not locate any other blood clots - just in lungs.; I experienced extreme shortness of breath/I could not catch my breath; heart was 'resting' at approximately 145 beats per minute./elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnancy) received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine, lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 07May2021 at 10:00 (Batch/Lot Number: EW0182) as unknown, single for COVID-19 immunization. No pregnancy at time of vaccination. Medical history included polycystic ovarian syndrome (Pcos), high cholesterol, and allergies: fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination. At 8:00 AM on 10May2021, the patient experienced extreme shortness of breath and an elevated heart rate. She could not catch her breath and her heart was 'resting' at approximately 145 beats per minute. She went to the local emergency room at which time she was taken back for testing, approximately 10 hours later, she was diagnosed with bilateral pulmonary embolism. Her legs were checked, and they could not locate any other blood clots - just in her lungs. Treatments (levofloxacin (LOVENOX) shots and oral blood thinners) received for the adverse events. The events required to visit emergency room/department or urgent care. The events were reported as serious with seriousness criteria of hospitalization (for 2 days) and life threatening (threatening illness, immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Heart rate increased, Pulmonary embolism, Ultrasound Doppler
Clinical narrative: bilateral pulmonary embolism; legs were checked and they could not locate any other blood clots - just in lungs.; I experienced extreme shortness of breath/I could not catch my breath; heart was 'resting' at approximately 145 beats per minute./elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnancy) received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine, lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 07May2021 at 10:00 (Batch/Lot Number: EW0182) as unknown, single for COVID-19 immunization. No pregnancy at time of vaccination. Medical history included polycystic ovarian syndrome (Pcos), high cholesterol, and allergies: fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination. At 8:00 AM on 10May2021, the patient experienced extreme shortness of breath and an elevated heart rate. She could not catch her breath and her heart was 'resting' at approximately 145 beats per minute. She went to the local emergency room at which time she was taken back for testing, approximately 10 hours later, she was diagnosed with bilateral pulmonary embolism. Her legs were checked, and they could not locate any other blood clots - just in her lungs. Treatments (levofloxacin (LOVENOX) shots and oral blood thinners) received for the adverse events. The events required to visit emergency room/department or urgent care. The events were reported as serious with seriousness criteria of hospitalization (for 2 days) and life threatening (threatening illness, immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: bilateral pulmonary embolism; legs were checked and they could not locate any other blood clots - just in lungs.; I experienced extreme shortness of breath/I could not catch my breath; heart was 'resting' at approximately 145 beats per minute./elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnancy) received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine, lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 07May2021 at 10:00 (Batch/Lot Number: EW0182) as unknown, single for COVID-19 immunization. No pregnancy at time of vaccination. Medical history included polycystic ovarian syndrome (Pcos), high cholesterol, and allergies: fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination. At 8:00 AM on 10May2021, the patient experienced extreme shortness of breath and an elevated heart rate. She could not catch her breath and her heart was 'resting' at approximately 145 beats per minute. She went to the local emergency room at which time she was taken back for testing, approximately 10 hours later, she was diagnosed with bilateral pulmonary embolism. Her legs were checked, and they could not locate any other blood clots - just in her lungs. Treatments (levofloxacin (LOVENOX) shots and oral blood thinners) received for the adverse events. The events required to visit emergency room/department or urgent care. The events were reported as serious with seriousness criteria of hospitalization (for 2 days) and life threatening (threatening illness, immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: bilateral pulmonary embolism; legs were checked and they could not locate any other blood clots - just in lungs.; I experienced extreme shortness of breath/I could not catch my breath; heart was 'resting' at approximately 145 beats per minute./elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient (no pregnancy) received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine, lot number: EW0182), via an unspecified route of administration, administered in Arm Left on 07May2021 at 10:00 (Batch/Lot Number: EW0182) as unknown, single for COVID-19 immunization. No pregnancy at time of vaccination. Medical history included polycystic ovarian syndrome (Pcos), high cholesterol, and allergies: fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination. At 8:00 AM on 10May2021, the patient experienced extreme shortness of breath and an elevated heart rate. She could not catch her breath and her heart was 'resting' at approximately 145 beats per minute. She went to the local emergency room at which time she was taken back for testing, approximately 10 hours later, she was diagnosed with bilateral pulmonary embolism. Her legs were checked, and they could not locate any other blood clots - just in her lungs. Treatments (levofloxacin (LOVENOX) shots and oral blood thinners) received for the adverse events. The events required to visit emergency room/department or urgent care. The events were reported as serious with seriousness criteria of hospitalization (for 2 days) and life threatening (threatening illness, immediate risk of death from the event). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chest discomfort, Chills, Erythema, Pruritus
Clinical narrative: My skin felt as if it was on fire. Warm to touch and resembled a sunburn; my skin from head to foot would turn red excluding my fingers and toes; Chills followed and extreme itchiness; Chills followed and extreme itchiness; This is a spontaneous report from a contactable female consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06May2021 17:45 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunisation. Medical history included asthma and chiari 1 malformation, and possible ileus colon (still under review). Concomitant medications included docusate sodium (COLACE), vitamins, allergy medications (meds) & asthma meds. The patient's known allergies was reported as 'sensitive to prednisone.' Patient was not diagnosed with COVID-19 prior to vaccination. Patient stated "on three separate occasions (Saturday- 08May2021 01:00PM, Monday and today, Wednesday) my skin from head to foot would turn red excluding my fingers and toes. My skin felt as if it was on fire. Warm to touch and resembled a sunburn. Chills followed and extreme itchiness. I would take allergy medication and a hot bath to bring myself back to normal. Visited emergency clinic but symptoms subsided upon arrival (Monday). Advised I needed urgent care today. Pictures available if needed." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included steroid prescription and diphenhydramine (BENADRYL). Outcome of the events was unknown. Patient had not been tested for COVID-19 since the vaccination.  Information on batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: My skin felt as if it was on fire. Warm to touch and resembled a sunburn; my skin from head to foot would turn red excluding my fingers and toes; Chills followed and extreme itchiness; Chills followed and extreme itchiness; This is a spontaneous report from a contactable female consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06May2021 17:45 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunisation. Medical history included asthma and chiari 1 malformation, and possible ileus colon (still under review). Concomitant medications included docusate sodium (COLACE), vitamins, allergy medications (meds) & asthma meds. The patient's known allergies was reported as 'sensitive to prednisone.' Patient was not diagnosed with COVID-19 prior to vaccination. Patient stated "on three separate occasions (Saturday- 08May2021 01:00PM, Monday and today, Wednesday) my skin from head to foot would turn red excluding my fingers and toes. My skin felt as if it was on fire. Warm to touch and resembled a sunburn. Chills followed and extreme itchiness. I would take allergy medication and a hot bath to bring myself back to normal. Visited emergency clinic but symptoms subsided upon arrival (Monday). Advised I needed urgent care today. Pictures available if needed." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included steroid prescription and diphenhydramine (BENADRYL). Outcome of the events was unknown. Patient had not been tested for COVID-19 since the vaccination.  Information on batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Erythema, Pruritus, Skin burning sensation
Clinical narrative: My skin felt as if it was on fire. Warm to touch and resembled a sunburn; my skin from head to foot would turn red excluding my fingers and toes; Chills followed and extreme itchiness; Chills followed and extreme itchiness; This is a spontaneous report from a contactable female consumer (patient herself). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 06May2021 17:45 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunisation. Medical history included asthma and chiari 1 malformation, and possible ileus colon (still under review). Concomitant medications included docusate sodium (COLACE), vitamins, allergy medications (meds) & asthma meds. The patient's known allergies was reported as 'sensitive to prednisone.' Patient was not diagnosed with COVID-19 prior to vaccination. Patient stated "on three separate occasions (Saturday- 08May2021 01:00PM, Monday and today, Wednesday) my skin from head to foot would turn red excluding my fingers and toes. My skin felt as if it was on fire. Warm to touch and resembled a sunburn. Chills followed and extreme itchiness. I would take allergy medication and a hot bath to bring myself back to normal. Visited emergency clinic but symptoms subsided upon arrival (Monday). Advised I needed urgent care today. Pictures available if needed." Events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included steroid prescription and diphenhydramine (BENADRYL). Outcome of the events was unknown. Patient had not been tested for COVID-19 since the vaccination.  Information on batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Anticoagulant therapy, Blood test, Computerised tomogram abdomen, Computerised tomogram abnormal
Clinical narrative: I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism; This is a spontaneous report from a contactable healthcare professional (patient herself). A 36-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration in right arm on 26Jan2021 11:00 (Batch/Lot Number: EL1283) as 2nd dose, single; and via an unspecified route of administration in left arm on 08Jan2021 16:15 (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included vitamin B6, escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (UNISOM), and prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported "I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism (on 14May2021). I was treated in the hospital from 14May2021 - 16May2021. I am home now and am on anticoagulant medication for an extended period of time. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was treated with IV heparin drip/blood pressure medicine. The patient was 18 Weeks pregnant at the onset of the event and was due to deliver on 10May2021. The patient underwent Covid test: negative on 09May2021 (Nasal swab). Outcome of the event was recovering.; Sender's Comments: Based on the information provided, the event pulmonary embolism is considered unlikely related to suspect product BNT162B2 (BNT162B2), (Batch/Lot Number: EL1283) as 2nd dose, single; and (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The event occurred 3 months 18 days after the last dose of the  suspect product.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Exposure during pregnancy, Induced labour, Inflammation
Clinical narrative: I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism; This is a spontaneous report from a contactable healthcare professional (patient herself). A 36-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration in right arm on 26Jan2021 11:00 (Batch/Lot Number: EL1283) as 2nd dose, single; and via an unspecified route of administration in left arm on 08Jan2021 16:15 (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included vitamin B6, escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (UNISOM), and prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported "I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism (on 14May2021). I was treated in the hospital from 14May2021 - 16May2021. I am home now and am on anticoagulant medication for an extended period of time. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was treated with IV heparin drip/blood pressure medicine. The patient was 18 Weeks pregnant at the onset of the event and was due to deliver on 10May2021. The patient underwent Covid test: negative on 09May2021 (Nasal swab). Outcome of the event was recovering.; Sender's Comments: Based on the information provided, the event pulmonary embolism is considered unlikely related to suspect product BNT162B2 (BNT162B2), (Batch/Lot Number: EL1283) as 2nd dose, single; and (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The event occurred 3 months 18 days after the last dose of the  suspect product.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pre-eclampsia, Pulmonary embolism, Ultrasound Doppler normal
Clinical narrative: I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism; This is a spontaneous report from a contactable healthcare professional (patient herself). A 36-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration in right arm on 26Jan2021 11:00 (Batch/Lot Number: EL1283) as 2nd dose, single; and via an unspecified route of administration in left arm on 08Jan2021 16:15 (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included vitamin B6, escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (UNISOM), and prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported "I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism (on 14May2021). I was treated in the hospital from 14May2021 - 16May2021. I am home now and am on anticoagulant medication for an extended period of time. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was treated with IV heparin drip/blood pressure medicine. The patient was 18 Weeks pregnant at the onset of the event and was due to deliver on 10May2021. The patient underwent Covid test: negative on 09May2021 (Nasal swab). Outcome of the event was recovering.; Sender's Comments: Based on the information provided, the event pulmonary embolism is considered unlikely related to suspect product BNT162B2 (BNT162B2), (Batch/Lot Number: EL1283) as 2nd dose, single; and (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The event occurred 3 months 18 days after the last dose of the  suspect product.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: I developed a pulmonary embolism; BNT162B2 on 08Jan2021 as 1st dose, on 26Jan2021 as 2nd dose; I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism; This is a spontaneous report from a contactable healthcare professional (patient herself). A 36-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration in right arm on 26Jan2021 11:00 (Batch/Lot Number: EL1283) as 2nd dose, single; and via an unspecified route of administration in left arm on 08Jan2021 16:15 (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included vitamin B6, escitalopram oxalate (LEXAPRO), diphenhydramine hydrochloride (UNISOM), and prenatal vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. The patient reported "I was only four days out from delivering a healthy baby boy when I developed a pulmonary embolism (on 14May2021). I was treated in the hospital from 14May2021 - 16May2021. I am home now and am on anticoagulant medication for an extended period of time. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was treated with IV heparin drip/blood pressure medicine. The patient was 18 Weeks pregnant at the onset of the event and was due to deliver on 10May2021. The patient underwent Covid test: negative on 09May2021 (Nasal swab). Outcome of the event was recovering.; Sender's Comments: Based on the information provided, the event pulmonary embolism is considered unlikely related to suspect product BNT162B2 (BNT162B2), (Batch/Lot Number: EL1283) as 2nd dose, single; and (Batch/Lot Number: EK5730) as 1st dose, single for COVID-19 immunization. The event occurred 3 months 18 days after the last dose of the  suspect product.
Age: 63.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Haemorrhage, Mouth haemorrhage, Platelet count decreased
Clinical narrative: Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.
Age: 63.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Blood folate normal, Computerised tomogram abdomen normal, Epstein-Barr virus antibody positive, Flow cytometry, Full blood count abnormal
Clinical narrative: Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.
Age: 63.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: HIV test negative, Haptoglobin normal, Hepatitis viral test negative, Immunoglobulin therapy, Oral blood blister
Clinical narrative: Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.
Age: 63.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Rash, Refractory cytopenia with unilineage dysplasia
Clinical narrative: Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.
Age: 63.0
Sex: M
Vaccine: UNK, COVID19, COVID19
Symptoms: Vitamin B12 normal
Clinical narrative: Patient noted petechial rash on his hands on 5/18/21. On 5/19/21, patient woke up and noted a blood blister on inside of his cheek. On the morning of 5/20/21, patient noted many more additional blisters with more petechial rash on his lower legs and arms. Patient called PCP, who ordered CBC. Patient presented to the hospital in the evening of 5/20/21. Patient remains hospitalized. Received high dose IV corticosteroids, IVIG. Now on oral high dose corticosteroids, received vincristine 2 mg and Nplate 10 mcg/kg/dose 5/27/21. Received multiple platelet transfusions. Refractory, no improvement observed as of 5/28/21.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dysphagia, Facial paralysis, Feeding tube user
Clinical narrative: Severe sore throat; severe pain; could not swallow; Ramsay Hunt syndrome; herpes zoster/shingles; cannot speak; half face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 as 1st dose, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included irbesartan. On 18Mar2021 16:00, a severe sore throat began, on 21Mar2021, the patient entered for emergency to hospital, severe pain and could not swallow, on 22Mar2021 he was hospitalized, for 14 days, the first 3 in the intensive care unit. Doctors have given his ailment different names: Ramsay Hunt syndrome, herpes zoster, shingles. On 04Mar2021 they sent me home, but under medical supervision from the hospital. To this date 22May2021 the patient continue with the adverse effects: he cannot swallow, tube feeding into the stomach, he cannot speak, half face paralyzed. The patient received treatment for ae included steroids, antivirals, analgesics. AE_treatment Lupus Erythematosus, Rheumatoid Arthritis, Fibromyalgia (pending confirmation). The adverse event result in visit to the doctor's office or other healthcare professional, Emergency room / department, Hospitalization, Life-threatening illness (immediate risk of death from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Herpes zoster oticus, Intensive care, Magnetic resonance imaging, Oropharyngeal pain
Clinical narrative: Severe sore throat; severe pain; could not swallow; Ramsay Hunt syndrome; herpes zoster/shingles; cannot speak; half face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 as 1st dose, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included irbesartan. On 18Mar2021 16:00, a severe sore throat began, on 21Mar2021, the patient entered for emergency to hospital, severe pain and could not swallow, on 22Mar2021 he was hospitalized, for 14 days, the first 3 in the intensive care unit. Doctors have given his ailment different names: Ramsay Hunt syndrome, herpes zoster, shingles. On 04Mar2021 they sent me home, but under medical supervision from the hospital. To this date 22May2021 the patient continue with the adverse effects: he cannot swallow, tube feeding into the stomach, he cannot speak, half face paralyzed. The patient received treatment for ae included steroids, antivirals, analgesics. AE_treatment Lupus Erythematosus, Rheumatoid Arthritis, Fibromyalgia (pending confirmation). The adverse event result in visit to the doctor's office or other healthcare professional, Emergency room / department, Hospitalization, Life-threatening illness (immediate risk of death from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swallow study, X-ray
Clinical narrative: Severe sore throat; severe pain; could not swallow; Ramsay Hunt syndrome; herpes zoster/shingles; cannot speak; half face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 as 1st dose, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included irbesartan. On 18Mar2021 16:00, a severe sore throat began, on 21Mar2021, the patient entered for emergency to hospital, severe pain and could not swallow, on 22Mar2021 he was hospitalized, for 14 days, the first 3 in the intensive care unit. Doctors have given his ailment different names: Ramsay Hunt syndrome, herpes zoster, shingles. On 04Mar2021 they sent me home, but under medical supervision from the hospital. To this date 22May2021 the patient continue with the adverse effects: he cannot swallow, tube feeding into the stomach, he cannot speak, half face paralyzed. The patient received treatment for ae included steroids, antivirals, analgesics. AE_treatment Lupus Erythematosus, Rheumatoid Arthritis, Fibromyalgia (pending confirmation). The adverse event result in visit to the doctor's office or other healthcare professional, Emergency room / department, Hospitalization, Life-threatening illness (immediate risk of death from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Herpes zoster, Herpes zoster oticus, Lack of spontaneous speech, Oropharyngeal pain
Clinical narrative: Severe sore throat; severe pain; could not swallow; Ramsay Hunt syndrome; herpes zoster/shingles; cannot speak; half face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 as 1st dose, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included irbesartan. On 18Mar2021 16:00, a severe sore throat began, on 21Mar2021, the patient entered for emergency to hospital, severe pain and could not swallow, on 22Mar2021 he was hospitalized, for 14 days, the first 3 in the intensive care unit. Doctors have given his ailment different names: Ramsay Hunt syndrome, herpes zoster, shingles. On 04Mar2021 they sent me home, but under medical supervision from the hospital. To this date 22May2021 the patient continue with the adverse effects: he cannot swallow, tube feeding into the stomach, he cannot speak, half face paralyzed. The patient received treatment for ae included steroids, antivirals, analgesics. AE_treatment Lupus Erythematosus, Rheumatoid Arthritis, Fibromyalgia (pending confirmation). The adverse event result in visit to the doctor's office or other healthcare professional, Emergency room / department, Hospitalization, Life-threatening illness (immediate risk of death from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Paralysis
Clinical narrative: Severe sore throat; severe pain; could not swallow; Ramsay Hunt syndrome; herpes zoster/shingles; cannot speak; half face paralyzed; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 as 1st dose, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included irbesartan. On 18Mar2021 16:00, a severe sore throat began, on 21Mar2021, the patient entered for emergency to hospital, severe pain and could not swallow, on 22Mar2021 he was hospitalized, for 14 days, the first 3 in the intensive care unit. Doctors have given his ailment different names: Ramsay Hunt syndrome, herpes zoster, shingles. On 04Mar2021 they sent me home, but under medical supervision from the hospital. To this date 22May2021 the patient continue with the adverse effects: he cannot swallow, tube feeding into the stomach, he cannot speak, half face paralyzed. The patient received treatment for ae included steroids, antivirals, analgesics. AE_treatment Lupus Erythematosus, Rheumatoid Arthritis, Fibromyalgia (pending confirmation). The adverse event result in visit to the doctor's office or other healthcare professional, Emergency room / department, Hospitalization, Life-threatening illness (immediate risk of death from the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.