chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Heart rate increased, Pharyngeal swelling, Pruritus
Clinical narrative: Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Itching; Burning in my throat and chest and arm; Burning in my throat and chest and arm; Throat swelling; Chest pain/burning in her throat and chest; Rapid heart beat; This is a spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm on 16Mar2021 at 02:00 PM at single dose (lot number: EN6208, expiration date: 30Jun2021) for COVID-19 immunization. Medical history included known allergies to 32 meds and nuts and shellfish, asthma, COPD and seizures and chronic lung disease. Concomitant medications included prednisone and topiramate (TOPAMAX) in two weeks. The patient had no other vaccine in four weeks. The patient was not pregnant when vaccination. The patient was given the covid 19 shot and within mins. The patient tested the shot and started to have itching and burning in her throat and chest and arm and given 50 mgs of Benadryl in her inhaler then a hour later had to go to ER due her throat swelling closed and chest pain, rapid heart beat was given Benadryl n Prednisone. Events started from 16Mar2021 02:15 PM. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient was recovered with lasting effects. Treatment was received for AE at ER 50 mgs Benadryl and 60 mgs of Prednisone. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovered with sequel. Seriousness criteria was reported as life-threatening.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Hypertension, SARS-CoV-2 test
Clinical narrative: shortness of breath; high blood pressure; This is a spontaneous report from a contactable consumer (patient's friend). A 51-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown) via an unspecified route of administration on 17Mar2021 (at the age of 51-years old) as SINGLE DOSE for COVID-19 immunisation. Medical history included cardiac event and stent placement in Jan2021. The patient's concomitant medications were not reported. On 18Mar2021 at 10:30am, patient was admitted to the ER (Emergency Room) due to shortness of breath and high blood pressure. He had cardiac event and a stent placed in Jan2021. Patient was admitted due to not knowing if the issues were due to the COVID shot or the recent heart issues. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room or urgent care and hospitalization on 18Mar2021. The patient was not tested for COVID prior to vaccination. Patient was tested for COVID (Nasal swab) post-vaccination on 18Mar2021, results pending. The outcome for both events was unknown.    Information about Batch/Lot number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, C-reactive protein, Drug screen, Electroencephalogram, Full blood count
Clinical narrative: Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lumbar puncture, Magnetic resonance imaging, Nausea, Pyrexia
Clinical narrative: Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Vision blurred, Vomiting
Clinical narrative: Began having seizures; Presented to the ER on 17 March 2021 for headache with blurry vision; Presented to the ER on 17 March 2021 for headache with blurry vision; Also had persistent nausea and subsequent vomiting; Also had persistent nausea and subsequent vomiting; Fever X1 to 100.4F on day of presentation/no further sz; This is a spontaneous report from a contactable physician. A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscularly in right arm on 08Mar2021 (lot number: EN6206) at single dose for COVID-19 immunization. Medical history included headache and irregular periods, ongoing hospitalization. No known allergies. Concomitant medications included birth control pills. No other vaccine in four weeks. No COVID prior vaccination. Vaccine received during existing hospitalization. The patient began having seizures (hospitalization prolonged, life threatening) on 16Mar2021 12:00, presented to the ER on 17Mar2021 for headache with blurry vision (hospitalization prolonged, life threatening) on 16Mar2021 12:00, also had persistent nausea and subsequent vomiting (hospitalization prolonged, life threatening) on 16Mar2021 12:00, fever x1 to 100.4F on day of presentation/no further seizure (hospitalization prolonged, life threatening) on 16Mar2021 12:00. Clinical course: Presented to the ER on 17March2021 for headache with blurry vision. Patient reported symptoms for 1 day prior. Also had persistent nausea and subsequent vomiting. Presented to the ED at 23:00. Began having seizures. EEG shows localized to the occipital region. Fever X1 to 100.4F on day of presentation no further sz. LP shows 1 WBC, Gram stain negative. Cultures negative. HSV pending. On ceftriaxone and acyclovir. Continues to have focal sz on EEG now on 3 AEDs. MRI with contrast negative. CBC unremarkable. CRP elevated to 0.8 (normal less than 0.5). Tox screen negative. COVID tested post vaccination: Nasal Swab (SARS-CoV-2 Cepheid) with result of negative on 17Mar2021. Therapeutic measures were taken as a result of all the events which included treatment with IVIG, Antibiotics, Steroids, Antiepileptics. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events cannot be completely excluded based on temporal association and known drug safety profile.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Deep vein thrombosis, Echocardiogram, Pulmonary thrombosis, Ultrasound scan
Clinical narrative: Developed DVT blood clots in legs and clots in lungs.; Developed DVT blood clots in legs and clots in lungs.; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6198) on 06Mar2021 12:30 PM at left arm for COVID-19 immunisation. Medical history included known allergies: Clindamycin and high blood pressure. Historical vaccine was 1st dose of BNT162B2 (lot number EN6201) on 14Feb2021 01:15 PM at left arm for COVID-19 immunisation. Concomitant drugs included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), omeprazole, nortriptyline hydrochloride (NORTRIPTYLIN). The patient developed DVT blood clots in legs and clots in lungs on 07Mar2021 08:00 AM. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Patient was hospitalized for 3 days and received treatment. The patient had computerised tomogram (CAT) scan, ultrasound, echocardiogram. Event outcome was not resolved.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Discomfort, Mobility decreased, Muscular weakness, Pain
Clinical narrative: could not move; fever went to 102.3; shaking so bad; my legs felt like rubber and every time i would try to get up i would fall down; terrible pain; serious discomfort; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer reported that he received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6208) on 15Mar2021 02:00 PM at right arm for COVID-19 immunisation. Medical history included kidney disease, known allergies: Penicillin and high blood pressure. The patient had received other medications in two weeks. The patient reported everything was going great. He took a nap 15 hours after shot, woke up hour later and could not move. Fever went to 102.3 and he was shaking so bad and his legs felt like rubber and every time he would try to get up he would fall down. He was so scared he called somebody to come be with him, things got better about 28 hours of terrible pain and serious discomfort. He was in such pain and he need to know if he should arrange someone to be with him for second dose. Event onset date was reported as 16Mar2021 10:00 AM. The event resulted in: Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment was received as paracetamol (TYLENOL EX). Outcome of the event was not resolved.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: could not move; fever went to 102.3; shaking so bad; my legs felt like rubber and every time i would try to get up i would fall down; terrible pain; serious discomfort; This is a spontaneous report from a contactable consumer. This 63-year-old male consumer reported that he received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EN6208) on 15Mar2021 02:00 PM at right arm for COVID-19 immunisation. Medical history included kidney disease, known allergies: Penicillin and high blood pressure. The patient had received other medications in two weeks. The patient reported everything was going great. He took a nap 15 hours after shot, woke up hour later and could not move. Fever went to 102.3 and he was shaking so bad and his legs felt like rubber and every time he would try to get up he would fall down. He was so scared he called somebody to come be with him, things got better about 28 hours of terrible pain and serious discomfort. He was in such pain and he need to know if he should arrange someone to be with him for second dose. Event onset date was reported as 16Mar2021 10:00 AM. The event resulted in: Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Treatment was received as paracetamol (TYLENOL EX). Outcome of the event was not resolved.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Chest discomfort
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Ear swelling, Heart rate, Heart rate increased
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Heart rate
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Intensive care, Metabolic function test normal, Pruritus, Swelling
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Arthropod bite, Blood test, Condition aggravated, Hypersensitivity
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Intensive care
Clinical narrative: anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure  and heart rate; elevated blood pressure  and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: multiple bilateral DVTs; pulmonary embolus; This is a spontaneous report from a contactable Physician (Patient). A 66-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6200, Expiration date was not reported), via an unspecified route of administration, in Arm Left on 23Feb2021 13:15 as single dose, the first dose via an unspecified route of administration, a in Arm Left on 02Feb2021 13:15 as single dose for covid-19 immunization. Medical history included Subarachnoid hemorrhage (SAH), hypertension (htn), degenerative discs, malignant melanoma and prostatectomy (2 years 3 months). Concomitant medications included atorvastatin calcium and lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took cephalosporin for allergies. After receiving the second dose patient experienced pulmonary embolus on an unspecified date in 2021 and multiple bilateral DVTs diagnosed on 11Mar2021. As per the reporter seriousness criteria reported as emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient did not receive any other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient was not tested Covid post vaccination. Therapeutic measures were taken as a result of pulmonary embolus multiple bilateral dvts. The outcome of the events was not recovered.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of Pulmonary Embolus and Deep Vein Thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypoaesthesia, Nausea, Nervousness
Clinical narrative: Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Tremor, Wheezing
Clinical narrative: Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous; Immediately felt tingling, got shaky and nauseous/shakes; Immediately felt tingling, got shaky and nauseous; hard time swallowing and couldn't breathe right; hard time swallowing and couldn't breathe right; Waves of heart racing; her left leg and arm, her right leg had pins and needles and loss of feeling; wheezing; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Mar2021 09:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Medical history included none. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Patient experienced immediately felt tingling, got shaky and nauseous. It was coming in waves. she was having a hard time swallowing and couldn't breathe right. She was in the holding. For 15 minutes and she received dismissed annoyed no help from an EMT working in the waiting area for effects. She left. Got a mile down the road and called 911 she was unable to get enough oxygen in. The ambulance arrived and immediately gave her epinephrine, Benadryl, and a breathing treatment along with other medications. She arrived at the hospital and she was doing better and they kept her for observation. She was feeling fine, left with an Epipen and prednisone. The next day (18Mar2021) she felt great until the night time she started wheezing again. She woke up on Friday (19Mar2021). Having shakes and hard time breathing and waves of heart racing. she made a doctor's appointment and received a inhaler. Her symptoms were not getting better and she took Benadryl which helped. By that night her left leg and arm, her right leg had pins and needles and loss of feeling. Treatment included Epinephrine, Benadryl, Prednisone, Albuterol. No COVID tested post vaccination. Events immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right required clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. Outcome of immediately felt tingling, got shaky and nauseous, swallowing and couldn't breathe right was recovering.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: flu feel like symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (unspecified trade name), via an unspecified route of administration on 11Feb2021 17:00 (Batch/Lot number was not reported) at 57-year-old as single dose for covid-19 immunization. Medical history included iodine allergy, "Iodine"(without other specified information), covid-19 prior vaccination, blood pressure abnormal and thyroid disorder. Concomitant medications included insulin for an unspecified indication, blood pressure meds, thyroid medicine. No other vaccine in four weeks. The patient had 24 hour flu feel like symptoms on the first vaccine on 12Feb2021 10:00 with outcome of recovered on 13Feb2021 10:00. The event was life threatening illness (immediate risk of death from the event). No treatment received. The patient did not tested for COVID post vaccination.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Linked Report(s) : 2021316565 Same patient, same drug, different dose number/event