chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Panniculitis, Skin exfoliation
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Wound drainage
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Burning sensation, Cellulitis, Rash
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Thermal burn
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Cellulitis, Drug hypersensitivity, Pain, Pain in extremity
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Panniculitis, Ultrasound scan, X-ray
Clinical narrative: had an allergic reaction to it; cellulitis of left upper extremity; Panniculitis; Persisting pain; Pain in arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 52-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 09Apr2021 (Lot# EW0162), at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, blood pressure. Concomitant medication included unknown blood pressure medicine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 19Mar2021 at 09:15 (Lot# ER2613) for COVID-19 immunisation with no adverse effect. The patient had an allergic reaction to the 2nd dose of the vaccine. She stated that it burned her skin, her skin came off, skin was burning and i red. She was burning on left arm/extremities burning sensation of. It opened up and made a wound. It spread from her inner arm gone on the top of her breast, it was warm to the touch, it was burning in the inside of her. She had redness that turned into bruising. She could see a red circle and a red circle going down her arm getting bigger and redder. There were bruise marks like a map on her arm. The symptoms were spreading more on her body, and it was redder and warmer to touch. The bottom of her arm where the muscle would be at like the bicep or whatever part this is, was burning to move her arm and just burning. Her arm was on fire. Looking at her chest where her armpit is going to the top of her shoulder there was a red big spot. There were 5 big spots that came overnight going down her right breast. It was red, like a burgundy bruise. It was a burning hot sensation and was hurting inside, not outside. It was burning on the inside, and that was what was making burns come on outside of the skin. While she was in the hospital they diagnosed cellulitis of the left upper extremity. A neurologist  thought she had panniculitis on left arm. The doctors thought it was an infection. The events required emergency room visit and physician office visit such as personal care physician, a wound doctor, dermatologist, neurologist, allergist, epidemiologist and an infectious disease doctor. Therapeutic measures were taken as a result of the events and included treatment with Levaquin 750 mg oral, Vancomycin, steroids, sildersulsadiazine cream, Clobetasol Propionate cream, Silvadene, Polysporin (lot# 1480Z, Exp date 20Apr2022) or Bacitracin, ice, Curad things for her dressing. During hospitalization the patient underwent lab tests and procedures which included blood work,  X-ray, ultrasound all with unknown results. The patient was hospitalized from 13Apr2021 to 20Apr2021 for drug hypersensitivity, skin burning sensation, erythema, skin exfoliation, burning sensation, contusion, wound. Outcome of all events was unknown except for erythema , burning sensation and contusion which was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carotid artery dissection, Carotid artery occlusion, Cerebral artery occlusion
Clinical narrative: BLOOD CLOT; COLLAPSED; This spontaneous report received from a consumer concerned a 58 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's had perfect health in NOV-2020 or DEC-2020. The patient was a teenage runner in terms of heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient was hundred percent fine but then he collapsed and was taken to the hospital. He was diagnosed with a blood clot and immediately surgery was attempted to break the clot. But, the patient died subsequently. The cause of death was blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapsed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210506470-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot, Collapsed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Embolic stroke
Clinical narrative: BLOOD CLOT; COLLAPSED; This spontaneous report received from a consumer concerned a 58 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's had perfect health in NOV-2020 or DEC-2020. The patient was a teenage runner in terms of heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient was hundred percent fine but then he collapsed and was taken to the hospital. He was diagnosed with a blood clot and immediately surgery was attempted to break the clot. But, the patient died subsequently. The cause of death was blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapsed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210506470-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot, Collapsed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Physical examination, Syncope, Thrombosis
Clinical narrative: BLOOD CLOT; COLLAPSED; This spontaneous report received from a consumer concerned a 58 year old white and Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's had perfect health in NOV-2020 or DEC-2020. The patient was a teenage runner in terms of heart condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient was hundred percent fine but then he collapsed and was taken to the hospital. He was diagnosed with a blood clot and immediately surgery was attempted to break the clot. But, the patient died subsequently. The cause of death was blood clot. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapsed was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20210506470-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot, Collapsed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: BLOOD CLOT
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation error
Clinical narrative: - The pharmacist was careless and did not dilute the shot. Was given 0.3ml undiluted of the second vaccine shot! - Headache, fatigue, and achy joints started the evening of the shot and persisted for at least 5 days - Fatigue and headache continued for the next week after as well. Patient does not typically get headaches
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Product preparation issue
Clinical narrative: - The pharmacist was careless and did not dilute the shot. Was given 0.3ml undiluted of the second vaccine shot! - Headache, fatigue, and achy joints started the evening of the shot and persisted for at least 5 days - Fatigue and headache continued for the next week after as well. Patient does not typically get headaches
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: difficulty breathing; Fever between 100-102 for 1 week; stiff joints; muscle spasms; elevated HR and BP; elevated HR and BP; splotchy red skin; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation, at 31 years old. Medical history included covid-19 from an unknown date. The patient previously received the first dose of BNT162B2 (Lot number: EP6955) on 26Mar2021 (left arm) for covid-19 immunisation. Patient is not pregnant at vaccination time. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced difficulty breathing, fever between 100-102 for 1 week, stiff joints, muscle spasms, elevated hr and bp, elevated hr and bp, splotchy red skin on 19Apr2021 which required emergency room visit. The patient underwent lab tests and procedures which included blood pressure increased: elevated, body temperature: 100-102, heart rate: elevated all on 19Apr2021.  Therapeutic measures were taken as a result of the events. Outcome of the event Fever between 100-102 for 1 week was recovered on 26Apr2021, while outcome of the other events was recovered on an unspecified date.  Information on Lot/Batch number was obtained. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Swelling
Clinical narrative: difficulty breathing; Fever between 100-102 for 1 week; stiff joints; muscle spasms; elevated HR and BP; elevated HR and BP; splotchy red skin; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation, at 31 years old. Medical history included covid-19 from an unknown date. The patient previously received the first dose of BNT162B2 (Lot number: EP6955) on 26Mar2021 (left arm) for covid-19 immunisation. Patient is not pregnant at vaccination time. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced difficulty breathing, fever between 100-102 for 1 week, stiff joints, muscle spasms, elevated hr and bp, elevated hr and bp, splotchy red skin on 19Apr2021 which required emergency room visit. The patient underwent lab tests and procedures which included blood pressure increased: elevated, body temperature: 100-102, heart rate: elevated all on 19Apr2021.  Therapeutic measures were taken as a result of the events. Outcome of the event Fever between 100-102 for 1 week was recovered on 26Apr2021, while outcome of the other events was recovered on an unspecified date.  Information on Lot/Batch number was obtained. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Body temperature, Dyspnoea, Erythema, Heart rate
Clinical narrative: difficulty breathing; Fever between 100-102 for 1 week; stiff joints; muscle spasms; elevated HR and BP; elevated HR and BP; splotchy red skin; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation, at 31 years old. Medical history included covid-19 from an unknown date. The patient previously received the first dose of BNT162B2 (Lot number: EP6955) on 26Mar2021 (left arm) for covid-19 immunisation. Patient is not pregnant at vaccination time. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced difficulty breathing, fever between 100-102 for 1 week, stiff joints, muscle spasms, elevated hr and bp, elevated hr and bp, splotchy red skin on 19Apr2021 which required emergency room visit. The patient underwent lab tests and procedures which included blood pressure increased: elevated, body temperature: 100-102, heart rate: elevated all on 19Apr2021.  Therapeutic measures were taken as a result of the events. Outcome of the event Fever between 100-102 for 1 week was recovered on 26Apr2021, while outcome of the other events was recovered on an unspecified date.  Information on Lot/Batch number was obtained. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint stiffness, Muscle spasms, Palpitations, Pyrexia
Clinical narrative: difficulty breathing; Fever between 100-102 for 1 week; stiff joints; muscle spasms; elevated HR and BP; elevated HR and BP; splotchy red skin; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for covid-19 immunisation, at 31 years old. Medical history included covid-19 from an unknown date. The patient previously received the first dose of BNT162B2 (Lot number: EP6955) on 26Mar2021 (left arm) for covid-19 immunisation. Patient is not pregnant at vaccination time. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced difficulty breathing, fever between 100-102 for 1 week, stiff joints, muscle spasms, elevated hr and bp, elevated hr and bp, splotchy red skin on 19Apr2021 which required emergency room visit. The patient underwent lab tests and procedures which included blood pressure increased: elevated, body temperature: 100-102, heart rate: elevated all on 19Apr2021.  Therapeutic measures were taken as a result of the events. Outcome of the event Fever between 100-102 for 1 week was recovered on 26Apr2021, while outcome of the other events was recovered on an unspecified date.  Information on Lot/Batch number was obtained. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest discomfort, Contusion, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: I have been to the emergency room twice with my platelets at 4
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Presyncope
Clinical narrative: I have been to the emergency room twice with my platelets at 4
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Immunoglobulin therapy, Platelet count decreased
Clinical narrative: I have been to the emergency room twice with my platelets at 4
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Joint stiffness, Loss of personal independence in daily activities
Clinical narrative: 2 days after receiving dose #2 on 4/7/2021, patient developed left side arm, shoulder and knee pain. He developed bilateral hip pain and bilateral hand swelling. Seen in Urgent Care 4/28/2021 and 5/8/2021. Seen by primary care 5/10/2021.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: 2 days after receiving dose #2 on 4/7/2021, patient developed left side arm, shoulder and knee pain. He developed bilateral hip pain and bilateral hand swelling. Seen in Urgent Care 4/28/2021 and 5/8/2021. Seen by primary care 5/10/2021.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Haematocrit decreased, Pain in extremity, Peripheral swelling
Clinical narrative: 2 days after receiving dose #2 on 4/7/2021, patient developed left side arm, shoulder and knee pain. He developed bilateral hip pain and bilateral hand swelling. Seen in Urgent Care 4/28/2021 and 5/8/2021. Seen by primary care 5/10/2021.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Platelet count increased, Red blood cell count decreased, Red blood cell sedimentation rate increased, Rheumatoid factor increased
Clinical narrative: 2 days after receiving dose #2 on 4/7/2021, patient developed left side arm, shoulder and knee pain. He developed bilateral hip pain and bilateral hand swelling. Seen in Urgent Care 4/28/2021 and 5/8/2021. Seen by primary care 5/10/2021.
Age: 0.25
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Hypoaesthesia oral, Nausea, Paraesthesia oral, Throat tightness
Clinical narrative: anaphylactic shock; my throat was getting tight again and pressure/throat was closing up; lips were tingling; Not feeling well; started getting tired again; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiration date: Jul2021), via an unspecified route of administration on left arm on 24Apr2021 09:55 as single dose for covid-19 immunisation. Medical history included Asthma (Asthma was diagnosed when she was a baby or a child), Irregular heart rate, Allergy multiple (Patient allergies were diagnosed as being seasonal, she doesn't know exactly when. She says she recently had an anaphylactic reaction after eating sushi. She said she also has environmental allergies), right ear hearing impairment and Mild cerebral palsy (diagnosed since she was a baby, it correlates with her mild cerebral palsy). Concomitant medications included unspecified flu shot given on 24Mar2021. The patient reported, she received the first dose of Pfizer vaccine and was monitored for 30 minutes because of my history of allergies. The doctor and paramedic gave medication, Benadryl. 3-4 hours later, the medicine wore off and again was feeling the effects again she was getting tired, her throat was getting tight again and pressure, throat was closing up and her lips were tingling. She went to urgent care they said it was in anaphylactic shock on 24Apr2021 and gave a bunch of medications, steroids and epi-pen and Benadryl they monitored me for 3 - 4 hours, sent her home. Next day, Sunday not feeling any better went to the emergency room, was admitted for anaphylactic shock, they gave same medications, Benadryl, steroids, and epi-pen, they kept 2 nights, overnight for observation. Beta blockers were given for her heart, which she had never had to be on those before but she has a history of an irregular heart. They also gave her saline IV fluids. She says they gave her a steroid, Prednisone 20mg, to take twice a day by mouth (discard date:27Apr2022), Famotidine 20mg, to take twice a day by mouth (discard date: 27Apr2022) and Fexofenadine (discard date: 27Apr2022). She was discharged Tuesday night. Reporter seriousness was assessed as serious as the patient went to emergency room; admitted me into the hospital for 3 days. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 0.25
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Fatigue, Malaise, Paraesthesia oral, Throat tightness
Clinical narrative: anaphylactic shock; my throat was getting tight again and pressure/throat was closing up; lips were tingling; Not feeling well; started getting tired again; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiration date: Jul2021), via an unspecified route of administration on left arm on 24Apr2021 09:55 as single dose for covid-19 immunisation. Medical history included Asthma (Asthma was diagnosed when she was a baby or a child), Irregular heart rate, Allergy multiple (Patient allergies were diagnosed as being seasonal, she doesn't know exactly when. She says she recently had an anaphylactic reaction after eating sushi. She said she also has environmental allergies), right ear hearing impairment and Mild cerebral palsy (diagnosed since she was a baby, it correlates with her mild cerebral palsy). Concomitant medications included unspecified flu shot given on 24Mar2021. The patient reported, she received the first dose of Pfizer vaccine and was monitored for 30 minutes because of my history of allergies. The doctor and paramedic gave medication, Benadryl. 3-4 hours later, the medicine wore off and again was feeling the effects again she was getting tired, her throat was getting tight again and pressure, throat was closing up and her lips were tingling. She went to urgent care they said it was in anaphylactic shock on 24Apr2021 and gave a bunch of medications, steroids and epi-pen and Benadryl they monitored me for 3 - 4 hours, sent her home. Next day, Sunday not feeling any better went to the emergency room, was admitted for anaphylactic shock, they gave same medications, Benadryl, steroids, and epi-pen, they kept 2 nights, overnight for observation. Beta blockers were given for her heart, which she had never had to be on those before but she has a history of an irregular heart. They also gave her saline IV fluids. She says they gave her a steroid, Prednisone 20mg, to take twice a day by mouth (discard date:27Apr2022), Famotidine 20mg, to take twice a day by mouth (discard date: 27Apr2022) and Fexofenadine (discard date: 27Apr2022). She was discharged Tuesday night. Reporter seriousness was assessed as serious as the patient went to emergency room; admitted me into the hospital for 3 days. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 0.25
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Angioedema, Wheezing
Clinical narrative: anaphylactic shock; my throat was getting tight again and pressure/throat was closing up; lips were tingling; Not feeling well; started getting tired again; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiration date: Jul2021), via an unspecified route of administration on left arm on 24Apr2021 09:55 as single dose for covid-19 immunisation. Medical history included Asthma (Asthma was diagnosed when she was a baby or a child), Irregular heart rate, Allergy multiple (Patient allergies were diagnosed as being seasonal, she doesn't know exactly when. She says she recently had an anaphylactic reaction after eating sushi. She said she also has environmental allergies), right ear hearing impairment and Mild cerebral palsy (diagnosed since she was a baby, it correlates with her mild cerebral palsy). Concomitant medications included unspecified flu shot given on 24Mar2021. The patient reported, she received the first dose of Pfizer vaccine and was monitored for 30 minutes because of my history of allergies. The doctor and paramedic gave medication, Benadryl. 3-4 hours later, the medicine wore off and again was feeling the effects again she was getting tired, her throat was getting tight again and pressure, throat was closing up and her lips were tingling. She went to urgent care they said it was in anaphylactic shock on 24Apr2021 and gave a bunch of medications, steroids and epi-pen and Benadryl they monitored me for 3 - 4 hours, sent her home. Next day, Sunday not feeling any better went to the emergency room, was admitted for anaphylactic shock, they gave same medications, Benadryl, steroids, and epi-pen, they kept 2 nights, overnight for observation. Beta blockers were given for her heart, which she had never had to be on those before but she has a history of an irregular heart. They also gave her saline IV fluids. She says they gave her a steroid, Prednisone 20mg, to take twice a day by mouth (discard date:27Apr2022), Famotidine 20mg, to take twice a day by mouth (discard date: 27Apr2022) and Fexofenadine (discard date: 27Apr2022). She was discharged Tuesday night. Reporter seriousness was assessed as serious as the patient went to emergency room; admitted me into the hospital for 3 days. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Productive cough, Pulmonary congestion
Clinical narrative: Pt states she felt chest congestion, fatigue and "disconnected' for approx. one month after her first dose.   Pt felt well enough after one month, that she decided to get the second dose on 4/19/2021
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Pt states she felt chest congestion, fatigue and "disconnected' for approx. one month after her first dose.   Pt felt well enough after one month, that she decided to get the second dose on 4/19/2021
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Balance disorder, Blood pressure increased, Cough, Headache
Clinical narrative: Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events.  Follow-up attempts are completed. Information about lot/batch number cannot obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Muscular weakness, Rhinorrhoea
Clinical narrative: Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events.  Follow-up attempts are completed. Information about lot/batch number cannot obtained.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Blood pressure measurement, Hot flush, Migraine
Clinical narrative: Her blood pressure went over 220; Migraine; Her balance was off as well; She has been experiencing excessive hot flashes; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunisation. Medical history included hot flush. The patient's concomitant medications were not reported. Patient mentioned that about 45 minutes after getting it, her blood pressure went over 220. Her normal blood pressure is 132/72 or 74 or 76. After she was released from the ER in the hospital, they asked her to take migraine medications for the migraine she has experienced afterward in Apr2021. She mentioned that she cannot get rid of the migraine and she has been experiencing excessive hot flashes, more than what she was having before. Her balance was off as well. She was asking if this has been reported and for what to do. She was also asking if this will most likely happen during her 2nd shot as well as she was not looking forward to it. She has consulted several doctors already. Patient still have a migraine that has been ongoing for 2 weeks and states it's "not a fun thing." She states she spoke with a neurologist who has gotten phone calls from people who have received Pfizer's and other's COVID-19 vaccines and are experiencing "headaches for days." Caller states that there was nothing medically wrong with her. She states that her blood pressure "never spiked" like that before. She reports that she has taken migraine medication and Percocet for the headaches and was also prescribed Prednisone as a "hope to try to get rid of the headaches." Outcome of the event migraine was not recovered, whereas unknown for other events.  Follow-up attempts are completed. Information about lot/batch number cannot obtained.