chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pulmonary infarction, Scan with contrast abnormal
Clinical narrative: BILATERAL PULMONARY EMBOLISM; This spontaneous report received from a parent via social media concerned an 18 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bilateral pulmonary embolism, and was hospitalized on 19-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient's parent via social media concerns an 18-year-old male of specified race/ethnicity who was hospitalized for bilateral pulmonary embolism an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms, diagnostic testing (e.g. platelet count, anti-Platelet Factor 4 antibody, d-Dimer, coagulopathy panel), corrective treatment, and outcome were not reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from vaccine safety research), the relationship of the pulmonary embolism to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: BILATERAL PULMONARY EMBOLISM; This spontaneous report received from a parent via social media concerned an 18 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bilateral pulmonary embolism, and was hospitalized on 19-MAY-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pulmonary embolism was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This spontaneous report received from a patient's parent via social media concerns an 18-year-old male of specified race/ethnicity who was hospitalized for bilateral pulmonary embolism an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms, diagnostic testing (e.g. platelet count, anti-Platelet Factor 4 antibody, d-Dimer, coagulopathy panel), corrective treatment, and outcome were not reported. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from vaccine safety research), the relationship of the pulmonary embolism to vaccination is considered unclassifiable due to insufficient information. Additional information will be requested if contact information becomes available.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, COVID-19, Chest pain, Cough, Myocarditis
Clinical narrative: developed diarrhea, pharyngitis, headache. " pneumonia like symptoms" admitted to the hospital and later died
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, SARS-CoV-2 test positive
Clinical narrative: developed diarrhea, pharyngitis, headache. " pneumonia like symptoms" admitted to the hospital and later died
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: developed diarrhea, pharyngitis, headache. " pneumonia like symptoms" admitted to the hospital and later died
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, Diarrhoea, Headache, Pharyngitis
Clinical narrative: developed diarrhea, pharyngitis, headache. " pneumonia like symptoms" admitted to the hospital and later died
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory symptom, SARS-CoV-2 test positive
Clinical narrative: developed diarrhea, pharyngitis, headache. " pneumonia like symptoms" admitted to the hospital and later died
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Fatigue, Headache, Muscle spasms, Pain in extremity
Clinical narrative: CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Polymerase chain reaction, Tachycardia
Clinical narrative: CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest pain, Computerised tomogram, Feeling abnormal, Headache
Clinical narrative: CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain, Pain in extremity
Clinical narrative: CHEST PAIN; NUMBNESS IN FINGERS ON LEFT HAND AND LEFT ARM; FELT WEIRD; PAIN; PAIN IN NECK; PAIN IN ARM; PAIN IN HEAD ON LEFT SIDE; LACK OF ENERGY WHEN WALKING OR WORKING; This spontaneous report received from a patient concerned a 45 year old male. The patient's weight was 175 pounds, and height was not reported. The patient's concurrent conditions included glaucoma. The patient experienced does not feel good when treated with metoclopramide. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced numbness in fingers on left hand and left arm. On 18-APR-2021, the subject experienced felt weird. On 18-APR-2021, the subject experienced pain. On 18-APR-2021, the subject experienced pain in neck. On 18-APR-2021, the subject experienced pain in arm. On 18-APR-2021, the subject experienced pain in head on left side. On 18-APR-2021, the subject experienced lack of energy when walking or working. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, numbness in fingers on left hand and left arm, lack of energy when walking or working, and pain in head on left side, and the outcome of felt weird, pain, pain in arm and pain in neck was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; This is a spontaneous report from a contactable consumer (patient).  A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 17:00 (Batch/Lot Number: EWO177), age at vaccination of 23-years-old, as single dose,for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding on 07Jun2021 11:00 AM. No treatments were given for the events. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal disorder, Vaginal haemorrhage
Clinical narrative: Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; Excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding; This is a spontaneous report from a contactable consumer (patient).  A 23-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 17:00 (Batch/Lot Number: EWO177), age at vaccination of 23-years-old, as single dose,for covid-19 immunisation. Medical history was none. The patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (ESTARYLLA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced excessive bleeding in the vaginal area and what looks like skin like shedding/mucus shedding on 07Jun2021 11:00 AM. No treatments were given for the events. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was not recovered from the events.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Heart rate increased
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lethargy, Nausea, Neck pain, Palpitations
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Sleep disorder, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Carotid pulse increased, Chest pain, Hypertension, Metamorphopsia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in extremity, Palpitations, Vision blurred
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Hypertension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Following 2nd dose, patient reports extreme pain in back/chest/arm and neck and hospitalization for extreme high blood pressure. Heart pounding & carotid pumping as per patient even though she was extremely calm. Patient is still experiencing same adverse effects. Extreme blurred and distorted vision.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Electrocardiogram normal, Fibrin D dimer increased, Heart rate increased
Clinical narrative: Tolerated #1 COVID-19 vaccine well. Recieved #2 vaccine and the following morning has significate chest pain and a bit of shortness of breathe.  Was seen at Hospital ER.   Heart rate 110-130, EKG normal, labs were normal except Ddimer was elevated. Nuclear study to r/o pulmonary embolism was negative. Given IV fluids and chest pain resolved. Discharged 8 hrs after arrival.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Lethargy, Pain, Pain in extremity, Ventilation/perfusion scan
Clinical narrative: Tolerated #1 COVID-19 vaccine well. Recieved #2 vaccine and the following morning has significate chest pain and a bit of shortness of breathe.  Was seen at Hospital ER.   Heart rate 110-130, EKG normal, labs were normal except Ddimer was elevated. Nuclear study to r/o pulmonary embolism was negative. Given IV fluids and chest pain resolved. Discharged 8 hrs after arrival.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chest pain, Dyspnoea, Electrocardiogram normal, Fibrin D dimer increased
Clinical narrative: Tolerated #1 COVID-19 vaccine well. Recieved #2 vaccine and the following morning has significate chest pain and a bit of shortness of breathe.  Was seen at Hospital ER.   Heart rate 110-130, EKG normal, labs were normal except Ddimer was elevated. Nuclear study to r/o pulmonary embolism was negative. Given IV fluids and chest pain resolved. Discharged 8 hrs after arrival.
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging normal
Clinical narrative: Tolerated #1 COVID-19 vaccine well. Recieved #2 vaccine and the following morning has significate chest pain and a bit of shortness of breathe.  Was seen at Hospital ER.   Heart rate 110-130, EKG normal, labs were normal except Ddimer was elevated. Nuclear study to r/o pulmonary embolism was negative. Given IV fluids and chest pain resolved. Discharged 8 hrs after arrival.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: she broke out in a massive rash on her legs, stomach and arms, which is now working its way to her ears scalp and neck/ She's covered from head to toe with this rash; Insatiable itching coming from inside/ The important part is this Insatiable itching that is getting worse and is coming from like inside.; She had a terrible terrible reaction from this vaccine and its getting worse; . She has had a severe reaction to the Pfizer vaccine; She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture; This is a spontaneous report from a contactable consumer (reported for her Sister). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter reported for her sister that three days after the injection she broke out in a massive rash on her legs, stomach and arms, which was now working its way to her ears scalp and neck. She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture. Patient's doctor prescribed the eight-day prednisone steroids, cortisone cream, and anti-histamine spray. Nothing was helping. She has had a severe reaction to the Pfizer vaccine. Now her doctor prescribed a medicine called Doxipen. The caller stated she was afraid that her sister was going to die. Caller really thinks her sister was going to die from this vaccine. Patient had a terrible reaction from this vaccine and it was getting worse. Insatiable itching coming from inside. The vaccine caused like a nerve thing to happen. She does not have a month. Reporter stated that it was three weeks and her sister was beyond herself. Reporter stated that was covered from head to toe with this rash. Reporter also stated that she was told other people have gone through this also. The reporter was asking for Pfizer help as nothing was helping her sister (the patient). The patient received eight-day prednisone steroids, cortisone cream, and anti-histamine spray as treatment. The outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Pruritus, Rash, Vaccination complication
Clinical narrative: she broke out in a massive rash on her legs, stomach and arms, which is now working its way to her ears scalp and neck/ She's covered from head to toe with this rash; Insatiable itching coming from inside/ The important part is this Insatiable itching that is getting worse and is coming from like inside.; She had a terrible terrible reaction from this vaccine and its getting worse; . She has had a severe reaction to the Pfizer vaccine; She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture; This is a spontaneous report from a contactable consumer (reported for her Sister). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter reported for her sister that three days after the injection she broke out in a massive rash on her legs, stomach and arms, which was now working its way to her ears scalp and neck. She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture. Patient's doctor prescribed the eight-day prednisone steroids, cortisone cream, and anti-histamine spray. Nothing was helping. She has had a severe reaction to the Pfizer vaccine. Now her doctor prescribed a medicine called Doxipen. The caller stated she was afraid that her sister was going to die. Caller really thinks her sister was going to die from this vaccine. Patient had a terrible reaction from this vaccine and it was getting worse. Insatiable itching coming from inside. The vaccine caused like a nerve thing to happen. She does not have a month. Reporter stated that it was three weeks and her sister was beyond herself. Reporter stated that was covered from head to toe with this rash. Reporter also stated that she was told other people have gone through this also. The reporter was asking for Pfizer help as nothing was helping her sister (the patient). The patient received eight-day prednisone steroids, cortisone cream, and anti-histamine spray as treatment. The outcome of events was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Peripheral swelling, Pruritus, Rash
Clinical narrative: she broke out in a massive rash on her legs, stomach and arms, which is now working its way to her ears scalp and neck/ She's covered from head to toe with this rash; Insatiable itching coming from inside/ The important part is this Insatiable itching that is getting worse and is coming from like inside.; She had a terrible terrible reaction from this vaccine and its getting worse; . She has had a severe reaction to the Pfizer vaccine; She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture; This is a spontaneous report from a contactable consumer (reported for her Sister). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 72-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter reported for her sister that three days after the injection she broke out in a massive rash on her legs, stomach and arms, which was now working its way to her ears scalp and neck. She was frightened it might go into her throat. Patient was going insane because the itching was beyond torture. Patient's doctor prescribed the eight-day prednisone steroids, cortisone cream, and anti-histamine spray. Nothing was helping. She has had a severe reaction to the Pfizer vaccine. Now her doctor prescribed a medicine called Doxipen. The caller stated she was afraid that her sister was going to die. Caller really thinks her sister was going to die from this vaccine. Patient had a terrible reaction from this vaccine and it was getting worse. Insatiable itching coming from inside. The vaccine caused like a nerve thing to happen. She does not have a month. Reporter stated that it was three weeks and her sister was beyond herself. Reporter stated that was covered from head to toe with this rash. Reporter also stated that she was told other people have gone through this also. The reporter was asking for Pfizer help as nothing was helping her sister (the patient). The patient received eight-day prednisone steroids, cortisone cream, and anti-histamine spray as treatment. The outcome of events was unknown.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Pt reports breaking out into hives upon second dose of Pfizer vaccine. Denies SOB/ trouble swallowing. Hives
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Pt reports breaking out into hives upon second dose of Pfizer vaccine. Denies SOB/ trouble swallowing. Hives
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Biopsy skin abnormal, Blood fibrinogen increased, Eosinophil count, Perivascular dermatitis
Clinical narrative: Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient).   A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering.  Reporter considered events as serious.   Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 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: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell vacuolisation, Skin lesion, Urticarial vasculitis
Clinical narrative: Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient).   A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering.  Reporter considered events as serious.   Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 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: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Rash macular, Rash pruritic, Swelling of eyelid, Urticarial vasculitis
Clinical narrative: Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient).   A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering.  Reporter considered events as serious.   Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 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: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Consciousness fluctuating
Clinical narrative: I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown.   Information about batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Disorientation, Fall, Loss of consciousness
Clinical narrative: I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown.   Information about batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Memory impairment, Near drowning, Road traffic accident, Solar lentigo, X-ray abnormal
Clinical narrative: I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown.   Information about batch/Lot number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Burning sensation, Confusional state, Hot flush, Product dose omission issue
Clinical narrative: I am so confused; There is a sore there where I got it; I got a burning sensation in my whole body, like a hot flash almost.; I got a burning sensation in my whole body, like a hot flash almost.; I am not taking the second shot; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 60-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, in Left Arm on 28May2021 (at the age of 60-years-old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history included Fibromyalgia syndrome; Diabetes; Conversion disorder; Arthritis; and consumer stated, "I have a Pacemaker. The patient's concomitant medications included insulin aspart (NOVOLOG) taken for diabetes mellitus; gabapentin (GABAPENTIN) taken for neuropathy peripheral; tizanidine (TIZANIDINE) taken for muscle relaxant therapy; meloxicam (MELOXICAM) taken for inflammation; and Klonopin. Consumer stated, no prior vaccinations within 4 weeks of prior vaccination. On an unspecified date, the patient reported that she was so confused, there is a sore there where she got it, she got a burning sensation in her whole body, like a hot flash almost, and she supposed to get the second shot on 07June2021but she was not taking it. She further stated that she had a bad reaction to the Pfizer shot. They had to put her in a nursing home. On an unspecified date, the patient underwent lab tests and procedures which included blood test: unknown, and sars-cov-2 test: unknown. The outcome for all the events was unknown.   Information about batch/Lot number has been requested.