chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Laboratory test, Myocarditis
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, Solution for injection, Lot number was ER8731), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant was not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that 48 hours after receiving the 2nd Pfizer Biontech COVID vaccine she woke up with chest pains and the next morning went to urgent care where she had an irregular EKG. The sent her to the local hospital where her troponin was 7. The patient underwent lab tests and procedures which included electrocardiogram irregular on 18Apr2021, troponin was 7. Event took place after use of product. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chest pain.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Ultrasound scan
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, Solution for injection, Lot number was ER8731), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant was not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that 48 hours after receiving the 2nd Pfizer Biontech COVID vaccine she woke up with chest pains and the next morning went to urgent care where she had an irregular EKG. The sent her to the local hospital where her troponin was 7. The patient underwent lab tests and procedures which included electrocardiogram irregular on 18Apr2021, troponin was 7. Event took place after use of product. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chest pain.The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram abnormal, Troponin, Troponin increased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 17-years-old female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID VACCINE, Solution for injection, Lot number was ER8731), via an unspecified route of administration on 15Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant was not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that 48 hours after receiving the 2nd Pfizer Biontech COVID vaccine she woke up with chest pains and the next morning went to urgent care where she had an irregular EKG. The sent her to the local hospital where her troponin was 7. The patient underwent lab tests and procedures which included electrocardiogram irregular on 18Apr2021, troponin was 7. Event took place after use of product. The outcome of the events was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chest pain.The case will be reassessed once new information is available. 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: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Brain stem thrombosis, Cerebrovascular accident, Computerised tomogram abnormal
Clinical narrative: I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; This is a spontaneous report from a contactable consumer. A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose (at the age of 53 years old) for COVID-19 immunisation.  Medical history included depression, pre-diabetes and hysterectomy from 2003 hormones due to hysterectomy in 2003. Concomitant medications included metformin, semaglutide (OZEMPIC), estradiol, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lisdexamfetamine mesilate (VYVANSE) and ascorbic acid (C [ASCORBIC ACID]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (lot number=EL9262) at 20Jan2021 03:00 AM, on the right arm for COVID-19 immunisation.  The patient stated on 24Mar2021, "I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face." Patient received blood thinners as treatment. The patient had emergency and physician visit. The patient was hospitalized for 2 days. The outcome of the event was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Joint range of motion decreased, Magnetic resonance imaging abnormal
Clinical narrative: I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; This is a spontaneous report from a contactable consumer. A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose (at the age of 53 years old) for COVID-19 immunisation.  Medical history included depression, pre-diabetes and hysterectomy from 2003 hormones due to hysterectomy in 2003. Concomitant medications included metformin, semaglutide (OZEMPIC), estradiol, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lisdexamfetamine mesilate (VYVANSE) and ascorbic acid (C [ASCORBIC ACID]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (lot number=EL9262) at 20Jan2021 03:00 AM, on the right arm for COVID-19 immunisation.  The patient stated on 24Mar2021, "I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face." Patient received blood thinners as treatment. The patient had emergency and physician visit. The patient was hospitalized for 2 days. The outcome of the event was not recovered.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face.; This is a spontaneous report from a contactable consumer. A non-pregnant 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 12Feb2021 15:00 (Batch/Lot Number: EL9269) as single dose (at the age of 53 years old) for COVID-19 immunisation.  Medical history included depression, pre-diabetes and hysterectomy from 2003 hormones due to hysterectomy in 2003. Concomitant medications included metformin, semaglutide (OZEMPIC), estradiol, amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), lisdexamfetamine mesilate (VYVANSE) and ascorbic acid (C [ASCORBIC ACID]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 (lot number=EL9262) at 20Jan2021 03:00 AM, on the right arm for COVID-19 immunisation.  The patient stated on 24Mar2021, "I had a stroke. The blood clot is on the left side of the brain which has affected the right side of my body: right leg, right foot, right arm, right hand, and the right side of my face." Patient received blood thinners as treatment. The patient had emergency and physician visit. The patient was hospitalized for 2 days. The outcome of the event was not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Dizziness
Clinical narrative: Patient felt light-headed and experienced slight loss of vision.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Breath sounds abnormal, Cardiac arrest, Confusional state, Cyanosis
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Diarrhoea, Dyspnoea, Electrocardiogram, Endotracheal intubation
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Livedo reticularis, Musculoskeletal discomfort, Pulmonary embolism, Pulseless electrical activity, Pupil fixed
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Resuscitation, Seizure, Syncope, Vomiting
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dyspnoea
Clinical narrative: Shortness of breath.  Passed away on 4/19/2021
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Blood pressure increased, Chills, Dyspnoea
Clinical narrative: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: heart was racing and had sharp pains; heart was racing and had sharp pains; chills; body aches; fatigue; sweat; blood vessels felt like she had boiling blood running through them; nauseous; stomach cramps; headache; short of breath; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 14Apr2021 at single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Concomitant medications included spironolactone taken for an unspecified indication, start and stop date were not reported; drospirenone, ethinylestradiol (SYEDA) taken for birth control. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 34 years old, administered in arm left on 24Mar2021 11:00 at single dose for covid-19 immunization and experienced covid test result positive. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart was racing and had sharp pains, chills, body aches, fatigue, sweat, blood vessels felt like she had boiling blood running through them, nauseous, stomach cramps, headache, short of breath, all on 14Apr2021 15:00. Clinical course: Within hours the patient had the chills, body aches and fatigue again. She went to bed and woke up covered in sweat and in severe pain. Her blood vessels felt like she had boiling blood running through them. Her heart was racing and had sharp pains. Every inch of her body was in severe pain. She was also nauseous, had stomach cramps and a headache. She had never been in so much pain in her life and she had given birth to 4 children without any drugs so she can handle pain. She was not sure if it was the pain, panic or another side effect but she was also short of breath. This all lasted a few hours. No treatment was received for all events. The outcome of the event was recovered with lasting effects/ recovered with sequelae.  Information about lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, Cardiac failure congestive, Cardiorenal syndrome, General physical health deterioration, Ischaemic cardiomyopathy
Clinical narrative: Patient hospitalized within 6 weeks of receiving COVID vaccination. Patient died on 4/16/2021.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Transplant failure
Clinical narrative: Patient hospitalized within 6 weeks of receiving COVID vaccination. Patient died on 4/16/2021.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient hospitalized within 6 weeks of receiving COVID vaccination. Patient died on 4/16/2021.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Deep vein thrombosis, Platelet factor 4, Venogram normal
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 34 year old white and not Hispanic or Latino female. The patients height, and weight were not reported. The patient was not pregnant at the time of report, The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. patient do not have any underlying health condition, no birth control and no hormone therapy at time of vaccination. no history of blood clot in family.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, patient experienced dilated veins over arm where she got the vaccine, it looked very large and when patient went to the clinic. Patient was advised to go in the emergency room. Patient was hospitalized on 20-Apr-2021. The doctor at the hospital thought that the blood clot may have been there a couple of days. Patients mother said formal diagnosis was deep vein thrombosis. There was no history of blood clots in her family. Patient got her period when side effect happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210443276-deep vein thrombosis This event is considered unassessable. The event 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 34 year old white and not Hispanic or Latino female. The patients height, and weight were not reported. The patient was not pregnant at the time of report, The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. patient do not have any underlying health condition, no birth control and no hormone therapy at time of vaccination. no history of blood clot in family.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, patient experienced dilated veins over arm where she got the vaccine, it looked very large and when patient went to the clinic. Patient was advised to go in the emergency room. Patient was hospitalized on 20-Apr-2021. The doctor at the hospital thought that the blood clot may have been there a couple of days. Patients mother said formal diagnosis was deep vein thrombosis. There was no history of blood clots in her family. Patient got her period when side effect happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210443276-deep vein thrombosis This event is considered unassessable. The event 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test normal, Computerised tomogram head normal, Injection site thrombosis, Magnetic resonance imaging head normal
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 34 year old white and not Hispanic or Latino female. The patients height, and weight were not reported. The patient was not pregnant at the time of report, The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. patient do not have any underlying health condition, no birth control and no hormone therapy at time of vaccination. no history of blood clot in family.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, patient experienced dilated veins over arm where she got the vaccine, it looked very large and when patient went to the clinic. Patient was advised to go in the emergency room. Patient was hospitalized on 20-Apr-2021. The doctor at the hospital thought that the blood clot may have been there a couple of days. Patients mother said formal diagnosis was deep vein thrombosis. There was no history of blood clots in her family. Patient got her period when side effect happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210443276-deep vein thrombosis This event is considered unassessable. The event 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Pregnancy test urine negative, Ultrasound Doppler abnormal, Vein disorder
Clinical narrative: DEEP VEIN THROMBOSIS; This spontaneous report received from a consumer concerned a 34 year old white and not Hispanic or Latino female. The patients height, and weight were not reported. The patient was not pregnant at the time of report, The patient's concurrent conditions included non-alcoholic, and non-smoker, and other pre-existing medical conditions included patient has no known allergies and no drug abuse or illicit drug usage. patient do not have any underlying health condition, no birth control and no hormone therapy at time of vaccination. no history of blood clot in family.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, patient experienced dilated veins over arm where she got the vaccine, it looked very large and when patient went to the clinic. Patient was advised to go in the emergency room. Patient was hospitalized on 20-Apr-2021. The doctor at the hospital thought that the blood clot may have been there a couple of days. Patients mother said formal diagnosis was deep vein thrombosis. There was no history of blood clots in her family. Patient got her period when side effect happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210443276-deep vein thrombosis This event is considered unassessable. The event 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.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: Got the JJ vaccine on 3/19/21; began having flu like symptoms a week later,  The symptoms were becoming milder except for the cough. On Monday 4/5/21 I felt a sharp pain in my right lung and I began spitting up brown phlegm with tinges of blood, Returned to the doctor to get chest x-rays believing it was pneumonia; chest xray neg.  MD immediately suspected a pulmonary embolism. MD sent me to the ER where I was taken for a cat scan, I had to be admitted to the hospital and put on blood thinners. After an echocardiogram was performed to check for damage to my heart, I was cleared to go home and prescribed Fondaparinux injections. I will be taking an injection every day for the next 3 months 4/5 with symptoms of PE, confirmed 4/6. Platelets 374 on admission.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest X-ray normal, Computerised tomogram thorax abnormal, Cough, Echocardiogram normal
Clinical narrative: Got the JJ vaccine on 3/19/21; began having flu like symptoms a week later,  The symptoms were becoming milder except for the cough. On Monday 4/5/21 I felt a sharp pain in my right lung and I began spitting up brown phlegm with tinges of blood, Returned to the doctor to get chest x-rays believing it was pneumonia; chest xray neg.  MD immediately suspected a pulmonary embolism. MD sent me to the ER where I was taken for a cat scan, I had to be admitted to the hospital and put on blood thinners. After an echocardiogram was performed to check for damage to my heart, I was cleared to go home and prescribed Fondaparinux injections. I will be taking an injection every day for the next 3 months 4/5 with symptoms of PE, confirmed 4/6. Platelets 374 on admission.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoptysis, Influenza like illness, Platelet count normal, Pulmonary embolism, Pulmonary pain
Clinical narrative: Got the JJ vaccine on 3/19/21; began having flu like symptoms a week later,  The symptoms were becoming milder except for the cough. On Monday 4/5/21 I felt a sharp pain in my right lung and I began spitting up brown phlegm with tinges of blood, Returned to the doctor to get chest x-rays believing it was pneumonia; chest xray neg.  MD immediately suspected a pulmonary embolism. MD sent me to the ER where I was taken for a cat scan, I had to be admitted to the hospital and put on blood thinners. After an echocardiogram was performed to check for damage to my heart, I was cleared to go home and prescribed Fondaparinux injections. I will be taking an injection every day for the next 3 months 4/5 with symptoms of PE, confirmed 4/6. Platelets 374 on admission.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Sputum discoloured
Clinical narrative: Got the JJ vaccine on 3/19/21; began having flu like symptoms a week later,  The symptoms were becoming milder except for the cough. On Monday 4/5/21 I felt a sharp pain in my right lung and I began spitting up brown phlegm with tinges of blood, Returned to the doctor to get chest x-rays believing it was pneumonia; chest xray neg.  MD immediately suspected a pulmonary embolism. MD sent me to the ER where I was taken for a cat scan, I had to be admitted to the hospital and put on blood thinners. After an echocardiogram was performed to check for damage to my heart, I was cleared to go home and prescribed Fondaparinux injections. I will be taking an injection every day for the next 3 months 4/5 with symptoms of PE, confirmed 4/6. Platelets 374 on admission.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable health care professional retired nurse, the patient A 61-years-old female patient (nurse) received the first dose bnt162b2 (PFIZER-BIONTECH COVID 19 MRNA VACCINE), dose 1 injection right arm   on 31Mar2021(at the age of 61 years old) (Batch/Lot Number: ER8733, Expiry Date 31Jul2021) as SINGLE DOSE for covid-19 immunization. Medical history included thyroid disorder and  blood pressure abnormal. Concomitant medication includes Thyroid medicine and two blood pressure pills  (caller states she does not think that puts her at a higher risk for contracting COVID). 'Patient had no other vaccines on the same day as the COVID vaccine.  On 15Apr2021, The patient experienced tested positive for covid-19 (medically significant) on 15Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (nasal swab) on 15Apr2021. Caller reports that her test was not a rapid test, it was a nasal swab that said results would come within 24 - 48 hours, but the caller actually got her results the same day as the test was performed.  It was mentioned second dose of the product, scheduled for greater than 21 days after the first dose (no further details were provided). The patient called  inquiring about/ if she should get her second dose of the product, and if so, when should she get the second dose, since she tested positive for COVID-19 in between the two doses of the product. Caller has not yet had her second dose of the product. The clinical outcome of the events was unknown. Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection Drug result: Unrelated.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID 19 MRNA VACCINE), cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Condition aggravated, Fatigue, Injection site erythema, Injection site rash
Clinical narrative: Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received the second dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 13:30 (at the age of 57-years-old) as single dose for Covid-19 immunization.  Medical history included Acute Idiopathic Pancreatitis. Concomitant medications included Centrum Silver multivitamin and ademetionine (SAM-E). The patient previously received the first dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 26Mar2021 13:15 (at the age of 57-years-old) as single dose for Covid-19 immunization. Within 24 hours of receiving the second dose of bnt162b2 on 17Apr2021, the patient experienced fatigue, fever 101.2, sore arm, red rash at injection site. Five days after receiving the second dose of bnt162b2, on 21Apr2020, the patient was rushed to the hospital at 15:00 with Acute Idiopathic Pancreatitis. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3days from 21Apr2021 to 24Apr2021. The patient underwent lab tests and procedures which included Nasal Swab/COVID 19 ALLINA MOLECULAR PCR on 21Apr2021 with negative result, CT scan on unspecified date with unknown result, and blood tests on unspecified date with unknown result. Therapeutic measures were taken as a result of the events which included fluids and pain medication. The outcome of the events were recovering.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipase increased, Pain in extremity, Pancreatitis acute, Pyrexia
Clinical narrative: Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received the second dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 13:30 (at the age of 57-years-old) as single dose for Covid-19 immunization.  Medical history included Acute Idiopathic Pancreatitis. Concomitant medications included Centrum Silver multivitamin and ademetionine (SAM-E). The patient previously received the first dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 26Mar2021 13:15 (at the age of 57-years-old) as single dose for Covid-19 immunization. Within 24 hours of receiving the second dose of bnt162b2 on 17Apr2021, the patient experienced fatigue, fever 101.2, sore arm, red rash at injection site. Five days after receiving the second dose of bnt162b2, on 21Apr2020, the patient was rushed to the hospital at 15:00 with Acute Idiopathic Pancreatitis. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3days from 21Apr2021 to 24Apr2021. The patient underwent lab tests and procedures which included Nasal Swab/COVID 19 ALLINA MOLECULAR PCR on 21Apr2021 with negative result, CT scan on unspecified date with unknown result, and blood tests on unspecified date with unknown result. Therapeutic measures were taken as a result of the events which included fluids and pain medication. The outcome of the events were recovering.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Body temperature, Computerised tomogram, Disease recurrence, Fatigue
Clinical narrative: Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received the second dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 13:30 (at the age of 57-years-old) as single dose for Covid-19 immunization.  Medical history included Acute Idiopathic Pancreatitis. Concomitant medications included Centrum Silver multivitamin and ademetionine (SAM-E). The patient previously received the first dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 26Mar2021 13:15 (at the age of 57-years-old) as single dose for Covid-19 immunization. Within 24 hours of receiving the second dose of bnt162b2 on 17Apr2021, the patient experienced fatigue, fever 101.2, sore arm, red rash at injection site. Five days after receiving the second dose of bnt162b2, on 21Apr2020, the patient was rushed to the hospital at 15:00 with Acute Idiopathic Pancreatitis. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3days from 21Apr2021 to 24Apr2021. The patient underwent lab tests and procedures which included Nasal Swab/COVID 19 ALLINA MOLECULAR PCR on 21Apr2021 with negative result, CT scan on unspecified date with unknown result, and blood tests on unspecified date with unknown result. Therapeutic measures were taken as a result of the events which included fluids and pain medication. The outcome of the events were recovering.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pancreatitis, Pyrexia, SARS-CoV-2 test, Vaccination site rash
Clinical narrative: Acute Idiopathic Pancreatitis; Acute Idiopathic Pancreatitis; fatigue; fever 101.2; sore arm; red rash at injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old male patient received the second dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER8731), via an unspecified route of administration, administered in right arm on 16Apr2021 13:30 (at the age of 57-years-old) as single dose for Covid-19 immunization.  Medical history included Acute Idiopathic Pancreatitis. Concomitant medications included Centrum Silver multivitamin and ademetionine (SAM-E). The patient previously received the first dose of bnt162b2 (Pfizer- BioNTech COVID 19, Lot Number: ER2613), via an unspecified route of administration, administered in right arm on 26Mar2021 13:15 (at the age of 57-years-old) as single dose for Covid-19 immunization. Within 24 hours of receiving the second dose of bnt162b2 on 17Apr2021, the patient experienced fatigue, fever 101.2, sore arm, red rash at injection site. Five days after receiving the second dose of bnt162b2, on 21Apr2020, the patient was rushed to the hospital at 15:00 with Acute Idiopathic Pancreatitis. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 3days from 21Apr2021 to 24Apr2021. The patient underwent lab tests and procedures which included Nasal Swab/COVID 19 ALLINA MOLECULAR PCR on 21Apr2021 with negative result, CT scan on unspecified date with unknown result, and blood tests on unspecified date with unknown result. Therapeutic measures were taken as a result of the events which included fluids and pain medication. The outcome of the events were recovering.