chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Fatigue, Headache
Clinical narrative: transient heart arrhythmia usually lasting 5-15 seconds.; pronounced exhaustion; occasional mild headaches; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the second dose of BNT162B2 (Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 26Apr2021 17:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient medical history included insomnia. The patient had no known allergies. Concomitant medication included mirtazapine taken as sleep aid. The patient previously received the first dose of BNT162B2 (Lot Number: ER8734) administered in left arm on 05Apr2021 18:00 (at the age of 51-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Apr2021 19:00, the patient experienced pronounced exhaustion, occasional mild headaches, and a transient heart arrhythmia usually lasting 5-15 seconds.  These symptoms have not subsided, and the arrhythmia became persistent enough last night that it required a trip to the local ER. The consistent heart palpitations which ultimately brought him into the ER. The patient was referred to a local cardiologist and was told not to worry about the arrhythmia, that it would clear up in a few days. The reported events resulted in Emergency room/department or urgent care. There was no treatment received for the events. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coordination abnormal, Electromyogram, Loss of personal independence in daily activities, Magnetic resonance imaging, Neuralgic amyotrophy
Clinical narrative: brachial neuritis; Diagnosed with Parsonage Turner Syndrome; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in Apr2021 at 49 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other medications within 2 weeks of vaccination or any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 in Arm Left on 18Mar2021 16:45 at 49 years old for covid-19 immunization. Patient stated that he had gotten both shots of the Covid 19 Vaccine. A couple of weeks after the second dose of the vaccine on 23Apr2021 he woke up and could not feel anything in his left hand. His left pinky and left ring finger were numb and virtually paralyzed. States he went to the hospital where he was diagnosed with Parsonage Turner Syndrome. He was diagnosed with brachial neuritis 2 weeks after his second shot. Been in extreme pain and his left hand was partially paralyzed. Said that the only ways he could have developed Parsonage Turner Syndrome was if he had recently recovered from a virus or recently gotten a vaccine. Stated he cannot go to work, he cannot use his left hand. Stated he did not want to say that he was completely disabled. His wife has Multiple Sclerosis and now he was the one disabled. Said he needed to know how he was going to pay his mortgage now that this had happened to him. Stated he would've rather just caught Covid. He stated what can be done by Pfizer about crippling someone with their vaccine? Treatment received for the events included steroids and multiple medications. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, and disability or permanent damage. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: brachial neuritis; Diagnosed with Parsonage Turner Syndrome; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in Apr2021 at 49 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other medications within 2 weeks of vaccination or any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 in Arm Left on 18Mar2021 16:45 at 49 years old for covid-19 immunization. Patient stated that he had gotten both shots of the Covid 19 Vaccine. A couple of weeks after the second dose of the vaccine on 23Apr2021 he woke up and could not feel anything in his left hand. His left pinky and left ring finger were numb and virtually paralyzed. States he went to the hospital where he was diagnosed with Parsonage Turner Syndrome. He was diagnosed with brachial neuritis 2 weeks after his second shot. Been in extreme pain and his left hand was partially paralyzed. Said that the only ways he could have developed Parsonage Turner Syndrome was if he had recently recovered from a virus or recently gotten a vaccine. Stated he cannot go to work, he cannot use his left hand. Stated he did not want to say that he was completely disabled. His wife has Multiple Sclerosis and now he was the one disabled. Said he needed to know how he was going to pay his mortgage now that this had happened to him. Stated he would've rather just caught Covid. He stated what can be done by Pfizer about crippling someone with their vaccine? Treatment received for the events included steroids and multiple medications. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, and disability or permanent damage. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuralgic amyotrophy, Radiculitis brachial
Clinical narrative: brachial neuritis; Diagnosed with Parsonage Turner Syndrome; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, in Apr2021 at 49 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient didn't receive any other medications within 2 weeks of vaccination or any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 in Arm Left on 18Mar2021 16:45 at 49 years old for covid-19 immunization. Patient stated that he had gotten both shots of the Covid 19 Vaccine. A couple of weeks after the second dose of the vaccine on 23Apr2021 he woke up and could not feel anything in his left hand. His left pinky and left ring finger were numb and virtually paralyzed. States he went to the hospital where he was diagnosed with Parsonage Turner Syndrome. He was diagnosed with brachial neuritis 2 weeks after his second shot. Been in extreme pain and his left hand was partially paralyzed. Said that the only ways he could have developed Parsonage Turner Syndrome was if he had recently recovered from a virus or recently gotten a vaccine. Stated he cannot go to work, he cannot use his left hand. Stated he did not want to say that he was completely disabled. His wife has Multiple Sclerosis and now he was the one disabled. Said he needed to know how he was going to pay his mortgage now that this had happened to him. Stated he would've rather just caught Covid. He stated what can be done by Pfizer about crippling someone with their vaccine? Treatment received for the events included steroids and multiple medications. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, hospitalization, and disability or permanent damage. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram, Pulmonary thrombosis, X-ray
Clinical narrative: Numerous blood clots in both lungs; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730, expiry date not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 09:00 AM as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included degenerative disc disease, fibromyalgia, hypothyroidism, migraines, known allergies to tape and anise allergy. The patient had negative nasal swab on 07Nov2020. The patient had no covid prior to vaccination. Concomitant medications included morphine at 15 mg, twice a day; oxycodone (XTAMPZA ER) at 36 mg; and heparin; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 as COVID-19 immunization on 19Mar2021 09:00 AM (at the age of 61 years old) (brand Pfizer, lot en6208) administered on the left arm. The patient had no other vaccine in four weeks. On 30Apr2021 09:00 AM, patient had numerous blood clots in both lungs. On 01May2021 to May2021, she was admitted to the hospital for 2 days with numerous blood clots in both lungs. After several tests (May2021), they could not find any reason for getting these clots. So, thinking the only other thing patient did different was get the covid vaccine. The event was reported as serious medically significant, life threatening, and had caused hospitalization from 01May2021 to an unspecified date in May2021. It resulted to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Heparin IV. The patient had not recovered from the event numerous blood clots in both lungs.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: Numerous blood clots in both lungs; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730, expiry date not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 09:00 AM as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included degenerative disc disease, fibromyalgia, hypothyroidism, migraines, known allergies to tape and anise allergy. The patient had negative nasal swab on 07Nov2020. The patient had no covid prior to vaccination. Concomitant medications included morphine at 15 mg, twice a day; oxycodone (XTAMPZA ER) at 36 mg; and heparin; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 as COVID-19 immunization on 19Mar2021 09:00 AM (at the age of 61 years old) (brand Pfizer, lot en6208) administered on the left arm. The patient had no other vaccine in four weeks. On 30Apr2021 09:00 AM, patient had numerous blood clots in both lungs. On 01May2021 to May2021, she was admitted to the hospital for 2 days with numerous blood clots in both lungs. After several tests (May2021), they could not find any reason for getting these clots. So, thinking the only other thing patient did different was get the covid vaccine. The event was reported as serious medically significant, life threatening, and had caused hospitalization from 01May2021 to an unspecified date in May2021. It resulted to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Heparin IV. The patient had not recovered from the event numerous blood clots in both lungs.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Anticoagulant therapy, Balance disorder, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fine motor skill dysfunction, Haemoglobin decreased, Haptoglobin increased, Headache, Hypoperfusion
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: International normalised ratio normal, Laboratory test, Magnetic resonance imaging abnormal, Platelet count increased, Prothrombin time prolonged
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Superior sagittal sinus thrombosis, Transverse sinus thrombosis, Venous thrombosis, White blood cell count increased
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous thrombosis, Cerebrovascular accident, Computerised tomogram, Headache, Magnetic resonance imaging
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: I started experiencing non stop headaches.  Then I went to the emergency room a week later where they diagnosed me with Cerebral Venous Thrombosis and Stroke. I lost the use of my left hand. I've never had blood clots before or a history of blood clots in my family.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Computerised tomogram thorax abnormal, Pulmonary embolism, Scan with contrast abnormal
Clinical narrative: found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration, administered in Left arm on 04May2021 at 09:00 AM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Medical history included Hypothyroidism, previous experience with WPW (wolff-parkinson-white) syndrome and SVT (Supraventricular tachycardia), known allergies with Penicillin and latex. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID, strength: 88 ug). The patient previously received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown) administered in Left arm on 13Apr2021 at 07:45 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues on 05May2021 at 02:30 AM. Events were resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all events included began taking apixoban immediately. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Chest pain, Pulmonary embolism
Clinical narrative: found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration, administered in Left arm on 04May2021 at 09:00 AM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Medical history included Hypothyroidism, previous experience with WPW (wolff-parkinson-white) syndrome and SVT (Supraventricular tachycardia), known allergies with Penicillin and latex. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID, strength: 88 ug). The patient previously received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown) administered in Left arm on 13Apr2021 at 07:45 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues on 05May2021 at 02:30 AM. Events were resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all events included began taking apixoban immediately. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Pulmonary embolism
Clinical narrative: found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; Chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration, administered in Left arm on 04May2021 at 09:00 AM (at the age of 36-year-old) at single dose for COVID-19 immunisation. Medical history included Hypothyroidism, previous experience with WPW (wolff-parkinson-white) syndrome and SVT (Supraventricular tachycardia), known allergies with Penicillin and latex. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID, strength: 88 ug). The patient previously received first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date unknown) administered in Left arm on 13Apr2021 at 07:45 PM (at the age of 36-year-old) at single dose for COVID-19 immunisation. No other vaccine received in four weeks. The patient experienced chest pressure and pain, found a blood clot in right lung (pulmonary embolism) with no prior blood clot issues on 05May2021 at 02:30 AM. Events were resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all events included began taking apixoban immediately. No COVID tested post vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: got acute deep vein thrombosis of right lower extremities; inflamation and blood clot in vein; inflamation and blood clot in vein; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old female patient reported for herself  that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 (Batch/Lot number was not reported) at the age of 53-years-old, as single dose for covid-19 immunisation.   The patient had no medical history. The patient's concomitant medications were not reported.   The patient reported: I got acute Deep Vein Thrombosis of right lower extremities, inflammation and blood clot in vein on 19Apr2021 01:00 AM. The patient was visited by physician in Emergency Room. The reported events were deep vein thrombosis, thrombosis and inflammation, all considered life-threatening. Clinical outcome of the events was not recovered. Lab tests: CBC with auto diff CBC/ ETC.  Unspecified therapeutic measures were taken as a result of the events.   The patient was not diagnosed with COVID-19 prior to vaccination and since the patient was not vaccinated.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Full blood count, Inflammation, Thrombosis
Clinical narrative: got acute deep vein thrombosis of right lower extremities; inflamation and blood clot in vein; inflamation and blood clot in vein; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old female patient reported for herself  that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 (Batch/Lot number was not reported) at the age of 53-years-old, as single dose for covid-19 immunisation.   The patient had no medical history. The patient's concomitant medications were not reported.   The patient reported: I got acute Deep Vein Thrombosis of right lower extremities, inflammation and blood clot in vein on 19Apr2021 01:00 AM. The patient was visited by physician in Emergency Room. The reported events were deep vein thrombosis, thrombosis and inflammation, all considered life-threatening. Clinical outcome of the events was not recovered. Lab tests: CBC with auto diff CBC/ ETC.  Unspecified therapeutic measures were taken as a result of the events.   The patient was not diagnosed with COVID-19 prior to vaccination and since the patient was not vaccinated.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Aortic dilatation, Blood alkaline phosphatase normal, Blood bilirubin normal, Computerised tomogram abdomen
Clinical narrative: Acute Hemmoragic Pancreatitis; This is a spontaneous report from a contactable healthcare professional (patient). This 50-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EWO175) on 24Apr2021 at 11:15 (at 50 years of age), in left arm, for COVID-19 immunization. Medical history included hypertension, obesity and cholecystectomy. Known allergies: no. The first dose of BNT162B2 vaccine was given on 03Apr2021 at 11:00 AM (at 50 years of age), in left arm, Lot number: ER8734. 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. Concomitant medications included paracetamol (TYLENOL) and Areds2-eye vitamin/mineral supplement. On 25Apr2021 at 15:00 the patient experienced acute hemmoragic pancreatitis. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 4 days, life threatening illness (immediate risk of death from the event). The event required treatment with IV fluids, morphine, norco. The patient was recovering at the time of report. Since the vaccination, the patient had been tested for COVID-19: (SARS-COV-2 NAA (COVID-19) nasal swab) on 26Apr2021 with negative result.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported event  acute hemorrhagic pancreatitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count abnormal, Hepatic enzyme abnormal, Lipase, Mesenteric haematoma, Mesenteric haemorrhage
Clinical narrative: Acute Hemmoragic Pancreatitis; This is a spontaneous report from a contactable healthcare professional (patient). This 50-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EWO175) on 24Apr2021 at 11:15 (at 50 years of age), in left arm, for COVID-19 immunization. Medical history included hypertension, obesity and cholecystectomy. Known allergies: no. The first dose of BNT162B2 vaccine was given on 03Apr2021 at 11:00 AM (at 50 years of age), in left arm, Lot number: ER8734. 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. Concomitant medications included paracetamol (TYLENOL) and Areds2-eye vitamin/mineral supplement. On 25Apr2021 at 15:00 the patient experienced acute hemmoragic pancreatitis. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 4 days, life threatening illness (immediate risk of death from the event). The event required treatment with IV fluids, morphine, norco. The patient was recovering at the time of report. Since the vaccination, the patient had been tested for COVID-19: (SARS-COV-2 NAA (COVID-19) nasal swab) on 26Apr2021 with negative result.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported event  acute hemorrhagic pancreatitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis haemorrhagic, Peripancreatic varices, Platelet count normal, Prothrombin time normal
Clinical narrative: Acute Hemmoragic Pancreatitis; This is a spontaneous report from a contactable healthcare professional (patient). This 50-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EWO175) on 24Apr2021 at 11:15 (at 50 years of age), in left arm, for COVID-19 immunization. Medical history included hypertension, obesity and cholecystectomy. Known allergies: no. The first dose of BNT162B2 vaccine was given on 03Apr2021 at 11:00 AM (at 50 years of age), in left arm, Lot number: ER8734. 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. Concomitant medications included paracetamol (TYLENOL) and Areds2-eye vitamin/mineral supplement. On 25Apr2021 at 15:00 the patient experienced acute hemmoragic pancreatitis. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 4 days, life threatening illness (immediate risk of death from the event). The event required treatment with IV fluids, morphine, norco. The patient was recovering at the time of report. Since the vaccination, the patient had been tested for COVID-19: (SARS-COV-2 NAA (COVID-19) nasal swab) on 26Apr2021 with negative result.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported event  acute hemorrhagic pancreatitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become 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: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis haemorrhagic, SARS-CoV-2 test
Clinical narrative: Acute Hemmoragic Pancreatitis; This is a spontaneous report from a contactable healthcare professional (patient). This 50-year-old non-pregnant female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EWO175) on 24Apr2021 at 11:15 (at 50 years of age), in left arm, for COVID-19 immunization. Medical history included hypertension, obesity and cholecystectomy. Known allergies: no. The first dose of BNT162B2 vaccine was given on 03Apr2021 at 11:00 AM (at 50 years of age), in left arm, Lot number: ER8734. 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. Concomitant medications included paracetamol (TYLENOL) and Areds2-eye vitamin/mineral supplement. On 25Apr2021 at 15:00 the patient experienced acute hemmoragic pancreatitis. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 4 days, life threatening illness (immediate risk of death from the event). The event required treatment with IV fluids, morphine, norco. The patient was recovering at the time of report. Since the vaccination, the patient had been tested for COVID-19: (SARS-COV-2 NAA (COVID-19) nasal swab) on 26Apr2021 with negative result.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported event  acute hemorrhagic pancreatitis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become 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: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Computerised tomogram head, Head discomfort, Magnetic resonance imaging head
Clinical narrative: Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via unknown route of administration on the left arm on 02Feb2021 at 11:30 AM, as a 1st single dose for covid-19 immunization. Medical history of the patient was none. Patient did not have any known allergies. Patient did not receive any other medications in two weeks after vaccination. Patient did not receive any vaccine within 4 weeks prior to the first dose of vaccine. Prior to vaccination, patient did not diagnose with Covid-19. On 10Feb2021 at 01:00 AM after receiving first dose of vaccine, patient experienced extreme pressure in brain, screaming tinnitus, muscle cramps and aches, which was resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received for the events included medicine (unspecified). Since the vaccination, patient has not been tested for Covid-19. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging neck, Tinnitus
Clinical narrative: Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via unknown route of administration on the left arm on 02Feb2021 at 11:30 AM, as a 1st single dose for covid-19 immunization. Medical history of the patient was none. Patient did not have any known allergies. Patient did not receive any other medications in two weeks after vaccination. Patient did not receive any vaccine within 4 weeks prior to the first dose of vaccine. Prior to vaccination, patient did not diagnose with Covid-19. On 10Feb2021 at 01:00 AM after receiving first dose of vaccine, patient experienced extreme pressure in brain, screaming tinnitus, muscle cramps and aches, which was resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received for the events included medicine (unspecified). Since the vaccination, patient has not been tested for Covid-19. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral disorder, Muscle spasms, Myalgia, Tinnitus
Clinical narrative: Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; Extreme pressure in brain, Screaming tinnitus, Muscle cramps and aches; This is a spontaneous report from contactable consumer (patient). A 36-year-old male patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via unknown route of administration on the left arm on 02Feb2021 at 11:30 AM, as a 1st single dose for covid-19 immunization. Medical history of the patient was none. Patient did not have any known allergies. Patient did not receive any other medications in two weeks after vaccination. Patient did not receive any vaccine within 4 weeks prior to the first dose of vaccine. Prior to vaccination, patient did not diagnose with Covid-19. On 10Feb2021 at 01:00 AM after receiving first dose of vaccine, patient experienced extreme pressure in brain, screaming tinnitus, muscle cramps and aches, which was resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received for the events included medicine (unspecified). Since the vaccination, patient has not been tested for Covid-19. Outcome of the events were not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Throat irritation
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05May2021 (Lot Number: ER8735, at age of 42-year-old) as single dose for covid-19 immunization. Medical history included multiple sclerosis. The patient's concomitant medications were not reported. Patient stated that she needed to report that she went into anaphylactic shock after getting the Pfizer COVID Vaccine. Wednesday it was 05May2021. Patient had to go to emergency room where she was getting Steroid, Benadryl and Toradol. Patient had complete blood count (CBC), thyroid function, they are all normal. The outcome of the event was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Full blood count, Thyroid function test
Clinical narrative: Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 05May2021 (Lot Number: ER8735, at age of 42-year-old) as single dose for covid-19 immunization. Medical history included multiple sclerosis. The patient's concomitant medications were not reported. Patient stated that she needed to report that she went into anaphylactic shock after getting the Pfizer COVID Vaccine. Wednesday it was 05May2021. Patient had to go to emergency room where she was getting Steroid, Benadryl and Toradol. Patient had complete blood count (CBC), thyroid function, they are all normal. The outcome of the event was unknown.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging
Clinical narrative: I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Metamorphopsia, Rapid alternating movement test abnormal, Visual impairment
Clinical narrative: I awoke with distorted vision in my Left eye.; a stroke; visual impairment; This is a spontaneous report from a contactable Other Health Professional (patient). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), via an unspecified route of administration, administered in arm left on 19 Jan 2021 at 19:00 (Batch/Lot Number: EL3302) as 2nd dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included omeprazole (PRILOSEC [OMEPRAZOLE]), rosuvastatin, metoprolol, and ezetimibe (ZETIA), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2 (lot number: EL1284) in the left arm on 29Dec2020 07:00 PM for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to COVID-19 vaccine. He was not diagnosed with COVID-19 prior vaccination. It was reported that the patient awoke with distorted vision in his left eye. He went to the emergency room and was diagnosed with a stroke. He was subsequently transferred to the (hospital name) Level 1 Stroke Center. He continued to have visual impairment. The events started on 30Apr2021 07:00 AM. The patient was hospitalized for 5 days. The events was reported serious life-threatening, hospitalization and disabling/incapacitating. Therapeutic measures were taken as a result of the events with TPA. He had been tested for COVID-19 since the vaccination through rapid test (nasal swab) on 01May2021 with negative result. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood fibrinogen normal, Computerised tomogram head normal, Fibrin D dimer normal, Immune thrombocytopenia, International normalised ratio normal
Clinical narrative: LOW BLOOD PLATELET COUNT; SMALL BLISTER IN MOUTH; RED DOTS ALL OVER HER BODY PRIMARILY ON LEGS AND ARMS; HEADACHE; BRUISES; This spontaneous report received from a consumer concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient did not have any known allergies. the patient did not have drug abuse or illicit drug usage. 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced bruises, and was hospitalized (date unspecified). On 16-MAR-2021, the subject experienced headache. On 05-MAY-2021, Laboratory data included: CT scan (NR: not provided) no brain injury. On an unspecified date, the subject experienced low blood platelet count, small blister in mouth, and red dots all over her body primarily on legs and arms, and was hospitalized. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low blood platelet count of 4000 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bruises, headache, low blood platelet count, small blister in mouth and red dots all over her body primarily on legs and arms was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210509067-covid-19 vaccine ad26.cov2.s - Low blood platelet count, Bruises, Small blister in mouth. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210509067-covid-19 vaccine ad26.cov2.s Headache and Red dots all over her body primarily on legs and arms. This event(s) is labeled per RSI and is therefore considered potentially related