chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Diagnosed with a stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 12Apr2021 14:00 (received at the age of 66-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. Medical history included hypertension, high cholesterol, anxiety and allergy to penicillin. The patient had no history of COVID-19 and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EN6198), on 22Mar2021 14:30 (received at the age of 66-years-old) for COVID-19 immunization. The patient previously took macrodantin and metronidazole in which she experienced allergy. On 13Apr2021 17:00, the patient started feeling right-sided leg weakness. And by Thursday, 15Apr2021, she had arm weakness and a mild right mouth droop. She was diagnosed with a stroke on 17Apr2021. The patient stated that she thought for three days it was just a vaccine side effect and would get better, but it ended up getting worse. The adverse event stroke started on 13Apr2021 at 17:00. The adverse event resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized for 6 days. It was unknown if the patient received corrective treatment. Outcome of the event was recovered with sequel on an unspecified date.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Haematemesis, Haematochezia
Clinical narrative: he puke blood; blood in his stool but this afternoon was just whole blood; This is a spontaneous report from a contactable consumer (parent). This consumer reported for an 18-year-old male patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 11May2021 at 11:30 (at the age of 18-years-old) as unknown, single for COVID-19 immunisation. Medical history was not reported. There were no concomitant medications. The reporter's son had the vaccine yesterday around 11:30 in the morning and this morning (12May2021), he puke blood and then this afternoon he just puke blood, this morning was blood in his stool but this afternoon was just whole blood. The reporter doesn't know if that was related or because of the vaccine. The outcome of the events was unknown.    Information about lot/batch has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Glycosylated haemoglobin decreased, Headache, IIIrd nerve paralysis, Investigation
Clinical narrative: double vision, palsy of third optic nerve in right eye; Glycosylated Hemoglobin A1C 5.8; headache every day after second dose for 2 months; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Arm Left on 03Feb2021 (Batch/Lot Number: EL3302) at the age of 73-years-old as 2ND DOSE, SINGLE for COVID-19 immunization.  Medical history included ongoing tachycardia and blood cholesterol abnormal (reported as cholesterol). Ongoing concomitant medications included metoprolol (METOPROLOL) taken for tachycardia; rosuvastatin calcium (ROSUVASTIN) taken for blood cholesterol abnormal (reported as cholesterol); and clopidogrel bisulfate (PLAVIX) taken for prophylaxis, all taken since unknown dates. The patient received the 1st dose of PFIZER-BIONTECH COVID-19 VACCINE on 13Jan2021 (Batch/Lot Number: EL0142) at the age of 73-years-old as COVID-19 immunization. Then, the 2nd dose on 03Feb2021. After the second dose on 03Feb2021, she had a headache that started that day and every day for two months which she never got headaches before this. Her headaches have resolved about three weeks ago (Apr2021) and the doctor prescribed her medication, but she did not have to take it.  Then on 18Mar2021 (6 weeks after the second dose), she woke up, got up, walked down her hall and saw three front doors - she mentioned that she was having double vision. She went to the hospital where she was admitted on 18Mar2021 to an observation decision unit for 26 hours (19Mar2021). She was tested for a stroke but was not having a stroke. She was then diagnosed with eye palsy in third optical nerve of her right eye. Her right eye was somewhat improved as she can move it up down left and right. Her right eye was no longer paralyzed, her eyelid will now open and close where initially it just wanted to stay closed, but her vision was still distorted. She was still treating it with patching her eyes off and on. The patient also had glycosylated haemoglobin (A1C) was 5.8 - borderline taken on unknown date and waiting for A1C results. The patient recovered from headache in Apr2021 while recovering from "double vision, palsy of third optic nerve in right eye"
Sex: F
Vaccine: COVID19
Symptoms: Headache, IIIrd nerve paralysis
Clinical narrative: had some double vision issues, which was later diagnosed as palsy in the third optical nerve from right eye; I had a headache, that lasted for several weeks; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on unspecified date as single dose for COVID-19 immunization. Six (6 weeks) later after 2nd dose on 18Mar2021, the patient woke up and had some double vision issues, which was later diagnosed as palsy in the third optical nerve from right eye. Also, she was just curious because she never gets headaches, and within hours of getting second dose on unspecified date in Feb2021 she had a headache, that lasted for several weeks. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a non-contactable consumer (patient herself). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 24Mar2021 at 11:00 (Batch/Lot Number: EP6955) as the 1st dose, single and intramuscularly, administered in the left arm on 14Apr2021 at 09:00 (Batch/Lot Number: EP6955) as the 2nd dose, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the workplace clinic. Relevant medical history included depression and known allergies to eggs when younger; both from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (PROZAC) and lamotrigine (LAMICTAL); both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 12May2021 at 10:00, the patient experienced positive COVID-19 test with symptoms of severe throat lesions. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included Covid test via Nasal Swab, which was negative on 02May2021 and positive on 12May2021. Therapeutic measures were taken as a result of positive COVID-19 test with symptoms, which included medication for severe throat lesions. The patient was recovering from the event.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included dupilumab (DUPIXENT) taken for an unspecified indication, start and stop date were not reported.  The patient experienced severe allergic reaction about 2 weeks after receiving second dose. The event was assessed as medically significant on an unspecified date with outcome of unknown.   Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Post menopausal bleeding started occurring 2 days after 2nd dose.; This is a spontaneous report from a contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 11:45 (Batch/Lot Number: EW0167) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation, age at vaccination unknown, at doctor's office. Medical history included breast cancer, high blood pressure from an unknown date and unknown if ongoing. Patient is not pregnant during vaccination. Concomitant medications included tamoxifen; lisinopril; trazodone taken for an unspecified indication, start and stop date were not reported. The patient previously took quinoa. Patient received the first dose BNT162B2 on 19Apr2021 11:30 (lot number EW0164, via left arm) for covid-19 immunisation and experienced Some very light spotting occurred after first dose. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced post menopausal bleeding started occurring 2 days after 2nd dose on 12May2021 16:00 requiring physician office visit. No hospitalization involved.  Some very light spotting occurred after first dose. Patient have not had a period in over a year. Due to taking Tamoxifen for breast cancer diagnosis 4 years ago, I have scheduled an appointment with her OBGyn on 17May2021 to be checked out. Outcome of the event was not recovered. Seriousness criteria reported as non-serious.  No follow-up attempts are needed; information about lot/batch number has been obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Headache, Pyrexia
Clinical narrative: hallucinations; High fever; headaches; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12May2021 11:45 (Lot Number: Eu0173) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient previously had BNT162B2 (lot number: Er8736) 1st dose on 20Apr2021 10:45 AM in the left arm at 36 years old for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hallucinations, high fever and headaches on 13May2021 02:00. The facility where the most recent COVID-19 vaccine was administered was in the School or Student Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Gait inability, Joint swelling
Clinical narrative: Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; Knee swelling to previous injuries. Swelling has gotten so bad I cannot walk.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0175), via an unspecified route of administration in left arm on 29Apr2021 at 15:30 (at the age of 34-years-old) at 2nd dose, single for COVID-19 immunization. Medical history included knee swelling from previous injuries. Prior to vaccination, the patient was not diagnosed with COVID-19 and she has no known allergies. Concomitant medications were reported as none. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications received within 2 weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, she has not been tested for COVID-19. The patient reported that she had knee swelling from previous injuries and the swelling has gotten so bad that she could not walk on 01May2021 at 12:00. She did not receive any treatment in response to the events. The outcome of the events was recovering. The events were reported as serious causing disability/incapacity/ permanent damage.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Renal function test, Renal impairment
Clinical narrative: "positive" covid-19 after first covid 19 vaccine; "positive" covid-19 after first covid 19 vaccine; kidney function levels going down "blood work"; This is a spontaneous report from a contactable healthcare professional and a consumer. A 73-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) from 29Oct2020 and ongoing for psoriatic arthritis. The patient reported new symptom of kidney function levels going down "blood work" so he was seeing a specialist. Specific results of tests not available. The patient reported he had recent "positive" covid-19 after first covid-19 vaccine with symptoms, lasted a few weeks. The patient recovered from "positive" covid-19 after first covid 19 vaccine on an unspecified date while outcome of other event was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: "positive" covid-19 after first covid 19 vaccine; "positive" covid-19 after first covid 19 vaccine; kidney function levels going down "blood work"; This is a spontaneous report from a contactable healthcare professional and a consumer. A 73-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) from 29Oct2020 and ongoing for psoriatic arthritis. The patient reported new symptom of kidney function levels going down "blood work" so he was seeing a specialist. Specific results of tests not available. The patient reported he had recent "positive" covid-19 after first covid-19 vaccine with symptoms, lasted a few weeks. The patient recovered from "positive" covid-19 after first covid 19 vaccine on an unspecified date while outcome of other event was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension
Clinical narrative: diaphoretic; hypotensive; This is a spontaneous report from a contactable consumer (patient's mother).  A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscular, administered in Arm Left on 02May2021 15:20 (at the age of 34-years-old) (Batch/Lot Number: EW0171; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation.  The patient had not medical history. The patient's concomitant medications were not reported.  12 minutes after receiving the vaccine, the patient became hypotensive and diaphoretic for about 1 to 1.5 minutes. He was scheduled for his second dose on 23May2021. The outcome of the events was recovered. The events were assessed as serious, medically significant.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Mental impairment, Seizure like phenomena, Speech disorder
Clinical narrative: seizure-like effects; tried to speak but her brain could not process it; difficulty in speaking; having slurred speech/more episodes with her tongue and slurred speech episodes; This is a spontaneous report from a contactable nurse (reported for herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (lot number: not known) at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller is a 65-year-old retired nurse who took the 1st dose of the Pfizer COVID Vaccine. She experienced seizure-like effects after vaccination, in which she had difficulty in speaking, almost having slurred speech. She mentioned that she tried to speak but her brain could not process it. During the first onset, the medications prescribed to her seemed to not work, she had more episodes with her tongue and slurred speech episodes. She went from taking her medications once a day to now twice day, attributing to her regained ability to speak. She was recommended not to get the 2nd dose. She will be having an MRI and MRA and will follow up for 4 months. She is asking if this has been reported and if she should go get her 2nd dose. The outcome of all events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test, Magnetic resonance imaging, Pruritus, Rash macular
Clinical narrative: A pain and intense pressure in her chest/ Chest pain; Extreme itching to the palm of her hand; runny nose; Some blotches on right hand; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 57 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0179, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 as a first dose, single dose for covid-19 immunisation. Medical history included mini strokes (wherein patient felt weird and dizzy prior to vaccine) from an unknown date and unknown if ongoing. Patient have an ongoing hernia, confirmed as popped up before the vaccine, they said she would need to have surgery, maybe in a couple of months. Patient had a family history of aneurysms. Concomitant medication included clopidogrel bisulfate (PLAVIX) at 75mg once a day by mouth  taken for mini strokes, from Apr2021 (also reported as started two days before the Covid vaccine), as patient had mini strokes that showed up on the MRI in Oct2020, wherein patient felt weird and dizzy prior to vaccine. She did start Plavix 2 weeks prior to the vaccine, she was unsure if they knew that she was on Plavix when she got her vaccine. On 10May2021, patient experienced a pain and intense pressure in her chest/ chest pain and she went to the ED on Monday morning (May2021), they did testing on her, and had to be admitted from 10May2021 to 11May2021, everything was negative. Chest pain was completely gone by Monday night. On 12May2021, patient had extreme itching to the palm of her hand. She was looking for information about a side effect she was experiencing and she stated her hands were itching, that she got the vaccine on 30Apr2021, itching started yesterday 12May2021, and stated every time she thinks its getting better it starts up again and it was intense itching, that saw some blotches on right hand creeping up (2021), they did subside and the itching continued. She also noticed a runny nose, started Tuesday (11May2021), and seemed to be coinciding with the itchy hands states it was persisting. The patient recovered from chest pain on 10May2021 but had not recovered from runny nose and extreme itching to the palm of her hand. The outcome of the event some blotches on right hand was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: A pain and intense pressure in her chest/ Chest pain; Extreme itching to the palm of her hand; runny nose; Some blotches on right hand; This is a spontaneous report received from a contactable consumer (patient reported for herself). A 57 year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0179, expiry date not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 as a first dose, single dose for covid-19 immunisation. Medical history included mini strokes (wherein patient felt weird and dizzy prior to vaccine) from an unknown date and unknown if ongoing. Patient have an ongoing hernia, confirmed as popped up before the vaccine, they said she would need to have surgery, maybe in a couple of months. Patient had a family history of aneurysms. Concomitant medication included clopidogrel bisulfate (PLAVIX) at 75mg once a day by mouth  taken for mini strokes, from Apr2021 (also reported as started two days before the Covid vaccine), as patient had mini strokes that showed up on the MRI in Oct2020, wherein patient felt weird and dizzy prior to vaccine. She did start Plavix 2 weeks prior to the vaccine, she was unsure if they knew that she was on Plavix when she got her vaccine. On 10May2021, patient experienced a pain and intense pressure in her chest/ chest pain and she went to the ED on Monday morning (May2021), they did testing on her, and had to be admitted from 10May2021 to 11May2021, everything was negative. Chest pain was completely gone by Monday night. On 12May2021, patient had extreme itching to the palm of her hand. She was looking for information about a side effect she was experiencing and she stated her hands were itching, that she got the vaccine on 30Apr2021, itching started yesterday 12May2021, and stated every time she thinks its getting better it starts up again and it was intense itching, that saw some blotches on right hand creeping up (2021), they did subside and the itching continued. She also noticed a runny nose, started Tuesday (11May2021), and seemed to be coinciding with the itchy hands states it was persisting. The patient recovered from chest pain on 10May2021 but had not recovered from runny nose and extreme itching to the palm of her hand. The outcome of the event some blotches on right hand was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, SARS-CoV-2 test
Clinical narrative: Afib; came down with symptoms on the following weekend/had every Covid symptom except smell and taste/still has a lingering fever, body aches and cough tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a 62-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EW0171; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in the left arm on 27Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 27Apr2021, was exposed during over the weekend then began having COVID symptoms. The patient came down with symptoms on the following weekend and is still suffering from symptoms. The patient clarified that he had every Covid symptom except smell and taste and that he still has a lingering fever, body aches and cough since 01May2021. The patient tested positive for COVID-19 on an unspecified date. The patient is due to get a second dose on 18May2021 and wanted to know if he should get the second dose. He also wanted to know if when he holds off for several weeks before getting second dose, would it affect the efficacy. The patient also reported that after the first dose he went into Afib and he had to be on a blood thinner. He knows that it mentioned something about blood thinners in the paper that he got after the first dose. He wanted to know if he should get the second dose since he had to be on a blood thinner recently. The outcome of the event Afib was unknown while the outcome of the event came down with symptoms on the following weekend/had every covid symptom except smell and taste/still has a lingering fever, body aches and cough tested positive for covid-19 was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling of body temperature change, Headache, Loss of consciousness
Clinical narrative: body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Seizure
Clinical narrative: body aches; chills; headache; dizziness; goes from being cold and hot; passing out a few times; shaking similar to seizure/eyes kind of glazed; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EW0182), via an unspecified route of administration, administered in arm left on 11May2021 08:00 (at the age of 57-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drugstore. The patient medical history included covid before, he had a bad case of it from Nov2020. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19, lot number was not reported) on 20Apr2021 (at the age of 57-years-old) as 1st dose, single dose for covid-19 immunisation, and experienced all of the same symptoms (body aches, chills, goes from being cold and hot, headache and dizziness) but he did not pass out. The patient always gets the flu vaccine. The patient's concomitant medications were not reported. On 11May2021 15:15, the patient experienced passing out a few times, eyes kind of glazed, and shaking similar to seizure; and at 19:00, the patient body pain, chills, headache, dizziness and goes from being cold and hot. The outcome of the events was unknown.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I am seeing swelling in left lymph gland- near the collar bone; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 22Apr2021 09:00 (at the age of 30-year-old) as 2nd dose, single for COVID-19 immunization.  The patient medical history was not reported. The patient had no known allergies. Concomitant medication included paracetamol. The patient previously received the first dose of BNT162B2 (Lot Number: ER8737), administered in right arm on 31Mar2021 15:00 (at the age of 30-year-old) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was seeing swelling in left lymph gland- near the collar bone on 09May2021 19:00. The event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included an antibiotic that was prescribed by doctor, Cefdinir 300mg. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Ocular vascular disorder
Clinical narrative: blood clot on her left eye; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, expiry and lot number were not reported), via an unspecified route of administration, administered in the left arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient woke up with a blood clot on her left eye on an unspecified date. Outcome of the event was unknown.   No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Smear test
Clinical narrative: Non traumatic insidious stroke right brain leaving left side paralysis; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 28Jan2021 13:45 (lot number: EL9262) at 2nd dose, single for COVID-19 immunization. Medical history included coronary artery bypass grafting (CABG). Concomitant medications included metoprolol, atorvastatin (reported as 'atorvasten'), tamsulosin, and clopidogrel (reported as 'clopidigrol'), all taken for unspecified indications, start and stop dates were not reported, these medications were received by the patient within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in arm left on 07Jan2021 13:30 (lot number: EL3246) at 1st dose, single for COVID-19 immunization. The patient experienced non traumatic insidious stroke right brain leaving left side paralysis on 15Feb2021 12:30. The event reported assessed as serious which required hospitalization and resulted to disability. Hospitalization: 28 days. The event resulted to emergency room/department or urgent care. Treatment received included intensive care unit (ICU) care (1 week) and rehab hospital (3 weeks). The patient was not diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination (unknown result on an unspecified date). The patient also underwent nasal swab on 22Feb2021 with negative result. The outcome of the event was recovering.  Follow-up information has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Erythema, Gait disturbance, Gait inability, Pain in extremity
Clinical narrative: swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: swollen and red leg; swollen and red leg; blood clot in right leg; Pain in right leg; her husband cannot walk, he is limping; her husband cannot walk, he is limping; This is a spontaneous report from contactable consumers (patient and wife). A 61-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 at vaccination age of 61-year-old via an unspecified route of administration on 21Apr2021 13:00 (Lot Number: ER3732; Expiration Date: 30Nov2022) as 2nd dose, single for covid-19 immunisation. Medical history included ongoing high cholesterol and ongoing prostate [having to go to the bathroom frequently] (prostatic disorder). The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) at vaccination age of 61-year-old on 26Mar2021 3:45 pm for covid-19 immunisation. Concomitant medications included (LIPITOR) ongoing since unspecified date (reported as 3 or 4 years ago) for blood cholesterol increased, and tamsulosin on an unspecified therapy dates (reported as he has been taking it for years now) for prostate/having to go to the bathroom frequently (prostatic disorder). The patient did not receive other vaccine in the last four weeks prior to vaccination. The patient received the vaccine from a pharmacy. The patient reported that one week after getting the second vaccine, he had pain in his right leg (28Apr2021). He stated that he did know what was going on, but he continued to work. He added that last Monday (10May2021) it got worse, so he contacted his primary care doctor and he went today (12May2021) because his leg was swollen, red and he had pain. His doctor sent him to the ER (emergency room). The patient mentioned that the ER did a CAT scan on 12May2021 and found that he had a blood clot in his right leg (reported as 10May2021). The patient's wife comes on the line and stated the reason her husband called to report was because it could be from the vaccine, but they are not sure. The wife added that her husband went to the pharmacy to pick up the blood thinner and they told him to report this. She also stated that all the side effects could happen, but he did know the side effects and he just wanted to report because the pharmacy told him to report. She mentioned that her husband started complaining his leg hurt because he has to do yard work. She states that it got worse and worse and she saw his leg get swollen and she was like you need to go to the doctor. The wife mentioned that the leg is more swollen and painful, but is the same, her husband cannot walk, he is limping on an unspecified date in 2021. She stated that her husband has just started taking medication, yesterday and today. The outcome of the event thrombosis leg was not recovered while the outcome of the other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: EM-like eruption; This is a spontaneous report from a non-contactable physician. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), intramuscular on Feb2021 as 1st dose, single dose for COVID-19 immunization given in the doctor's office. The patient's medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. Not diagnosed with COVID-19 prior to vaccination. Unknown if tested for COVID-19 post vaccination. The patient experienced Erythema Multiforme (EM)-like eruption and rash 2 weeks after the 1st vaccine on Feb2021. No mucosal involvement. The patient was treated with topical and oral steroids. The outcome of the events was recovered.   No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Erythema multiforme, Rash) and the BNT162B2 cannot be excluded.   "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Thrombosis
Clinical narrative: large blood clots during menstruation; irregular menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (Lot Number: er8731), via an unspecified route of administration in Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced irregular menstrual cycle and large blood clots during menstruation, both on 04May2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Headache, Musculoskeletal disorder, Speech disorder
Clinical narrative: Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Confusional state, Dysgraphia, Hypoacusis
Clinical narrative: Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events.  Information on lot/batch number was available. Additional information has been requested.