chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Headache, Photophobia
Clinical narrative: continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Lethargy, Nasal congestion
Clinical narrative: headache; on and off chills; lethargic; nasal congestion; started feeling run down; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received 2nd dose of bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in left arm on 16Feb2021 12:00 at single dose for covid-19 immunisation. Medical history included nocturnal seizures, hypothyroid, sinus infections, seasonal allergies, allergies to sulfa drugs. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine, glucosamine, naproxen sodium (ALEVE), cetirizine hydrochloride (ZYRTEC). The patient previously received 1st dose of bnt162b2 on 26Jan2021 at 11:00 in left arm for covid-19 immunisation. At about 11 pm after the vaccination (16Feb2021 23:00), started feeling run down. Woke up the next morning (17Feb2021) with headache, on and off chills, lethargic, with nasal congestion. No treatment received in response to the events. The outcome of events was recovering. This case was reported as non-serious. The patient was not pregnant. 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.   Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am floating; fever of 101.1; chills; body aches; extreme fatigue; This is a spontaneous report from a contactable other health care professional (patient).   A 23-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EM9810, intramuscular on 12Feb2021 14:15 (at the age of 23-years-old) as a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were none.  Historical vaccine information included BNT162B2 (Pfizer BioNtech), lot unknown False, administration date 22Jan2021 01:45 AM, dose number 1 for COVID-19 immunization (at 23 years old). 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, patient has not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient reported she was on day 5 post second vaccine and am still experiencing a lingering headache, nausea and spells of dizziness. These ease up some with acetaminophen (TYLENOL), but do not fully go away nor has she noticed any improvement in her symptoms. The headache started approximately 11 hours after her vaccination 13Feb2021 01:15. The following day unspecified date Feb2021, she had fever of 101.1, chills, body aches, extreme fatigue, and a worsening headache. This headache has continued and is still present, coming and going in severity. She had spells where she feels like she was floating on unspecified date in Feb2021 and feeling extremely dizzy while also being nauseated. She has not seen any reports of these symptoms lasting this long after vaccination.  "The adverse events started on 17Feb2021 at 12:00 PM". The patient underwent lab tests and procedures which included body temperature: 101.1 (fever) on 17Feb2021. No treatment was received for feel like I am floating, fever of 101.1, chills, body aches and extreme fatigue. Outcome of the events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: headache/ lingering headache; nausea; spells of dizziness/feeling extremely dizzy; feel like I am floating; fever of 101.1; chills; body aches; extreme fatigue; This is a spontaneous report from a contactable other health care professional (patient).   A 23-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EM9810, intramuscular on 12Feb2021 14:15 (at the age of 23-years-old) as a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were none.  Historical vaccine information included BNT162B2 (Pfizer BioNtech), lot unknown False, administration date 22Jan2021 01:45 AM, dose number 1 for COVID-19 immunization (at 23 years old). 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, patient has not been tested for COVID-19. Patient did not have allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient reported she was on day 5 post second vaccine and am still experiencing a lingering headache, nausea and spells of dizziness. These ease up some with acetaminophen (TYLENOL), but do not fully go away nor has she noticed any improvement in her symptoms. The headache started approximately 11 hours after her vaccination 13Feb2021 01:15. The following day unspecified date Feb2021, she had fever of 101.1, chills, body aches, extreme fatigue, and a worsening headache. This headache has continued and is still present, coming and going in severity. She had spells where she feels like she was floating on unspecified date in Feb2021 and feeling extremely dizzy while also being nauseated. She has not seen any reports of these symptoms lasting this long after vaccination.  "The adverse events started on 17Feb2021 at 12:00 PM". The patient underwent lab tests and procedures which included body temperature: 101.1 (fever) on 17Feb2021. No treatment was received for feel like I am floating, fever of 101.1, chills, body aches and extreme fatigue. Outcome of the events was recovering.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cerebrovascular accident, Computerised tomogram, Musculoskeletal pain, Pain in extremity
Clinical narrative: stroke; Joint pain; In the palm of my hand I might jump out of my skin; ; arm was hardly sore at all; right arm at the shoulder, elbow, and fingers is hurting at the joints; This is a spontaneous report from a contactable consumer. This 67-year-old  male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9269) single dose, dose 1 via unknown route of administration in the left arm for COVID-19 vaccination on 12Feb2021 at 14:30. There were no additional vaccines administered on the same date as the COVID-19 vaccine. Medical history included pneumonia five times on an unknown date, septicemia one time, melanoma cancer in 2015, Factor V Leiden, high blood pressure and blood thinner. Prior Vaccinations (within 4 weeks): Concomitant medications included lisinopril from 2008 and ongoing for high blood pressure and warfarin 9.5 mg daily from 2008  and ongoing for blood thinner. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On an unknown date, the patient's arm was hardly sore at all and he had a stroke. On 13Feb2021, the patient experienced joint pain, in the palm of his hand if he presses right in the dead center he thinks he is going to jump out of the skin and right arm at the shoulder, elbow and fingers is hurting at the joints. When he first felt it in his right arm it wasn't horrible and it seemed like it got worse the next day. Then it seemed like it tapered off a little bit. On 16Feb2021, the pain woke him up in the middle of the night. The events did not require an emergency room or physician's office visit. He gets the flu shot every year and he has no symptoms whatsoever. The clinical outcome of stroke, joint pain, in the palm of my hand I might jump out of my skin, arm was hardly sore at all and right arm at the shoulder, elbow, and fingers is hurting at the joints were unknown.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: fever; fatigue; headache; muscle pain; thirst; insomnia; This is a spontaneous report from a non-contactable other health professional (HCP) reported for himself. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in the right arm on 16Feb2021 at single dose for COVID-19 immunization. The relevant medical history included covid-19 (if covid prior vaccination: Yes) from an unspecified date. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX). The patient previously received first dose of BNT162B2 at the age of 28 years old on 27Jan2021 for COVID-19 immunization (lot number: EL3247, vaccine location: Right arm). The patient experienced fever, fatigue, headache, muscle pain, thirst, severe enough to cause insomnia and interfere with work on 16Feb2021. No treatment was received for the events. The seriousness was reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: fever; fatigue; headache; muscle pain; thirst; insomnia; This is a spontaneous report from a non-contactable other health professional (HCP) reported for himself. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration in the right arm on 16Feb2021 at single dose for COVID-19 immunization. The relevant medical history included covid-19 (if covid prior vaccination: Yes) from an unspecified date. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride (OSTEO BI-FLEX). The patient previously received first dose of BNT162B2 at the age of 28 years old on 27Jan2021 for COVID-19 immunization (lot number: EL3247, vaccine location: Right arm). The patient experienced fever, fatigue, headache, muscle pain, thirst, severe enough to cause insomnia and interfere with work on 16Feb2021. No treatment was received for the events. The seriousness was reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test, Cardiac stress test, Dyspnoea, Hyperhidrosis
Clinical narrative: she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization.  Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she  could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart.  She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Myocardial infarction, Pain, Thrombosis, Ultrasound scan
Clinical narrative: she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization.  Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she  could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart.  She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization.  Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she  could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart.  She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization.  Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she  could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart.  She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood test, Cardiac stress test, Dyspnoea, Hyperhidrosis
Clinical narrative: massive heart attack; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Feb2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included a pacemaker and a heart condition. On Feb2021 (two days after the vaccination), she was rushed to the hospital by ambulance thinking she had a massive heart attack. The patient was hospitalized for two and a half days in Feb2021. The clinical outcome of massive heart attack was unknown.  Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal chest pain, Myocardial infarction, Pain, Thrombosis, Ultrasound scan
Clinical narrative: massive heart attack; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Feb2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included a pacemaker and a heart condition. On Feb2021 (two days after the vaccination), she was rushed to the hospital by ambulance thinking she had a massive heart attack. The patient was hospitalized for two and a half days in Feb2021. The clinical outcome of massive heart attack was unknown.  Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: massive heart attack; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Feb2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included a pacemaker and a heart condition. On Feb2021 (two days after the vaccination), she was rushed to the hospital by ambulance thinking she had a massive heart attack. The patient was hospitalized for two and a half days in Feb2021. The clinical outcome of massive heart attack was unknown.  Information on Lot /Batch Number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: massive heart attack; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on Feb2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history included a pacemaker and a heart condition. On Feb2021 (two days after the vaccination), she was rushed to the hospital by ambulance thinking she had a massive heart attack. The patient was hospitalized for two and a half days in Feb2021. The clinical outcome of massive heart attack was unknown.  Information on Lot /Batch Number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Heart rate
Clinical narrative: had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship.  The case will be reassessed 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea, Pain in extremity, Presyncope, Pyrexia
Clinical narrative: had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship.  The case will be reassessed 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome, Tunnel vision
Clinical narrative: had tunnel vision ups on walking to bathroom and almost blacked out; had tunnel vision ups on walking to bathroom and almost blacked out; Achy and restless legs; Achy and restless legs; nauseous however did not allow self to vomit; headache; fatigue; rapid heart beat; low grade fever; chills; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) via an unspecified route of administration on 16Feb2021 12:45 at single dose (left arm) for COVID-19 immunization. Medical history included hypothyroidism, and allergies: Sulfa. The patient was not pregnant. Concomitant medication included topiramate (TOPIMAX), metformin, levothyroxine, and phentermine. The patient received 1st dose of bnt162b2 for COVID-19 immunization on 26Jan2021, 12:45pm (lot EL9263). On 17Feb2021 03:30, the patient experienced achy and restless legs, nauseous however did not allow self to vomit, had tunnel vision ups on walking to bathroom and almost blacked out, headache, fatigue, rapid heart beat, low grade fever, and chills. The patient had no treatment for the events. The patient had no other vaccine in four weeks and had no covid prior vaccination. Patient was not covid tested post vaccination. Outcome of events was recovering.; Sender's Comments: A possible contribution role of the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of Tunnel vision cannot be completely excluded due to temporal relationship.  The case will be reassessed 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.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Facial paralysis, Investigation
Clinical narrative: face paralysis; This is a spontaneous report from a contactable consumer reporting on behalf of her husband.  A 43 year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 06Feb2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medications were not reported. The reporter stated her husband received the first dose of the COVID 19 vaccine on 06Feb2021 and was scheduled for the second dose on 19Feb2021 He woke up today (18Feb) with face paralysis. He went to the doctor, got a CT scan and other studies, and everything is normal. The reported stated that the doctor said it was probably the vaccine. Doctor prescribed medication and told him not to get the second dose. Lab data included CT scan and "other studies" on 18Feb2021 which were normal. The clinical outcomes of facial paralysis was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: in hospital because he caught the covid virus; pneumonia; positive when they were going to send him to rehab; positive when they were going to send him to rehab; This is a spontaneous report from contactable consumers (patient's wife and son). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified as a SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (it was just under 100 days since he had COVID).  The patient's concomitant medications were not reported.  The consumer reported her husband is in hospital because he caught the covid virus on an unknown date. The consumer was with her son who added some additional information stating that at first they had his father in the hospital because he had pneumonia on unknown date. He tested negative [for Covid-19] the first two times and then was positive when they were going to send him to rehab. They think it was false positive because it was just under 100 days since he had COVID and he didn't have any symptoms. They say you can test for Covid-19 4 or 5 months after Covid and still test positive. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Haemorrhage, Headache
Clinical narrative: Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Bleeding upon injection; large bruise; extreme nausea; chills; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) solution for injection, via an unspecified route of administration at right arm on 11Feb2021 at 4:15 PM at single dose for COVID-19 immunization. Medical history included allergies to penicillin, glaucoma (reported as glaucomo) and high blood pressure. Concomitant medication included metroprolol. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 20Jan2021 at single dose for COVID-19 immunization. The patient was not pregnant. The vaccine was administered at a hospital. There was no other vaccine in four weeks. The patient was no COVID prior to vaccination and she was not tested for COVID post vaccination. The patient experienced bleeding upon injection, large bruise, extreme nausea, chills, fatigue, and headache, all on 12Feb2021 at 04:00 AM. She did not receive any treatment in response to the events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast pain, Encephalitis, Eye pain, Feeling abnormal
Clinical narrative: brain pain and the neck pain being a possible encephalitis; some nodules under the arm and leg; right shoulder pain at the site of an old shoulder injury; pain under her arm and into her right breast that started on Saturday with nodules; nodules in her right leg that hurt; headache at the base of her brain and in front; intense neck pain; joints aching/all her joints ache; felt queasy; had sharp pain in both eyes; brain fog; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EM9810) , via an unspecified route of administration on 09Feb2021 at 11:30 (at the age of 67 years old) on left arm at single dose for covid-19 immunisation at a mall vaccination facility.  The patient medical history was none.  There were no concomitant medications. The patient stated she had some pretty severe reactions after getting the first dose of the Pfizer COVID 19 vaccine on 09Feb2021 at 1130AM in the left arm. The patient experienced "brain pain and the neck pain being a possible encephalitis" on an unspecified date with outcome of unknown , intense neck pain on 10Feb2021 to 13Feb2021 with outcome of recovered , joints aching/all her joints ache on 10Feb2021 to 18Feb2021 with outcome of recovered , felt queasy on 10Feb2021 to 12Feb2021 with outcome of recovered , had sharp pain in both eyes  on 10Feb2021 to 12Feb2021 with outcome of recovered , brain fog on 10Feb2021 to 13Feb2021 with outcome of recovered , some nodules under the arm and leg on 13Feb2021 with outcome of not recovered , headache at the base of her brain and in front on 10Feb2021 to 13Feb2021 with outcome of recovered , right shoulder pain at the site of an old shoulder injury on 13Feb2021 to 13Feb2021 with outcome of recovered , pain under her arm and into her right breast that started on Saturday with nodules on 13Feb2021 and ongoing with outcome of recovering, and nodules in her right leg that hurt on 13feb2021 with outcome of not recovered. She was afraid of getting the second dose and inquired advice about getting the second shot. Relevant tests were none.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Neck pain, Nodule
Clinical narrative: brain pain and the neck pain being a possible encephalitis; some nodules under the arm and leg; right shoulder pain at the site of an old shoulder injury; pain under her arm and into her right breast that started on Saturday with nodules; nodules in her right leg that hurt; headache at the base of her brain and in front; intense neck pain; joints aching/all her joints ache; felt queasy; had sharp pain in both eyes; brain fog; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EM9810) , via an unspecified route of administration on 09Feb2021 at 11:30 (at the age of 67 years old) on left arm at single dose for covid-19 immunisation at a mall vaccination facility.  The patient medical history was none.  There were no concomitant medications. The patient stated she had some pretty severe reactions after getting the first dose of the Pfizer COVID 19 vaccine on 09Feb2021 at 1130AM in the left arm. The patient experienced "brain pain and the neck pain being a possible encephalitis" on an unspecified date with outcome of unknown , intense neck pain on 10Feb2021 to 13Feb2021 with outcome of recovered , joints aching/all her joints ache on 10Feb2021 to 18Feb2021 with outcome of recovered , felt queasy on 10Feb2021 to 12Feb2021 with outcome of recovered , had sharp pain in both eyes  on 10Feb2021 to 12Feb2021 with outcome of recovered , brain fog on 10Feb2021 to 13Feb2021 with outcome of recovered , some nodules under the arm and leg on 13Feb2021 with outcome of not recovered , headache at the base of her brain and in front on 10Feb2021 to 13Feb2021 with outcome of recovered , right shoulder pain at the site of an old shoulder injury on 13Feb2021 to 13Feb2021 with outcome of recovered , pain under her arm and into her right breast that started on Saturday with nodules on 13Feb2021 and ongoing with outcome of recovering, and nodules in her right leg that hurt on 13feb2021 with outcome of not recovered. She was afraid of getting the second dose and inquired advice about getting the second shot. Relevant tests were none.
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, visual, Psychotic disorder
Clinical narrative: seeing people/things that are not there; having psychosis issues; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program. This consumer reported for a patient (father) that: A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unknown date in Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller states that his dad had the first dose of the COVID-19 Shot a little over two weeks ago in Feb2021. Caller stated that lately in Feb2021, his dad was having psychosis issues, and was seeing people/things that are not there. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Drug ineffective, Dyspnoea, Erythema
Clinical narrative: felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown.  Information on Lot/Batch number requested
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Nausea, Pain, Pyrexia
Clinical narrative: felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown.  Information on Lot/Batch number requested
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Swelling face
Clinical narrative: felt like I was getting COVID again; felt like I was getting COVID again; could barely walk; chills; nauseated; wasn't breathing well; swollen, red cheeks; red cheeks; headache; constant pain in my body; fever never got higher than 99.46F; A 94-years-old female patient received the first dose of dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included covid-19 from Mar2020. Concomitant medication included Tylenol and Tramadol. The patient reported that the evening I got the first dose, I had chills for 24 hours, I was nauseated, I wasn't breathing well. I had swollen, red cheeks. My fever never got higher than 99.46F. I called because I could barely walk. I went to the hospital. I felt like I was getting COVID again. I took me about 3 days to get over the side effects. I had a bad headache. I told the doctor in the ER my problem and he asked why I thought it was reaction. I'm 94 years old. I take Tylenol every day. I take Tramadol for constant pain in my body. I finally just told them I wanted to go home; they weren't doing anything for me at the hospital. The outcome of the events chills, nauseated, wasn't breathing well, swollen, red cheeks, fever never got higher than 99.46F, I could barely walk, felt like I was getting COVID again, bad headache was unknown.  Information on Lot/Batch number requested