chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid normal, Ataxia, Carotid artery occlusion, Computerised tomogram head normal
Clinical narrative: Patient is a 67 years old male with past medical history of chronic back pain, gout who presented emergency room today following sudden onset of dizziness, nausea and vomiting with unsteady gait at work.  Patient gives history of having Pfizer COVID-19 vacillation at approximately 10 AM today and patient symptoms started at 1300 after patient has returned to work as a painter.  Patient denies focal extremity weakness no slurred speech, no headache and no blurred vision. On evaluation emergency room patient was thought to have evidence of acute posterior stroke and consult was requested.  Neurology recommended patient for TPA for acute posterior stroke/CVA and patient symptoms as resolved greatly prior to my evaluation post TPA.  Patient denies any headache, dizziness during my evaluation.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Magnetic resonance imaging, Vomiting
Clinical narrative: Patient is a 67 years old male with past medical history of chronic back pain, gout who presented emergency room today following sudden onset of dizziness, nausea and vomiting with unsteady gait at work.  Patient gives history of having Pfizer COVID-19 vacillation at approximately 10 AM today and patient symptoms started at 1300 after patient has returned to work as a painter.  Patient denies focal extremity weakness no slurred speech, no headache and no blurred vision. On evaluation emergency room patient was thought to have evidence of acute posterior stroke and consult was requested.  Neurology recommended patient for TPA for acute posterior stroke/CVA and patient symptoms as resolved greatly prior to my evaluation post TPA.  Patient denies any headache, dizziness during my evaluation.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Cerebrovascular accident, Computerised tomogram head normal, Dizziness, Gait disturbance
Clinical narrative: Patient is a 67 years old male with past medical history of chronic back pain, gout who presented emergency room today following sudden onset of dizziness, nausea and vomiting with unsteady gait at work.  Patient gives history of having Pfizer COVID-19 vacillation at approximately 10 AM today and patient symptoms started at 1300 after patient has returned to work as a painter.  Patient denies focal extremity weakness no slurred speech, no headache and no blurred vision. On evaluation emergency room patient was thought to have evidence of acute posterior stroke and consult was requested.  Neurology recommended patient for TPA for acute posterior stroke/CVA and patient symptoms as resolved greatly prior to my evaluation post TPA.  Patient denies any headache, dizziness during my evaluation.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Sinusitis, Spinal osteoarthritis, Stenosis, Vomiting
Clinical narrative: Patient is a 67 years old male with past medical history of chronic back pain, gout who presented emergency room today following sudden onset of dizziness, nausea and vomiting with unsteady gait at work.  Patient gives history of having Pfizer COVID-19 vacillation at approximately 10 AM today and patient symptoms started at 1300 after patient has returned to work as a painter.  Patient denies focal extremity weakness no slurred speech, no headache and no blurred vision. On evaluation emergency room patient was thought to have evidence of acute posterior stroke and consult was requested.  Neurology recommended patient for TPA for acute posterior stroke/CVA and patient symptoms as resolved greatly prior to my evaluation post TPA.  Patient denies any headache, dizziness during my evaluation.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypoaesthesia, Myalgia, Nerve compression
Clinical narrative: Patient presented to the ED and was subsequently hospitalized on 4/2/2021 new onset atrial flutter was one of the diagnoses.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Patient presented to the ED and was subsequently hospitalized on 4/2/2021 new onset atrial flutter was one of the diagnoses.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial flutter
Clinical narrative: Patient presented to the ED and was subsequently hospitalized on 4/2/2021 new onset atrial flutter was one of the diagnoses.
Age: 103.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Hemiparesis, Paralysis, Thrombosis
Clinical narrative: CEREBRAL STROKE (PARALYZED ON LEFT SIDE OF BODY); This spontaneous report received from a consumer concerned an 103 year old white Not hispanic or latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol user, non smoker, seasonal allergy, and allergy to bug bites, and other pre-existing medical conditions included the patient did not have any medications and no chronic illness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergy. The batch number was not reported and it has been requested. On 14-APR-2021, the patient experienced cerebral stroke (possibly 2 strokes). Initially patient used her arms but shortly after that patient was unable to use arms could not speak and walk. On 28-APR-2021, the patients left side of body was paralyzed and on same day patient died while in hospice care due to cerebral stroke and left side of body was paralyzed. Patient was in bed much of the time but patient fed herself when food was offered to patient. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210503966-covid-19 vaccine ad26.cov2.s-cerebral stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: CEREBRAL STROKE
Age: 103.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: CEREBRAL STROKE (PARALYZED ON LEFT SIDE OF BODY); This spontaneous report received from a consumer concerned an 103 year old white Not hispanic or latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included alcohol user, non smoker, seasonal allergy, and allergy to bug bites, and other pre-existing medical conditions included the patient did not have any medications and no chronic illness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included loratadine for seasonal allergy. The batch number was not reported and it has been requested. On 14-APR-2021, the patient experienced cerebral stroke (possibly 2 strokes). Initially patient used her arms but shortly after that patient was unable to use arms could not speak and walk. On 28-APR-2021, the patients left side of body was paralyzed and on same day patient died while in hospice care due to cerebral stroke and left side of body was paralyzed. Patient was in bed much of the time but patient fed herself when food was offered to patient. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210503966-covid-19 vaccine ad26.cov2.s-cerebral stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: CEREBRAL STROKE
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Injection site pain, Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Varicella
Clinical narrative: Shingles; This is a spontaneous report from a contactable Nurse (Patient). A 71-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection; Lot Number: EL9264, Expiration date: 05May2021), via an unspecified route of administration, on 05Feb2021 (at the age of 71 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no other products, patient history and investigation assessment. Caller was due for her second dose on Friday. Caller had been diagnosed with shingles and was taking Valtrex. Caller wanted to know what to do about the second dose in regards to her shingles diagnosis. Caller wanted to know what to do about getting the second shot of the covid 19 vaccine because she was taking Valtrex. She received her first injection Friday 05Feb and then last week she came down with shingles which was adult chicken pox. She was currently taking Valacyclovir which was generic Valtrex, 3000 mg per day and she was finishing that on next Wednesday the 24Feb. Her question was and she asked, neither her PCP nor pharmacist was able to answer this. She wanted to know was she still able to get the second dose this coming Friday. Her shingles began last Wednesday (17Feb2021). She told it was still ongoing, she was still on the medication until this coming Wednesday. It was improved. No further information provided. Regarding product details she told the card had little, tiny writing. She did not see an NDC Number and dose was unknown to the patient. The patient received treatment for the event Shingles with Valtrex. The outcome of the events was recovering. The reporter assessed event as serious and told the shingles was not directly related to the vaccine.; Sender's Comments: Based on the information provided, the reported shingles is likely an intercurrent condition that is unrelated to BNT162B2.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable Nurse (Patient). A 71-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection; Lot Number: EL9264, Expiration date: 05May2021), via an unspecified route of administration, on 05Feb2021 (at the age of 71 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no other products, patient history and investigation assessment. Caller was due for her second dose on Friday. Caller had been diagnosed with shingles and was taking Valtrex. Caller wanted to know what to do about the second dose in regards to her shingles diagnosis. Caller wanted to know what to do about getting the second shot of the covid 19 vaccine because she was taking Valtrex. She received her first injection Friday 05Feb and then last week she came down with shingles which was adult chicken pox. She was currently taking Valacyclovir which was generic Valtrex, 3000 mg per day and she was finishing that on next Wednesday the 24Feb. Her question was and she asked, neither her PCP nor pharmacist was able to answer this. She wanted to know was she still able to get the second dose this coming Friday. Her shingles began last Wednesday (17Feb2021). She told it was still ongoing, she was still on the medication until this coming Wednesday. It was improved. No further information provided. Regarding product details she told the card had little, tiny writing. She did not see an NDC Number and dose was unknown to the patient. The patient received treatment for the event Shingles with Valtrex. The outcome of the events was recovering. The reporter assessed event as serious and told the shingles was not directly related to the vaccine.; Sender's Comments: Based on the information provided, the reported shingles is likely an intercurrent condition that is unrelated to BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Blood immunoglobulin G, Cough, Dyspnoea, Gait disturbance
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Illness, Meniere's disease, Taste disorder, Throat tightness
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Dizziness, Dyspnoea
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Immediate post-injection reaction, Lymphadenopathy, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Taste disorder
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Blood test, Chest X-ray, Condition aggravated, Dyspnoea
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear, nose and throat examination, Eastern Cooperative Oncology Group performance status, Fatigue, Hypersensitivity, Illness
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Meniere's disease, Pain in extremity
Clinical narrative: She got her vaccine, and immediately had a sodium taste in her mouth.  She has weakness, very hard to breath, her face was swelling and her lymph nodes were swollen, and the sodium taste is getting worse and she can't get it out of her mouth.  Her Meniere's medicine is not helping at all, and she is not able to drive.  She is really weak and went to the ER twice and they did some chest X-rays that were fine.  They took blood and told her that her sodium was fine, and she feels that was wrong it should be low.  She has a lot of problems with sodium.  The 2nd time she went they did nothing, gave her a nebulous treatment and she could not do that as her throat was swelling up and has had a sore throat since that visit and that breathing treatment.  They told her that it was something like her inhaler, and didn't give her anything else.  She was then discharged after 3 hours.  She is too weak to walk so is in a wheelchair.  She is dead tired and has extreme weakness, and the salt taste in her mouth is BAD.  The breathing is real bad, and so is the dizziness which is making her Meniere's bad and all she wants to do is sleep from being so tired.    She has two bad knees and is able to walk, but due to the pain she has been using a wheelchair.  She has an APT on Tuesday with a pulmonary specialist.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone, COVID-19, Chest X-ray, Computerised tomogram head, Computerised tomogram spine
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Culture urine, Dizziness, Echocardiogram, Electrocardiogram
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Full blood count, Glycosylated haemoglobin, Head injury, Headache
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Loss of consciousness, Magnetic resonance imaging head, Metabolic function test, SARS-CoV-2 antibody test positive
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Troponin T, Ultrasound Doppler
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Dizziness, Fall, Head injury, Headache
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, SARS-CoV-2 test
Clinical narrative: blacked out getting up from the bed; concussion; fell; hit the left side of the head; headaches; dizziness; This is a spontaneous report from a contactable consumer (patient).    A non-pregnant 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 03Mar2021 15:15 (Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included adenoid cystic carcinoma from an unknown date and unknown if ongoing, tracheal cancer from an unknown date and unknown if ongoing, "hypothyroidis" from an unknown date and unknown if ongoing.  Concomitant medications included levothyroxine sodium (SYNTHROID) 0.137 mg taken for an unspecified indication, start and stop date were not reported; simvastatin 40 mg taken for an unspecified indication, start and stop date were not reported; losartan 50 taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 03Mar2021 17:00, the patient had headaches and dizziness following the shot.  On 17Mar2021, blacked out getting up from the bed, fell and hit the left side of the head causing a concussion. The adverse event resulted doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for blacked out getting up from the bed and concussion for 1 days. The patient underwent lab tests and procedures which included COVID tested (Nasal Swab): negative on 06Apr2021.  Therapeutic measures were taken as a result of blacked out getting up from the bed, concussion, headaches, dizziness, fall. Treatment for the events included Medication and Physical Therapy. Outcome of blacked out getting up from the bed, concussion, headaches, dizziness, hit the left side of the head  and fall were recovering.   Information about lot/batch number can be obtained. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: My face was paralyzed, could not speak, lips were numb and no taste.  I was in ICU for 3 days and 3 days on the  Neurological dept.  They had given ICIG for 5 days which helped me on the road to my recovery.  I still have vision issues.  Small improvements every day,
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Aphasia, Computerised tomogram head, Facial paralysis, Guillain-Barre syndrome
Clinical narrative: My face was paralyzed, could not speak, lips were numb and no taste.  I was in ICU for 3 days and 3 days on the  Neurological dept.  They had given ICIG for 5 days which helped me on the road to my recovery.  I still have vision issues.  Small improvements every day,
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Immunoglobulin therapy, Intensive care, Lumbar puncture abnormal, Visual impairment
Clinical narrative: My face was paralyzed, could not speak, lips were numb and no taste.  I was in ICU for 3 days and 3 days on the  Neurological dept.  They had given ICIG for 5 days which helped me on the road to my recovery.  I still have vision issues.  Small improvements every day,
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Body mass index, Body temperature, Deep vein thrombosis, Heart rate
Clinical narrative: Blood clot developed in the leg 10 days after the injection
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Physical examination, Respiratory rate, Ultrasound Doppler
Clinical narrative: Blood clot developed in the leg 10 days after the injection
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan abnormal
Clinical narrative: Blood clot developed in the leg 10 days after the injection
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Feeling hot, Nausea, Pallor
Clinical narrative: Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, lips puffy
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Tongue disorder
Clinical narrative: Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, lips puffy
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Headache, Hot flush, Lip swelling, Magnetic resonance imaging head
Clinical narrative: Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, lips puffy
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Paraesthesia, Taste disorder
Clinical narrative: Immediate nausea, hot flashes, odd taste in mouth, headache that worsened with time, feet tingling, lips puffy
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Metamorphopsia, Ocular discomfort, Photopsia, Vision blurred
Clinical narrative: BLEEDING IN EYES; RETINAL TEAR OR DETACHED RETINA; RETINAL TEAR OR DETACHED RETINA; INCREDIBLY PAINFUL INJECTION; REALLY TIRED; This spontaneous report received from a patient concerned a 65 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no eye problem in the past.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced incredibly painful shot upon administration, immediately the patient was really tired. Three hours after the vaccination, his vision became cloudy and blurry. He then fell asleep. On 05-APR-2021, the patient experienced no peripheral vision. On 06-APR-2021, the patient woke up and had a little improvement in cloudiness but the patient stated that about 20 percent of his vision was still cloudy/blurry. The patient experienced pressure behind eyes, right eye distortion. The patient began to see bright flashes and round floaters. On 06-APR-2021, the patient experienced bleeding in eyes, retinal tear and detached retina that affected the patient's ability to work. On 07-APR-2021, morning, he was then referred to an eye specialist for ongoing eye issues. He went to see physician. He had been back to the eye specialist 2 additional times since then with ongoing eye issues. He had been told he has bleeding in his eyes, a retina tear or detached retina and still no peripheral vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from incredibly painful injection on 05-APR-2021, had not recovered from retinal tear or detached retina and bleeding in eyes and the outcome of really tired was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509138-Covid-19 vaccine ad26.cov2.s-Eye heamorrhage, Retinal tear ,Retinal detachment. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events