chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Seizure, Tremor
Clinical narrative: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged.  Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination.  Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Mydriasis, Pallor, Tremor
Clinical narrative: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged.  Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination.  Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Electrocardiogram, Heart rate
Clinical narrative: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged.  Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination.  Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Loss of consciousness, Muscle tightness, Musculoskeletal stiffness, Mydriasis, Oxygen saturation
Clinical narrative: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged.  Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination.  Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pallor, Seizure, Tremor
Clinical narrative: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged.  Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination.  Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Feeling abnormal, Pericarditis
Clinical narrative: Acute pericarditis; he thought he was died, that he had an out of body experience at the hospital, like he was watching himself and his wife hold his hand; This is a spontaneous report from a Pfizer-sponsored program COVAX Support from a contactable consumer (patient). A 73 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 72 years old, via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Lot Number: EP7583) as single doses for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previous took first dose of BNT162B2 at the age of 72 years old, on 15Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunisation.  The patient experienced acute pericarditis on 29Jul2021. He thought he was died, that he had an out of body experience at the hospital, like he was watching himself and his wife hold his hand.  The patient was hospitalized for acute pericarditis from 29Jul2021 to 31Jul2021.  Therapeutic measures were taken as a result of acute pericarditis including nitroglycerin and anti-inflammatory drugs. The outcome of acute pericarditis was recovering, of other event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Near death experience, Pericarditis
Clinical narrative: Acute pericarditis; he thought he was died, that he had an out of body experience at the hospital, like he was watching himself and his wife hold his hand; This is a spontaneous report from a Pfizer-sponsored program COVAX Support from a contactable consumer (patient). A 73 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 72 years old, via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Lot Number: EP7583) as single doses for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previous took first dose of BNT162B2 at the age of 72 years old, on 15Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunisation.  The patient experienced acute pericarditis on 29Jul2021. He thought he was died, that he had an out of body experience at the hospital, like he was watching himself and his wife hold his hand.  The patient was hospitalized for acute pericarditis from 29Jul2021 to 31Jul2021.  Therapeutic measures were taken as a result of acute pericarditis including nitroglycerin and anti-inflammatory drugs. The outcome of acute pericarditis was recovering, of other event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Loud ringing in ears and sometimes it pulsates; This is a spontaneous report from a contactable other healthcare professional, patient. A 38-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 11:45 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included just high cholesterol controlled with medication. The patient had no known allergies to medications, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN); for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 20Apr2021 at 08:00, the patient experienced loud ringing in ears and sometimes it was pulsating but not always. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the event loud ringing in ears and sometimes it was pulsating was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood culture negative, Blood test normal, Chills, Cognitive disorder, Computerised tomogram normal
Clinical narrative: Loss of consciousness; Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient's wife). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 30Sep2021), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient and his wife received the COVID-19 Pfizer vaccine last Friday, 23Jul2021, and it was reported that the patient was currently in the hospital due to loss of consciousness, fever, chills, and body aches which started on 30Jul2021. The patient was hospitalized from 31Jul2021. They have tested the patient for everything in the hospital on 31Jul2021, infections and everything they could find, but still couldn't find anything. They've ran multiple blood tests, and nothing came up. When asked for the lot number, the reported stated that it's 026569, it's either P or F, and then A, 7484. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Electroencephalogram normal, Lumbar puncture normal, Magnetic resonance imaging normal, Oral herpes
Clinical narrative: Loss of consciousness; Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient's wife). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 30Sep2021), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient and his wife received the COVID-19 Pfizer vaccine last Friday, 23Jul2021, and it was reported that the patient was currently in the hospital due to loss of consciousness, fever, chills, and body aches which started on 30Jul2021. The patient was hospitalized from 31Jul2021. They have tested the patient for everything in the hospital on 31Jul2021, infections and everything they could find, but still couldn't find anything. They've ran multiple blood tests, and nothing came up. When asked for the lot number, the reported stated that it's 026569, it's either P or F, and then A, 7484. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Loss of consciousness; Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient's wife). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 30Sep2021), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient and his wife received the COVID-19 Pfizer vaccine last Friday, 23Jul2021, and it was reported that the patient was currently in the hospital due to loss of consciousness, fever, chills, and body aches which started on 30Jul2021. The patient was hospitalized from 31Jul2021. They have tested the patient for everything in the hospital on 31Jul2021, infections and everything they could find, but still couldn't find anything. They've ran multiple blood tests, and nothing came up. When asked for the lot number, the reported stated that it's 026569, it's either P or F, and then A, 7484. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Investigation, Loss of consciousness, Pain
Clinical narrative: Loss of consciousness; Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer (patient's wife). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, expiration date: 30Sep2021), via an unspecified route of administration in left arm on 23Jul2021 (at the age of 41-years-old) at dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were reported as none. The patient and his wife received the COVID-19 Pfizer vaccine last Friday, 23Jul2021, and it was reported that the patient was currently in the hospital due to loss of consciousness, fever, chills, and body aches which started on 30Jul2021. The patient was hospitalized from 31Jul2021. They have tested the patient for everything in the hospital on 31Jul2021, infections and everything they could find, but still couldn't find anything. They've ran multiple blood tests, and nothing came up. When asked for the lot number, the reported stated that it's 026569, it's either P or F, and then A, 7484. The outcome of the events was not recovered.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inflammation, Inflammatory marker increased, Loss of personal independence in daily activities, Mastication disorder
Clinical narrative: I was very tired; pain progressed over the course of 5 days.; couldn't move/couldnt move for 5 days, needed help bathing, eating and moving; severe inflammation level of 20,000; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 11:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included asthma, pre-diabetic, allergic to nuts and shellfish from an unknown date. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on an unspecified date in 2021 with a negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, it was reported that the patient was very tired and in pain, pain progressed over the course of 5 days and it became severe to the point that patient couldn't move, patient couldn't move for 5 days, and needed help bathing, eating and moving. The patient also had severe inflammation level of 20,000 on 26May2021. The patient was hospitalized 7 days due to the events. The events resulted in doctor or other healthcare professional office/clinic and Emergency room/urgent care visit. Treatment was unknown. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Pain in extremity, Pain in jaw
Clinical narrative: I was very tired; pain progressed over the course of 5 days.; couldn't move/couldnt move for 5 days, needed help bathing, eating and moving; severe inflammation level of 20,000; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 11:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included asthma, pre-diabetic, allergic to nuts and shellfish from an unknown date. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on an unspecified date in 2021 with a negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, it was reported that the patient was very tired and in pain, pain progressed over the course of 5 days and it became severe to the point that patient couldn't move, patient couldn't move for 5 days, and needed help bathing, eating and moving. The patient also had severe inflammation level of 20,000 on 26May2021. The patient was hospitalized 7 days due to the events. The events resulted in doctor or other healthcare professional office/clinic and Emergency room/urgent care visit. Treatment was unknown. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Inflammation, Movement disorder, Pain, SARS-CoV-2 test
Clinical narrative: I was very tired; pain progressed over the course of 5 days.; couldn't move/couldnt move for 5 days, needed help bathing, eating and moving; severe inflammation level of 20,000; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 11:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included asthma, pre-diabetic, allergic to nuts and shellfish from an unknown date. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 via nasal swab on an unspecified date in 2021 with a negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, it was reported that the patient was very tired and in pain, pain progressed over the course of 5 days and it became severe to the point that patient couldn't move, patient couldn't move for 5 days, and needed help bathing, eating and moving. The patient also had severe inflammation level of 20,000 on 26May2021. The patient was hospitalized 7 days due to the events. The events resulted in doctor or other healthcare professional office/clinic and Emergency room/urgent care visit. Treatment was unknown. The outcome of the events was not recovered.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Optical coherence tomography, Visual field tests
Clinical narrative: worsening symptoms in R eye - vision loss for 1-2 minutes; worsening symptoms in R eye - vision loss for 1-2 minutes; persistent sparkles in the middle and peripheral vision of right eye/  pin-sized white dots, and dim/pixilated vision; an intermittent blue blob that moves around the visual field and settles in the lower half of her vision; dark floaters with pin-sized white dots; visual field is consistently limited on the right; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (COVID 19, Brand: Pfizer), via an unspecified route of administration, administered in left arm on 15May2021 10:00 (Batch/Lot Number: EW0176) at the age of 18 years old as dose 2, single for covid-19 immunisation. Medical history included hypermobility, connective spectrum, mild acne; known allergies: oral allergy syndrome with many fresh fruits (self- limited). The patient was not pregnant. Concomitant medication(s) included spironolactone and tretinoin (RETIN A), both taken for acne, start and stop dates were not reported. The patient previously took first dose of BNT162B2 (COVID 19, Brand: Pfizer; Batch/Lot Number: ER8735) administered in left arm on 23Apr2021 at 02:30 PM and reported that approximately 1-2 weeks after first Pfizer vaccine, experienced symptoms in R eye described as intermittent loss of vision, sparkles/blue blob, and visual blacking out with movement (mainly when standing up). 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, and since the vaccination, has not been tested for COVID-19. On May2021 (also reported that adverse event start time: 12:00 AM), approximately 2-3 days after second Pfizer vaccine, the patient had worsening symptoms in R eye - vision loss for 1-2 minutes when scanning a computer screen with eyes, turning head, or changing positions from sitting to standing. The event was considered as serious by the reporter. Other symptoms include persistent sparkles in the middle and peripheral vision of right eye, an intermittent blue blob that moves around the visual field and settles in the lower half of her vision, dark floaters with pin-sized white dots, and dim/pixilated vision. Vision 20/20 OU with correction; the visual field is consistently limited on the right. The patient underwent lab tests and procedures on May2021which included Eye exams, laser tomography, and visual field abnormal. All labs: within normal limits (WNL). Retin A D/C-ed. Dx: B/L papilledema (R > L) of unknown etiology. For repeat MRI/MRV and possible spinal tap (unknown results). Unknown if treatment was received due to adverse events. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Blindness transient, Condition aggravated, Cyanopsia, Laboratory test, Lumbar puncture
Clinical narrative: worsening symptoms in R eye - vision loss for 1-2 minutes; worsening symptoms in R eye - vision loss for 1-2 minutes; persistent sparkles in the middle and peripheral vision of right eye/  pin-sized white dots, and dim/pixilated vision; an intermittent blue blob that moves around the visual field and settles in the lower half of her vision; dark floaters with pin-sized white dots; visual field is consistently limited on the right; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (COVID 19, Brand: Pfizer), via an unspecified route of administration, administered in left arm on 15May2021 10:00 (Batch/Lot Number: EW0176) at the age of 18 years old as dose 2, single for covid-19 immunisation. Medical history included hypermobility, connective spectrum, mild acne; known allergies: oral allergy syndrome with many fresh fruits (self- limited). The patient was not pregnant. Concomitant medication(s) included spironolactone and tretinoin (RETIN A), both taken for acne, start and stop dates were not reported. The patient previously took first dose of BNT162B2 (COVID 19, Brand: Pfizer; Batch/Lot Number: ER8735) administered in left arm on 23Apr2021 at 02:30 PM and reported that approximately 1-2 weeks after first Pfizer vaccine, experienced symptoms in R eye described as intermittent loss of vision, sparkles/blue blob, and visual blacking out with movement (mainly when standing up). 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, and since the vaccination, has not been tested for COVID-19. On May2021 (also reported that adverse event start time: 12:00 AM), approximately 2-3 days after second Pfizer vaccine, the patient had worsening symptoms in R eye - vision loss for 1-2 minutes when scanning a computer screen with eyes, turning head, or changing positions from sitting to standing. The event was considered as serious by the reporter. Other symptoms include persistent sparkles in the middle and peripheral vision of right eye, an intermittent blue blob that moves around the visual field and settles in the lower half of her vision, dark floaters with pin-sized white dots, and dim/pixilated vision. Vision 20/20 OU with correction; the visual field is consistently limited on the right. The patient underwent lab tests and procedures on May2021which included Eye exams, laser tomography, and visual field abnormal. All labs: within normal limits (WNL). Retin A D/C-ed. Dx: B/L papilledema (R > L) of unknown etiology. For repeat MRI/MRV and possible spinal tap (unknown results). Unknown if treatment was received due to adverse events. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Ophthalmological examination, Optical coherence tomography, Visual field defect, Visual field tests
Clinical narrative: worsening symptoms in R eye - vision loss for 1-2 minutes; worsening symptoms in R eye - vision loss for 1-2 minutes; persistent sparkles in the middle and peripheral vision of right eye/  pin-sized white dots, and dim/pixilated vision; an intermittent blue blob that moves around the visual field and settles in the lower half of her vision; dark floaters with pin-sized white dots; visual field is consistently limited on the right; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (COVID 19, Brand: Pfizer), via an unspecified route of administration, administered in left arm on 15May2021 10:00 (Batch/Lot Number: EW0176) at the age of 18 years old as dose 2, single for covid-19 immunisation. Medical history included hypermobility, connective spectrum, mild acne; known allergies: oral allergy syndrome with many fresh fruits (self- limited). The patient was not pregnant. Concomitant medication(s) included spironolactone and tretinoin (RETIN A), both taken for acne, start and stop dates were not reported. The patient previously took first dose of BNT162B2 (COVID 19, Brand: Pfizer; Batch/Lot Number: ER8735) administered in left arm on 23Apr2021 at 02:30 PM and reported that approximately 1-2 weeks after first Pfizer vaccine, experienced symptoms in R eye described as intermittent loss of vision, sparkles/blue blob, and visual blacking out with movement (mainly when standing up). 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, and since the vaccination, has not been tested for COVID-19. On May2021 (also reported that adverse event start time: 12:00 AM), approximately 2-3 days after second Pfizer vaccine, the patient had worsening symptoms in R eye - vision loss for 1-2 minutes when scanning a computer screen with eyes, turning head, or changing positions from sitting to standing. The event was considered as serious by the reporter. Other symptoms include persistent sparkles in the middle and peripheral vision of right eye, an intermittent blue blob that moves around the visual field and settles in the lower half of her vision, dark floaters with pin-sized white dots, and dim/pixilated vision. Vision 20/20 OU with correction; the visual field is consistently limited on the right. The patient underwent lab tests and procedures on May2021which included Eye exams, laser tomography, and visual field abnormal. All labs: within normal limits (WNL). Retin A D/C-ed. Dx: B/L papilledema (R > L) of unknown etiology. For repeat MRI/MRV and possible spinal tap (unknown results). Unknown if treatment was received due to adverse events. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Visual impairment, Vitreous floaters
Clinical narrative: worsening symptoms in R eye - vision loss for 1-2 minutes; worsening symptoms in R eye - vision loss for 1-2 minutes; persistent sparkles in the middle and peripheral vision of right eye/  pin-sized white dots, and dim/pixilated vision; an intermittent blue blob that moves around the visual field and settles in the lower half of her vision; dark floaters with pin-sized white dots; visual field is consistently limited on the right; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (COVID 19, Brand: Pfizer), via an unspecified route of administration, administered in left arm on 15May2021 10:00 (Batch/Lot Number: EW0176) at the age of 18 years old as dose 2, single for covid-19 immunisation. Medical history included hypermobility, connective spectrum, mild acne; known allergies: oral allergy syndrome with many fresh fruits (self- limited). The patient was not pregnant. Concomitant medication(s) included spironolactone and tretinoin (RETIN A), both taken for acne, start and stop dates were not reported. The patient previously took first dose of BNT162B2 (COVID 19, Brand: Pfizer; Batch/Lot Number: ER8735) administered in left arm on 23Apr2021 at 02:30 PM and reported that approximately 1-2 weeks after first Pfizer vaccine, experienced symptoms in R eye described as intermittent loss of vision, sparkles/blue blob, and visual blacking out with movement (mainly when standing up). 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, and since the vaccination, has not been tested for COVID-19. On May2021 (also reported that adverse event start time: 12:00 AM), approximately 2-3 days after second Pfizer vaccine, the patient had worsening symptoms in R eye - vision loss for 1-2 minutes when scanning a computer screen with eyes, turning head, or changing positions from sitting to standing. The event was considered as serious by the reporter. Other symptoms include persistent sparkles in the middle and peripheral vision of right eye, an intermittent blue blob that moves around the visual field and settles in the lower half of her vision, dark floaters with pin-sized white dots, and dim/pixilated vision. Vision 20/20 OU with correction; the visual field is consistently limited on the right. The patient underwent lab tests and procedures on May2021which included Eye exams, laser tomography, and visual field abnormal. All labs: within normal limits (WNL). Retin A D/C-ed. Dx: B/L papilledema (R > L) of unknown etiology. For repeat MRI/MRV and possible spinal tap (unknown results). Unknown if treatment was received due to adverse events. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Blindness transient, Cyanopsia, Visual impairment
Clinical narrative: worsening symptoms in R eye - vision loss for 1-2 minutes; worsening symptoms in R eye - vision loss for 1-2 minutes; persistent sparkles in the middle and peripheral vision of right eye/  pin-sized white dots, and dim/pixilated vision; an intermittent blue blob that moves around the visual field and settles in the lower half of her vision; dark floaters with pin-sized white dots; visual field is consistently limited on the right; This is a spontaneous report from a contactable consumer (patient). An 18-year-old female patient received BNT162B2 (COVID 19, Brand: Pfizer), via an unspecified route of administration, administered in left arm on 15May2021 10:00 (Batch/Lot Number: EW0176) at the age of 18 years old as dose 2, single for covid-19 immunisation. Medical history included hypermobility, connective spectrum, mild acne; known allergies: oral allergy syndrome with many fresh fruits (self- limited). The patient was not pregnant. Concomitant medication(s) included spironolactone and tretinoin (RETIN A), both taken for acne, start and stop dates were not reported. The patient previously took first dose of BNT162B2 (COVID 19, Brand: Pfizer; Batch/Lot Number: ER8735) administered in left arm on 23Apr2021 at 02:30 PM and reported that approximately 1-2 weeks after first Pfizer vaccine, experienced symptoms in R eye described as intermittent loss of vision, sparkles/blue blob, and visual blacking out with movement (mainly when standing up). 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, and since the vaccination, has not been tested for COVID-19. On May2021 (also reported that adverse event start time: 12:00 AM), approximately 2-3 days after second Pfizer vaccine, the patient had worsening symptoms in R eye - vision loss for 1-2 minutes when scanning a computer screen with eyes, turning head, or changing positions from sitting to standing. The event was considered as serious by the reporter. Other symptoms include persistent sparkles in the middle and peripheral vision of right eye, an intermittent blue blob that moves around the visual field and settles in the lower half of her vision, dark floaters with pin-sized white dots, and dim/pixilated vision. Vision 20/20 OU with correction; the visual field is consistently limited on the right. The patient underwent lab tests and procedures on May2021which included Eye exams, laser tomography, and visual field abnormal. All labs: within normal limits (WNL). Retin A D/C-ed. Dx: B/L papilledema (R > L) of unknown etiology. For repeat MRI/MRV and possible spinal tap (unknown results). Unknown if treatment was received due to adverse events. Adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Optical coherence tomography, Visual field tests
Clinical narrative: intermittent loss of vision; sparkles/blue blob; visual "blacking out" with movement (mainly when standing up); This is a spontaneous report from a contactable consumer (patient). An 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: ER8735) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history included hypermobility, connective spectrum, mild acne, and oral allergy syndrome with many fresh fruits (self- limited) from an unknown date. Concomitant medications included spironolactone taken for an unspecified indication and tretinoin (RETIN A) taken for acne, both start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in May2021, it was reported that the patient experienced intermittent loss of vision with sparkles/blue blob and visual "blacking out" with movement (mainly when standing up). The patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit because of the events. Treatment was unknown. The outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Blindness transient, Condition aggravated, Cyanopsia, Laboratory test, Lumbar puncture
Clinical narrative: intermittent loss of vision; sparkles/blue blob; visual "blacking out" with movement (mainly when standing up); This is a spontaneous report from a contactable consumer (patient). An 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: ER8735) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history included hypermobility, connective spectrum, mild acne, and oral allergy syndrome with many fresh fruits (self- limited) from an unknown date. Concomitant medications included spironolactone taken for an unspecified indication and tretinoin (RETIN A) taken for acne, both start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in May2021, it was reported that the patient experienced intermittent loss of vision with sparkles/blue blob and visual "blacking out" with movement (mainly when standing up). The patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit because of the events. Treatment was unknown. The outcome of the events was not recovered.
Age: 18.0
Sex: F
Vaccine: UNK, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Ophthalmological examination, Optical coherence tomography, Visual field defect, Visual field tests
Clinical narrative: intermittent loss of vision; sparkles/blue blob; visual "blacking out" with movement (mainly when standing up); This is a spontaneous report from a contactable consumer (patient). An 18-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: ER8735) as dose 1, single for COVID-19 immunization at a pharmacy. Medical history included hypermobility, connective spectrum, mild acne, and oral allergy syndrome with many fresh fruits (self- limited) from an unknown date. Concomitant medications included spironolactone taken for an unspecified indication and tretinoin (RETIN A) taken for acne, both start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in May2021, it was reported that the patient experienced intermittent loss of vision with sparkles/blue blob and visual "blacking out" with movement (mainly when standing up). The patient had a doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit because of the events. Treatment was unknown. The outcome of the events was not recovered.