chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray limb, X-ray of pelvis and hip
Clinical narrative: My mom received her second vaccine on March 3 at approximately 2:00 PM.  On March 4, approximately 16 hours after her vaccination, she woke with an excruciating pain behind her right eye.  Her condition continued to decline and an ambulance was called and she was taken to our local hospital.  Local hospital transported her via helicopter to another facility, a Level 1 Trauma Center, where she underwent an emergency craniotomy for a hemorrhagic stroke.  During surgery it was discovered that she had an arteriovenous malformation (AVM).  She spent over two weeks in Hospital and an additional three weeks at a Rehabilitation Hospital.  She is home now undergoing home physical, occupational, and speech therapy. She suffers from significant left side neglect and is in a wheelchair, unable to walk or move her arm and hand. She vision in the lower left quadrant of both eyes. She was revived and resuscitated during her craniotomy. Prior to her stroke, she was a healthy, vibrant, independent 71 year old. Although the AVM can be congenital, a prior MRI of her brain in 2015 never picked it up and was reported as normal.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Flushing, Hypertension, Skin warm
Clinical narrative: Trouble breathing, tightness chest - Blood pressure 200/100.  Called EMS, EKG .  Blood pressure rose 215/100.  Sent to ER ER Record  The patient presents with chest pain and shortness of breath.  She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath.  An ambulance was summoned to the store where she was getting the immunization.  They gave her 4 baby aspirin and evaluated her.  She opted to come by private vehicle.  The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time shortened, Bilirubin urine, Blood ketone body, Brain natriuretic peptide normal, Chest discomfort
Clinical narrative: Trouble breathing, tightness chest - Blood pressure 200/100.  Called EMS, EKG .  Blood pressure rose 215/100.  Sent to ER ER Record  The patient presents with chest pain and shortness of breath.  She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath.  An ambulance was summoned to the store where she was getting the immunization.  They gave her 4 baby aspirin and evaluated her.  She opted to come by private vehicle.  The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal, Feeling hot
Clinical narrative: Trouble breathing, tightness chest - Blood pressure 200/100.  Called EMS, EKG .  Blood pressure rose 215/100.  Sent to ER ER Record  The patient presents with chest pain and shortness of breath.  She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath.  An ambulance was summoned to the store where she was getting the immunization.  They gave her 4 baby aspirin and evaluated her.  She opted to come by private vehicle.  The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer normal, International normalised ratio normal, Nitrite urine absent, Protein urine absent, Prothrombin time shortened
Clinical narrative: Trouble breathing, tightness chest - Blood pressure 200/100.  Called EMS, EKG .  Blood pressure rose 215/100.  Sent to ER ER Record  The patient presents with chest pain and shortness of breath.  She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath.  An ambulance was summoned to the store where she was getting the immunization.  They gave her 4 baby aspirin and evaluated her.  She opted to come by private vehicle.  The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Urinary tract infection, Urine leukocyte esterase, Urobilinogen urine, pH urine normal
Clinical narrative: Trouble breathing, tightness chest - Blood pressure 200/100.  Called EMS, EKG .  Blood pressure rose 215/100.  Sent to ER ER Record  The patient presents with chest pain and shortness of breath.  She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath.  An ambulance was summoned to the store where she was getting the immunization.  They gave her 4 baby aspirin and evaluated her.  She opted to come by private vehicle.  The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Chest pain, Dyspnoea, Headache, Neck pain
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palatal swelling, Presyncope, Vision blurred
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Chest discomfort, Dyspnoea, Feeling hot, Headache
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Syncope
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cold sweat, Dyspnoea, Fatigue, Headache, Hot flush
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Hypotension, Musculoskeletal chest pain, Neck pain, Syncope
Clinical narrative: fainted; headache; shortness of breath; chest tightness; pain/burning the left neck; pain/burning the left neck; mild nausea; 70% side from waist to head is warm; This is a spontaneous report received from a contactable consumer. A 37-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number:UNKNOWN), via unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient concomitant medications were not reported. On 07Apr2021, the patient reported that he fainted right after the vaccine received. The patient was also stated after the vaccine he had headache, shortness of the breath, chest tightness lasted 3-4 days, pain/burning the left neck, 70% side from waist to head is warm and mild nausea. The outcome of the events fainted, headache, shortness of the breath, pain/burning the left neck, 70% side from waist to head is warm and mild nausea was unknown. The outcome of the event chest tightness was recovered.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Audiogram, Headache, Migraine, Pain
Clinical narrative: pain down right arm; right elbow throbbing; right hand numb; Tinnitus; pain across forehead right eye; hearing loss; pain across forehead right eye; migraine/migraine for next 24 hours; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EP6955) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included Lichen planus, 7 years before 2021, Rash on scalp, given benadryl and blue light for scalp. No recurrence, adhesive tape allergy. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 02:30 PM (Lot Number: EN6208) as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported.  The patient previously took benadryl for rash, bnt162b2 for covid-19 immunisation.  The patient experienced 2nd shot pain across forehead right eye migraine then pain down right arm right elbow throbbing right hand numb while sitting at (facility). Migraine for next 24 hours. Onset of Tinnitus 3 days after. Thought it would work itself out. Went to ENT on 26Apr2021 and have hearing loss.  Prescribed Prednisone. No change in tinnitus. Never had tinnitus before until got the vaccine.  Not on any medications, active and eat healthy. Have follow up on 11May2021. This is a problem, found a Facebook group with over 2000+ members having same symptoms. All event onset date was 05Apr2021 10:00 AM. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: pain down right arm; right elbow throbbing; right hand numb; Tinnitus; pain across forehead right eye; hearing loss; pain across forehead right eye; migraine/migraine for next 24 hours; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EP6955) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included Lichen planus, 7 years before 2021, Rash on scalp, given benadryl and blue light for scalp. No recurrence, adhesive tape allergy. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 02:30 PM (Lot Number: EN6208) as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported.  The patient previously took benadryl for rash, bnt162b2 for covid-19 immunisation.  The patient experienced 2nd shot pain across forehead right eye migraine then pain down right arm right elbow throbbing right hand numb while sitting at (facility). Migraine for next 24 hours. Onset of Tinnitus 3 days after. Thought it would work itself out. Went to ENT on 26Apr2021 and have hearing loss.  Prescribed Prednisone. No change in tinnitus. Never had tinnitus before until got the vaccine.  Not on any medications, active and eat healthy. Have follow up on 11May2021. This is a problem, found a Facebook group with over 2000+ members having same symptoms. All event onset date was 05Apr2021 10:00 AM. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Deafness, Eye pain, Headache, Hypoaesthesia
Clinical narrative: pain down right arm; right elbow throbbing; right hand numb; Tinnitus; pain across forehead right eye; hearing loss; pain across forehead right eye; migraine/migraine for next 24 hours; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EP6955) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included Lichen planus, 7 years before 2021, Rash on scalp, given benadryl and blue light for scalp. No recurrence, adhesive tape allergy. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 02:30 PM (Lot Number: EN6208) as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported.  The patient previously took benadryl for rash, bnt162b2 for covid-19 immunisation.  The patient experienced 2nd shot pain across forehead right eye migraine then pain down right arm right elbow throbbing right hand numb while sitting at (facility). Migraine for next 24 hours. Onset of Tinnitus 3 days after. Thought it would work itself out. Went to ENT on 26Apr2021 and have hearing loss.  Prescribed Prednisone. No change in tinnitus. Never had tinnitus before until got the vaccine.  Not on any medications, active and eat healthy. Have follow up on 11May2021. This is a problem, found a Facebook group with over 2000+ members having same symptoms. All event onset date was 05Apr2021 10:00 AM. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Pain in extremity, Tinnitus
Clinical narrative: pain down right arm; right elbow throbbing; right hand numb; Tinnitus; pain across forehead right eye; hearing loss; pain across forehead right eye; migraine/migraine for next 24 hours; This is a spontaneous report from a contactable consumer (patient).   A 55-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (Lot Number: EP6955) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included Lichen planus, 7 years before 2021, Rash on scalp, given benadryl and blue light for scalp. No recurrence, adhesive tape allergy. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration, administered in Arm Left on 12Mar2021 02:30 PM (Lot Number: EN6208) as single dose for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported.  The patient previously took benadryl for rash, bnt162b2 for covid-19 immunisation.  The patient experienced 2nd shot pain across forehead right eye migraine then pain down right arm right elbow throbbing right hand numb while sitting at (facility). Migraine for next 24 hours. Onset of Tinnitus 3 days after. Thought it would work itself out. Went to ENT on 26Apr2021 and have hearing loss.  Prescribed Prednisone. No change in tinnitus. Never had tinnitus before until got the vaccine.  Not on any medications, active and eat healthy. Have follow up on 11May2021. This is a problem, found a Facebook group with over 2000+ members having same symptoms. All event onset date was 05Apr2021 10:00 AM. Therapeutic measures were taken as a result of events. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Intracardiac thrombus, Pulmonary thrombosis
Clinical narrative: DEATH DUE TO MULTIPLE BLOOD CLOTS  IN RIGHT LUNG
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Death, Pulmonary embolism
Clinical narrative: DEATH DUE TO MULTIPLE BLOOD CLOTS  IN RIGHT LUNG
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness neurosensory, Deafness unilateral, Ear discomfort
Clinical narrative: Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and could hear a loud tone in my head/ears; noise got worse and more intense as well as higher pitched/a loud tone going through my head, tinnitus; severe loud high pitched screeching noise that gave her a terrible headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Apr2021 11:30 (Batch/Lot Number: EW 171) as 1st dose, single for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis (mildly), allergy: latex and Sulfa. Concomitant medication included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported. Patient woke up the morning after vaccine (01May2021 07:00) and immediately noticed ears were both stuffy and it was difficult to hear. Patient had heavy pressure and could hear a loud tone in head/ears that was consistent and never stopped. Throughout the day the noise got worse and more intense as well as higher pitched. By that evening (01May2021 19:00) patient realized she had no hearing in right ear at all. Only severe loud high pitched screeching noise that gave her a terrible headache. She saw her ENT (ear, nose, throat) on Monday AM (03May2021) and they did audiology test and confirmed 100% loss of hearing in right ear! Severe tinnitus at deafening pitch and 24/7 nonstop, no silence ever since Saturday 01May2021.  The Dr. prescribed her 60 mg prednisone over 7 days then taper down over 2nd week. Patient had MRI of brain on 12May2021 and follow up appoint on 18May2021. She met with her primary care doctor on 05May2021 to discuss all and she did a great deal of bloodwork and all normal. Investigation on unknown date included blood sugar increased. The events of ears were both stuffy and it was difficult to hear/ heavy pressure and could hear a loud tone in head/ears/ noise got worse and more intense as well as higher pitched/a loud tone going through head, tinnitus and no hearing in right ear at all were resulted in Physician Office Visit and received treatment included prednisone and were reported as serious with seriousness criteria: disability. Outcome of blood sugar increased was unknown. Outcome of other events was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Tinnitus
Clinical narrative: Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and could hear a loud tone in my head/ears; noise got worse and more intense as well as higher pitched/a loud tone going through my head, tinnitus; severe loud high pitched screeching noise that gave her a terrible headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Apr2021 11:30 (Batch/Lot Number: EW 171) as 1st dose, single for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis (mildly), allergy: latex and Sulfa. Concomitant medication included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported. Patient woke up the morning after vaccine (01May2021 07:00) and immediately noticed ears were both stuffy and it was difficult to hear. Patient had heavy pressure and could hear a loud tone in head/ears that was consistent and never stopped. Throughout the day the noise got worse and more intense as well as higher pitched. By that evening (01May2021 19:00) patient realized she had no hearing in right ear at all. Only severe loud high pitched screeching noise that gave her a terrible headache. She saw her ENT (ear, nose, throat) on Monday AM (03May2021) and they did audiology test and confirmed 100% loss of hearing in right ear! Severe tinnitus at deafening pitch and 24/7 nonstop, no silence ever since Saturday 01May2021.  The Dr. prescribed her 60 mg prednisone over 7 days then taper down over 2nd week. Patient had MRI of brain on 12May2021 and follow up appoint on 18May2021. She met with her primary care doctor on 05May2021 to discuss all and she did a great deal of bloodwork and all normal. Investigation on unknown date included blood sugar increased. The events of ears were both stuffy and it was difficult to hear/ heavy pressure and could hear a loud tone in head/ears/ noise got worse and more intense as well as higher pitched/a loud tone going through head, tinnitus and no hearing in right ear at all were resulted in Physician Office Visit and received treatment included prednisone and were reported as serious with seriousness criteria: disability. Outcome of blood sugar increased was unknown. Outcome of other events was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood glucose increased, Blood test, Deafness, Ear congestion
Clinical narrative: Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and could hear a loud tone in my head/ears; noise got worse and more intense as well as higher pitched/a loud tone going through my head, tinnitus; severe loud high pitched screeching noise that gave her a terrible headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Apr2021 11:30 (Batch/Lot Number: EW 171) as 1st dose, single for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis (mildly), allergy: latex and Sulfa. Concomitant medication included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported. Patient woke up the morning after vaccine (01May2021 07:00) and immediately noticed ears were both stuffy and it was difficult to hear. Patient had heavy pressure and could hear a loud tone in head/ears that was consistent and never stopped. Throughout the day the noise got worse and more intense as well as higher pitched. By that evening (01May2021 19:00) patient realized she had no hearing in right ear at all. Only severe loud high pitched screeching noise that gave her a terrible headache. She saw her ENT (ear, nose, throat) on Monday AM (03May2021) and they did audiology test and confirmed 100% loss of hearing in right ear! Severe tinnitus at deafening pitch and 24/7 nonstop, no silence ever since Saturday 01May2021.  The Dr. prescribed her 60 mg prednisone over 7 days then taper down over 2nd week. Patient had MRI of brain on 12May2021 and follow up appoint on 18May2021. She met with her primary care doctor on 05May2021 to discuss all and she did a great deal of bloodwork and all normal. Investigation on unknown date included blood sugar increased. The events of ears were both stuffy and it was difficult to hear/ heavy pressure and could hear a loud tone in head/ears/ noise got worse and more intense as well as higher pitched/a loud tone going through head, tinnitus and no hearing in right ear at all were resulted in Physician Office Visit and received treatment included prednisone and were reported as serious with seriousness criteria: disability. Outcome of blood sugar increased was unknown. Outcome of other events was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Headache, Magnetic resonance imaging head, Tinnitus
Clinical narrative: Blood sugar increased; no hearing in my right ear at all; ears were both stuffy; heavy pressure and could hear a loud tone in my head/ears; noise got worse and more intense as well as higher pitched/a loud tone going through my head, tinnitus; severe loud high pitched screeching noise that gave her a terrible headache; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 30Apr2021 11:30 (Batch/Lot Number: EW 171) as 1st dose, single for COVID-19 immunisation. Medical history included fibromyalgia, osteoarthritis (mildly), allergy: latex and Sulfa. Concomitant medication included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported. Patient woke up the morning after vaccine (01May2021 07:00) and immediately noticed ears were both stuffy and it was difficult to hear. Patient had heavy pressure and could hear a loud tone in head/ears that was consistent and never stopped. Throughout the day the noise got worse and more intense as well as higher pitched. By that evening (01May2021 19:00) patient realized she had no hearing in right ear at all. Only severe loud high pitched screeching noise that gave her a terrible headache. She saw her ENT (ear, nose, throat) on Monday AM (03May2021) and they did audiology test and confirmed 100% loss of hearing in right ear! Severe tinnitus at deafening pitch and 24/7 nonstop, no silence ever since Saturday 01May2021.  The Dr. prescribed her 60 mg prednisone over 7 days then taper down over 2nd week. Patient had MRI of brain on 12May2021 and follow up appoint on 18May2021. She met with her primary care doctor on 05May2021 to discuss all and she did a great deal of bloodwork and all normal. Investigation on unknown date included blood sugar increased. The events of ears were both stuffy and it was difficult to hear/ heavy pressure and could hear a loud tone in head/ears/ noise got worse and more intense as well as higher pitched/a loud tone going through head, tinnitus and no hearing in right ear at all were resulted in Physician Office Visit and received treatment included prednisone and were reported as serious with seriousness criteria: disability. Outcome of blood sugar increased was unknown. Outcome of other events was not resolved.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Palpitations, Somnolence, Vertigo
Clinical narrative: Passed out 15 min into taking first vaccine jab; Have been dizzy ever since with palpitations; Have been dizzy ever since with palpitations; Could hardly walk few steps; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 16Apr2021 15:00 as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient passed out 15 min into taking first vaccine jab on 16Apr2021. She has been dizzy ever since with palpitations. Initial 2 weeks after vaccine, her dizziness was very severe, and could hardly walk few steps. Her physician mentioned she has developed vertigo and prescribed Meclizine which made it even worse for her, so she stopped taking it. Though the dizziness was not severe right at 3 weeks, it didn't stop, and she experiences it throughout the day. The adverse events resulted a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Gait disturbance, Loss of consciousness, Palpitations, Vertigo
Clinical narrative: Passed out 15 min into taking first vaccine jab; Have been dizzy ever since with palpitations; Have been dizzy ever since with palpitations; Could hardly walk few steps; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 16Apr2021 15:00 as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient passed out 15 min into taking first vaccine jab on 16Apr2021. She has been dizzy ever since with palpitations. Initial 2 weeks after vaccine, her dizziness was very severe, and could hardly walk few steps. Her physician mentioned she has developed vertigo and prescribed Meclizine which made it even worse for her, so she stopped taking it. Though the dizziness was not severe right at 3 weeks, it didn't stop, and she experiences it throughout the day. The adverse events resulted a doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Throat irritation
Clinical narrative: Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright red and puffy; I couldn't breath; Rash on left arm; Dizzy; injection site enlarged and swollen like 5 inches; injection site enlarged and swollen like 5 inches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm left on 06May2021 at 08:50 AM (lot number: EW0173) as single dose for COVID-19 immunisation. Medical history included blood pressure high (patient thought the diagnosis date was last year, she was not taking any medication it's mild high blood pressure) and surgery (6 weeks ago). Concomitant medications were not provided. No medication before the shot. Yesterday (06May2021), the patient had the Pfizer (first) shot and was since then patient was in Emergency Room. The patient experienced after having covid vaccination, anaphylactic reaction. Patient got the shot 06May2021 at 8:50 and the reaction started and that change of her body and increased heart rate and everything, increased quickly for 10-15 minutes. Patient stated she was very painful (Covid vaccination) for few hours. Patient was still experiencing some symptoms. She added, there was new symptoms her face was bright red and puffy and injection site had enlarged and swollen like 5 inches, after her injection an Ambulance came and they rush her to the emergency room and they gave her Benadryl and Epinephrine (treatment) because she couldn't breath, she had a rash on left arm, dizzy, increased heart rate and she could not breath and in the Hospital they gave her "Morsef-Metho prednisone (Further not clarified) (treatment). Hospitalization not clarified. Lab data included heart rate was increased on unspecified date. Treatment received for the event included on prednisone 20 mg 2 tablet for 4 days and then Cetirizine 10 mg, one tablet by mouth twice daily for 4 days. The outcome of the events not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Erythema, Heart rate
Clinical narrative: Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright red and puffy; I couldn't breath; Rash on left arm; Dizzy; injection site enlarged and swollen like 5 inches; injection site enlarged and swollen like 5 inches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm left on 06May2021 at 08:50 AM (lot number: EW0173) as single dose for COVID-19 immunisation. Medical history included blood pressure high (patient thought the diagnosis date was last year, she was not taking any medication it's mild high blood pressure) and surgery (6 weeks ago). Concomitant medications were not provided. No medication before the shot. Yesterday (06May2021), the patient had the Pfizer (first) shot and was since then patient was in Emergency Room. The patient experienced after having covid vaccination, anaphylactic reaction. Patient got the shot 06May2021 at 8:50 and the reaction started and that change of her body and increased heart rate and everything, increased quickly for 10-15 minutes. Patient stated she was very painful (Covid vaccination) for few hours. Patient was still experiencing some symptoms. She added, there was new symptoms her face was bright red and puffy and injection site had enlarged and swollen like 5 inches, after her injection an Ambulance came and they rush her to the emergency room and they gave her Benadryl and Epinephrine (treatment) because she couldn't breath, she had a rash on left arm, dizzy, increased heart rate and she could not breath and in the Hospital they gave her "Morsef-Metho prednisone (Further not clarified) (treatment). Hospitalization not clarified. Lab data included heart rate was increased on unspecified date. Treatment received for the event included on prednisone 20 mg 2 tablet for 4 days and then Cetirizine 10 mg, one tablet by mouth twice daily for 4 days. The outcome of the events not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Pain, Rash, Swelling face, Vaccination site mass
Clinical narrative: Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright red and puffy; I couldn't breath; Rash on left arm; Dizzy; injection site enlarged and swollen like 5 inches; injection site enlarged and swollen like 5 inches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm left on 06May2021 at 08:50 AM (lot number: EW0173) as single dose for COVID-19 immunisation. Medical history included blood pressure high (patient thought the diagnosis date was last year, she was not taking any medication it's mild high blood pressure) and surgery (6 weeks ago). Concomitant medications were not provided. No medication before the shot. Yesterday (06May2021), the patient had the Pfizer (first) shot and was since then patient was in Emergency Room. The patient experienced after having covid vaccination, anaphylactic reaction. Patient got the shot 06May2021 at 8:50 and the reaction started and that change of her body and increased heart rate and everything, increased quickly for 10-15 minutes. Patient stated she was very painful (Covid vaccination) for few hours. Patient was still experiencing some symptoms. She added, there was new symptoms her face was bright red and puffy and injection site had enlarged and swollen like 5 inches, after her injection an Ambulance came and they rush her to the emergency room and they gave her Benadryl and Epinephrine (treatment) because she couldn't breath, she had a rash on left arm, dizzy, increased heart rate and she could not breath and in the Hospital they gave her "Morsef-Metho prednisone (Further not clarified) (treatment). Hospitalization not clarified. Lab data included heart rate was increased on unspecified date. Treatment received for the event included on prednisone 20 mg 2 tablet for 4 days and then Cetirizine 10 mg, one tablet by mouth twice daily for 4 days. The outcome of the events not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Anaphylactic reaction; increased heart rate; painful; Face was bright red and puffy; Face was bright red and puffy; I couldn't breath; Rash on left arm; Dizzy; injection site enlarged and swollen like 5 inches; injection site enlarged and swollen like 5 inches; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm left on 06May2021 at 08:50 AM (lot number: EW0173) as single dose for COVID-19 immunisation. Medical history included blood pressure high (patient thought the diagnosis date was last year, she was not taking any medication it's mild high blood pressure) and surgery (6 weeks ago). Concomitant medications were not provided. No medication before the shot. Yesterday (06May2021), the patient had the Pfizer (first) shot and was since then patient was in Emergency Room. The patient experienced after having covid vaccination, anaphylactic reaction. Patient got the shot 06May2021 at 8:50 and the reaction started and that change of her body and increased heart rate and everything, increased quickly for 10-15 minutes. Patient stated she was very painful (Covid vaccination) for few hours. Patient was still experiencing some symptoms. She added, there was new symptoms her face was bright red and puffy and injection site had enlarged and swollen like 5 inches, after her injection an Ambulance came and they rush her to the emergency room and they gave her Benadryl and Epinephrine (treatment) because she couldn't breath, she had a rash on left arm, dizzy, increased heart rate and she could not breath and in the Hospital they gave her "Morsef-Metho prednisone (Further not clarified) (treatment). Hospitalization not clarified. Lab data included heart rate was increased on unspecified date. Treatment received for the event included on prednisone 20 mg 2 tablet for 4 days and then Cetirizine 10 mg, one tablet by mouth twice daily for 4 days. The outcome of the events not recovered.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Chest X-ray, Dysstasia, Electrocardiogram, Hypotension
Clinical narrative: she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; passed out and was in the hospital ED for 12 hours but was not admitted; This is a spontaneous report received from a contactable consumer (patient's mother). A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 on unspecified date for as single dose COVID-19 immunisation. On 06May2021, patient passed out and was in the hospital ED for 12 hours but was not admitted. She states she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low (on an unspecified date). She wants to know if there have been reports of syncope or vasovagal reactions associated with the vaccine. The outcome of the event was reported as unknown.   Follow-up needed. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Syncope
Clinical narrative: she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; passed out and was in the hospital ED for 12 hours but was not admitted; This is a spontaneous report received from a contactable consumer (patient's mother). A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 on unspecified date for as single dose COVID-19 immunisation. On 06May2021, patient passed out and was in the hospital ED for 12 hours but was not admitted. She states she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low (on an unspecified date). She wants to know if there have been reports of syncope or vasovagal reactions associated with the vaccine. The outcome of the event was reported as unknown.   Follow-up needed. Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood calcium decreased, Blood pressure decreased, Blood pressure measurement, Chest X-ray, Dysstasia
Clinical narrative: she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low; passed out and was in the hospital ED for 12 hours but was not admitted; This is a spontaneous report received from a contactable consumer (patient's mother). A 16-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes BNT162B2 on unspecified date for as single dose COVID-19 immunisation. On 06May2021, patient passed out and was in the hospital ED for 12 hours but was not admitted. She states she had hypotension for 9 hours and was unable to sit up because her blood pressure was so low (on an unspecified date). She wants to know if there have been reports of syncope or vasovagal reactions associated with the vaccine. The outcome of the event was reported as unknown.   Follow-up needed. Information about batch/lot number has been requested.