chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Exercise electrocardiogram abnormal, Loss of consciousness, Urine analysis
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: Hypotension, 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: Bedridden, Hypotension, Loss of consciousness
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.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Sudden hearing loss, Tinnitus
Clinical narrative: Sudden hearing loss and tinnitus; Sudden hearing loss and tinnitus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: unknown), administered in left arm on 09Jan2021 for COVID-19 immunisation. The patient experienced sudden hearing loss and tinnitus on 11Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included oral steroids, injected steroids and hearing aid. The outcome of the events was not recovered. Seriousness criteria of both events was reported as disabling/incapacitating.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sudden hearing loss, Tinnitus
Clinical narrative: Sudden hearing loss and tinnitus; Sudden hearing loss and tinnitus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jan2021 (at the age of 42-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included known allergy to Sulfa. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: unknown), administered in left arm on 09Jan2021 for COVID-19 immunisation. The patient experienced sudden hearing loss and tinnitus on 11Mar2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included oral steroids, injected steroids and hearing aid. The outcome of the events was not recovered. Seriousness criteria of both events was reported as disabling/incapacitating.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal distension, Breast enlargement, Intermenstrual bleeding, Nipple pain
Clinical narrative: Breakthrough uterine mid-cycle spotting/bleeding; Swollen Breasts; This is a spontaneous report from a contactable consumer (reporting for herself). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02May2021 at 10:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D); magnesium; ascorbic acid (VIT C); ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Apr2021 (Batch/Lot number: ER8730) in Arm Left via COVID-19 immunization and experienced swollen breasts. On 09May2021 (reported as one week after second dose), the patient experienced breakthrough uterine mid-cycle spotting/bleeding and swollen breasts. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Breast swelling, Uterine haemorrhage
Clinical narrative: Breakthrough uterine mid-cycle spotting/bleeding; Swollen Breasts; This is a spontaneous report from a contactable consumer (reporting for herself). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 02May2021 at 10:45 (Batch/Lot Number: EW0169) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included ergocalciferol (VIT D); magnesium; ascorbic acid (VIT C); ascorbic acid, biotin, folic acid, iodine, nicotinic acid, omega-3 fatty acids, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine, vitamin b12 nos, vitamin e nos (PRENATAL + DHA), all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Apr2021 (Batch/Lot number: ER8730) in Arm Left via COVID-19 immunization and experienced swollen breasts. On 09May2021 (reported as one week after second dose), the patient experienced breakthrough uterine mid-cycle spotting/bleeding and swollen breasts. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy normal, Haematochezia
Clinical narrative: five bowel movements with large amounts of blood; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 10Apr2021 at 08:45 (Lot Number: EL9264; Expiration Date: May2021) as a single dose for COVID-19 immunization.  Medical history included high blood pressure and is allergic to aloe from an unknown date and unknown if ongoing. Concomitant medications included metoprolol tartrate (manufacturer unknown); paroxetine (manufacturer unknown) and cetirizine hydrochloride (ZYRTEC R) all taken for an unspecified indication, start and stop date 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 previously received the first dose of bnt162b2 (lot number: EL9263, expiration date: May21) on 13Mar2021 at 08:45 on the right arm for COVID-19 immunization. It was reported that the patient got the second dose in the morning and everything was fine from then but on 14Apr2021 at 18:00 the patient had five bowel movements with large amounts of blood. The patient went to her physician and they ordered a colonoscopy. The colonoscopy came back completely fine, no evidence of diverticulitis, polyps, ulcers and hemorrhoids. The patient added that she has not had any bloody stool in her life until that day. The event was recovered on Apr2021.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Haematochezia
Clinical narrative: five bowel movements with large amounts of blood; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 10Apr2021 at 08:45 (Lot Number: EL9264; Expiration Date: May2021) as a single dose for COVID-19 immunization.  Medical history included high blood pressure and is allergic to aloe from an unknown date and unknown if ongoing. Concomitant medications included metoprolol tartrate (manufacturer unknown); paroxetine (manufacturer unknown) and cetirizine hydrochloride (ZYRTEC R) all taken for an unspecified indication, start and stop date 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 previously received the first dose of bnt162b2 (lot number: EL9263, expiration date: May21) on 13Mar2021 at 08:45 on the right arm for COVID-19 immunization. It was reported that the patient got the second dose in the morning and everything was fine from then but on 14Apr2021 at 18:00 the patient had five bowel movements with large amounts of blood. The patient went to her physician and they ordered a colonoscopy. The colonoscopy came back completely fine, no evidence of diverticulitis, polyps, ulcers and hemorrhoids. The patient added that she has not had any bloody stool in her life until that day. The event was recovered on Apr2021.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Fatigue, Headache, Pain
Clinical narrative: 1st, it started with headaches and hot flashes. 2nd day, body aches; sweats; fever. 3rd day, weakness. 4th day, very tired and weakness. Went to ED. I was diagnosed with pneumonia and COVID (positive). Out of work for 2 weeks. Still can't sleep on my back.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, SARS-CoV-2 test positive
Clinical narrative: 1st, it started with headaches and hot flashes. 2nd day, body aches; sweats; fever. 3rd day, weakness. 4th day, very tired and weakness. Went to ED. I was diagnosed with pneumonia and COVID (positive). Out of work for 2 weeks. Still can't sleep on my back.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Fatigue, Headache, Hot flush
Clinical narrative: 1st, it started with headaches and hot flashes. 2nd day, body aches; sweats; fever. 3rd day, weakness. 4th day, very tired and weakness. Went to ED. I was diagnosed with pneumonia and COVID (positive). Out of work for 2 weeks. Still can't sleep on my back.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pain, Pneumonia, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 1st, it started with headaches and hot flashes. 2nd day, body aches; sweats; fever. 3rd day, weakness. 4th day, very tired and weakness. Went to ED. I was diagnosed with pneumonia and COVID (positive). Out of work for 2 weeks. Still can't sleep on my back.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: 1st, it started with headaches and hot flashes. 2nd day, body aches; sweats; fever. 3rd day, weakness. 4th day, very tired and weakness. Went to ED. I was diagnosed with pneumonia and COVID (positive). Out of work for 2 weeks. Still can't sleep on my back.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Exophthalmos, Ultrasound thyroid abnormal
Clinical narrative: Graves eye disease; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 26Jan2021 10:00 at age of 53-year-old (Lot Number: El3249) at single dose for COVID-19 immunization. Medical history included high blood pressure. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 22:00, the patient experienced bulging eye within 12 hours of first shot and being diagnosed as Graves eye disease. The adverse event resulted in doctor or other healthcare professional office/clinic visit. On going treatment was received for the adverse event. The outcome of the event was not resolved. Since the vaccination, the patient had not been tested for COVID-19.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Endocrine ophthalmopathy
Clinical narrative: Graves eye disease; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 26Jan2021 10:00 at age of 53-year-old (Lot Number: El3249) at single dose for COVID-19 immunization. Medical history included high blood pressure. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jan2021 22:00, the patient experienced bulging eye within 12 hours of first shot and being diagnosed as Graves eye disease. The adverse event resulted in doctor or other healthcare professional office/clinic visit. On going treatment was received for the adverse event. The outcome of the event was not resolved. Since the vaccination, the patient had not been tested for COVID-19.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Blood test, Echocardiogram, Electrocardiogram ST segment elevation, Intensive care
Clinical narrative: Patient with no past medical history received second dose of Pfizer COVID-19 vaccine on 5/7/21 presented to ED on 5/10/21 after onset of chest pain the evening of 5/9/21.  Found to have acute myocarditis.  The patient was treated with colchicine along with diuretics for mild acute systolic heart failure and low dose beta blockers.  The patient was hospitalized through 5/13/21
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Troponin
Clinical narrative: Patient with no past medical history received second dose of Pfizer COVID-19 vaccine on 5/7/21 presented to ED on 5/10/21 after onset of chest pain the evening of 5/9/21.  Found to have acute myocarditis.  The patient was treated with colchicine along with diuretics for mild acute systolic heart failure and low dose beta blockers.  The patient was hospitalized through 5/13/21
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute left ventricular failure, C-reactive protein increased, Catheterisation cardiac normal, Chest pain, Echocardiogram abnormal
Clinical narrative: Patient with no past medical history received second dose of Pfizer COVID-19 vaccine on 5/7/21 presented to ED on 5/10/21 after onset of chest pain the evening of 5/9/21.  Found to have acute myocarditis.  The patient was treated with colchicine along with diuretics for mild acute systolic heart failure and low dose beta blockers.  The patient was hospitalized through 5/13/21
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction decreased, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myocarditis, N-terminal prohormone brain natriuretic peptide increased
Clinical narrative: Patient with no past medical history received second dose of Pfizer COVID-19 vaccine on 5/7/21 presented to ED on 5/10/21 after onset of chest pain the evening of 5/9/21.  Found to have acute myocarditis.  The patient was treated with colchicine along with diuretics for mild acute systolic heart failure and low dose beta blockers.  The patient was hospitalized through 5/13/21
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin I increased, Ventricular hypokinesia
Clinical narrative: Patient with no past medical history received second dose of Pfizer COVID-19 vaccine on 5/7/21 presented to ED on 5/10/21 after onset of chest pain the evening of 5/9/21.  Found to have acute myocarditis.  The patient was treated with colchicine along with diuretics for mild acute systolic heart failure and low dose beta blockers.  The patient was hospitalized through 5/13/21
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiovascular symptom, Chest discomfort
Clinical narrative: 15 mins after vaccine I got tightness in my chest that felt like it was in my heart . It lasted for ten hours. I let the facility know but at the time they thought maybe it was just anxiety so I stayed for about an hour near the facility just in case and then went directly to my doctors office.  Chest tightness and tachycardia. It stopped for 5 days and on 5th day my pulse was 122 and tightness in my heart became a regular symptom .At worst my pulse was 133. It should be in the low 80?s.   A month later  I still get some tightness in my heart area / chest . My D Dimer is double what it should be and my blood was so thick 3 weeks post vaccine it took 6-8 sticks to get blood from me which is not normal for me.   I also had a lot muscle pain throughout body the first week after vaccine , some headache , a worse than normal period but the heart reaction has been the most concerning.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fibrin D dimer increased, Headache, Menstruation irregular, Myalgia
Clinical narrative: 15 mins after vaccine I got tightness in my chest that felt like it was in my heart . It lasted for ten hours. I let the facility know but at the time they thought maybe it was just anxiety so I stayed for about an hour near the facility just in case and then went directly to my doctors office.  Chest tightness and tachycardia. It stopped for 5 days and on 5th day my pulse was 122 and tightness in my heart became a regular symptom .At worst my pulse was 133. It should be in the low 80?s.   A month later  I still get some tightness in my heart area / chest . My D Dimer is double what it should be and my blood was so thick 3 weeks post vaccine it took 6-8 sticks to get blood from me which is not normal for me.   I also had a lot muscle pain throughout body the first week after vaccine , some headache , a worse than normal period but the heart reaction has been the most concerning.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: 15 mins after vaccine I got tightness in my chest that felt like it was in my heart . It lasted for ten hours. I let the facility know but at the time they thought maybe it was just anxiety so I stayed for about an hour near the facility just in case and then went directly to my doctors office.  Chest tightness and tachycardia. It stopped for 5 days and on 5th day my pulse was 122 and tightness in my heart became a regular symptom .At worst my pulse was 133. It should be in the low 80?s.   A month later  I still get some tightness in my heart area / chest . My D Dimer is double what it should be and my blood was so thick 3 weeks post vaccine it took 6-8 sticks to get blood from me which is not normal for me.   I also had a lot muscle pain throughout body the first week after vaccine , some headache , a worse than normal period but the heart reaction has been the most concerning.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Inflammation, Pyrexia, Syncope, Tinnitus
Clinical narrative: ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Dizziness, Inflammation
Clinical narrative: ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nausea, Pain, Presyncope, Pyrexia
Clinical narrative: ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Renal pain, Syncope, Tinnitus
Clinical narrative: ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: Troponin levels of 5995 (normal is 0- 18); Myopericarditis; Chest pain at pain level 7; Fever; chills; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 11:00 (Batch/Lot Number: EW0175) (at the age of 18 years old) as 2nd dose, single for COVID-19 Immunization. Medical history included attention deficit hyperactivity disorder (ADHD, not currently taking any medication). Concomitant medications included sertraline hydrochloride (ZOLOFT); multivitamins; and cod-liver oil (FISH OIL [COD-LIVER OIL] capsule), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and had allergy; and received the first dose of BNT162B2 administered in left arm on 13Apr2021 10:45 (Lot number: EW0169) for COVID-19 immunization. On 04May2021 23:00, the patient experienced fever and chills. On 05May2021 11:00, the patient experienced chest pain and continued for 48 hours later. The patient went to urgent case 06May2021 at 19:00 and the doctor said it was a normal reaction to vaccine and to go to emergency room (ER) if it gets worse. On 07May2021 05:00, chest pain at pain level 7, the patient to ER. He was admitted to ER following Troponin levels of 5995 (normal is 0-18). He was admitted to hospital. Echocardiogram diagnosis was myopericarditis. The patient was hospitalized for myopericarditis and troponin levels of 5995 (normal is 0- 18) from 07May2021 to 09May2021 for 2 days (it was also reported that "The patient was hospitalized for fever, chills, chest pain at pain level 7 for 2 days"). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the events was unknown. Facility type vaccine was in the hospital (Facility where the most recent COVID-19 vaccine was administered in the hospital). The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests on 07May2021 included COVID test: negative and Rapid SARS COV2 by PCR (Nasal Swab): negative. The outcome of the events was not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram, Myocarditis, Pain assessment
Clinical narrative: Troponin levels of 5995 (normal is 0- 18); Myopericarditis; Chest pain at pain level 7; Fever; chills; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 11:00 (Batch/Lot Number: EW0175) (at the age of 18 years old) as 2nd dose, single for COVID-19 Immunization. Medical history included attention deficit hyperactivity disorder (ADHD, not currently taking any medication). Concomitant medications included sertraline hydrochloride (ZOLOFT); multivitamins; and cod-liver oil (FISH OIL [COD-LIVER OIL] capsule), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and had allergy; and received the first dose of BNT162B2 administered in left arm on 13Apr2021 10:45 (Lot number: EW0169) for COVID-19 immunization. On 04May2021 23:00, the patient experienced fever and chills. On 05May2021 11:00, the patient experienced chest pain and continued for 48 hours later. The patient went to urgent case 06May2021 at 19:00 and the doctor said it was a normal reaction to vaccine and to go to emergency room (ER) if it gets worse. On 07May2021 05:00, chest pain at pain level 7, the patient to ER. He was admitted to ER following Troponin levels of 5995 (normal is 0-18). He was admitted to hospital. Echocardiogram diagnosis was myopericarditis. The patient was hospitalized for myopericarditis and troponin levels of 5995 (normal is 0- 18) from 07May2021 to 09May2021 for 2 days (it was also reported that "The patient was hospitalized for fever, chills, chest pain at pain level 7 for 2 days"). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the events was unknown. Facility type vaccine was in the hospital (Facility where the most recent COVID-19 vaccine was administered in the hospital). The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests on 07May2021 included COVID test: negative and Rapid SARS COV2 by PCR (Nasal Swab): negative. The outcome of the events was not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Troponin, Troponin increased
Clinical narrative: Troponin levels of 5995 (normal is 0- 18); Myopericarditis; Chest pain at pain level 7; Fever; chills; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 11:00 (Batch/Lot Number: EW0175) (at the age of 18 years old) as 2nd dose, single for COVID-19 Immunization. Medical history included attention deficit hyperactivity disorder (ADHD, not currently taking any medication). Concomitant medications included sertraline hydrochloride (ZOLOFT); multivitamins; and cod-liver oil (FISH OIL [COD-LIVER OIL] capsule), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and had allergy; and received the first dose of BNT162B2 administered in left arm on 13Apr2021 10:45 (Lot number: EW0169) for COVID-19 immunization. On 04May2021 23:00, the patient experienced fever and chills. On 05May2021 11:00, the patient experienced chest pain and continued for 48 hours later. The patient went to urgent case 06May2021 at 19:00 and the doctor said it was a normal reaction to vaccine and to go to emergency room (ER) if it gets worse. On 07May2021 05:00, chest pain at pain level 7, the patient to ER. He was admitted to ER following Troponin levels of 5995 (normal is 0-18). He was admitted to hospital. Echocardiogram diagnosis was myopericarditis. The patient was hospitalized for myopericarditis and troponin levels of 5995 (normal is 0- 18) from 07May2021 to 09May2021 for 2 days (it was also reported that "The patient was hospitalized for fever, chills, chest pain at pain level 7 for 2 days"). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the events was unknown. Facility type vaccine was in the hospital (Facility where the most recent COVID-19 vaccine was administered in the hospital). The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests on 07May2021 included COVID test: negative and Rapid SARS COV2 by PCR (Nasal Swab): negative. The outcome of the events was not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chills, Echocardiogram abnormal, Electrocardiogram abnormal, Heart injury
Clinical narrative: Troponin levels of 5995 (normal is 0- 18); Myopericarditis; Chest pain at pain level 7; Fever; chills; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 11:00 (Batch/Lot Number: EW0175) (at the age of 18 years old) as 2nd dose, single for COVID-19 Immunization. Medical history included attention deficit hyperactivity disorder (ADHD, not currently taking any medication). Concomitant medications included sertraline hydrochloride (ZOLOFT); multivitamins; and cod-liver oil (FISH OIL [COD-LIVER OIL] capsule), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and had allergy; and received the first dose of BNT162B2 administered in left arm on 13Apr2021 10:45 (Lot number: EW0169) for COVID-19 immunization. On 04May2021 23:00, the patient experienced fever and chills. On 05May2021 11:00, the patient experienced chest pain and continued for 48 hours later. The patient went to urgent case 06May2021 at 19:00 and the doctor said it was a normal reaction to vaccine and to go to emergency room (ER) if it gets worse. On 07May2021 05:00, chest pain at pain level 7, the patient to ER. He was admitted to ER following Troponin levels of 5995 (normal is 0-18). He was admitted to hospital. Echocardiogram diagnosis was myopericarditis. The patient was hospitalized for myopericarditis and troponin levels of 5995 (normal is 0- 18) from 07May2021 to 09May2021 for 2 days (it was also reported that "The patient was hospitalized for fever, chills, chest pain at pain level 7 for 2 days"). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the events was unknown. Facility type vaccine was in the hospital (Facility where the most recent COVID-19 vaccine was administered in the hospital). The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests on 07May2021 included COVID test: negative and Rapid SARS COV2 by PCR (Nasal Swab): negative. The outcome of the events was not recovered.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pain, Pericarditis, Pyrexia, Troponin increased
Clinical narrative: Troponin levels of 5995 (normal is 0- 18); Myopericarditis; Chest pain at pain level 7; Fever; chills; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 04May2021 11:00 (Batch/Lot Number: EW0175) (at the age of 18 years old) as 2nd dose, single for COVID-19 Immunization. Medical history included attention deficit hyperactivity disorder (ADHD, not currently taking any medication). Concomitant medications included sertraline hydrochloride (ZOLOFT); multivitamins; and cod-liver oil (FISH OIL [COD-LIVER OIL] capsule), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and had allergy; and received the first dose of BNT162B2 administered in left arm on 13Apr2021 10:45 (Lot number: EW0169) for COVID-19 immunization. On 04May2021 23:00, the patient experienced fever and chills. On 05May2021 11:00, the patient experienced chest pain and continued for 48 hours later. The patient went to urgent case 06May2021 at 19:00 and the doctor said it was a normal reaction to vaccine and to go to emergency room (ER) if it gets worse. On 07May2021 05:00, chest pain at pain level 7, the patient to ER. He was admitted to ER following Troponin levels of 5995 (normal is 0-18). He was admitted to hospital. Echocardiogram diagnosis was myopericarditis. The patient was hospitalized for myopericarditis and troponin levels of 5995 (normal is 0- 18) from 07May2021 to 09May2021 for 2 days (it was also reported that "The patient was hospitalized for fever, chills, chest pain at pain level 7 for 2 days"). The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the events was unknown. Facility type vaccine was in the hospital (Facility where the most recent COVID-19 vaccine was administered in the hospital). The patient had no COVID prior vaccination and was tested for COVID post vaccination. The patient underwent lab tests on 07May2021 included COVID test: negative and Rapid SARS COV2 by PCR (Nasal Swab): negative. The outcome of the events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Thrombosis
Clinical narrative: I started having shortness of breath and went to the emergency room.  It was determined I had blood clots in both lungs based on a CT Scan; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Lot Number: EW0153) as 2ND DOSE,SINGLE for covid-19 immunisation. Medical history included Sleep apnoea. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication(s) included phentermine hydrochloride (LOMAIRA); fluoxetine; loratadine (CLARITIN); diphenhydramine and Charlotte24 (unspecified). The patient previously took morphine and tetracycline and experienced drug allergy. Patient took the first dose of bnt162b2 (lot number EN6207) in right arm on 17Mar2021 for covid-19 immunisation.  The patient started having shortness of breath and went to the emergency room on 10May2021. It was determined she had blood clots in both lungs based on a CT Scan. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient hospitalized for two days. Patient received blood thinners as treatment. The patient had covid test type post vaccination nasal swab on 14May2021 with negative result. The outcome was recovering.