chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericardial effusion, Pericarditis constrictive, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor positive
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram abnormal, Pericardial effusion, Pericarditis, Respiratory viral panel
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Three days after receiving second dose of Moderna vaccine patient began experiencing chest pain presented to ED on 4/9/21 CTE negative for PE, covid negative, respiratory viral panel negative.  Echocardiogram revealed pericardial effusion.  Patient diagnosed with pericarditis patient admitted 4/14/21 with ongoing chest pain due to pericarditis
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: sore throat, cough and tested positive; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient's daughter) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Her dad took the 1st dose last 26Feb2021. After taking the 1st dose he experienced sore throat, cough and tested positive in 2021. The patient underwent lab tests and procedures which included COVID-19 test: positive in 2021. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: sore throat, cough and tested positive; This is a spontaneous report from a Pfizer sponsored program . A contactable consumer (patient's daughter) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Her dad took the 1st dose last 26Feb2021. After taking the 1st dose he experienced sore throat, cough and tested positive in 2021. The patient underwent lab tests and procedures which included COVID-19 test: positive in 2021. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Eye swelling, Swelling face
Clinical narrative: Eyes swollen; big water bags underneath them; It is now worse than it was; This is a spontaneous report from a contactable consumer (patient) . A 59-year-old male patient received initial dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown) dose 1 via unspecified route of administered on 02Apr21 as 1st DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced eyes swollen; big water bags underneath them eyes swollen; big water bags underneath them was reported as worsened and had been having problems ever since then. The patient did not have any trouble breathing or anything like that and laughs and says he just looks ugly when he looks in the mirror.The patient says that he called about a week ago and was told to go to the Emergency Room.  He says he did not do a report at that time. On 03Apr2021, the patient states that his symptoms started on and it was now worse than it was and says he must be allergic to something. The patient was told not to get the second dose of the vaccine due to this reaction. the patient thinks he had Covid virus last year during the summer; he had a cough that would not go away. Caller states he was going to go get medical attention this morning to see if there was anything they could do about the swelling. States he has decided he isn't going to; he was going to tough it out. Also states that he just got done with his mother's funeral service. States she lived a long life. States he just seems to have a lot going on but it was going to all be okay. The patient says his neighbor took the same Covid vaccine and had told the caller to go get it. The patient neighbor didn't have any reaction.The Caller states he was glad he had Benadryl at home. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye swelling
Clinical narrative: Eyes swollen; big water bags underneath them; It is now worse than it was; This is a spontaneous report from a contactable consumer (patient) . A 59-year-old male patient received initial dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown) dose 1 via unspecified route of administered on 02Apr21 as 1st DOSE SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced eyes swollen; big water bags underneath them eyes swollen; big water bags underneath them was reported as worsened and had been having problems ever since then. The patient did not have any trouble breathing or anything like that and laughs and says he just looks ugly when he looks in the mirror.The patient says that he called about a week ago and was told to go to the Emergency Room.  He says he did not do a report at that time. On 03Apr2021, the patient states that his symptoms started on and it was now worse than it was and says he must be allergic to something. The patient was told not to get the second dose of the vaccine due to this reaction. the patient thinks he had Covid virus last year during the summer; he had a cough that would not go away. Caller states he was going to go get medical attention this morning to see if there was anything they could do about the swelling. States he has decided he isn't going to; he was going to tough it out. Also states that he just got done with his mother's funeral service. States she lived a long life. States he just seems to have a lot going on but it was going to all be okay. The patient says his neighbor took the same Covid vaccine and had told the caller to go get it. The patient neighbor didn't have any reaction.The Caller states he was glad he had Benadryl at home. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Injection site pain, Malaise, Pyrexia, Sleep disorder
Clinical narrative: Fever; painful injection site; severe body aches; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration in the left arm on 24Apr2021 at 12:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine 150 ug from an unknown date for an unknown indication; and liothyronine 10 ug from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number ER8730) on 03Apr2021 at 12:30 (at the age of 52-years-old) for COVID-19 immunisation. The patient reported that within 15 hours she had a fever of 102 and over, severe body aches, and painful injection site. After 12 hours she reported taking 2 ibuprofen and her fever broke; 12 hours later her fever went back to 102.4 and had not broken yet after taking 3 ibuprofens. The clinical outcomes of fever, severe body aches and painful injection site were reported as not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever; painful injection site; severe body aches; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration in the left arm on 24Apr2021 at 12:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in the four weeks prior to the COVID vaccine. Concomitant medications included levothyroxine 150 ug from an unknown date for an unknown indication; and liothyronine 10 ug from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number ER8730) on 03Apr2021 at 12:30 (at the age of 52-years-old) for COVID-19 immunisation. The patient reported that within 15 hours she had a fever of 102 and over, severe body aches, and painful injection site. After 12 hours she reported taking 2 ibuprofen and her fever broke; 12 hours later her fever went back to 102.4 and had not broken yet after taking 3 ibuprofens. The clinical outcomes of fever, severe body aches and painful injection site were reported as not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Troponin I increased
Clinical narrative: Myocarditis
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: Myocarditis
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Loss of personal independence in daily activities, Sleep disorder, Tinnitus
Clinical narrative: Vacine administered on 8 April 2021. Adverse event began at 8 PM ops 10 April 2021. Loud ringing sound woke me up in the evening. Subsequently diagnosed as tinnitus. No prior history of condition. Ringing has been constant, with some days worse than others. Difficul to concentrate, increased anxiety at times.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Adverse event, Anxiety, Deafness, Disturbance in attention
Clinical narrative: Vacine administered on 8 April 2021. Adverse event began at 8 PM ops 10 April 2021. Loud ringing sound woke me up in the evening. Subsequently diagnosed as tinnitus. No prior history of condition. Ringing has been constant, with some days worse than others. Difficul to concentrate, increased anxiety at times.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Vacine administered on 8 April 2021. Adverse event began at 8 PM ops 10 April 2021. Loud ringing sound woke me up in the evening. Subsequently diagnosed as tinnitus. No prior history of condition. Ringing has been constant, with some days worse than others. Difficul to concentrate, increased anxiety at times.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pulmonary thrombosis
Clinical narrative: When I woke up I was having trouble breathing and chest felt like a knife was being stuck in me and taking deep breath is when I felt the pain on the left side where my heart is at.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: When I woke up I was having trouble breathing and chest felt like a knife was being stuck in me and taking deep breath is when I felt the pain on the left side where my heart is at.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Painful respiration, Pulmonary thrombosis
Clinical narrative: When I woke up I was having trouble breathing and chest felt like a knife was being stuck in me and taking deep breath is when I felt the pain on the left side where my heart is at.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: When I woke up I was having trouble breathing and chest felt like a knife was being stuck in me and taking deep breath is when I felt the pain on the left side where my heart is at.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: UPPER LIP GROWING AND MOVING UP ON FACE; TERRIBLE REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Vaccination site was not reported. No concomitant medications were reported.  On 06-MAY-2021, two days after vaccination the patient experienced top lip started to swell on the right side. Three hours later patient drove to the emergency room from work and then was hospitalized. Patient could feel and see upper lip growing and moving up on face, she experienced terrible reaction. Patient was scared. Number of days for hospitalization was not reported. It was unknown whether the patient was discharged from the hospital or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the upper lip growing and moving up on face and terrible reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546972-covid-19 vaccine ad26.cov2.s- upper lip growing and moving up my face, terrible reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Nonspecific reaction
Clinical narrative: UPPER LIP GROWING AND MOVING UP ON FACE; TERRIBLE REACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total, administered on 04-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. Vaccination site was not reported. No concomitant medications were reported.  On 06-MAY-2021, two days after vaccination the patient experienced top lip started to swell on the right side. Three hours later patient drove to the emergency room from work and then was hospitalized. Patient could feel and see upper lip growing and moving up on face, she experienced terrible reaction. Patient was scared. Number of days for hospitalization was not reported. It was unknown whether the patient was discharged from the hospital or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the upper lip growing and moving up on face and terrible reaction was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210546972-covid-19 vaccine ad26.cov2.s- upper lip growing and moving up my face, terrible reaction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Troponin increased
Clinical narrative: Myocarditis; Chest pain; Elevated troponins; This is a spontaneous report from a contactable pharmacist. A 22-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular in the left arm on 06May2021 11: 00 am at 22-year-old as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient had no known allergies. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  for COVID-19 immunization. The patient experienced chest pain, myocarditis, elevated troponins on 09May2021 at 03:30 AM. The events resulted in: Emergency room/department or urgent care, Hospitalization. Days of hospitalization was 3 days. The patient had no covid prior vaccination. The patient had had covid test post vaccination, on 10May2021 with negative result. Outcome of the events was recovering. This report is serious with seriousness criteria-caused/prolonged hospitalization.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of  BNT162B2 cannot be excluded.  The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees, and Investigators, as appropriate.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 antibody test, Troponin increased
Clinical narrative: Myocarditis; Chest pain; Elevated troponins; This is a spontaneous report from a contactable pharmacist. A 22-year-old male patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular in the left arm on 06May2021 11: 00 am at 22-year-old as single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient had no known allergies. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)  for COVID-19 immunization. The patient experienced chest pain, myocarditis, elevated troponins on 09May2021 at 03:30 AM. The events resulted in: Emergency room/department or urgent care, Hospitalization. Days of hospitalization was 3 days. The patient had no covid prior vaccination. The patient had had covid test post vaccination, on 10May2021 with negative result. Outcome of the events was recovering. This report is serious with seriousness criteria-caused/prolonged hospitalization.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of  BNT162B2 cannot be excluded.  The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to  Committees, and Investigators, as appropriate.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Cardiac function test, Cold sweat, Feeling hot
Clinical narrative: Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Neck pain, Pain in extremity, Pain in jaw, Tremor
Clinical narrative: Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Mobility decreased, Pain in extremity, Pain in jaw
Clinical narrative: Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Contusion, Rash, Rash pruritic, Urine analysis
Clinical narrative: itchy rash; rash starting on my arms, moved to my back, then my chest and neck/The rash got worse; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left in Mar2021 at the age of 55-years-old (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included known allergies sulfa from an unknown date, blood pressure abnormal and allergy from an unknown date. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); calcium all taken for an unspecified indication, start and stop date were not reported and unspecified medicine for blood pressure abnormal and unspecified medicine for allergy. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. On 20Mar2021 17:00, 48 hours after the first vaccine the patient developed a rash starting on her arms, moved to her back, then her chest and neck.  She went to the doctor and received a steroid shot for the itchy rash.  The rash got worse by 4/4, returned to the doctor for additional treatment.  She was given Triamcinolone Acetonide to apply to the rash. The 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 included steroid shot, triamcinolone acetonide cream. The outcome of the events was not resolved.  Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash; rash starting on my arms, moved to my back, then my chest and neck/The rash got worse; This is a spontaneous report from a contactable consumer (patient).  A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left in Mar2021 at the age of 55-years-old (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included known allergies sulfa from an unknown date, blood pressure abnormal and allergy from an unknown date. Concomitant medications included ascorbic acid (VIT C); ergocalciferol (VIT D); calcium all taken for an unspecified indication, start and stop date were not reported and unspecified medicine for blood pressure abnormal and unspecified medicine for allergy. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant. On 20Mar2021 17:00, 48 hours after the first vaccine the patient developed a rash starting on her arms, moved to her back, then her chest and neck.  She went to the doctor and received a steroid shot for the itchy rash.  The rash got worse by 4/4, returned to the doctor for additional treatment.  She was given Triamcinolone Acetonide to apply to the rash. The 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 included steroid shot, triamcinolone acetonide cream. The outcome of the events was not resolved.  Information about lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: Sudden reduction of left ear hearing; This is a spontaneous report from a contactable consumer (patient).    A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 14:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Reason why batch/lot is Unknown: Misplaced/discarded. Medical history included allergies: crustaceans. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sudden reduction of left ear hearing on 11May2021 18:45. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis
Clinical narrative: Sudden reduction of left ear hearing; This is a spontaneous report from a contactable consumer (patient).    A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 14:45 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Reason why batch/lot is Unknown: Misplaced/discarded. Medical history included allergies: crustaceans. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID- 19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sudden reduction of left ear hearing on 11May2021 18:45. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue discomfort, Tongue erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 30Apr2021 at 13:00 (Lot Number: EP6955) (at the age of 67-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Apr2021 at 13:00 (Lot Number: ER8737) (at the age of 67-year-old) as single dose for COVID-19 immunisation.  The patient experienced swollen red and burning tongue on 02May2021 with outcome of recovered on 08May2021. The events required emergency room visit (not the emergency room in the hospital, but one of those after care places) and physician office visit, both on 06May2021. Therapeutic measures were taken as a result of the events and included some mouthwash stuff and take a vitamin. No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Intensive care, Myocarditis, Troponin increased
Clinical narrative: Chest  pain, elevated cardiac enzymes (troponin), myocarditis. Peak troponin 11.6 on 5/7. CMR demonstrating myocarditis
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Magnetic resonance imaging heart, Myocardial necrosis marker increased, Myocarditis
Clinical narrative: Chest  pain, elevated cardiac enzymes (troponin), myocarditis. Peak troponin 11.6 on 5/7. CMR demonstrating myocarditis
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Chest  pain, elevated cardiac enzymes (troponin), myocarditis. Peak troponin 11.6 on 5/7. CMR demonstrating myocarditis
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Echocardiogram, Electrocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Myocaditis
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Myocaditis
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Magnetic resonance imaging heart, Myocarditis, Troponin T
Clinical narrative: Myocaditis
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal tenderness, Bradycardia, C-reactive protein increased, Chest pain, Cough
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Culture throat, Cytomegalovirus test negative, Echocardiogram, Echocardiogram normal, Electrocardiogram
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Epstein-Barr virus antigen positive, Epstein-Barr virus test negative, Eructation
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer normal, Full blood count, Headache, Malaise, Myalgia
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Oropharyngeal pain, Pain, Pain in extremity, Palpitations
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pharyngitis, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 RNA undetectable, SARS-CoV-2 antibody test positive
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Serum ferritin normal, Streptococcal infection, Streptococcus test, Streptococcus test negative, Transaminases increased
Clinical narrative: 3 days after the 2nd dose of the Pfizer vaccine was administered, patient began to feel ill with a sore throat, body aches, swollen lymph nodes in the throat, and headache. He did not improve the next day or at all through the 4th day of having these symptoms. On the fifth day (Friday) he woke up with a fever (102 degrees). Mom took him to the pediatrician where they did an exam and a strep culture (it came back negative). The doctor sent patient home with orders to rest and drink fluids. The next day (Saturday), mom took patient to the local urgent care center to get a Covid test. There, they performed another exam, another strep culture and both rapid and lab Covid tests. All came back negative. He was prescribed and began antibiotics in case the sore throat was indeed strep. That same day, patient complained of his chest hurting and feeling tight. Sunday, he woke up with pronounced chest pain and said his left arm hurt. We thought it might be trapped gas and worked to get it out. He finally tired and slept but woke up complaining about the same chest pain and tightness. Again he tired to burp and move his body to release what we thought was trapped gas and again went to sleep. He woke up around midnight with severe chest pain radiating down his left arm. Mom took him to Emergency room where he was examined and questioned and later transferred to the other Hospital where he was admitted Monday morning to the pediatric cardiac ICU. It was determined that he was experiencing an acute myocarditis of unknown etiology.