chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Epistaxis, Heavy menstrual bleeding, Oral purpura, Platelet count
Clinical narrative: Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5.         No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Thrombocytopenia
Clinical narrative: Non-stop flow of period bleeding like peeing Blood after second vaccine; Thrombocytopenia Diagnosis after second vaccine; Bruised all over the body after second vaccine; Platelet level was 5on blood test after second vaccine; Nose Bleeding; Oral Purpura on the Lip after second vaccine; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) and THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced EPISTAXIS (Nose Bleeding) and ORAL PURPURA (Oral Purpura on the Lip after second vaccine). On 19-May-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine) (seriousness criteria hospitalization, medically significant and life threatening). On 27-May-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine) (seriousness criteria medically significant and life threatening), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine). The patient was hospitalized from 27-May-2021 to 28-May-2021 due to HEAVY MENSTRUAL BLEEDING. At the time of the report, HEAVY MENSTRUAL BLEEDING (Non-stop flow of period bleeding like peeing Blood after second vaccine), THROMBOCYTOPENIA (Thrombocytopenia Diagnosis after second vaccine), EPISTAXIS (Nose Bleeding), ORAL PURPURA (Oral Purpura on the Lip after second vaccine), CONTUSION (Bruised all over the body after second vaccine) and PLATELET COUNT DECREASED (Platelet level was 5on blood test after second vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: 5 (Low) 5.         No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chest pain, Myocarditis, Troponin increased
Clinical narrative: Chest pain two days after receiving second dose of vaccine that lasted for about an hour. Located in center of chest, associated with some shortness of breath.
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram abnormal, Troponin increased
Clinical narrative: Chest pain two days after receiving second dose of vaccine that lasted for about an hour. Located in center of chest, associated with some shortness of breath.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram normal, Troponin increased
Clinical narrative: Myocarditis. Received vaccine #2 on 5/17/21 (first dose on 4/26/21). Developed waxing/waning chest pain starting 2-3 weeks after 2nd vaccination. Then arrived to medical care on 6/16 with elevated troponin. Normal echocardiogram, admitted from 6/16-6/19 at an outside facility, troponin trended down with supportive care and ibuprofen. Re-presented to care on 6/22 with worsened chest pain and increased troponin, higher than initial. On monitoring from 6/22-6/23, developed short run of VT and was given IVIg. Troponin then trended down and discharged on 6/25. Echo again normal function. Cardiac MRI with normal biventricular function, positive for myocarditis.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Condition aggravated, Echocardiogram normal, Immunoglobulin therapy
Clinical narrative: Myocarditis. Received vaccine #2 on 5/17/21 (first dose on 4/26/21). Developed waxing/waning chest pain starting 2-3 weeks after 2nd vaccination. Then arrived to medical care on 6/16 with elevated troponin. Normal echocardiogram, admitted from 6/16-6/19 at an outside facility, troponin trended down with supportive care and ibuprofen. Re-presented to care on 6/22 with worsened chest pain and increased troponin, higher than initial. On monitoring from 6/22-6/23, developed short run of VT and was given IVIg. Troponin then trended down and discharged on 6/25. Echo again normal function. Cardiac MRI with normal biventricular function, positive for myocarditis.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Troponin increased, Ventricular tachycardia, Viral test negative
Clinical narrative: Myocarditis. Received vaccine #2 on 5/17/21 (first dose on 4/26/21). Developed waxing/waning chest pain starting 2-3 weeks after 2nd vaccination. Then arrived to medical care on 6/16 with elevated troponin. Normal echocardiogram, admitted from 6/16-6/19 at an outside facility, troponin trended down with supportive care and ibuprofen. Re-presented to care on 6/22 with worsened chest pain and increased troponin, higher than initial. On monitoring from 6/22-6/23, developed short run of VT and was given IVIg. Troponin then trended down and discharged on 6/25. Echo again normal function. Cardiac MRI with normal biventricular function, positive for myocarditis.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment abnormal
Clinical narrative: HEADACHE AND LETHARGY AFTER VACCINATION. ON 6/18 COMPLAINED OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. EVALUATED BY PEDIATRICIAN THEN REFERRED TO CARDIOLOOGY.  ADMITTED TO ON 6/18 WHERE BLOODWORK SHOWED ELEVATED TROPONIN LEVEL. TRANSFERRED BY AMBULANCE TO  HOSPITAL FOR ADMISSION. DIAGNOSED WITH MYOCARDITIS.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: HEADACHE AND LETHARGY AFTER VACCINATION. ON 6/18 COMPLAINED OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. EVALUATED BY PEDIATRICIAN THEN REFERRED TO CARDIOLOOGY.  ADMITTED TO ON 6/18 WHERE BLOODWORK SHOWED ELEVATED TROPONIN LEVEL. TRANSFERRED BY AMBULANCE TO  HOSPITAL FOR ADMISSION. DIAGNOSED WITH MYOCARDITIS.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort
Clinical narrative: HEADACHE AND LETHARGY AFTER VACCINATION. ON 6/18 COMPLAINED OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. EVALUATED BY PEDIATRICIAN THEN REFERRED TO CARDIOLOOGY.  ADMITTED TO ON 6/18 WHERE BLOODWORK SHOWED ELEVATED TROPONIN LEVEL. TRANSFERRED BY AMBULANCE TO  HOSPITAL FOR ADMISSION. DIAGNOSED WITH MYOCARDITIS.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Headache, Lethargy, Myocarditis
Clinical narrative: HEADACHE AND LETHARGY AFTER VACCINATION. ON 6/18 COMPLAINED OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. EVALUATED BY PEDIATRICIAN THEN REFERRED TO CARDIOLOOGY.  ADMITTED TO ON 6/18 WHERE BLOODWORK SHOWED ELEVATED TROPONIN LEVEL. TRANSFERRED BY AMBULANCE TO  HOSPITAL FOR ADMISSION. DIAGNOSED WITH MYOCARDITIS.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: HEADACHE AND LETHARGY AFTER VACCINATION. ON 6/18 COMPLAINED OF CHEST TIGHTNESS AND SHORTNESS OF BREATH. EVALUATED BY PEDIATRICIAN THEN REFERRED TO CARDIOLOOGY.  ADMITTED TO ON 6/18 WHERE BLOODWORK SHOWED ELEVATED TROPONIN LEVEL. TRANSFERRED BY AMBULANCE TO  HOSPITAL FOR ADMISSION. DIAGNOSED WITH MYOCARDITIS.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states that she woke up in the middle of the night a few days after receiving the vaccine feeling unwell. She reports itchy palms, hives, and malaise. She was hospitalized for 2 days and received epinephrine and steroids in the hospital. She is feeling better post-hospitalization.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypotension, Malaise, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states that she woke up in the middle of the night a few days after receiving the vaccine feeling unwell. She reports itchy palms, hives, and malaise. She was hospitalized for 2 days and received epinephrine and steroids in the hospital. She is feeling better post-hospitalization.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states that she woke up in the middle of the night a few days after receiving the vaccine feeling unwell. She reports itchy palms, hives, and malaise. She was hospitalized for 2 days and received epinephrine and steroids in the hospital. She is feeling better post-hospitalization.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Hypotension, Nausea, Pruritus, Urticaria
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Hypotension-Medium, Additional Details: Patient states that she woke up in the middle of the night a few days after receiving the vaccine feeling unwell. She reports itchy palms, hives, and malaise. She was hospitalized for 2 days and received epinephrine and steroids in the hospital. She is feeling better post-hospitalization.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Asthma, Chest X-ray, Chest pain, Cough
Clinical narrative: Rash that got worse; This is a spontaneous report from a contactable Nurse (patient herself). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. After 2nd dose of Pfizer COVID-19 vaccine on 08Jun2021, patient experienced rash that got worse 1st and 2nd day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Patient was still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this. Once she went off the prednisone and Benadryl her symptoms come back. Patient was still taking medications, when time for next dose, her symptoms started to come back. She had no problem with first shot. With the second shot when rash started getting red and bumps started and 3 days later woke up and could not breath, took Benadryl and inhalers and it startled again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it was the vaccination. She had read the cardiac situation, she read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it was 2 inch red circle around the injection area, this came up yesterday, not sure if it was because she got the other injection in arm. It was enquired when she got her second COVID shot. She was currently having, prednisone tapered dose 60mg on 2nd dose. She enquired when she waited to take it at 10, she had a hard time breathing, it was wearing off. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events rash, dyspnoea, chest pain and anaphylactic reaction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Influenza virus test, Investigation
Clinical narrative: Rash that got worse; This is a spontaneous report from a contactable Nurse (patient herself). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. After 2nd dose of Pfizer COVID-19 vaccine on 08Jun2021, patient experienced rash that got worse 1st and 2nd day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Patient was still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this. Once she went off the prednisone and Benadryl her symptoms come back. Patient was still taking medications, when time for next dose, her symptoms started to come back. She had no problem with first shot. With the second shot when rash started getting red and bumps started and 3 days later woke up and could not breath, took Benadryl and inhalers and it startled again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it was the vaccination. She had read the cardiac situation, she read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it was 2 inch red circle around the injection area, this came up yesterday, not sure if it was because she got the other injection in arm. It was enquired when she got her second COVID shot. She was currently having, prednisone tapered dose 60mg on 2nd dose. She enquired when she waited to take it at 10, she had a hard time breathing, it was wearing off. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events rash, dyspnoea, chest pain and anaphylactic reaction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Metabolic function test, Peripheral swelling, Rash, Rash papular
Clinical narrative: Rash that got worse; This is a spontaneous report from a contactable Nurse (patient herself). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. After 2nd dose of Pfizer COVID-19 vaccine on 08Jun2021, patient experienced rash that got worse 1st and 2nd day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Patient was still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this. Once she went off the prednisone and Benadryl her symptoms come back. Patient was still taking medications, when time for next dose, her symptoms started to come back. She had no problem with first shot. With the second shot when rash started getting red and bumps started and 3 days later woke up and could not breath, took Benadryl and inhalers and it startled again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it was the vaccination. She had read the cardiac situation, she read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it was 2 inch red circle around the injection area, this came up yesterday, not sure if it was because she got the other injection in arm. It was enquired when she got her second COVID shot. She was currently having, prednisone tapered dose 60mg on 2nd dose. She enquired when she waited to take it at 10, she had a hard time breathing, it was wearing off. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events rash, dyspnoea, chest pain and anaphylactic reaction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Skin discolouration, Vaccination site erythema
Clinical narrative: Rash that got worse; This is a spontaneous report from a contactable Nurse (patient herself). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. After 2nd dose of Pfizer COVID-19 vaccine on 08Jun2021, patient experienced rash that got worse 1st and 2nd day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Patient was still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this. Once she went off the prednisone and Benadryl her symptoms come back. Patient was still taking medications, when time for next dose, her symptoms started to come back. She had no problem with first shot. With the second shot when rash started getting red and bumps started and 3 days later woke up and could not breath, took Benadryl and inhalers and it startled again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it was the vaccination. She had read the cardiac situation, she read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it was 2 inch red circle around the injection area, this came up yesterday, not sure if it was because she got the other injection in arm. It was enquired when she got her second COVID shot. She was currently having, prednisone tapered dose 60mg on 2nd dose. She enquired when she waited to take it at 10, she had a hard time breathing, it was wearing off. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events rash, dyspnoea, chest pain and anaphylactic reaction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Rash
Clinical narrative: Rash that got worse; This is a spontaneous report from a contactable Nurse (patient herself). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. After 2nd dose of Pfizer COVID-19 vaccine on 08Jun2021, patient experienced rash that got worse 1st and 2nd day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Patient was still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this. Once she went off the prednisone and Benadryl her symptoms come back. Patient was still taking medications, when time for next dose, her symptoms started to come back. She had no problem with first shot. With the second shot when rash started getting red and bumps started and 3 days later woke up and could not breath, took Benadryl and inhalers and it startled again in the middle of the night where she needed to get to the ER. She had an abnormal EKG to follow up on and some chest pain. She was concerned because it was the vaccination. She had read the cardiac situation, she read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it was 2 inch red circle around the injection area, this came up yesterday, not sure if it was because she got the other injection in arm. It was enquired when she got her second COVID shot. She was currently having, prednisone tapered dose 60mg on 2nd dose. She enquired when she waited to take it at 10, she had a hard time breathing, it was wearing off. The patient underwent lab tests and procedures which included electrocardiogram: abnormal on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events rash, dyspnoea, chest pain and anaphylactic reaction cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 regulatory authorities, ethics committees. and investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Fatigue, Feeling abnormal, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in left arm on 11Mar2021 at 08:00, (at an unknown age) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to food, medications, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any other medications within two weeks of vaccination. On 11Mar2021 at 00:00, the patient experienced headache, rash and vertigo. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, rash and vertigo was not resolved at the time of this report. Information about lot/ batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Rash, Vertigo
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route administration in left arm on 11Mar2021 at 08:00, (at an unknown age) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to food, medications, or other products (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any other medications within two weeks of vaccination. On 11Mar2021 at 00:00, the patient experienced headache, rash and vertigo. The patient did not receive any treatment for the reported events. The clinical outcome of the events headache, rash and vertigo was not resolved at the time of this report. Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bundle branch block right, Chest X-ray normal, Chest discomfort, Chest pain, Dizziness
Clinical narrative: I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my heart rate increased so I dialed 911. I then started to lose feeling in my left hand. Then when the ambulance picked me up, my right hand started to go numb. The doctors at emergency think its possibly anxiety and I had a panic attack. I am taking anxiety meds for the anxiety but I am still having heart palpitations.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer normal, Full blood count normal, International normalised ratio normal, Metabolic function test normal
Clinical narrative: I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my heart rate increased so I dialed 911. I then started to lose feeling in my left hand. Then when the ambulance picked me up, my right hand started to go numb. The doctors at emergency think its possibly anxiety and I had a panic attack. I am taking anxiety meds for the anxiety but I am still having heart palpitations.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Panic attack, Prothrombin time normal, Sinus tachycardia
Clinical narrative: I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my heart rate increased so I dialed 911. I then started to lose feeling in my left hand. Then when the ambulance picked me up, my right hand started to go numb. The doctors at emergency think its possibly anxiety and I had a panic attack. I am taking anxiety meds for the anxiety but I am still having heart palpitations.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Hypoaesthesia, Palpitations, Panic attack
Clinical narrative: I felt dizzy at 12 PM on the 17th of June 2021. Then at 1 pm I started to feel dizzy and then my heart rate increased so I dialed 911. I then started to lose feeling in my left hand. Then when the ambulance picked me up, my right hand started to go numb. The doctors at emergency think its possibly anxiety and I had a panic attack. I am taking anxiety meds for the anxiety but I am still having heart palpitations.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Patient was seen on 6/25/21 by PCP and diagnosed with Shingles (Herpes Zoster).
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient was seen on 6/25/21 by PCP and diagnosed with Shingles (Herpes Zoster).
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered, Pain in extremity
Clinical narrative: Vaccine was diluted using the incorrect diluent - bacteriostatic normal saline was used instead of preservative-free normal saline.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Vaccine was diluted using the incorrect diluent - bacteriostatic normal saline was used instead of preservative-free normal saline.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Intensive care
Clinical narrative: 18 days after 2nd Moderna COVID vaccine patient developed severe headaches, at third visit CT was done showing extensive cavernous sinus thrombosis confirmed with MRI/MRV.  Patient was transferred to inpatient neurosurgery and is  still inpatient on anticoagulation.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Sinus congestion, Sinusitis
Clinical narrative: 18 days after 2nd Moderna COVID vaccine patient developed severe headaches, at third visit CT was done showing extensive cavernous sinus thrombosis confirmed with MRI/MRV.  Patient was transferred to inpatient neurosurgery and is  still inpatient on anticoagulation.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cavernous sinus thrombosis, Computerised tomogram head abnormal, Fibrin D dimer, Headache
Clinical narrative: 18 days after 2nd Moderna COVID vaccine patient developed severe headaches, at third visit CT was done showing extensive cavernous sinus thrombosis confirmed with MRI/MRV.  Patient was transferred to inpatient neurosurgery and is  still inpatient on anticoagulation.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Venogram abnormal
Clinical narrative: 18 days after 2nd Moderna COVID vaccine patient developed severe headaches, at third visit CT was done showing extensive cavernous sinus thrombosis confirmed with MRI/MRV.  Patient was transferred to inpatient neurosurgery and is  still inpatient on anticoagulation.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Loss of consciousness, Nausea, Paraesthesia
Clinical narrative: 2 mins after receiving the vaccine he became dizzy and nauseous. Then later loss conscious, hands were clenched and was unresponsive for 45 seconds. Fever and slight headache currently.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Joint contracture, Loss of consciousness, Nausea
Clinical narrative: 2 mins after receiving the vaccine he became dizzy and nauseous. Then later loss conscious, hands were clenched and was unresponsive for 45 seconds. Fever and slight headache currently.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Unresponsive to stimuli
Clinical narrative: 2 mins after receiving the vaccine he became dizzy and nauseous. Then later loss conscious, hands were clenched and was unresponsive for 45 seconds. Fever and slight headache currently.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Erythema, Induration, Tenderness
Clinical narrative: Patient described symptoms of very painful arm, tender to touch, swollen with feeling terrible and nauseous on 6/29/2021 but had been feeling this way for several days. Patient was referred to her primary doctor on 6/29/2021 from pharmacy. Patient went to doctor who diagnosis her with cellulitis and given an antibiotic on 6/29/2021.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Nausea, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient described symptoms of very painful arm, tender to touch, swollen with feeling terrible and nauseous on 6/29/2021 but had been feeling this way for several days. Patient was referred to her primary doctor on 6/29/2021 from pharmacy. Patient went to doctor who diagnosis her with cellulitis and given an antibiotic on 6/29/2021.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Skin swelling, Skin warm
Clinical narrative: Patient received Covid-19 Moderna vaccine on 6/23/2021. She came to the pharmacy on 6/29/2021 to report that she noticed that she developed some reaction to the vaccine. She said that she observed some kind of lumps (hard swellings on the surface of her skin) that are swollen and  warm to touch on various parts of her body- on the neck, arms, abdomen, soles  of her feet and palms of her hand
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Autonomic nervous system imbalance, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: Facial flushing, palpitations and orthostasis 3 days following first injection.  Within 10 days the patient began experiences headaches and distal dysesthesias in her hands and feet.  At the time of my examination on 1/9/21 she had widespread hyperreflexia.  She continued to manifest signs of dysautonomia with rapid and disproportionate increases in heart rate with trivial activity.  Her presentation was consistent with acute transverse myelitis.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: DNA antibody negative, Dysaesthesia, Flushing, Headache, Heart rate increased
Clinical narrative: Facial flushing, palpitations and orthostasis 3 days following first injection.  Within 10 days the patient began experiences headaches and distal dysesthesias in her hands and feet.  At the time of my examination on 1/9/21 she had widespread hyperreflexia.  She continued to manifest signs of dysautonomia with rapid and disproportionate increases in heart rate with trivial activity.  Her presentation was consistent with acute transverse myelitis.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperreflexia, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Myelitis transverse, Orthostatic hypotension
Clinical narrative: Facial flushing, palpitations and orthostasis 3 days following first injection.  Within 10 days the patient began experiences headaches and distal dysesthesias in her hands and feet.  At the time of my examination on 1/9/21 she had widespread hyperreflexia.  She continued to manifest signs of dysautonomia with rapid and disproportionate increases in heart rate with trivial activity.  Her presentation was consistent with acute transverse myelitis.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Red blood cell sedimentation rate normal, Rheumatoid factor negative, SARS-CoV-2 test negative
Clinical narrative: Facial flushing, palpitations and orthostasis 3 days following first injection.  Within 10 days the patient began experiences headaches and distal dysesthesias in her hands and feet.  At the time of my examination on 1/9/21 she had widespread hyperreflexia.  She continued to manifest signs of dysautonomia with rapid and disproportionate increases in heart rate with trivial activity.  Her presentation was consistent with acute transverse myelitis.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Cough, Nasopharyngitis, Pyrexia
Clinical narrative: Golf ball sized lump in left armpit for 6 days. Also on day 2 post vaccine a horrible cold with cough  & fever of 101.5 lasted for 2 days. Has had a cough & cold for over 8 days now.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suffocation feeling, Tremor, Urticaria
Clinical narrative: Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Palpitations, Pharyngeal oedema
Clinical narrative: Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Patient received vaccine together with his family (he was 3rd out of 4). He said the shot hurt. After all were vaccinated, he said he felt weird. I had him sit for monitoring with his family. His parent told me he still felt weird, and that they walked around the store, but now he has a bad headache and feels a little winded. I had him sit in the immunization room with mask off for further monitoring. After a few more minutes, he said it felt like he was suffocating. I administered 1 Epi-Pen at 10:08PM in his left thigh and called an ambulance. Soon after, he was shaking/shivering, but said it was getting easier to breathe. EMT arrived shortly after, noted the hives on his back, and took him to the hospital.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fungal infection, Rash
Clinical narrative: shortness of breath (covid negative)  extreme sensitivity to fungal infections rashes
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Electrocardiogram normal, Facial paralysis, Hypoaesthesia
Clinical narrative: Developed Bells Paulsy on 14th June 2021, Could not shut left eye at all, Droop in left mouth area. Went to urgent care as thought I was haveing a stroke. They performed ekg & catscan with neg results of stroke. Put me on prednisone & Valacyclovir. Its week three and I can force my eye shut but still can not close normally, still have numbness in left cheek and lip droop.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fluid retention, Headache, Inflammation, Laboratory test
Clinical narrative: Fever chills headache, two days in bed ,after two weeks I started giant  Weight like 7 pounds in one week and my doctor told me I have water inflammation caused by the vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pyrexia, Weight increased
Clinical narrative: Fever chills headache, two days in bed ,after two weeks I started giant  Weight like 7 pounds in one week and my doctor told me I have water inflammation caused by the vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Menstruation irregular, Migraine, Pain
Clinical narrative: Irregular menstrual bleeding (bleeding started again, last day of last period was 1.5 weeks ago). Extreme fatigue. Severe pain (6 out 10 pain scale) in right arm. Headache/migraine that has lasted 2 days. Body aches. Chills. Thirst.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thirst
Clinical narrative: Irregular menstrual bleeding (bleeding started again, last day of last period was 1.5 weeks ago). Extreme fatigue. Severe pain (6 out 10 pain scale) in right arm. Headache/migraine that has lasted 2 days. Body aches. Chills. Thirst.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Angioplasty, Antinuclear antibody, Blood copper normal, Blood thyroid stimulating hormone normal, Cardiac stress test normal
Clinical narrative: The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination.  She was taken to the cardiac cath lab after negative troponins and a negative stress test.   Two coronary stents were placed in the setting of single vessel disease.  She suffered a mild myocardial infarct during angioplasty.  The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting.  She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs.  She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes.  Her presentation was consistent with acute transverse myelitis.  As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.