chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: pt experienced lip and tongue swelling after driving home from her vaccination. She stayed for 15 minutes for observation post vaccination, denied any symptoms at that time and was dismissed. Her symptoms began when she was driving home. Patient denied needing any emergency attention, denies going to the ED or telling her PMD until soon before her second dose was scheduled.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Given to patient age 17 years old, indicated for patients 18 and up
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given to patient age 17 years old, indicated for patients 18 and up
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Dizziness, Dysarthria, Dysgeusia, Eye irritation
Clinical narrative: metallic taste; flushing; rapid heart rate; Fever; burning sensation inside lips, tongue, back of throat, roof of mouth; burning sensation inside lips, tongue, back of throat, roof of mouth; difficulting forming words, stuttering; lack of coordination; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN0205), via an unspecified route of administration on the right arm on 02Mar2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis (which was being treated at the time of report), Bell's Palsy and pre-eclampsia both from 20 years ago; patient also had known allergies to sulfa drugs, contrast dye, shellfish and a gluten intolerance. Concomitant medication included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE SOD) and rheum rhaponticum root (ESTROVERA). Patient had no other vaccines within four weeks, did not have COVID-19 prior to vaccination, was not pregnant and was vaccinated at a Public Health Clinic/Administration facility. The patient experienced metallic taste, flushing, rapid heart rate, fever, burning sensation inside lips, tongue, back of throat, roof of mouth, difficulting forming words, stuttering, lack of coordination on 02Mar2021 10:15. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and were reported as life-threatening illnesses (immediate risk of death from the event). Therapeutic measures as a result of the events included Benedryl and dexamethasone injection. Patient has not been tested for COVID-19 post-vaccination. Outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Paraesthesia, Paraesthesia oral
Clinical narrative: metallic taste; flushing; rapid heart rate; Fever; burning sensation inside lips, tongue, back of throat, roof of mouth; burning sensation inside lips, tongue, back of throat, roof of mouth; difficulting forming words, stuttering; lack of coordination; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN0205), via an unspecified route of administration on the right arm on 02Mar2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis (which was being treated at the time of report), Bell's Palsy and pre-eclampsia both from 20 years ago; patient also had known allergies to sulfa drugs, contrast dye, shellfish and a gluten intolerance. Concomitant medication included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE SOD) and rheum rhaponticum root (ESTROVERA). Patient had no other vaccines within four weeks, did not have COVID-19 prior to vaccination, was not pregnant and was vaccinated at a Public Health Clinic/Administration facility. The patient experienced metallic taste, flushing, rapid heart rate, fever, burning sensation inside lips, tongue, back of throat, roof of mouth, difficulting forming words, stuttering, lack of coordination on 02Mar2021 10:15. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and were reported as life-threatening illnesses (immediate risk of death from the event). Therapeutic measures as a result of the events included Benedryl and dexamethasone injection. Patient has not been tested for COVID-19 post-vaccination. Outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Coordination abnormal, Dysgeusia, Dysphemia, Flushing, Heart rate
Clinical narrative: metallic taste; flushing; rapid heart rate; Fever; burning sensation inside lips, tongue, back of throat, roof of mouth; burning sensation inside lips, tongue, back of throat, roof of mouth; difficulting forming words, stuttering; lack of coordination; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN0205), via an unspecified route of administration on the right arm on 02Mar2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis (which was being treated at the time of report), Bell's Palsy and pre-eclampsia both from 20 years ago; patient also had known allergies to sulfa drugs, contrast dye, shellfish and a gluten intolerance. Concomitant medication included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE SOD) and rheum rhaponticum root (ESTROVERA). Patient had no other vaccines within four weeks, did not have COVID-19 prior to vaccination, was not pregnant and was vaccinated at a Public Health Clinic/Administration facility. The patient experienced metallic taste, flushing, rapid heart rate, fever, burning sensation inside lips, tongue, back of throat, roof of mouth, difficulting forming words, stuttering, lack of coordination on 02Mar2021 10:15. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and were reported as life-threatening illnesses (immediate risk of death from the event). Therapeutic measures as a result of the events included Benedryl and dexamethasone injection. Patient has not been tested for COVID-19 post-vaccination. Outcome of the events was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Oral discomfort, Pyrexia, Throat irritation
Clinical narrative: metallic taste; flushing; rapid heart rate; Fever; burning sensation inside lips, tongue, back of throat, roof of mouth; burning sensation inside lips, tongue, back of throat, roof of mouth; difficulting forming words, stuttering; lack of coordination; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN0205), via an unspecified route of administration on the right arm on 02Mar2021 10:15 at a single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis (which was being treated at the time of report), Bell's Palsy and pre-eclampsia both from 20 years ago; patient also had known allergies to sulfa drugs, contrast dye, shellfish and a gluten intolerance. Concomitant medication included levothyroxine sodium (SYNTHROID), liothyronine sodium (LIOTHYRONINE SOD) and rheum rhaponticum root (ESTROVERA). Patient had no other vaccines within four weeks, did not have COVID-19 prior to vaccination, was not pregnant and was vaccinated at a Public Health Clinic/Administration facility. The patient experienced metallic taste, flushing, rapid heart rate, fever, burning sensation inside lips, tongue, back of throat, roof of mouth, difficulting forming words, stuttering, lack of coordination on 02Mar2021 10:15. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and were reported as life-threatening illnesses (immediate risk of death from the event). Therapeutic measures as a result of the events included Benedryl and dexamethasone injection. Patient has not been tested for COVID-19 post-vaccination. Outcome of the events was recovering.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: I received the vaccine at 10:10 am on 2/13/2021. I began feeling as though I couldn't breath approximately 5-6 minutes after I received the vaccine. The difficulty breathing began to get worse and I got the attention of the nurse. She administered my first epi-pen at 10:18 am. I was transported from the observation room to the emergency department. On my way to the emergency department I  began to have difficulty breathing again and received a second dose of epinephrine. When I arrived at the emergency department I was given Benadryl, Zyrtec, and another medication.  I was monitored in the emergency department for 3 hours without further incident.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: I received the vaccine at 10:10 am on 2/13/2021. I began feeling as though I couldn't breath approximately 5-6 minutes after I received the vaccine. The difficulty breathing began to get worse and I got the attention of the nurse. She administered my first epi-pen at 10:18 am. I was transported from the observation room to the emergency department. On my way to the emergency department I  began to have difficulty breathing again and received a second dose of epinephrine. When I arrived at the emergency department I was given Benadryl, Zyrtec, and another medication.  I was monitored in the emergency department for 3 hours without further incident.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Angiogram pulmonary abnormal, Chest X-ray, Chest pain, Dyspnoea
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram, Fibrin D dimer increased, Full blood count, International normalised ratio
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, N-terminal prohormone brain natriuretic peptide, Painful respiration, Pleural effusion, Prothrombin time
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Tachycardia, Troponin, Ultrasound Doppler
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arteriogram carotid, Chest X-ray, Electrocardiogram, Fibrin D dimer, Full blood count
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pleural effusion, Pulmonary embolism, SARS-CoV-2 test, Ultrasound Doppler
Clinical narrative: unprovoked pulmonary emboli in my right lung with left pleural effusion; unprovoked pulmonary emboli in my right lung with left pleural effusion; This is a spontaneous report from a contactable nurse (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration at the left arm on 27Dec2020 19:30 at single dose for COVID-19 immunisation. Medical history included allergies to penicillin. Concomitant medication included omeprazole (PROTONIX) and sertraline hydrochloride (ZOLOFT). The patient was not pregnant at the time of vaccination. On 10Jan2021 12:00 (also reported as 14 days following vaccination), the patient had difficulty taking a deep breath, 15 days following vaccination, had more difficulty breathing. On 12Jan2021 (also reported as 16 days from vaccination), the patient developed mild chest pain with inspiration. She developed moderate to severe chest pain, tachycardia, and shortness of breath on 13Jan2021 (also reported as 17 days after vaccination). Her physician (PCP) obtained an EKG, CXR, COVID (nasal) swab, basic metabolic panel, CBC, and a D-dimer. She was notified by her PCP to go to the ED due to an elevated D-dimer. Following a CT angiogram of the chest, and venous duplex ultrasound of her lower extremities, she was diagnosed with unprovoked pulmonary emboli in right lung with left pleural effusion on an unspecified date. The patient had COVID (nasal) swab on 13Jan2021 with negative result. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events caused hospitalization for 1 day with IV Heparin therapy. The outcome of the events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Paraesthesia oral
Clinical narrative: Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received shot at 10:39 am showed signs at 10:42am
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Mild tongue swelling and tongue itching. No treatment given, signs dissipated in 1-2 hours. Received shot at 10:39 am showed signs at 10:42am
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Pulmonary embolism
Clinical narrative: Flu-like symptoms since the evening of his vaccination (2/25) - including generalized body aches, pain at injection site, dizziness,  pain behind his eyes.  Continued to feel the same way the following day (2/26) and spent most of the time in bed.  Got up from bed around 1am on 2/27 and went unresponsive.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Deep vein thrombosis, Dizziness, Eye pain, Influenza like illness
Clinical narrative: Flu-like symptoms since the evening of his vaccination (2/25) - including generalized body aches, pain at injection site, dizziness,  pain behind his eyes.  Continued to feel the same way the following day (2/26) and spent most of the time in bed.  Got up from bed around 1am on 2/27 and went unresponsive.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Pain, Pulmonary embolism, Unresponsive to stimuli
Clinical narrative: Flu-like symptoms since the evening of his vaccination (2/25) - including generalized body aches, pain at injection site, dizziness,  pain behind his eyes.  Continued to feel the same way the following day (2/26) and spent most of the time in bed.  Got up from bed around 1am on 2/27 and went unresponsive.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fatigue, Mobility decreased, Pain, Pulmonary embolism
Clinical narrative: Flu-like symptoms since the evening of his vaccination (2/25) - including generalized body aches, pain at injection site, dizziness,  pain behind his eyes.  Continued to feel the same way the following day (2/26) and spent most of the time in bed.  Got up from bed around 1am on 2/27 and went unresponsive.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Flu-like symptoms since the evening of his vaccination (2/25) - including generalized body aches, pain at injection site, dizziness,  pain behind his eyes.  Continued to feel the same way the following day (2/26) and spent most of the time in bed.  Got up from bed around 1am on 2/27 and went unresponsive.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Heart rate increased, Injection site erythema, Injection site pain
Clinical narrative: At 10:40 BP 142/78 HR 148 Resp 16 O2Sat 99 Normal resp effort A/O x4 Skin Signs: Cool and dry  Circulation: Cap refill <2 sec  Resp: Breath sound clear bilaterally  Observation At 10:55 BP 118/64 HR 98 Resp 14 O2Sat 99 Resp effort normal  Skin Signs: Warm and dry  Circulation: Cap refill <2 sec Mild redness/tenderness to palp around injection site BP, P, R are reduced >15 min. Pt states they feel normal  At 11:10 BP 118/70 HR 91 Resp 14 O2Sat 99 A/Ox4 Skin Signs: Warm and dry  Hands noticeably cool to touch  Circulation: Cap refill <2sec  No increased resp effort  Pt education, released to own recognizance  Pt appeared anxious upon first observation, decreasing slightly over time. Verified with R/N throughout observation. No concerning S/S after approx 15-20 min  Home by Self
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure decreased, Heart rate decreased, Injection site erythema, Injection site pain
Clinical narrative: At 10:40 BP 142/78 HR 148 Resp 16 O2Sat 99 Normal resp effort A/O x4 Skin Signs: Cool and dry  Circulation: Cap refill <2 sec  Resp: Breath sound clear bilaterally  Observation At 10:55 BP 118/64 HR 98 Resp 14 O2Sat 99 Resp effort normal  Skin Signs: Warm and dry  Circulation: Cap refill <2 sec Mild redness/tenderness to palp around injection site BP, P, R are reduced >15 min. Pt states they feel normal  At 11:10 BP 118/70 HR 91 Resp 14 O2Sat 99 A/Ox4 Skin Signs: Warm and dry  Hands noticeably cool to touch  Circulation: Cap refill <2sec  No increased resp effort  Pt education, released to own recognizance  Pt appeared anxious upon first observation, decreasing slightly over time. Verified with R/N throughout observation. No concerning S/S after approx 15-20 min  Home by Self
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory rate decreased
Clinical narrative: At 10:40 BP 142/78 HR 148 Resp 16 O2Sat 99 Normal resp effort A/O x4 Skin Signs: Cool and dry  Circulation: Cap refill <2 sec  Resp: Breath sound clear bilaterally  Observation At 10:55 BP 118/64 HR 98 Resp 14 O2Sat 99 Resp effort normal  Skin Signs: Warm and dry  Circulation: Cap refill <2 sec Mild redness/tenderness to palp around injection site BP, P, R are reduced >15 min. Pt states they feel normal  At 11:10 BP 118/70 HR 91 Resp 14 O2Sat 99 A/Ox4 Skin Signs: Warm and dry  Hands noticeably cool to touch  Circulation: Cap refill <2sec  No increased resp effort  Pt education, released to own recognizance  Pt appeared anxious upon first observation, decreasing slightly over time. Verified with R/N throughout observation. No concerning S/S after approx 15-20 min  Home by Self
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: "Modernal COVID-19 Vaccine EUA" Woke up the following morning with a temp of 102.2. About an hour later in was 103.5. Could not get the temp to come down. Went to ER, Temp went down while at the ER had a couple of 102 spkes later that evening.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Body temperature increased, Computerised tomogram normal, Epstein-Barr virus test negative, Mycobacterium test negative
Clinical narrative: "Modernal COVID-19 Vaccine EUA" Woke up the following morning with a temp of 102.2. About an hour later in was 103.5. Could not get the temp to come down. Went to ER, Temp went down while at the ER had a couple of 102 spkes later that evening.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Streptococcus test
Clinical narrative: "Modernal COVID-19 Vaccine EUA" Woke up the following morning with a temp of 102.2. About an hour later in was 103.5. Could not get the temp to come down. Went to ER, Temp went down while at the ER had a couple of 102 spkes later that evening.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram
Clinical narrative: Difficulty breathing about 8 hours after receiving the vaccine.  Also felt panicky due to not being able to catch breath.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Oxygen saturation, Panic reaction
Clinical narrative: Difficulty breathing about 8 hours after receiving the vaccine.  Also felt panicky due to not being able to catch breath.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Chest pain, Dizziness, Fatigue, Feeling cold
Clinical narrative: Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21;  used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21;  used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21;  used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21;  used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Throat tightness
Clinical narrative: Patient initially had some dizziness and nausea. subsequently complained of SOB and throat swelling. Patient given EpiPen, Benadryl , solumedrol and oxygen. Transferred to the ER
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Dyspnoea, Nausea, Pharyngeal swelling
Clinical narrative: Patient initially had some dizziness and nausea. subsequently complained of SOB and throat swelling. Patient given EpiPen, Benadryl , solumedrol and oxygen. Transferred to the ER
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Dizziness, Dyspnoea, Electrocardiogram T wave inversion
Clinical narrative: Diagnosed Myopericarditis.  Fatigue, low-grade fever, malaise 3/4/21. Friday evening 3/5/21, patient started feeling palpitations, pulse was in the 170s, and subsequent left-sided scapular pain and chest pain.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Tachycardia, Troponin I increased
Clinical narrative: Diagnosed Myopericarditis.  Fatigue, low-grade fever, malaise 3/4/21. Friday evening 3/5/21, patient started feeling palpitations, pulse was in the 170s, and subsequent left-sided scapular pain and chest pain.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood lactic acid, C-reactive protein increased, Chest pain, Echocardiogram abnormal
Clinical narrative: Diagnosed Myopericarditis.  Fatigue, low-grade fever, malaise 3/4/21. Friday evening 3/5/21, patient started feeling palpitations, pulse was in the 170s, and subsequent left-sided scapular pain and chest pain.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction normal, Fatigue, Malaise, Myocarditis, Palpitations
Clinical narrative: Diagnosed Myopericarditis.  Fatigue, low-grade fever, malaise 3/4/21. Friday evening 3/5/21, patient started feeling palpitations, pulse was in the 170s, and subsequent left-sided scapular pain and chest pain.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericardial effusion, Pyrexia, Red blood cell sedimentation rate normal, Troponin increased
Clinical narrative: Diagnosed Myopericarditis.  Fatigue, low-grade fever, malaise 3/4/21. Friday evening 3/5/21, patient started feeling palpitations, pulse was in the 170s, and subsequent left-sided scapular pain and chest pain.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A group of females walked in together. I gave a shot to the first one and when she got up, another one walked up and sat down in the chair.  I verified full name and DOB.  Went over all the yes and no questions that were answered.  Asked her if she has ever had a allergic reaction to medications or immunizations.  She answered no. I gave the shot to her while the other female was waiting close by. I was told at the end of the day the patient was only 16 and should not have received the Moderna shot because of her age (16).  Patient suffered No adverse effects.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A group of females walked in together. I gave a shot to the first one and when she got up, another one walked up and sat down in the chair.  I verified full name and DOB.  Went over all the yes and no questions that were answered.  Asked her if she has ever had a allergic reaction to medications or immunizations.  She answered no. I gave the shot to her while the other female was waiting close by. I was told at the end of the day the patient was only 16 and should not have received the Moderna shot because of her age (16).  Patient suffered No adverse effects.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Chills, Dizziness, Dyspnoea
Clinical narrative: Symptoms of feeling of doom and injection site itching after vaccine was received. No throat swelling, urticaria, hives, no progression of symptoms. Vital signs WNL -HR-90's, BP-140/80, 02 Sat-99%. Persistent dizzy and chills. Transported for evaluation to ER.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Symptoms of feeling of doom and injection site itching after vaccine was received. No throat swelling, urticaria, hives, no progression of symptoms. Vital signs WNL -HR-90's, BP-140/80, 02 Sat-99%. Persistent dizzy and chills. Transported for evaluation to ER.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chills, Dizziness, Injection site pruritus
Clinical narrative: Symptoms of feeling of doom and injection site itching after vaccine was received. No throat swelling, urticaria, hives, no progression of symptoms. Vital signs WNL -HR-90's, BP-140/80, 02 Sat-99%. Persistent dizzy and chills. Transported for evaluation to ER.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE information.; Improperly stored vaccines administered to patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies,concurrent condition and concomitant medication were not provided.  Between August 2020-September 2020, the following temperature excursions occurred. The vaccines experienced: temperature excursion of 6.5 degree Fahrenheit for 45 minutes. It was confirmed that no precious temperature excursions occurred neither a digital data logger was involved. The temperature excursion was not reported before administering the vaccines to the patient.  On 05-AUG-2020, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin(rHA)) (M-M-R II)(0.5 milliliter, lot # S014430, expiration date 09-MAY-2021, strength and route were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot # S030243, expiration date 26-SEP-2021, strength and route were not provided), both for prophylaxis (Improper storage of product in use). No additional adverse event (AE) information provided.; Sender's Comments:  US-009507513-2102USA008312:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional adverse event; Three doses of ROTATEQ were administered following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1694405, expiration date 06-DEC-2021, at a dose of 2 milliliter once, orally for prophylaxis. The vaccine experienced a temperature excursion, however, at the time of reporting, the reporter was waiting for multiple excursion form to be returned so no details were provided. Digital data logger was not involved. No adverse event was reported.; Sender's Comments:  US-009507513-2102USA008801:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: product storage error; This spontaneous report was received from an office manager referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.       On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S018595, expiration date 17-JUN-2021, at a dose of 0.5 milliliter (ml) (route of administration and anatomical site of vaccination were not reported) and with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021824, expiration date 25-JUN-2021, at a dose of 0.5 ml (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported), both for prophylaxis.      Both vaccines were stored in a temperature of 54.0 degree Fahrenheit (°F) for 43 hours as recorded by a data logger. There was no previous temperature excursion reported.