chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Rash macular, Rash papular, Rash pruritic, Urticaria
Clinical narrative: soreness in arm; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to sulfa, atrial fibrillation, CAD (coronary artery disease), DM type 2 (type 2 diabetes mellitus), implanted pacer/defibrillator, and gout. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included: apixaban (ELIQUIS,) propranolol hydrochloride (INDERAL), atorvastatin, glipizide, amiodarone, levothyroxine, furosemide sodium (LASIX), lisinopril, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced only soreness in arm following the first injection, on an unspecified date. The patient received his second dose on 23Feb2021. The outcome of the event was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021261868 Same patient/drug, different AE(2nd dose)
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the arm on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included: allergies to sulfa, atrial fibrillation, CAD (coronary artery disease), DM type 2 (type 2 diabetes mellitus), implanted pacer/defibrillator, and gout. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included: apixaban (ELIQUIS,) propranolol hydrochloride (INDERAL), atorvastatin, glipizide, amiodarone, levothyroxine, furosemide sodium (LASIX), lisinopril, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced only soreness in arm following the first injection, on an unspecified date. The patient received his second dose on 23Feb2021. The outcome of the event was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021261868 Same patient/drug, different AE(2nd dose)
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Patient stated she felt "itchy all over". Doctor on site was called. Zyrtec 10 mg sublingual administered. Itching improved after a few minutes. Patient was discharged.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Chest X-ray, Computerised tomogram head, Death, Dizziness
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Hypotonia, Pulse absent, Respiratory arrest
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Cardiac arrest, Cardiac failure congestive, Dyspnoea
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac failure congestive, Computerised tomogram, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging head, SARS-CoV-2 test, Syncope, X-ray
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arrhythmia, Body height, Cardiac arrest, Computerised tomogram, Echocardiogram
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Scan brain, Ultrasound scan, X-ray
Clinical narrative: shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation.  The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result  in 2021, echocardiogram: unknown result  in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result  in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021  and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Electrocardiogram normal, Throat tightness
Clinical narrative: Systemic: Throat felt itchy, but he never had any swelling.-Medium, Systemic: Shakiness-Mild, Additional Details: Pt waited 15 minutes, left.  Then felt throat tingling and tightness on his drive home.  Came back to the pharmacy, drank some water, we opted to give him loratadine instead of benadryl since he had a 2+ hour back home.  He stayed in the pharmacy for another hour and was able to drink water and eat a snack with no issues and wanted to continue on his trek home. He called us when he arrived home and was feeling fine.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal paraesthesia, Throat irritation, Throat tightness, Tremor
Clinical narrative: Systemic: Throat felt itchy, but he never had any swelling.-Medium, Systemic: Shakiness-Mild, Additional Details: Pt waited 15 minutes, left.  Then felt throat tingling and tightness on his drive home.  Came back to the pharmacy, drank some water, we opted to give him loratadine instead of benadryl since he had a 2+ hour back home.  He stayed in the pharmacy for another hour and was able to drink water and eat a snack with no issues and wanted to continue on his trek home. He called us when he arrived home and was feeling fine.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Paraesthesia, Throat irritation
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test positive, Arrhythmia, Blood test, Chest discomfort, Dizziness
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypertension, Tremor
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Allergy test, Anaphylactic reaction, Arrhythmia, Blood pressure measurement, Electrocardiogram
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Tremor
Clinical narrative: Two minutes after the vaccine I felt dizzy. My blood pressure when tested was very high. Forty five minutes when my blood pressure went down they told me to go home. When I reached the parking lot I was shaking uncontrollably, and I couldn't breathe. I was given Epinephrine and taken to the hospital. I was given Benadryl in the ambulance and when I got to the hospital I had arrhythmia. I was observed for three or four hours. Since that day my blood pressure is still high, and I feel pressure on my chest which comes and goes several times a day. I have seen my doctor for the blood pressure and chest tightness. I did not have high blood pressure before the vaccine. I have allergy  skin testing and it has confirmed that I am allergic to Polysorbate 80. It has been six weeks and I am still not recovered. Hospita
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Paraesthesia oral, Periorbital swelling, Swelling
Clinical narrative: Patient reports the vaccine around 1330 and about 30 minutes after she got it, she started feeling swelling in her lips and tongue. She then became short of breath and had difficulty breathing with swallowing. At the clinic she was given Benadryl, famotidine, and a dose of epinephrine. EMS was called and during transport to our hospital, she had difficulty swallowing and felt like she had some swelling in the throat again and received a second dose of IM epinephrine. Patient was then admitted to our hospital for observation overnight. At our hospital she was given Benadryl, and methylprednisolone and was then discharged home the following day.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Lip swelling, Pharyngeal swelling, Swollen tongue
Clinical narrative: Patient reports the vaccine around 1330 and about 30 minutes after she got it, she started feeling swelling in her lips and tongue. She then became short of breath and had difficulty breathing with swallowing. At the clinic she was given Benadryl, famotidine, and a dose of epinephrine. EMS was called and during transport to our hospital, she had difficulty swallowing and felt like she had some swelling in the throat again and received a second dose of IM epinephrine. Patient was then admitted to our hospital for observation overnight. At our hospital she was given Benadryl, and methylprednisolone and was then discharged home the following day.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809 and Expiration date was not reported), via unspecified route in left arm on 09Feb2021at single dose for COVID-19 immunization. Medical history included diabetes and overweight. Patient had an allergic reaction to medication. Clarified products as Bactrim and codeine. With Bactrim she had hives all over and went to ER. codeine made her do the exact same thing as she was now (stinging, burning and itching) and hadn't taken codeine or Bactrim for several years. She confirmed that she had no ndc/lot/exp for either codeine or Bactrim. The patient's concomitant medications were not reported (She takes so many medications). On 09Feb2021, four hours after the covid-19 vaccine, the patient experienced ongoing stinging, burning, and itching sensation on her scalp, face, and back. She states there is no visible rash, but these symptoms are consistent with her reaction to codeine. Have these symptoms been reported. Should she get her second dose that was due on 02Mar2021. It has been a full week. She called her doctor and the nurse asked him. Doctor didn't know if that was a listed side effect and should she get her second shot. Has been taking Benadryl (Wal-dryl Allergy HCi-25mg antihistamine, Exp: Jun2023, Formulation: 25mg capsules, provided: ORG11719008, 50844 and P120784), but that is not helping. Sometimes after taking Benadryl, it's better, but sometimes it will hit real hard again. Does not see very well. only took one capsule and tried not to take it over twice a day. She takes so many medications. Doesn't know what will mix with what. Therapeutic measures were taken as a result of adverse event. The outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Pruritus, Skin odour abnormal
Clinical narrative: ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809 and Expiration date was not reported), via unspecified route in left arm on 09Feb2021at single dose for COVID-19 immunization. Medical history included diabetes and overweight. Patient had an allergic reaction to medication. Clarified products as Bactrim and codeine. With Bactrim she had hives all over and went to ER. codeine made her do the exact same thing as she was now (stinging, burning and itching) and hadn't taken codeine or Bactrim for several years. She confirmed that she had no ndc/lot/exp for either codeine or Bactrim. The patient's concomitant medications were not reported (She takes so many medications). On 09Feb2021, four hours after the covid-19 vaccine, the patient experienced ongoing stinging, burning, and itching sensation on her scalp, face, and back. She states there is no visible rash, but these symptoms are consistent with her reaction to codeine. Have these symptoms been reported. Should she get her second dose that was due on 02Mar2021. It has been a full week. She called her doctor and the nurse asked him. Doctor didn't know if that was a listed side effect and should she get her second shot. Has been taking Benadryl (Wal-dryl Allergy HCi-25mg antihistamine, Exp: Jun2023, Formulation: 25mg capsules, provided: ORG11719008, 50844 and P120784), but that is not helping. Sometimes after taking Benadryl, it's better, but sometimes it will hit real hard again. Does not see very well. only took one capsule and tried not to take it over twice a day. She takes so many medications. Doesn't know what will mix with what. Therapeutic measures were taken as a result of adverse event. The outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Pain of skin, Pruritus, Skin burning sensation
Clinical narrative: ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; ongoing stinging, burning, and itching sensation on her scalp, face, and back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809 and Expiration date was not reported), via unspecified route in left arm on 09Feb2021at single dose for COVID-19 immunization. Medical history included diabetes and overweight. Patient had an allergic reaction to medication. Clarified products as Bactrim and codeine. With Bactrim she had hives all over and went to ER. codeine made her do the exact same thing as she was now (stinging, burning and itching) and hadn't taken codeine or Bactrim for several years. She confirmed that she had no ndc/lot/exp for either codeine or Bactrim. The patient's concomitant medications were not reported (She takes so many medications). On 09Feb2021, four hours after the covid-19 vaccine, the patient experienced ongoing stinging, burning, and itching sensation on her scalp, face, and back. She states there is no visible rash, but these symptoms are consistent with her reaction to codeine. Have these symptoms been reported. Should she get her second dose that was due on 02Mar2021. It has been a full week. She called her doctor and the nurse asked him. Doctor didn't know if that was a listed side effect and should she get her second shot. Has been taking Benadryl (Wal-dryl Allergy HCi-25mg antihistamine, Exp: Jun2023, Formulation: 25mg capsules, provided: ORG11719008, 50844 and P120784), but that is not helping. Sometimes after taking Benadryl, it's better, but sometimes it will hit real hard again. Does not see very well. only took one capsule and tried not to take it over twice a day. She takes so many medications. Doesn't know what will mix with what. Therapeutic measures were taken as a result of adverse event. The outcome of the events was not recovered.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: 11/28/2020 I wasgiven a Shringrix injection to my Left deltoid. I was advised that my Left arm may become sore. 11/30/2020 I noticed difficulty moving my left and right arms. Overthe next 3 days the difficulty moving and associated pain to shoulders neck, back, hips, handsand fingers. A call was placed every 6 hours for pain. After a week i converted to every 12 hours. On 28 Jan21 I felt less pain to my arms and back. 30 Jan21 I was getting dressed for work and realized my arms, necks, back and hips were no longer painful. My hands and fingers most days are stiff wit some pain.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: 11/28/2020 I wasgiven a Shringrix injection to my Left deltoid. I was advised that my Left arm may become sore. 11/30/2020 I noticed difficulty moving my left and right arms. Overthe next 3 days the difficulty moving and associated pain to shoulders neck, back, hips, handsand fingers. A call was placed every 6 hours for pain. After a week i converted to every 12 hours. On 28 Jan21 I felt less pain to my arms and back. 30 Jan21 I was getting dressed for work and realized my arms, necks, back and hips were no longer painful. My hands and fingers most days are stiff wit some pain.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Central nervous system lesion, Condition aggravated, Dysstasia, Finger deformity
Clinical narrative: Severe MS exacerbation requiring hospitalization and transfer to a long term SNF (was previously in Independent living facility)
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Magnetic resonance imaging, Progressive multiple sclerosis, X-ray
Clinical narrative: Severe MS exacerbation requiring hospitalization and transfer to a long term SNF (was previously in Independent living facility)
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Multiple sclerosis
Clinical narrative: Severe MS exacerbation requiring hospitalization and transfer to a long term SNF (was previously in Independent living facility)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: returned to her residence began complaining of arm pain, chills and body aches
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: returned to her residence began complaining of arm pain, chills and body aches
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My husband has been diagnosed with covid yesterday and has flu like symptoms; My husband has been diagnosed with covid yesterday and has flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated that we had the first vaccine 16Feb2021 and set for Tuesday, 09Mar2021 for the second one. My husband has been diagnosed with covid yesterday and has flu like symptoms (cough, sneezing, stuffy and no smell) on an unspecified date in 2021. Should he take the second dose next week. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Exposure to SARS-CoV-2
Clinical narrative: My husband has been diagnosed with covid yesterday and has flu like symptoms; My husband has been diagnosed with covid yesterday and has flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 16Feb2021 at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient stated that we had the first vaccine 16Feb2021 and set for Tuesday, 09Mar2021 for the second one. My husband has been diagnosed with covid yesterday and has flu like symptoms (cough, sneezing, stuffy and no smell) on an unspecified date in 2021. Should he take the second dose next week. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Pruritus
Clinical narrative: a sore reaction; short of breath; itching; This is a spontaneous report from a contactable consumer and from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and clopidogrel (CLOPIDOGREL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included stent placement from an unknown date. The patient's concomitant medications were not reported. The patient previously took plavix. It was reported that the patient experienced short of breath, itching and a sore reaction on an unspecified date in 2021. Reporter states he received the first dose of the Pfizer COVID vaccine on 28Jan2021. Three days later he started noticing he was becoming a little bit short of breath. His body was also itchy off and on. The itching lasts for about 45 minutes to an hour and then goes away. States he feels fine now. He is unsure if his reaction is coming from the vaccine or his medication. States he also started a new medication the same day he received the vaccine. He started the generic form of Plavix. States he had a stent placed a month before the vaccine and this resulted him in having to start this medication. The outcome of the event itching was recovering. Outcome of all the other events was unknown.   Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain, Pruritus
Clinical narrative: a sore reaction; short of breath; itching; This is a spontaneous report from a contactable consumer and from a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and clopidogrel (CLOPIDOGREL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included stent placement from an unknown date. The patient's concomitant medications were not reported. The patient previously took plavix. It was reported that the patient experienced short of breath, itching and a sore reaction on an unspecified date in 2021. Reporter states he received the first dose of the Pfizer COVID vaccine on 28Jan2021. Three days later he started noticing he was becoming a little bit short of breath. His body was also itchy off and on. The itching lasts for about 45 minutes to an hour and then goes away. States he feels fine now. He is unsure if his reaction is coming from the vaccine or his medication. States he also started a new medication the same day he received the vaccine. He started the generic form of Plavix. States he had a stent placed a month before the vaccine and this resulted him in having to start this medication. The outcome of the event itching was recovering. Outcome of all the other events was unknown.   Information on lot/batch number has been requested.