chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Nausea, Ophthalmological examination
Clinical narrative: eye infection; severe dehydration (6 pounds lost within 10 hours of the injection); severe dehydration (6 pounds lost within 10 hours of the injection); severe anxiety; panic attacks; high heart rate; chills; headaches; body aches; dizziness; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown), via an unspecified route of administration in left arm on 08Mar2021 11:30 (at the age of 45-year-old) as single dose for COVID-19 immunization at Other (Assisted Living Community). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW5318, and Expiration date: Unknown), via an unspecified route of administration in left arm on an unspecified date in Feb2021 14:00 as single dose for COVID-19 immunization. The patient previously took Erythromycin, Tetracycline, Cleocin, Bactrim and had allergies on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 08Mar2021, the patient experienced severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. She developed an eye infection for which she had to go to the doctor. The anxiety / panic continues. The patient had extreme fatigue for several weeks. Other symptoms lasted 48 hours. The events resulted in doctor or healthcare professional office/clinic visit. The patient reported that she went to eye doctor and got prescriptions (unspecified). The outcome of all events was reported as resolving.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Panic attack
Clinical narrative: eye infection; severe dehydration (6 pounds lost within 10 hours of the injection); severe dehydration (6 pounds lost within 10 hours of the injection); severe anxiety; panic attacks; high heart rate; chills; headaches; body aches; dizziness; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown), via an unspecified route of administration in left arm on 08Mar2021 11:30 (at the age of 45-year-old) as single dose for COVID-19 immunization at Other (Assisted Living Community). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW5318, and Expiration date: Unknown), via an unspecified route of administration in left arm on an unspecified date in Feb2021 14:00 as single dose for COVID-19 immunization. The patient previously took Erythromycin, Tetracycline, Cleocin, Bactrim and had allergies on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 08Mar2021, the patient experienced severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. She developed an eye infection for which she had to go to the doctor. The anxiety / panic continues. The patient had extreme fatigue for several weeks. Other symptoms lasted 48 hours. The events resulted in doctor or healthcare professional office/clinic visit. The patient reported that she went to eye doctor and got prescriptions (unspecified). The outcome of all events was reported as resolving.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Nausea, Pain
Clinical narrative: eye infection; severe dehydration (6 pounds lost within 10 hours of the injection); severe dehydration (6 pounds lost within 10 hours of the injection); severe anxiety; panic attacks; high heart rate; chills; headaches; body aches; dizziness; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown), via an unspecified route of administration in left arm on 08Mar2021 11:30 (at the age of 45-year-old) as single dose for COVID-19 immunization at Other (Assisted Living Community). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW5318, and Expiration date: Unknown), via an unspecified route of administration in left arm on an unspecified date in Feb2021 14:00 as single dose for COVID-19 immunization. The patient previously took Erythromycin, Tetracycline, Cleocin, Bactrim and had allergies on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 08Mar2021, the patient experienced severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. She developed an eye infection for which she had to go to the doctor. The anxiety / panic continues. The patient had extreme fatigue for several weeks. Other symptoms lasted 48 hours. The events resulted in doctor or healthcare professional office/clinic visit. The patient reported that she went to eye doctor and got prescriptions (unspecified). The outcome of all events was reported as resolving.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Panic attack, Weight decreased
Clinical narrative: eye infection; severe dehydration (6 pounds lost within 10 hours of the injection); severe dehydration (6 pounds lost within 10 hours of the injection); severe anxiety; panic attacks; high heart rate; chills; headaches; body aches; dizziness; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown), via an unspecified route of administration in left arm on 08Mar2021 11:30 (at the age of 45-year-old) as single dose for COVID-19 immunization at Other (Assisted Living Community). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW5318, and Expiration date: Unknown), via an unspecified route of administration in left arm on an unspecified date in Feb2021 14:00 as single dose for COVID-19 immunization. The patient previously took Erythromycin, Tetracycline, Cleocin, Bactrim and had allergies on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 08Mar2021, the patient experienced severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. She developed an eye infection for which she had to go to the doctor. The anxiety / panic continues. The patient had extreme fatigue for several weeks. Other symptoms lasted 48 hours. The events resulted in doctor or healthcare professional office/clinic visit. The patient reported that she went to eye doctor and got prescriptions (unspecified). The outcome of all events was reported as resolving.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anxiety, Cold sweat, Dizziness, Dyspnoea, Palpitations
Clinical narrative: eye infection; severe dehydration (6 pounds lost within 10 hours of the injection); severe dehydration (6 pounds lost within 10 hours of the injection); severe anxiety; panic attacks; high heart rate; chills; headaches; body aches; dizziness; nausea; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown), via an unspecified route of administration in left arm on 08Mar2021 11:30 (at the age of 45-year-old) as single dose for COVID-19 immunization at Other (Assisted Living Community). The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW5318, and Expiration date: Unknown), via an unspecified route of administration in left arm on an unspecified date in Feb2021 14:00 as single dose for COVID-19 immunization. The patient previously took Erythromycin, Tetracycline, Cleocin, Bactrim and had allergies on an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to vaccination. On 08Mar2021, the patient experienced severe anxiety / panic attacks, high heart rate, severe dehydration (6 pounds lost within 10 hours of the injection), chills, headaches, body aches, dizziness, nausea, extreme fatigue. She developed an eye infection for which she had to go to the doctor. The anxiety / panic continues. The patient had extreme fatigue for several weeks. Other symptoms lasted 48 hours. The events resulted in doctor or healthcare professional office/clinic visit. The patient reported that she went to eye doctor and got prescriptions (unspecified). The outcome of all events was reported as resolving.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac telemetry, Chest discomfort, Dyspepsia, Hyperhidrosis
Clinical narrative: difficulty breathing; Chest pressure; throat was tight; Elevated blood pressure (18/128); Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6200), via unspecified route of administration in the left arm, on 03Mar2021 at 10:30 AM (at the age of 47-year-old), as a 1st dose, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Yoli Alkalete (within 2 weeks of vaccination). Medical history included patient was allergic to medications, food, or other products. The patient age at vaccination was 47 Years and non-pregnant at the time of vaccination. The patient visited physician and emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 10:45 AM, the patient experienced chest pressure, nausea, throat was tight, elevated blood pressure (18/128), difficulty breathing. It was unknown if the patient received treatment for adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel (lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen therapy, Sensation of foreign body, Tachycardia
Clinical narrative: difficulty breathing; Chest pressure; throat was tight; Elevated blood pressure (18/128); Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6200), via unspecified route of administration in the left arm, on 03Mar2021 at 10:30 AM (at the age of 47-year-old), as a 1st dose, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Yoli Alkalete (within 2 weeks of vaccination). Medical history included patient was allergic to medications, food, or other products. The patient age at vaccination was 47 Years and non-pregnant at the time of vaccination. The patient visited physician and emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 10:45 AM, the patient experienced chest pressure, nausea, throat was tight, elevated blood pressure (18/128), difficulty breathing. It was unknown if the patient received treatment for adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel (lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Dyspnoea, Nausea
Clinical narrative: difficulty breathing; Chest pressure; throat was tight; Elevated blood pressure (18/128); Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6200), via unspecified route of administration in the left arm, on 03Mar2021 at 10:30 AM (at the age of 47-year-old), as a 1st dose, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Yoli Alkalete (within 2 weeks of vaccination). Medical history included patient was allergic to medications, food, or other products. The patient age at vaccination was 47 Years and non-pregnant at the time of vaccination. The patient visited physician and emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 10:45 AM, the patient experienced chest pressure, nausea, throat was tight, elevated blood pressure (18/128), difficulty breathing. It was unknown if the patient received treatment for adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel (lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: difficulty breathing; Chest pressure; throat was tight; Elevated blood pressure (18/128); Nausea; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6200), via unspecified route of administration in the left arm, on 03Mar2021 at 10:30 AM (at the age of 47-year-old), as a 1st dose, single for COVID-19 Immunisation. Medical history was not reported. Concomitant medications included Yoli Alkalete (within 2 weeks of vaccination). Medical history included patient was allergic to medications, food, or other products. The patient age at vaccination was 47 Years and non-pregnant at the time of vaccination. The patient visited physician and emergency room. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Mar2021 at 10:45 AM, the patient experienced chest pressure, nausea, throat was tight, elevated blood pressure (18/128), difficulty breathing. It was unknown if the patient received treatment for adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered with sequel (lasting effects).   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Hypoaesthesia, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Facial tingling; facial numbness on left side of face; numb lips; dry mouth; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: En6204), dose 1 via an unspecified route of administration, administered in Arm Left on 07Mar2021 at 12:00 (at the age of 33-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient's medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient previously took cipro (ciprofloxacin) and experienced drug hypersensitivity. There were no concomitant medications in two weeks.The patient did not received vaccine within 4 weeks prior to the suspect dose of vaccine. He did not have covid prior vaccination. On 08Mar2021 at 17:00, the patient experienced facial tingling, facial numbness on left side of face, numb lips and dry mouth. Patient did not receive any treatment for the events. He had not been tested for covid post vaccination. Outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Depressed mood, Dyspnoea, Throat tightness
Clinical narrative: Throat closed off. I could still breathe, but it was hard; I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice); I felt a bit strange; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:30 hours as dose 1, single (at the age of 44-years-old) for covid-19 immunisation. Medical history included some skin allergies, allergy to pollen and heartburn. Patient had no other vaccine in four weeks. Patient had no covid prior to vaccination. Concomitant medication(s) included estrogens conjugated (Premarin). Patient had not been covid tested post vaccination. On 03Mar2021 at 12:30 hours, within a minute of getting the vaccine, patient throat closed off. Patient could still breathe, but it was hard, also felt a strange sensation in her chest (this latter sensation she only remembered feeling twice), difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took her blood pressure, blood oxygen level, and listened to her lungs, heart, and throat. They said they sounded normal. After this, she waited at a parking lot for another 15- 20 minutes. Patient felt a bit strange, but she could breathe better. They did not inject the Epi pen. Patient had a doctor or other healthcare professional office/clinic visit for the events. The outcome for difficulty breathing was recovered on 03Mar2021 and recovered for rest of the events in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Auscultation, Blood pressure measurement, Chest discomfort, Dyspnoea, Feeling abnormal
Clinical narrative: Throat closed off. I could still breathe, but it was hard; I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice); I felt a bit strange; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:30 hours as dose 1, single (at the age of 44-years-old) for covid-19 immunisation. Medical history included some skin allergies, allergy to pollen and heartburn. Patient had no other vaccine in four weeks. Patient had no covid prior to vaccination. Concomitant medication(s) included estrogens conjugated (Premarin). Patient had not been covid tested post vaccination. On 03Mar2021 at 12:30 hours, within a minute of getting the vaccine, patient throat closed off. Patient could still breathe, but it was hard, also felt a strange sensation in her chest (this latter sensation she only remembered feeling twice), difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took her blood pressure, blood oxygen level, and listened to her lungs, heart, and throat. They said they sounded normal. After this, she waited at a parking lot for another 15- 20 minutes. Patient felt a bit strange, but she could breathe better. They did not inject the Epi pen. Patient had a doctor or other healthcare professional office/clinic visit for the events. The outcome for difficulty breathing was recovered on 03Mar2021 and recovered for rest of the events in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Throat tightness
Clinical narrative: Throat closed off. I could still breathe, but it was hard; I also felt a strange sensation in my chest (this latter sensation I only remember feeling twice); I felt a bit strange; Difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6198 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 at 12:30 hours as dose 1, single (at the age of 44-years-old) for covid-19 immunisation. Medical history included some skin allergies, allergy to pollen and heartburn. Patient had no other vaccine in four weeks. Patient had no covid prior to vaccination. Concomitant medication(s) included estrogens conjugated (Premarin). Patient had not been covid tested post vaccination. On 03Mar2021 at 12:30 hours, within a minute of getting the vaccine, patient throat closed off. Patient could still breathe, but it was hard, also felt a strange sensation in her chest (this latter sensation she only remembered feeling twice), difficulty breathing came and went for about 15-30 minutes. The EMS was called, and they took her blood pressure, blood oxygen level, and listened to her lungs, heart, and throat. They said they sounded normal. After this, she waited at a parking lot for another 15- 20 minutes. Patient felt a bit strange, but she could breathe better. They did not inject the Epi pen. Patient had a doctor or other healthcare professional office/clinic visit for the events. The outcome for difficulty breathing was recovered on 03Mar2021 and recovered for rest of the events in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness
Clinical narrative: Also had headaches for approximately two months but those have gone away for the most part; experience times where I feel off balance; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 at 15:00 (at the age of 62-years-old) and dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 (Lot Number: EL9266), both as single for COVID-19 immunisation. The patient did not had any medical history and known allergies. Concomitant medications included fluconazole. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 14:00, the patient experienced hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine. The onset was sudden and very abrupt. On 25Feb2021, the patient received the second vaccine and the condition continued. On an unspecified date, the patient "also had headaches for approximately two months but those have gone away for the most part" and "experience times where I feel off balance". The patient's hearing was so badly impacted that he had to get hearing aids for both ears. The adverse events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. The ear, nose and throat doctor prescribed prednisone. The outcome of event dizziness was unknown and was resolving for the rest of the events.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Dizziness, Headache, Tinnitus
Clinical narrative: Also had headaches for approximately two months but those have gone away for the most part; experience times where I feel off balance; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; Hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine on 03Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 at 15:00 (at the age of 62-years-old) and dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 (Lot Number: EL9266), both as single for COVID-19 immunisation. The patient did not had any medical history and known allergies. Concomitant medications included fluconazole. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Feb2021 at 14:00, the patient experienced hearing loss in both ears and tinnitus in both ears beginning approximately 10 days after first vaccine. The onset was sudden and very abrupt. On 25Feb2021, the patient received the second vaccine and the condition continued. On an unspecified date, the patient "also had headaches for approximately two months but those have gone away for the most part" and "experience times where I feel off balance". The patient's hearing was so badly impacted that he had to get hearing aids for both ears. The adverse events resulted in doctor or healthcare professional office/clinic visit and disability or permanent damage. The ear, nose and throat doctor prescribed prednisone. The outcome of event dizziness was unknown and was resolving for the rest of the events.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Hypertension, Sensation of foreign body, Tachycardia
Clinical narrative: Felt like there is a nut growing in her throat and her voice have change; Felt like there is a nut growing in her throat and her voice have change; Dizziness; Shortness of breath; She is so scared of getting it; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot number and expiry date unknown) via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, patient experienced a reaction and felt like there was a nut growing in her throat and her voice have change, and after that some symptoms came out as well like dizziness and shortness of breath. It was reported that the second dose was scheduled 3 weeks apart, but her appointment was cancelled and as of now patient have not received the second dose yet and it was more than 21 days already and she just wanted to know if she can still get it, but she was so scared of getting it. Patient still would like to get the vaccine even if it's more than 100 days apart. Patient asking what would happen and the risk of reaction for getting the 2nd dose. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Felt like there is a nut growing in her throat and her voice have change; Felt like there is a nut growing in her throat and her voice have change; Dizziness; Shortness of breath; She is so scared of getting it; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot number and expiry date unknown) via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, patient experienced a reaction and felt like there was a nut growing in her throat and her voice have change, and after that some symptoms came out as well like dizziness and shortness of breath. It was reported that the second dose was scheduled 3 weeks apart, but her appointment was cancelled and as of now patient have not received the second dose yet and it was more than 21 days already and she just wanted to know if she can still get it, but she was so scared of getting it. Patient still would like to get the vaccine even if it's more than 100 days apart. Patient asking what would happen and the risk of reaction for getting the 2nd dose. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Dyspnoea, Fear, Oropharyngeal discomfort
Clinical narrative: Felt like there is a nut growing in her throat and her voice have change; Felt like there is a nut growing in her throat and her voice have change; Dizziness; Shortness of breath; She is so scared of getting it; This is a spontaneous report from a contactable consumer (patient) via a Regulatory Authority. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; lot number and expiry date unknown) via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunisation. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in 2021, after receiving first dose of vaccination, patient experienced a reaction and felt like there was a nut growing in her throat and her voice have change, and after that some symptoms came out as well like dizziness and shortness of breath. It was reported that the second dose was scheduled 3 weeks apart, but her appointment was cancelled and as of now patient have not received the second dose yet and it was more than 21 days already and she just wanted to know if she can still get it, but she was so scared of getting it. Patient still would like to get the vaccine even if it's more than 100 days apart. Patient asking what would happen and the risk of reaction for getting the 2nd dose. The outcome of the events was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia oral, Lip swelling, Pharyngeal swelling, Pruritus, Sensation of foreign body
Clinical narrative: Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Peripheral swelling, Rash pruritic, Sensation of foreign body, Swelling of eyelid
Clinical narrative: Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Itchy rash; Hives over body; Fingers swelled; Eyelids swelled; lips swelled; Lump in throat; This is spontaneous report from contactable consumer, the patient. A 58-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 2613) via an unspecified route of administration in the left arm on 17Mar2021 at 13:30 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included lymphoma in 2012-13. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), Cholecalciferol (VITAMIN D3), Calcium pantothenate; Nicotinamide; Pyridoxine hydrochloride; riboflavin; Thiamine hydrochloride (B COMPLEX) and Esomeprazole magnesium (NEXIUM). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 07:30, the patient experienced, itchy rash, hives over body, fingers, eyelids and lips swelled and felt like a lump in her throat. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient took Benadryl as therapeutic treatment for the reported events. The clinical outcome of the event itchy rash, hives over body, fingers, eyelids and lips swelled and lump felt in her throat resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Flushing, Rash
Clinical narrative: pink cheeks, then red splotchy with bumps protruding back to hairline,pink neck; pink cheeks, then red splotchy with bumps protruding back to hairline,pink neck; I went to minor ER and prescribed steroids as of 28th is back to very pale pink with very slight rash and one more day of steroids.; Also, tremors became very bad and usually no effects in right hand or legs but legswobbled so that neighbor could see from across the street.; I could not eat with a spoon in right hand; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 16Mar2021 at 09:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation at other facility. The patient medical history included 2 heart murmurs, asthma, obese, slight essential tremor left hand. Concomitant medications included atorvastatin calcium (ATORVAST), hydrochloro, prantrop, and propranolol plus vitamin, received within2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tylox and experienced drug allergy. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Mar2021 at 12:00 (Wednesday) the patient experienced first pink cheeks, then red splotchy with bumps protruding back to hairline, pink neck, rash but no color on left side of neck. Patient became very oblivious by 48. Doctor prescribed her Benadryl with not effect so the 25Mar2021, she went to minor emergency room and prescribed with steroids as of 28Mar2021, she was back to very pale pink with very slight rash and one more day of steroids. Also, tremors became very bad and usually no effects in right hand or legs, but legs wobbled so that her neighbor could see from across the street, and she could not eat with a spoon in right hand. They seem to be calming down as of the 29Mar2021 but not back to original state yet. The adverse events resulted in emergency room/department or urgent care. Patient received benadryl for the events, then canceled and 5 days of steroids was prescribed as a treatment. The reporter considered the events as non-serious. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Rash, Rash macular, Skin discolouration, Tremor
Clinical narrative: pink cheeks, then red splotchy with bumps protruding back to hairline,pink neck; pink cheeks, then red splotchy with bumps protruding back to hairline,pink neck; I went to minor ER and prescribed steroids as of 28th is back to very pale pink with very slight rash and one more day of steroids.; Also, tremors became very bad and usually no effects in right hand or legs but legswobbled so that neighbor could see from across the street.; I could not eat with a spoon in right hand; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, administered in left arm on 16Mar2021 at 09:45 (at the age of 62-year-old) as a single dose for COVID-19 immunisation at other facility. The patient medical history included 2 heart murmurs, asthma, obese, slight essential tremor left hand. Concomitant medications included atorvastatin calcium (ATORVAST), hydrochloro, prantrop, and propranolol plus vitamin, received within2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tylox and experienced drug allergy. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Mar2021 at 12:00 (Wednesday) the patient experienced first pink cheeks, then red splotchy with bumps protruding back to hairline, pink neck, rash but no color on left side of neck. Patient became very oblivious by 48. Doctor prescribed her Benadryl with not effect so the 25Mar2021, she went to minor emergency room and prescribed with steroids as of 28Mar2021, she was back to very pale pink with very slight rash and one more day of steroids. Also, tremors became very bad and usually no effects in right hand or legs, but legs wobbled so that her neighbor could see from across the street, and she could not eat with a spoon in right hand. They seem to be calming down as of the 29Mar2021 but not back to original state yet. The adverse events resulted in emergency room/department or urgent care. Patient received benadryl for the events, then canceled and 5 days of steroids was prescribed as a treatment. The reporter considered the events as non-serious. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.