chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac stress test, Condition aggravated, Discomfort, Dyspnoea
Clinical narrative: shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Feeling abnormal, Heart rate increased, Injection site bruising, Oxygen saturation decreased
Clinical narrative: shortness of breath/when he gets up to do anything it goes to 80; shortness of breath/when he gets up to do anything it goes to 80; feels uncomfortable; blood pressure was elevated along with his heart rate; blood pressure was elevated along with his heart rate; It was given in the upper left arm, he also has a little bruise that is still there now; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3302) via an unspecified route of administration on 19Jan2021 15:30 at single dose in the upper left arm for COVID-19 immunisation. Medical history included back disorder and is waiting for back surgery, high blood pressure, and very likely diabetic. There were no concomitant medications. The patient received the vaccine on Tuesday afternoon, didn't notice anything until Saturday. On Saturday afternoon (23Jan2021) he had a couple severe/serious episodes of shortness of breath. He has no other symptoms. It was better on Sunday and is better today but he still feels uncomfortable on Jan2021. He bought a oximeter today and while at rest he is at 94 but when he gets up to do anything it goes to 80. He doesn't know if this has anything to do with the vaccine but wants to know where the shortness of breath is coming from, if it is a side effect. The vaccine was administered on 19Jan2021. He has been very inactive and is waiting for back surgery that has been put off due COVID, the hospital delayed the surgery. He is very likely diabetic and takes one pill a day for this. He also has high blood pressure but is controlled and normal range is 120/70. It was elevated along with his heart rate (on Jan2021) with the bad breathing or shortness of breath episodes. He is trying to get surgical clearance and so he had an echocardiogram the Monday before the vaccine was given and a stress test on the Thursday prior to that. It was given in the upper left arm, he also has a little bruise that is still there now (Jan2021). It was given about 3:30pm. No treatment received. Event outcome of shortness of breath was not recovered, of others was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Feeling abnormal, Headache, Injection site swelling
Clinical narrative: mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Pain, Pain in jaw
Clinical narrative: mental fogginess; headache; body ache; 99.5 temp; swollen lymph nodes; sore jaw (from lymph nodes); swollen lymph nodes; sore jaw (from lymph nodes); swollen injection site; severe tiredness; muscle pain; muscle stiffness (neck and upper extremities); This is a spontaneous report from a contactable consumer (patient herself). A 20-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL8982, expiration date was unknown), via an unspecified route of administration on the left arm on 25Jan2021 at 13:45 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the hospital. Relevant medical history included asthma and glucose intolerance; both from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included metformin and etonogestrel (NEXPLANON) for birth control. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in 4 weeks. The patient had no COVID-19 prior vaccination. On 25Jan2021 at 15:30, the patient experienced mental fogginess, headache, body ache, 99.5 temperature (temp), swollen lymph nodes; sore jaw (from lymph nodes), swollen injection site, severe tiredness, muscle pain, and muscle stiffness. The patient did not receive any treatment for the adverse events (AE). The patient was not tested for COVID-19 post vaccination (pending clarification). The patient was not recovered from all the events.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Disability, Disturbance in attention
Clinical narrative: Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3248), via an unspecified route of administration on 14Jan2021 15:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included COVID prior vaccination, high blood pressure and cholesterol. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced seem to have lapse in categorizing or focus on task on 14Jan2021 16:00, reported as disability. AE resulted in Emergency room/department or urgent care, Disability or permanent damage. No COVID tested post vaccination. AE treatment included emergency room call and treatment to left hand. Outcome of the event was not recovered.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Disturbance in attention, Feeling abnormal, Hand fracture, Memory impairment
Clinical narrative: Seem to have lapse in categorizing or focus on task; This is a spontaneous report from a contactable consumer (patient). This 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL3248), via an unspecified route of administration on 14Jan2021 15:00 at single dose on the left arm for COVID-19 immunization. The patient medical history included COVID prior vaccination, high blood pressure and cholesterol. No known allergies. The patient's concomitant medications were not reported. Facility type vaccine was hospital. No other vaccine received in four weeks. The patient experienced seem to have lapse in categorizing or focus on task on 14Jan2021 16:00, reported as disability. AE resulted in Emergency room/department or urgent care, Disability or permanent damage. No COVID tested post vaccination. AE treatment included emergency room call and treatment to left hand. Outcome of the event was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Crying, Fear, Lip swelling
Clinical narrative: 1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Paraesthesia oral, Pruritus
Clinical narrative: 1st dose: 01Jan2021/ 2nd dose: 25Jan2021; Angioedema and systemic anaphylaxis; Angioedema and systemic anaphylaxis; itchy face; Lips swollen; itchy mouth; tongue tingling; This is a spontaneous report from contactable Pharmacists. A 37-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN5318, Exp Date: 31May2021) intramuscular in right arm on 25Jan2021 15:45 at single dose for COVID-19 immunisation. She received the first dose on 01Jan2021 for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient experienced angioedema and systemic anaphylaxis on 25Jan2021, events resulted in emergency room/department or urgent care. The signs and symptoms of the anaphylactic reaction were described as itchy face and mouth 20-30 minutes after the vaccination, lips swollen, tongue tingling. Patient was scared and crying. Her lips started to swell. The patient require medical intervention, the patient was seen in the emergency department. It was unknown if the patient hospitalized, the patient was not admitted to an Intensive Care Unit. It was unknown it the patient received treatment. The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported. Events outcome was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Aphasia, Dyspnoea, Heart rate increased, Throat tightness
Clinical narrative: anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself.   A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Influenza, Loss of consciousness, Malaise
Clinical narrative: She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself.   A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pain
Clinical narrative: She felt same the way but worst; Lack of appetite; Passed out; Chills; Aches; Headache; Had no energy; Tired; Feeling sick; She was shaky, cold; She was shaky, cold; She had the flu; This is a spontaneous report from a contactable consumer reporting for herself.   A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL1284), via an unspecified route of administration left arm single dose on 18Jan2021 17:30 for covid-19 immunisation. Medical history was none. There were no concomitant medications. No other vaccine was received in four weeks.  The patient experienced passed out on 20Jan2021 14:00, tired on 18Jan2021 21:00, feeling sick on 18Jan2021 21:00, chills on 19Jan2021 09:00, aches on 19Jan2021 09:00, headache 19Jan2021 09:00, had no energy on 19Jan2021 09:00, lack of appetite on 22Jan2021 09:00, she was shaky in Jan2021, cold in Jan2021, she had the flu on Jan2021, she felt same the way but worst on an unspecified date. The outcome of the events was recovered on 22Jan2021
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Condition aggravated, Electrocardiogram normal
Clinical narrative: Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met."  And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Hypertension, Hypoaesthesia oral, Lip swelling
Clinical narrative: Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met."  And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nervousness, Palpitations, Tremor
Clinical narrative: Hands shaking and looked like she has Parkinson's; Blood pressure was 183 over something, which is high for her; Felt heart palpitations and pressure in her chest; Felt heart palpitations and pressure in her chest; Facial flushing, redness; Facial flushing, redness; Lips swollen and numb; Lips swollen and numb; Left arm stiffness; This is a spontaneous report from a contactable consumer reported for self. This 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 12:30 on Arm left at single dose (lot number: EL8982) for Protection from COVID. Medical history included diabetes, slightly elevated blood pressure, taking drops under her tongue for her 21 environmental allergies, clarified product as sublingual immunotherapy, had a reaction to some kind of steroid shot recently. Had bad hives from it. Believes the steroid shot started with "met."  And allergy to antibiotic. Concomitant drug included Sublingual immunotherapy, metformin at 500 mg and cetirizine hydrochloride (ZYRTEC). Past drug history included had Drug hypersensitivity to Neurontin, Detrol, Sulfur, and Neuropherntin. The patient experienced facial flushing, redness, and her lips felt like she had a Novocain shot on 22Jan2021. Her lips are still kind of numb. Can't feel her lips when she bites down on them. Believes reaction was fairly immediate. Sitting there for 15-20 min. Could feel a little facial flushing. Went home because (name withheld) is 45 minutes away from her house. By the time she got home was very flushed. Lips were getting more swollen and numb on 22Jan2021. Had an Epinephrine injection UPS Auto injector 0.3 mg, NDC: 49502 10201,Lot: 9FM783, Exp: Jun2021, Dose: injected one time in the middle of her right thigh and used it. Went to the ER. Had blood work and an EKG done. Was kept for five hours in ER. Had a chest x-ray. Blood pressure was 183 over something, which is high for her on 22Jan2021 that is controlled with medication. Experienced Hands shaking and looked like she has Parkinson's on 22Jan2021. Only lasted for a short time. Put on Prednisone for five days and told to see primary physician. Can't get into primary physician until Wednesday. Felt heart palpitations and pressure in her chest. Can't separate if it was the COVID-19 Vaccine or her nerves. She experienced Left arm stiffness on 22Jan2021. AEs require a visit to ER, was discharged from ER. Lab data on 22Jan2021 included Two sets of blood work separated by 3-4 hours: Unknown Results, Chest X-ray: Unknown Results, EKG: normal; on unknown date had a colonoscopy the day before the COVID-19 Vaccine: Unknown Results; Treatments were received for the events. Outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Dysaesthesia, Fatigue, Grip strength decreased
Clinical narrative: Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse.   A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021  at single dose via an unspecified route of administration in right deltoid  for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially.  At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Joint stiffness, Mobility decreased, Multiple sclerosis, Muscular weakness
Clinical narrative: Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse.   A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021  at single dose via an unspecified route of administration in right deltoid  for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially.  At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Bilateral arm weakness/dysesthesia; Bilateral arm weakness; Severe fatigue; Pretty bad swelling in the shoulder joint that she had the shot in; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; stiffness in her neck and joints, and in both of her hands, fingers, and elbows; her neck and joints, and in both of her hands, fingers, and elbows; stiffness in her neck and joints, and in both of her hands, fingers, and elbows.; She also had pain in both biceps; Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope; This is a spontaneous report from a contactable Nurse.   A 48-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021  at single dose via an unspecified route of administration in right deltoid  for COVID-19 immunization. Relevant medical history included Multiple sclerosis/Diagnosed in 1991 or 1992. She also had 2 previous reactions to a pneumonia vaccine two years in a row. About 30-45 minutes after she had fainting episodes. On 07Jan2021 within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope. On the same day she complained pretty bad swelling in the shoulder joint that she had the shot in, along with stiffness in her neck and joints, and in both of her hands, fingers, and elbows. She also had pain in both biceps. On 08Jan2021 the patient experienced severe fatigue and 10Jan2021 Bilateral arm weakness/dysesthesia. They were floppy noodles and she could hardly use them. She could not hold her purse in her hands. She has not had this issue before with her Multiple Sclerosis. This took about a full week and a half for that to go away. It was like weakness/dysesthesia. She talked to her doctor and he said he felt like the shot had exacerbated her Multiple Sclerosis potentially.  At the time of the reporting the patient was recovering from Bilateral arm weakness/dysesthesia. She recovered from fatigue on 09Jan2021, from 'Within 20 minutes she had a really weird sharp pain in her upper back the size of a cantelope' on 10Jan2021and from other reported events on 12Jan2021.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect BNT162B2 in triggering the onset of bilateral arm weakness/dysesthesia cannot be excluded. The events are confounded by underlying multiple sclerosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Dizziness, Feeling abnormal, Heart rate irregular
Clinical narrative: I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Feeling abnormal, Heart rate irregular, Shock symptom
Clinical narrative: I am having a feeling like I am in shock; I woke up last night not feeling right and this; Irregular heartbeat/Pulse 112/Pulse 108/went to 112; checked blood pressure, the lower number was high, upper number lower than what it usually is/130/96/then 110/78; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL3247) via an unspecified route of administration on 21Jan2021 10:00 am at single dose in left arm for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medication included ongoing atenolol for high blood pressure, ongoing amlodipine for high blood pressure, ongoing lisinopril for high blood pressure. The patient received the Pfizer COVID-19 vaccine at 10 am yesterday, her symptoms started last night and came on suddenly. She went and checked her blood pressure on 25Jan2021, the lower number was high, upper number lower than what it usually is, it was exactly: 130/96, Pulse 112, then 110/78 Pulse 108, after taking her medication. Her pulse went to 112, it does that when it gets irregular, it did get better after blood pressure medication atenolol. She woke up last night not feeling right and this morning, she was having a feeling like she was in shock. She developed an irregular heart beat last night on 25Jan2021. It is still bothering her. She had her first shot on Thursday of this past week. She is unsure if this is a side effect. Received the vaccine on 21Jan2021. She says it feels like it is right before you pass out. No treatment received. She is supposed to take blood pressure medication but she is being cautious right now. Her blood pressure medications are: Atenolol, Amlodipine, Lisinopril. She did not take them this morning, all have taken for years. Event outcome of irregular heartbeat was not recovered, while for others was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac fibrillation, Dry throat, Dysphonia, Fatigue, Heart rate increased
Clinical narrative: her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported.  The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Nausea, Sluggishness
Clinical narrative: her voice is still a little raspy; had a hard time speaking; fibrillation in her heart, and that felt rapid; fatigue/tired; sluggish; nausea; she was not feeling well; Dry throat; injection site pain; This is a spontaneous report from a contactable consumer reporting for self. This 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1280) on 24Jan2021 at 0.3 ml single by injection to left upper arm for COVID-19 immunisation (reported as works in assisted living). Medical history and concomitant medications were not reported.  The patient received the vaccine on 24Jan2021, Sunday morning, then 6 hours after started feeling injection site pain, it was really sore, but she packed it with ice that night and it was very slight now. She worked the following morning (25Jan2021), and was sluggish, fatigue, and tired. Also nausea (started in the afternoon), it was slight, she was not feeling well. She experienced fibrillation in her heart, and that felt rapid, that comes and goes. Also dry throat on 25Jan2021, not sore, just dry. Her voice was still a little raspy, not like it was yesterday, she had a hard time speaking, when talk and dry throat. The outcome of injection site pain was recovering, sluggish, fatigue/tired, nausea was not recovered, outcome of other events was unknown.