chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Cardiac discomfort, Chest pain, Dizziness, Echocardiogram
Clinical narrative: Angina like symptoms/Pressure and sharp pain around heart; may be she had got myocarditis or something; lightheaded/dizzy; Pressure and sharp pain around heart; Inflammatory markers higher than normal; chest pain just solely around heart; This is a spontaneous report from a contactable consumer(patient, not pregnant). This 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) at single dose via an unknown route in left arm on 07Apr2021 10:00 AM at 43-year-old for Covid-19 immunization. Medical history included known allergies with penicillin, dust, cats, dogs, horses. Patient weight was 203 (pounds). 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 vaccine, no any other medications the patient received within 2 weeks of vaccination. About 30 minutes after being vaccinated patient was very lightheaded/dizzy. The vaccination site was less than 7 minutes from home but she had to pull over and ask her husband to stay on phone with her. Angina like symptoms developed within an hour. Pressure and sharp pain around heart (only.) Advice nurse was called. Patient saw primary care facility, EKG was done. Patient was referred to Cardiologist, had two tests and ECHO done. Both test showed inflammatory markers higher than normal. It was further reported that what happened was right after she had the vaccination, she felt this sort of pressure in chest and it was only, they thought that may be she had got myocarditis or something. And it was like it lasted about 4 to 5 weeks and it was actually to the point where the doctor, cardiologist wasn't sure if he wanted to take the second vaccine. He wanted to wait until the results of echo came back and even though there was slight, patient did not know what they would call it vibration or abnormality very small. He notice, he thought she would be okay. She had ad chest pain just solely around heart, it wasn't anywhere else and just kind of this heavy sort of like pain, but it wasn't heart attack and she did not have any underlying health conditions over all, she was pretty healthy. Event onset date was 07Apr2021, the day that she took the shot. Pain around heart had dissipated. Outcome of "may be she had got myocarditis or something" was unknown. Outcome of the other events was resolving. Reporter seriousness for the report was unspecified. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Patient had both of vaccinations as of 05Jun2021 but she believed was an adverse reaction to the first.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Inflammatory marker increased, Laboratory test, Myocarditis
Clinical narrative: Angina like symptoms/Pressure and sharp pain around heart; may be she had got myocarditis or something; lightheaded/dizzy; Pressure and sharp pain around heart; Inflammatory markers higher than normal; chest pain just solely around heart; This is a spontaneous report from a contactable consumer(patient, not pregnant). This 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) at single dose via an unknown route in left arm on 07Apr2021 10:00 AM at 43-year-old for Covid-19 immunization. Medical history included known allergies with penicillin, dust, cats, dogs, horses. Patient weight was 203 (pounds). 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 vaccine, no any other medications the patient received within 2 weeks of vaccination. About 30 minutes after being vaccinated patient was very lightheaded/dizzy. The vaccination site was less than 7 minutes from home but she had to pull over and ask her husband to stay on phone with her. Angina like symptoms developed within an hour. Pressure and sharp pain around heart (only.) Advice nurse was called. Patient saw primary care facility, EKG was done. Patient was referred to Cardiologist, had two tests and ECHO done. Both test showed inflammatory markers higher than normal. It was further reported that what happened was right after she had the vaccination, she felt this sort of pressure in chest and it was only, they thought that may be she had got myocarditis or something. And it was like it lasted about 4 to 5 weeks and it was actually to the point where the doctor, cardiologist wasn't sure if he wanted to take the second vaccine. He wanted to wait until the results of echo came back and even though there was slight, patient did not know what they would call it vibration or abnormality very small. He notice, he thought she would be okay. She had ad chest pain just solely around heart, it wasn't anywhere else and just kind of this heavy sort of like pain, but it wasn't heart attack and she did not have any underlying health conditions over all, she was pretty healthy. Event onset date was 07Apr2021, the day that she took the shot. Pain around heart had dissipated. Outcome of "may be she had got myocarditis or something" was unknown. Outcome of the other events was resolving. Reporter seriousness for the report was unspecified. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Patient had both of vaccinations as of 05Jun2021 but she believed was an adverse reaction to the first.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Fatigue, Muscular weakness, Paranasal sinus hypersecretion
Clinical narrative: choking on phlegm; phlegm; Coughing; Serious sinus drainage; Fatigue; could not hold food down; This is a spontaneous report from a contactable consumer. This 21-year-old female consumer (patient) reported for herself:  Product detail: product=COVID 19, brand=Phizer Start Date/Time: [Phizer] 2Jun2021 03:30 PM Lot number=Bw0182 Lot unknown=False Dose number=1, Vaccine location=Left arm Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  Reported Event: Serious sinus drainage, coughing, fatigue (if I do fall asleep I will wake up choking on flem) can't hold food down  Prior to vaccination  Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Jun2021 If patient recovered: Not recovered If treatment AE: No If covid prior vaccination: Unknown If covid tested post vaccination: No  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough
Clinical narrative: choking on phlegm; phlegm; Coughing; Serious sinus drainage; Fatigue; could not hold food down; This is a spontaneous report from a contactable consumer. This 21-year-old female consumer (patient) reported for herself:  Product detail: product=COVID 19, brand=Phizer Start Date/Time: [Phizer] 2Jun2021 03:30 PM Lot number=Bw0182 Lot unknown=False Dose number=1, Vaccine location=Left arm Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No  Reported Event: Serious sinus drainage, coughing, fatigue (if I do fall asleep I will wake up choking on flem) can't hold food down  Prior to vaccination  Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 05Jun2021 If patient recovered: Not recovered If treatment AE: No If covid prior vaccination: Unknown If covid tested post vaccination: No  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 15:30 (Batch/Lot Number: ER8736) at the age of 16-years-old as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Clinic. Medical history included allergy to peanuts, tree nuts. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; dexmethylphenidate, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Lot number: W0158) on 13Apr2021 15:30 (at the age of 16-years-old) in Left arm for covid-19 immunisation. The patient experienced appendicitis (hospitalization, disability) on 30May2021 08:00. The patient was hospitalized for appendicitis for 2 days. Event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of appendicitis included Appendectomy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope
Clinical narrative: Hospitalization for cardiac syncope; Dizziness; Hypotension; This is a spontaneous report from a contactable physician. A non-pregnant 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on 30Apr2021 (at the age of 64-year-old) as single dose for COVID-19 immunization. Medical history included coronary artery disease (CAD) and hypertension (HTN). No known drug allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced hospitalization for cardiac syncope, dizziness, hypotension on 30Apr2021. The patient was hospitalized for all events for 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient received treatment for events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  Information about batch/lot number has been requested.; Sender's Comments: The events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association but consider also possible contributory effects from patient's medical history and/or concomitant medications. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Fatigue
Clinical narrative: Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (at the age of 40 years old, not pregnant at the time of vaccination) (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included migraine, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS-C), Gluten intolerance, Gulten allergy. Concomitant medications received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen; topiramate (TOPAMAX); linaclotide (LINZESS). The patient previously received the first dose of BNT162B2 (Pfizer, lot number: EJ686) in Left arm on 01Jan2021 (at the age of 40 years old) for Covid-19 immunization. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021, the patient experienced Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Beta blocker, labs, holter monitor, ekg, echo, str. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test Nasal Swab post vaccination with the result of Negative. The events were non-serious per the reporter. The outcome of the events was Recovered with lasting effects.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2  to the events of Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia cannot be excluded. The case will be reassessed once more information become 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Pyrexia, SARS-CoV-2 test, Tachycardia
Clinical narrative: Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (at the age of 40 years old, not pregnant at the time of vaccination) (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included migraine, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS-C), Gluten intolerance, Gulten allergy. Concomitant medications received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen; topiramate (TOPAMAX); linaclotide (LINZESS). The patient previously received the first dose of BNT162B2 (Pfizer, lot number: EJ686) in Left arm on 01Jan2021 (at the age of 40 years old) for Covid-19 immunization. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021, the patient experienced Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Beta blocker, labs, holter monitor, ekg, echo, str. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test Nasal Swab post vaccination with the result of Negative. The events were non-serious per the reporter. The outcome of the events was Recovered with lasting effects.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2  to the events of Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia cannot be excluded. The case will be reassessed once more information become 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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood pressure decreased, Blood pressure measurement, Cyanosis, Feeling cold
Clinical narrative: had to treat him with an ammonia thing to wake him up; could not see/lost vision at one time immediately afterwards; vision got all spotty; pupils got bigger than normal; Blue lips; white face; blood pressure really dropped; felt cold; This is a spontaneous report from a contactable consumer (father) reported for a son. A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm in muscle on 07May2021 17:00 (Batch/Lot number was not reported) at age of 19-year-old as single dose for covid-19 immunisation. There was no medical history.   No family medical history relevant to events.  There were no concomitant medications.  No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 07May2021, his vision got all spotty and he could not see, pupils got bigger than normal after the vaccine, had blue lips, white face, blood pressure really dropped, and he lost vision at one time immediately afterwards, and he felt cold. The time of onset of events was around 5pm. Events did not require a visit to emergency room or physician office. They stated they had given a thousand of this vaccine and this had never happened before. They stated they had never seen what happened to his son before. The patient did not get the second one yet and was told not to get it. All events happened a few minutes after the vaccine during the sitting/waiting period. About after 5 minutes the most after administration this all started and they had to treat him with an ammonia thing to wake him up. It's the one you break it under the nose and they were ready to do an Epi Pen also if needed. He improved within half an hour to 45 minutes of this. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Mentioned they all in his family did the Covid vaccine.  The patient improved and they advised him not to get the second one. It was Facility to tell them that. The pharmacist from there just gave them a call wanting to know why the son didn't return for the second dose and he explained what happened since this pharmacist did not know what happened that day. Patient did not see doctor or go to emergency room since his condition improved dramatically after about 45 minutes or so. Father kept asking patient how he felt or if there was need to see doctor and patient declined. The outcome of events was recovering.   Information about lot/batch number has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Mydriasis, Pallor, Visual impairment
Clinical narrative: had to treat him with an ammonia thing to wake him up; could not see/lost vision at one time immediately afterwards; vision got all spotty; pupils got bigger than normal; Blue lips; white face; blood pressure really dropped; felt cold; This is a spontaneous report from a contactable consumer (father) reported for a son. A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left upper arm in muscle on 07May2021 17:00 (Batch/Lot number was not reported) at age of 19-year-old as single dose for covid-19 immunisation. There was no medical history.   No family medical history relevant to events.  There were no concomitant medications.  No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 07May2021, his vision got all spotty and he could not see, pupils got bigger than normal after the vaccine, had blue lips, white face, blood pressure really dropped, and he lost vision at one time immediately afterwards, and he felt cold. The time of onset of events was around 5pm. Events did not require a visit to emergency room or physician office. They stated they had given a thousand of this vaccine and this had never happened before. They stated they had never seen what happened to his son before. The patient did not get the second one yet and was told not to get it. All events happened a few minutes after the vaccine during the sitting/waiting period. About after 5 minutes the most after administration this all started and they had to treat him with an ammonia thing to wake him up. It's the one you break it under the nose and they were ready to do an Epi Pen also if needed. He improved within half an hour to 45 minutes of this. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. Mentioned they all in his family did the Covid vaccine.  The patient improved and they advised him not to get the second one. It was Facility to tell them that. The pharmacist from there just gave them a call wanting to know why the son didn't return for the second dose and he explained what happened since this pharmacist did not know what happened that day. Patient did not see doctor or go to emergency room since his condition improved dramatically after about 45 minutes or so. Father kept asking patient how he felt or if there was need to see doctor and patient declined. The outcome of events was recovering.   Information about lot/batch number has been requested.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Bronchial pneumonia; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided), via an unspecified route of administration, on 25Apr2021 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, high blood pressure. Concomitant medications included lisinopril; amlodipine; insulin glargine (LANTUS); nefazodone hydrochloride (NOVO - NEFAZODONE-5HT2), it was reported "Novo was whatever it was when patient take his reading anywhere to 2 to 15". The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient experienced bronchial pneumonia (medically significant) in May2021. Patient got his second shot on 25Apr2021 and about may be not quite 2 weeks later patient had bronchial pneumonia that just about killed him and he was just wondering if that could be a possibility that he got that because other than that he was pretty healthy. No treatment received for event. The outcome of event was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal detachment, SARS-CoV-2 test
Clinical narrative: suddenly my vision in the left eye got blurry and I lost half of my visual field/was diagnosed with retinal detachment; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Mar2021 08:30 (Batch/Lot Number: ER8730) at the age of 45-years-old as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. On 13Apr2021 09:00 AM, suddenly her vision in the left eye got blurry and she lost half of her visual field. She was diagnosed with retinal detachment and had a surgery. She did not have any of the risk factors such as diabetes or hypertension. There's no other explanation for it and this condition has not been in her family history at all. No injuries, no accidents or any other cause. She suspected it could be a side effect given that this condition has been reported in autoimmune disorders (could be related to triggering the immune system), and/ or given that retinal detachment has been reported in Covid-19 as a rare symptom. She heard of three other cases of retinal detachment in her community, in the past couple of months. Given that it's a rare condition, coinciding with taking Pfizer vaccination was suspicious or at least worth some accurate research. Event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for 1 days and it is also resulted in disability. The patient underwent lab tests and procedures which included covid-19 virus test (Nasal Swab): negative   on 14Apr202. Therapeutic measures were taken as a result of retinal detachment included Surgery. The outcome of the event was Recovered/Resolved with Sequel. Since the vaccination, the patient was not been tested for COVID-19.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder disorder, Cystitis, Illness
Clinical narrative: Bladder problem; Cystitis; He has been really sick for 3 months after the second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 (Lot Number: ER8735) (at age of 48-year-old) as 2ND DOSE, SINGLE for covid-19 immunization. Patient took the first dose of vaccine on 15Mar2021 (Lot Number: EN6204) (at age of 48-year-old) for covid-19 immunization, no reactions until the second shot. The patient medical history was none. Family Medical History Relevant to AEs was also none. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks), there was no other vaccinations. The patient experienced bladder problem (hospitalization) in Apr2021 with outcome of not recovered, cystitis (hospitalization) in Apr2021 with outcome of unknown, He has been really sick for 3 months after the second dose (hospitalization) in 2021 with outcome of unknown. The second shot was on 03Apr2021. Bladder problem was two weeks after. It was 3 months back from this date. It was ongoing, his quality of life was gone. It was persisting. He sought out treatment from anywhere and everywhere he could. He has a bladder problem and he has several problems he didn't have before. It created what they call cystitis he thinks its IC for men. Cystitis stated the same time. It has worsened. Treatment was reported as "Yes, no just leave it at that". He has been really sick for 3 months after the second dose. The adverse events resulted in Emergency Room Visit and Physician Office Visit.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test, Uterine polyp
Clinical narrative: Uterine Polyps; received the first dose and the second dose of BNT162B2 on 24Feb2021; This is a spontaneous report from a contactable other HCP. A 31-year-old female other HCP (patient) reported that she received the first dose (at right arm, Lot No. EN5318) of BNT162B2 and the second dose (at left arm) of BNT162B2, both at single dose for COVID-19 immunisation on 24Feb2021 at 01:00 PM (as reported). Relevant history was unknown. Relevant concomitant drug was not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  List of any other medications the patient received within 2 weeks of vaccination: No. known_allergies: No. The patient experienced uterine polyps on 10May2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was hospitalized. Surgery was received as treatment. The outcome of event Uterine Polyps was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had Nasal Swab tested for COVID-19 on 03Jun2021 with negative result.; Sender's Comments: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the event uterine polyps  onset.  More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Thrombosis, Ultrasound scan
Clinical narrative: clots in her left calf; too afraid; This is a spontaneous report from a contactable consumer (patient).  A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right at the age of 72-year-old (as reported) on an unspecified date (Batch/Lot Number: ER8733) as single dose for COVID-19 immunisation.  Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization. Always got flu shot and so she got the shot to be safe. Caller stated she is calling about the COVID 19 vaccine. Caller stated she is just making this agent aware that after her first shot within 2 weeks she developed clots in her left calf. Caller stated she had went to the doctor for the clots and there was an ultrasound done and she was given blood thinners. Clots in her left calf: Caller stated she is not sure when this had developed or if it is still ongoing. Caller stated the doctor has not re-ultrasound her calf so she is not sure. Caller confirmed she is not sure of the outcome. COVID 19 vaccine: Caller stated on the vaccine card there is not a date of when she received the vaccine. Caller stated she could look at her calendar. Caller stated she is not sure when she received the first dose of the vaccine. Caller stated she did not get the second dose because she was too afraid. Vaccine Administered at Facility was No. No AE(s) require a visit to Emergency Room. Physician Office Visit for event clots in her left calf. Caller stated there is no history of blood clots. The patient underwent lab tests and procedures which included ultrasound scan: unknown results on unknown date.  Therapeutic measures were taken as a result of clots in her left calf. The outcome of events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Mastitis, Pain, Pyrexia
Clinical narrative: Body aches; I got mastitis three times following vaccination; Headache; Mild elevated temperature (99.5 degrees F)./ fever (102.5 degrees F); This is a spontaneous report received from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Apr2021 10:15 (Lot Number: EW0164) (at age of 34-year-old) as 1ST DOSE, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Right on 11May2021 10:30 (Lot Number: EW0183) (at age of 34-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital. Pregnancy at time of Vaccination was no. Medical history included postpartum, breastfeed two older children (Sep2015-Mar2018, and May2018-Feb2021). Patient had never knowingly gotten mastitis during those earlier times. No known allergies. Concomitant medications included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS), Ca/Mg citrate, both taken for an unspecified indication, start and stop date were not reported, in two weeks. Other medications in four weeks was no. Patient got mastitis three times following vaccination (she was breastfeeding a baby born 31Mar2021, prior to COVID vaccination). The first mastitis event (25Apr2021) included breast pain and redness (left breast, same side as vaccination shot), headache and mild elevated temperature (99.5 degrees F). The mastitis cleared within 48 hours with no antibiotics. The second mastitis event (10May2021) included breast pain and redness (left breast), fever (102.5 degrees F), body aches. The mastitis cleared within 36 hours with no antibiotics. The third mastitis event (17May2021) included breast pain and redness (left breast), headache, and mild elevated temperature (99.5 degrees F). The mastitis cleared within 36 hours with no antibiotics. Patient recovered from the first time mastitis in Apr2021, recovered from other events in 2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious. There was no covid prior vaccination, not tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021660641 same reporter/ product, diffrerent patient (baby case)
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: swelling of the bilateral antecubital fossa. Not hematoma, just edema; This is a spontaneous report from a contactable physician. A 74-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 59267-1000-1 and expiration date not provided), via intramuscular, in arm right, on 28Apr2021 11:15 (at the age of 74-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included polymyalgia rheumatica, monoclonal gammopathy of undetermined significance (MGUS). Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included prednisone; rosuvastatin calcium (CRESTOR). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 59267-1000-1 and expiration date not provided), via intramuscular, in right arm, on 07Apr2021 13:00 (at the age of 74-year-old, not pregnant), at single dose, for COVID-19 immunization. Other past drugs included iodine and experienced allergy. On 29Apr2021 (reported as "the next day"), the patient had swelling of the bilateral antecubital fossa. Not hematoma, just edema. Patient had underlying polymyalgia rheumatica and was on prednisone, but never had this happen before. Events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for events. The outcome of the events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Severe arthritic episode in left shoulder; This is a spontaneous report from a contactable consumer (patient).    A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 06May2021 13:30 (Batch/Lot Number: EW017q) at 42-years-old as single dose for covid-19 immunisation. Medical history included Arthritis, Tendinitis, Post-traumatic stress disorder (PTSD), Bipolar Depression, ADHD. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies included Soma, Trazadone. The patient was not pregnant. Historical vaccine included first dose of bnt162b2 (Lot number: ER8735) on 07Apr2021 13:00 at 42-years-old administered in Arm Right for covid-19 immunisation. The patient experienced severe arthritic episode in left shoulder (medically significant) on 10May2021 with outcome of not recovered. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 09Apr2021 12:00 (Batch/Lot Number: ER8729) at 64-years-old as single dose for covid-19 immunization. The patient was not pregnant. Known allergies: penicillin; mold/seasonal allergies. No other medical history. Concomitant medications included trazodone hydrochloride (TRAZODON) and ascorbic acid, calcium carbonate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin sodium phosphate, thiamine hydrochloride (MULTIVITAMIN [ASCORBIC ACID;CALCIUM CARBONATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE]). The day after her first shot on 10Apr2021 her upper Lip felt like it was swelling. For the next Two weeks her lips continued to feel Swollen but then would sting. This had continued. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 administered in Arm Right on 30Apr2021 11:30 am (Batch/Lot Number: EW0167) at 64-years-old as single dose for COVID-19 immunization. Last Wednesday 26May2021 her cheeks were very red and hot. In the past two weeks the rest of her face especially her checks and beneath her nose also feel Like they were swelling. This week her eyes were very red and Irritated. Above her upper lip was itchy. The strange lip feeling was very constant Whereas the hot cheeks and eyes Come in waves. When she lay down, there was a sensation in the back of her Left cheek in front of her ear. Adverse event start date was 10Apr2021 12:00 pm, AE resulted in [doctor or other healthcare Professional office/clinic visit, Emergency room/department or Urgent care]. Treatment received. No COVID-19 prior vaccination, no covid tested post vaccination. The outcome of the events was not recovered. The events were reported as non-serious.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021730515 same patient/ reporter/ product, different dose
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: I passed out in the bathroom; pulled the muscles in her back; This lead to uncontrollable muscle spasms in my back; dizziness; nausea/felt like I was going to throw up; I broke out into an all over clammy sweat and felt like I was going to throw up; body aches head to toe; low grade fever; This is a spontaneous report from a contactable other hcp (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 10:00 (Lot Number: EWO183) at the age of 57-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Known allergies included erythromyicine. Concomitant medication included fluoxetine (reported as floxitine) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2(lot number: EWD176) on 10May2021 05:00 PM at the age of 57-year-old, at arm left for covid-19 immunisation. On 01Jun2021, the patient experienced body aches head to toe, low grade fever. On 02Jun2021 08:00 AM, dizziness which lead to nausea which lead to a need to sit down immediately to avoid falling to the ground. Upon sitting, the patient broke out into an all over clammy sweat and felt like she was going to throw up. On the third time of getting up(03Jun2021), about 20 minutes after the first dizzy episode, she had to use the restroom. She passed out in the bathroom, woke up wedged between the toilet and the wall. The patient had no idea how long she was passed out. When she moved out of that position to stand up, she pulled the muscles in her back. This led to uncontrollable muscle spasms in her back. That morning (03Jun2021) Advice nurse directed her to the Urgent care due to passing out. She compromised with her doctor for lab work: blood and Urine, and EKG and muscle relaxer medication. 3 hours later, arriving home at 3:30 she took the medications and went to sleep. The muscle relaxer significantly reduced her pain. The adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included pain medications and lab results all showed normal levels. The patient had no covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the event pass out cannot be excluded completely. The case will be reassessed once more information become 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: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in right leg; This is a spontaneous report from a Non-contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Apr2021 (Batch/Lot number was not reported) at the age of 55-year-old as single dose for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medication included etodolac taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots in right leg on 23Apr2021 with outcome of recovered with sequelae on an unknow date. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included apixaban (ELIQUIS). Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Headache, Lymphadenitis
Clinical narrative: Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed in her chest and head; Feeling pressed in her chest and head; Weak muscles; Lymph nodes were inflamed on her neck; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20May2021 at 17:00, at the age of 45 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Past drug hisory included amoxicillin sodium/clavulanate potassium (AUGMENTIN) and sulpha.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the had never been patient diagnosed with COVID-19. The patient reported feeling really really weak, having dizziness, and feeling like she was going to faint many times a day. She was feeling pressed in her chest and head, and weak muscles, lymph nodes were inflamated on her neck, for 20 days from the vaccination. The onset date of all events was reported as 20May2021 at 17:30. Due to the events the patient visited her doctor and emergency room. She was treated with celecoxib (CELEBRA) and arginina aspartate (SRGENOR FORTE). A polymerase chain reaction/nasal swab for COVID-19 done on 01Jun2021 turned negative. The patient had not recovered from the above mentioned events.   Follow-up actions are needed. Further information has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Presyncope, SARS-CoV-2 test
Clinical narrative: Feeling like she was going to faint many times a day; Really really weak; Dizziness; Feeling pressed in her chest and head; Feeling pressed in her chest and head; Weak muscles; Lymph nodes were inflamed on her neck; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 20May2021 at 17:00, at the age of 45 years old, as 1st single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Past drug hisory included amoxicillin sodium/clavulanate potassium (AUGMENTIN) and sulpha.  The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the had never been patient diagnosed with COVID-19. The patient reported feeling really really weak, having dizziness, and feeling like she was going to faint many times a day. She was feeling pressed in her chest and head, and weak muscles, lymph nodes were inflamated on her neck, for 20 days from the vaccination. The onset date of all events was reported as 20May2021 at 17:30. Due to the events the patient visited her doctor and emergency room. She was treated with celecoxib (CELEBRA) and arginina aspartate (SRGENOR FORTE). A polymerase chain reaction/nasal swab for COVID-19 done on 01Jun2021 turned negative. The patient had not recovered from the above mentioned events.   Follow-up actions are needed. Further information has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Hot flush, SARS-CoV-2 test
Clinical narrative: Since getting my first shot on April 9, I have been having hot flashes, mostly and night; have not menstruated at all; This is a spontaneous report from a non contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) at the age of 48-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Medical history included ongoing pre-menopausal. The patient had no known allergies. Other medical history reported as none. Concomitant medication included mometasone furoate (NASONEX); fexofenadine hydrochloride (ALLEGRA); both taken for an unspecified indication, start and stop date were not reported. Since getting her first shot on 09Apr2021, the patient had been having hot flashes, mostly and night, and had not menstruated at all. Although she was pre-menopausal, she did not have these issues before being vaccinated. Adverse events start date was Apr2021. No treatment received for the events. The outcome of the events was not recovered. Events reported as non-serious. The patient had no Covid prior vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 30Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.