chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough decreased, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) received via Pfizer . A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included pneumonia from 1995 and ongoing, in 1995 patient caught an unknown lung infection in the , it almost killed her. When brother found her, her lips were blue and he could not tell if she was breathing. She had cough up stuff ever since, every day. And a walk around the block would have her breathing really hard. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient reported that after her second covid shot all that changed, she still coughed up stuff in the morning, but it was less, white to clear not green and less of it, still very sticky. She could go for a walk with her husband then and not be winded, patient thanked. The clinical outcome for the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypophagia, Nausea, Syncope
Clinical narrative: fainting; severe headache; nauseous; he usually eats really good and would eat all day and now he does not eat too much; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 10Sep2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.   A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on 25Aug2021 at 14:20 (at the age of 13-years-old) at dose 2, single for COVID-19 immunization. Medical history included being insulin-resistant and circumcision on 2014 (7 years ago). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular 04Aug2021 (at the age of 13-years-old) at dose 1, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy or drug store. The reporter called regarding her 13-year-old twin sons who received their second dose of Pfizer COVID-19 vaccine on Wednesday, 25Aug2021. She mentioned that the patient has been having a severe headache from 25Aug2021 and has been nauseous from Aug2021. She wanted to know what she should do regarding these. She was concerned about how her son felt because he has had a headache for 2 days and he usually eats really good and would eat all day and now, he did not eat too much, on Aug2021. She was worried and wanted to know if it was dangerous to have the headaches for 2 days. She wanted to know if there were any complications since he was insulin resistant, if him being insulin resistant made the effects worse. She mentioned that she made the people aware of his condition before getting the vaccine. On 10Sep2021, patient's mother reported that both her sons experienced headache and fainting for a second, 2-3 times after the vaccine on 25Aug2021 at 15:00. She mentioned that it was a hard moment and they didn't want to go a hospital due to contagious COVID-19. The patient's mother didn't know if it was serious or not, but she was really worried. Therapeutic measures were taken as a result of fainting and headache and included treatment with TYLENOL. The outcome of the events fainting and headache was not recovered and unknown for all other events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119413 same reporter and drug; similar events; different patients
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Disturbance in attention, Extra dose administered, Hypoaesthesia, Illness
Clinical narrative: I got my 3rd dose; I got my 3rd dose; heel of my hand and my little finger felt numb/My left hand up to my little finger have numbness,; I feel achy; felt ill; I got a little bit sick; felt weak/I am feeling kind of weak. I just didn't feel really good; I just couldn't pay attention like I should; tingling and still bad/I have some numbness in my right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 75-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number FC3181), via an unspecified route of administration, administered in Arm Right on 23Aug2021 (at the age of 75-years-old) as DOSE 3, SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis and pulmonary fibrosis from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. Concomitant medications included atenolol, warfarin, rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient got his 3rd Pfizer COVID shot on Monday and the patient thinks he might have had a reaction but not sure he had a reaction at all. On an unspecified date, the patient got a little bit sick yesterday, felt ill, felt weak, felt like he needed to lay down, his hand this morning-heel of his hand and his little finger felt numb and didn't know if that could be a side effect or something. The numbness in the heel of his hand and it's never happened before but he don't think it was-it's probably the way he slept, he thought. His left hand up to his little finger have numbness, tingling and still bad; he was wondering and worried if it could be symptoms of something concerning. The patient was feeling kind of weak. He just didn't feel really good ok and again that morning when got up he have some numbness in right hand. It is like his hands are little numb and it was still kind of numb feeling. He just wanted to know if that could be a reaction from the corona virus shot. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Off label use, Pain, Paraesthesia
Clinical narrative: I got my 3rd dose; I got my 3rd dose; heel of my hand and my little finger felt numb/My left hand up to my little finger have numbness,; I feel achy; felt ill; I got a little bit sick; felt weak/I am feeling kind of weak. I just didn't feel really good; I just couldn't pay attention like I should; tingling and still bad/I have some numbness in my right hand; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 75-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number FC3181), via an unspecified route of administration, administered in Arm Right on 23Aug2021 (at the age of 75-years-old) as DOSE 3, SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis and pulmonary fibrosis from an unknown date and unknown if ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. Concomitant medications included atenolol, warfarin, rosuvastatin taken for an unspecified indication, start and stop date were not reported. The patient got his 3rd Pfizer COVID shot on Monday and the patient thinks he might have had a reaction but not sure he had a reaction at all. On an unspecified date, the patient got a little bit sick yesterday, felt ill, felt weak, felt like he needed to lay down, his hand this morning-heel of his hand and his little finger felt numb and didn't know if that could be a side effect or something. The numbness in the heel of his hand and it's never happened before but he don't think it was-it's probably the way he slept, he thought. His left hand up to his little finger have numbness, tingling and still bad; he was wondering and worried if it could be symptoms of something concerning. The patient was feeling kind of weak. He just didn't feel really good ok and again that morning when got up he have some numbness in right hand. It is like his hands are little numb and it was still kind of numb feeling. He just wanted to know if that could be a reaction from the corona virus shot. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Maternal exposure during pregnancy, Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Heart fluttering and racing; Heart fluttering and racing; Itching; 31 weeks  pregnant at the time of vaccination; Facial tingling on right side; lips and tongue still tingle occasionally but duration of tingling is less than 10 mins; This is a spontaneous report from a contactable other healthcare professional via a Pfizer sponsored program . A 34-year-old pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration in left arm on 06Aug2021 10:00 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The Last Menstrual Period was in Dec2020. The gestation period was 31 weeks. The expected due date of the delivery was on 28Sep2021. The patient's medical history included Bell's palsy. The patient had no known allergies. Concomitant medications included VITAMIN D [VITAMIN D NOS], ZINC, prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Aug2021, the patient experienced itching (within 10 minutes of vaccine). On 07Aug2021, the patient experienced heart fluttering and racing (initiation 1 day after, duration about 4 days). On an unspecified date, the patient experienced facial tingling on right side (lips and tongue still tingle occasionally but duration of tingling is less than 10 mins). Therapeutic measures were taken as a result of events and included treatment with claritin. Seriousness of the events were reported as non-serious. The outcome of the event (itching, heart fluttering and racing) was recovered on an unspecified date in Aug2021 and event (facial tingling on right side, lips and tongue still tingle occasionally) was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event heart fluttering and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Heart fluttering and racing; Heart fluttering and racing; Itching; 31 weeks  pregnant at the time of vaccination; Facial tingling on right side; lips and tongue still tingle occasionally but duration of tingling is less than 10 mins; This is a spontaneous report from a contactable other healthcare professional via a Pfizer sponsored program . A 34-year-old pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0196), via an unspecified route of administration in left arm on 06Aug2021 10:00 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was pregnant at the time of vaccination. The Last Menstrual Period was in Dec2020. The gestation period was 31 weeks. The expected due date of the delivery was on 28Sep2021. The patient's medical history included Bell's palsy. The patient had no known allergies. Concomitant medications included VITAMIN D [VITAMIN D NOS], ZINC, prenatal vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Aug2021, the patient experienced itching (within 10 minutes of vaccine). On 07Aug2021, the patient experienced heart fluttering and racing (initiation 1 day after, duration about 4 days). On an unspecified date, the patient experienced facial tingling on right side (lips and tongue still tingle occasionally but duration of tingling is less than 10 mins). Therapeutic measures were taken as a result of events and included treatment with claritin. Seriousness of the events were reported as non-serious. The outcome of the event (itching, heart fluttering and racing) was recovered on an unspecified date in Aug2021 and event (facial tingling on right side, lips and tongue still tingle occasionally) was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event heart fluttering and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Syncope, Vaccination site pain
Clinical narrative: fainting; headache; muscle pain; pain at the injection site; The initial safety information received was reporting only non-serious adverse drug reaction(s). Upon receipt of follow-up information on 10Sep2021, this case now contains serious adverse reaction. Information processed together.    This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients (twins). This is the first of two reports.     A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular on 25Aug2021 at 14:20 (at the age of 13-years-old) at dose 2, single for COVID-19 immunization. Medical history included being insulin-resistant and circumcision on 2014 (7 years from this report). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), intramuscular 04Aug2021 (at the age of 13-years-old) at dose 1, single for COVID-19 immunization. On 25Aug2021 15:00, the patient experienced headache and fainting; muscle pain and pain at the injection site on unspecified date in Aug2021. The patient's mother wanted to know if there were any complications since patient is insulin resistant and if the condition made the effects worse. She mentioned that she made the people aware of their conditions before getting the vaccine. The mother was worried with the patient having headache and fainting for seconds about 2-3 times after vaccine and don't want to go a hospital for contagious about COVID-19. Therapeutic measures were taken as a result of headache and fainting and included treatment with TYLENOL. The outcome of the events fainting and headache was not recovered; all other events was unknown.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116680 same reporter, suspect drug and events; different patient
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperaesthesia, Lymphadenopathy
Clinical narrative: Swollen lymph node in neck, slightlyleft of adam's apple. Size of small wafer; Cool to touch; Dose 1 and Dose 2 administered on 08Mar2021; Dose 1 and Dose 2 administered on 08Mar2021; This is a spontaneous report from a contactable other HCP (Nurse).   A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199) dose 1 via an unspecified route of administration, administered in left arm on 08Mar2021 09:30 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in right arm on 08Mar2021 as dose 2, single (at the age of 50-year-old) for covid-19 immunisation. Medical history included hypertension, hyperlipidemia, gout, depression and anxiety from an unknown date and unknown if ongoing. Patient received unknown other medication in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date of Apr2021, the patient experienced swollen lymph node in neck, slightly left of adam's apple, size of small wafer, cool to touch, no redness. Persistent since Apr2021-not reduced in size. No treatment was given for the events. At the time of reporting, outcome of the event Dose 1 and Dose 2 administered on 08Mar2021 was unknown and rest events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer or other non HCP.     A 16-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EP7533), dose 1 intramuscularly, administered in Arm Right on 08Jul2021 11:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient experienced UTI on 15Jul2021 with outcome of recovered. Therapeutic measures were Ciprofloxacin taken as a result of UTI (urinary tract infection).   Follow-Up (02Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea
Clinical narrative: intense and frequent migraines, getting them 1-2 times weekly; extremely fatigued; nauseous; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6207 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 02Apr2021 as dose 2, single (at the age of 33-years-old) for COVID-19 immunisation. The patient medical history included allergy to penicillin and migraine (had gotten 2-3 a year prior) (both from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EN6202 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 as dose 1, single (at the age of 33-years-old) for COVID-19 immunisation. Patient did not take any other vaccine in four weeks and had no other concomitant medications in two weeks prior to COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested with COVID-19, post vaccination. On 12Apr2021, patient had intense and frequent migraines within a few weeks on her final dose. Patient had gotten 2-3 a year prior but now was getting them 1-2 times weekly and was extremely fatigued and nauseous. Patient stated that now almost 4 months later they have started to decrease, and patient was getting 1-2 a month. Patient was unsure if they will go completely back to a rare occurrence at this point but at least seem to be slowing down. No therapeutic measures were taken as a result of events. The outcome of all the events was recovering.    Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body height decreased, Somnolence
Clinical narrative: Sleepy; Patient mentions she shrunk; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 24 or 29Apr2021 (Batch/Lot Number: EW0170) as dose 1, single and via an unspecified route of administration in left arm on 18May2021 at 10:00 (Batch/Lot Number: EW0185) as dose 2, single for COVID-19 immunisation at pharmacy. Medical history included knee replacement from an unknown date in Aug2018 to an unknown date in Aug2018, gallstones and hysterectomy from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. She spoke with the other agent regarding Detro LA; she will be having a new company for it; and will have to call back to apply with them in Dec2021. She just wanted to say thank you to all the Pfizer agents as everyone has been so nice. Patient mentions she shrunk. Pfizer COVID 19 vaccine; treatment first dose, 24 or 29Apr2021 at 10:00 in the left arm; EW0170. Second dose, 18May2021 at 10:00AM in the left arm; EW0185. She was not sick; but she was a little sleepy; she had no hurting; no nothing; on either one; and no nausea. Caller corrected information, she will get the third dose or booster for the Pfizer COVID 19 vaccine in Jan2022. The events were not resulted in visit of emergency room and physician office. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Swelling
Clinical narrative: swelling of abdominal lymph nodes; exhibiting same painful symptoms now (2 wks after 2nd shot); swelling under right arm in armpit after 2nd shot; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0172), via an unspecified route of administration in the right arm on 16Aug2021 16:15 (at the age of 12-years-old) as dose 2, single for COVID-19 immunization. Medical history included acid reflux from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534), via an unspecified route of administration in the right arm on 26Jul2021 16:15 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization and experienced swelling of abdominal lymph nodes. The first time (dose 1) he was in so much pain that was taken to ER believing it to be appendicitis. They did CT and confirmed mesenteric lymphadenitis. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient exhibited same (as after first dose) painful symptoms then (2 weeks after 2nd shot, Aug2021). He also had swelling under right arm in armpit after 2nd shot. Events resulted in emergency room and physician office visit. Patient received prescription drugs as treatment for the adverse events. The clinical outcome for the events was recovering for events except not recovered for event, exhibiting same painful symptoms now (2 weeks after 2nd shot).  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Swelling
Clinical narrative: Heart attack/sharp pain in my chest; breathing problems; sweeling; This is a spontaneous report from a contactable consumer or other non-HCP (patient) via Medical Information Team. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 19May2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did Pfizer vaccine on 19May2021 and three days after first dose did have like heart attack, sharp pain in chest breathing problem swelling on 22May2021. Went to emergency room. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac stress test, Chest discomfort, Depressed mood
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8736) via unknown route of administration in left arm on 21Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included lisinopril. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7533) via unknown route of administration at left arm on 31Mar2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced very high Blood Pressure/his blood pressure shot up incredibly high, almost crisis level, stated he felt off the next day and his chest did not feel right. Patient received both doses of the Pfizer Covid-19 Vaccine. Had experienced an Adverse Event after his second dose on 21Apr2021. He felt off the next day, morning on 22Apr2021, his chest did not feel right, checked his blood pressure he was evaluated for very high Blood. His blood pressure shot up incredibly high, almost crisis level. Stated he went to the doctor, and they did an EKG, they found abnormalities on the EKG so they referred him to a cardiologist where he had a stress test and an ultrasound of his heart, states those test results came back negative. He was treated with lisinopril 40 mg and within 3-4 days it returned to normal levels. Stated he was now taking 20m and it was fine. He clarified that he was on a low dose of lisinopril prior to the vaccines. He was monitoring BP heavily prior to vaccine and he was borderline low before getting the second dose. Patient was required to receive a Flu shot this year through his employer. He has never received a Flu shot. He asked if he had a reaction to the Pfizer COvid-19 Vaccine, would he react the same with a Flu shot and have there been reported of a reaction to the Flu shot after experiencing a reaction to the Pfizer COvid-19 Vaccine? Patient stated that, It is hard to believe that Pfizer hasn't tested the Covid-19 Vaccine with the Flu Vaccine. It is probably the most common vaccine that people get every year. The patient underwent lab tests and procedures which included blood pressure measurement: very high, cardiac stress test: negative, electrocardiogram: abnormal, ultrasound chest: negative. Therapeutic measures were taken as a result of events, lisinopril. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Ultrasound chest
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 42-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8736) via unknown route of administration in left arm on 21Apr2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included lisinopril. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EP7533) via unknown route of administration at left arm on 31Mar2021 (at the age of 42-year-old) as single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced very high Blood Pressure/his blood pressure shot up incredibly high, almost crisis level, stated he felt off the next day and his chest did not feel right. Patient received both doses of the Pfizer Covid-19 Vaccine. Had experienced an Adverse Event after his second dose on 21Apr2021. He felt off the next day, morning on 22Apr2021, his chest did not feel right, checked his blood pressure he was evaluated for very high Blood. His blood pressure shot up incredibly high, almost crisis level. Stated he went to the doctor, and they did an EKG, they found abnormalities on the EKG so they referred him to a cardiologist where he had a stress test and an ultrasound of his heart, states those test results came back negative. He was treated with lisinopril 40 mg and within 3-4 days it returned to normal levels. Stated he was now taking 20m and it was fine. He clarified that he was on a low dose of lisinopril prior to the vaccines. He was monitoring BP heavily prior to vaccine and he was borderline low before getting the second dose. Patient was required to receive a Flu shot this year through his employer. He has never received a Flu shot. He asked if he had a reaction to the Pfizer COvid-19 Vaccine, would he react the same with a Flu shot and have there been reported of a reaction to the Flu shot after experiencing a reaction to the Pfizer COvid-19 Vaccine? Patient stated that, It is hard to believe that Pfizer hasn't tested the Covid-19 Vaccine with the Flu Vaccine. It is probably the most common vaccine that people get every year. The patient underwent lab tests and procedures which included blood pressure measurement: very high, cardiac stress test: negative, electrocardiogram: abnormal, ultrasound chest: negative. Therapeutic measures were taken as a result of events, lisinopril. The outcome of the events was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: post menopausal/received a period in 09Aug2021 that lasted almost 20 days/It was heavy on days 2-3 but sporadic the remaining days; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 57-years-old via an unspecified route of administration, administered in Arm Right on 14Jul2021 13:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included high blood pressure and postmenopausal from unknown dates. Concomitant medications included loteprednol etabonate (LOTREL); simvastatin and famotidine all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunisation. The patient reported that she is a post menopausal 57 year old woman who has not had a period/menstruatal in over 4+ years. She received a period in 09Aug2021 that lasted almost 20 days! It was heavy on days 2-3 but sporadic (sparactic) the remaining days. Spotting reappeared in September. The patient had no covid before vaccination and was not tested after vaccination. The patient was recovering from the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Feeling abnormal, Feeling hot, Pharyngeal swelling
Clinical narrative: Anaphylactic reaction; she felt weird like her throat was itchy; She got blotches above her bra line up to her neck and face; scalp was hot; felt wonky/ felt weird; swelling of the face and throat; swelling of the face and throat; difficulty of breathing; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left at the age of 52 years old on 01Mar2021 (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunisation. Medical history included type 2 diabetes mellitus (diagnosed in early 20's and reports that diabetes is under control), hypertension (reports that hypertension is under control), early ventricular heart beat (considered benign), menopause, had gall bladder out a few years ago, and hysterectomy last summer. Concomitant medications included metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; diltiazem hydrochloride (DILTIAZEM XR) taken for hypertension from an unspecified start date and ongoing; estradiol (ESTRA [ESTRADIOL]) taken for menopause from Aug2020 and ongoing; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; methylcellulose (CITRUCEL) taken for supplementation therapy from an unspecified start date and ongoing. The patient previously took flu shot. On 01Mar2021, the patient had an anaphylactic reaction including difficulty breathing and swelling of the face and throat. Within 4 to 5 minutes after she received the shot, she felt weird like her throat was itchy. She got blotches above her bra line up to her neck and face. Her scalp was hot. She did not have any trouble breathing. She felt wonky. She beeped the horn. The person who came over to her car, told her that it was just a like a little reaction and to sit there until she felt better. The patient stated that she sat there for close to an hour. The blotches went away but she still felt strange and her throat was still itchy. She went home and called her sister who told her that it sounded like she had had an anaphylactic reaction. The patient stated that she is not allergic to anything. She took a couple of Benadryl and went to sleep. When she woke up late that night, she felt fine clarified as she has completely recovered from all of her symptoms. The outcome of the events was recovered on 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Swelling face, Throat irritation
Clinical narrative: Anaphylactic reaction; she felt weird like her throat was itchy; She got blotches above her bra line up to her neck and face; scalp was hot; felt wonky/ felt weird; swelling of the face and throat; swelling of the face and throat; difficulty of breathing; This is a spontaneous report from a contactable consumer. A 52-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in arm left at the age of 52 years old on 01Mar2021 (Batch/Lot Number: EN6203) as dose 1, single for covid-19 immunisation. Medical history included type 2 diabetes mellitus (diagnosed in early 20's and reports that diabetes is under control), hypertension (reports that hypertension is under control), early ventricular heart beat (considered benign), menopause, had gall bladder out a few years ago, and hysterectomy last summer. Concomitant medications included metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; diltiazem hydrochloride (DILTIAZEM XR) taken for hypertension from an unspecified start date and ongoing; estradiol (ESTRA [ESTRADIOL]) taken for menopause from Aug2020 and ongoing; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VIT D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; methylcellulose (CITRUCEL) taken for supplementation therapy from an unspecified start date and ongoing. The patient previously took flu shot. On 01Mar2021, the patient had an anaphylactic reaction including difficulty breathing and swelling of the face and throat. Within 4 to 5 minutes after she received the shot, she felt weird like her throat was itchy. She got blotches above her bra line up to her neck and face. Her scalp was hot. She did not have any trouble breathing. She felt wonky. She beeped the horn. The person who came over to her car, told her that it was just a like a little reaction and to sit there until she felt better. The patient stated that she sat there for close to an hour. The blotches went away but she still felt strange and her throat was still itchy. She went home and called her sister who told her that it sounded like she had had an anaphylactic reaction. The patient stated that she is not allergic to anything. She took a couple of Benadryl and went to sleep. When she woke up late that night, she felt fine clarified as she has completely recovered from all of her symptoms. The outcome of the events was recovered on 2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Disturbance in attention, Fatigue, Pain in extremity
Clinical narrative: occasional pain radiating from my heart down my left arm; occasional pain radiating from my heart down my left arm; tightness in my heart and all around my heart; a lot of fatigue; difficulty concentrating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EWO173), via an unspecified route of administration, administered in left arm on 16Aug2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunization. Medical history included BPES syndrome from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not pregnant, was not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks prior. Concomitant medications included vitamin C, garlic, lysine, calcium, and multivitamins, all taken for an unspecified indication, start and stop date were not reported. The patient previously took cipro, metronidazole, tetracycline and Macrobid, and experienced allergies. On 16Aug2021, the patient felt like she had tightness in her heart and all around her heart, occasional pain radiating from her heart down her left arm, and also had a lot of fatigue and difficulty concentrating. This had been happening since she received the vaccine. No treatment was received for the events. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, General physical condition abnormal
Clinical narrative: since receiving the covid 19 vaccine I have been unsuccessful through multiple providers and every FDA cleared neuromodulator on the market to have ANY effect whatsoever on me; physical appearance was diminishing; high level of depression; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on an unspecified date in 2021 (Lot Number: FA6780) as dose 1, single and on 14Jul2021 14:30 (lot number: FA7485) as dose 2, single for COVID-19 immunization. The patient also received botulinum toxin type a (BOTOX) and botulinum toxin type a haemagglutinin complex (DYSPORT); routes of administration, start and stop dates, and indications were unspecified. Medical history included type 1 diabetes; no known allergies. Prior to vaccination, the patient was not pregnant, was not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks. Concomitant medication included phentermine hydrochloride, topiramate (QSYMIA); insulin degludec (TRESIBA); insulin lispro (HUMALOG); drospirenone, ethinylestradiol betadex clathrate (YAZ); and vitamin D, all taken for an unspecified indication, start and stop date were not reported. Prior to receiving the COVID-19 vaccine, the patient reported that she had no issues with any type of neuromodulator taking effect (Botox Or Dysport) but since receiving the COVID-19- vaccine, from 26Jul2021 16:30, she had been unsuccessful through multiple providers and every FDA cleared neuromodulator on the market to have any effect on her whatsoever. If more thorough research had been performed and the known possibility of side effects been made aware to her, it would have weighed heavily on her decision to vaccinate. At the time of report, the patient was dealing with a high level of depression as her physical appearance was diminishing without much of a solution available besides expensive and invasive cosmetic surgery procedures. Not to mention the large amount of money and time that she already invested into trying different brands of neuromodulators plus providers. No one seemed to be able to offer any explanation, information or valid solutions. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment included multiple ineffective neuromodulator injections. Outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Investigation, Myocardial infarction, Palpitations, Paraesthesia
Clinical narrative: states she went to the ER, they said she had a heart attack, treated her with a heparin drip; heart palpitations; tingling in both hands; hands blue & purple in color; circular rash on right breast; she just feels funny and has not been right; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot number EW0181) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 49 years old) via an unspecified route of administration in the left arm on 28Jun2021 (Batch/Lot number EW0181) for covid-19 immunization. Two weeks after the second vaccine (Aug2021), she experienced tingling in both hands, hands are blue and purple in color, and heart palpitations. She was seen and treated in the ER, heart attack was ruled out (as reported). She feels funny and symptoms feel worst. The patient was asking if the symptoms may be related to the vaccine. The patient stated that she is starting to feel some symptoms from having the shot. Starting about 2 weeks after the second dose of the vaccine, she has had a lot of tingling in her right hand and her heart has been palpating, symptoms of heart attack (both were reported as worsened). She went to the ER and they said she had a heart attack, treated her with a heparin drip. She waited in the ER for a bed for 24 hours, got a bed to be admitted at 5 o'clock the next day but she left the hospital on her own accord. The insurance company said it was not a heart attack, she stated that her right hand is also a blue or purple color, and that she has circular rash on her right breast, looks like ring worm but it is not. The patient also stated that she just feels funny and has not been right since the vaccinations. The patient thinks the heart attack was maybe on 10Aug2021. The patient stated, "the insurance company said that the chemical came out of the heart with a heart attack, the chemical that starts with a T, states it went from a 9 to a 2. States it explains that in a heart attack that level would not go down like that". The patient wanted to know what other symptoms could be connected with this shot. The outcome of the events "hands blue & purple in color", "circular rash on right breast" and "she just feels funny and has not been right" was unknown while the other events were not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: states she went to the ER, they said she had a heart attack, treated her with a heparin drip; heart palpitations; tingling in both hands; hands blue & purple in color; circular rash on right breast; she just feels funny and has not been right; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot number EW0181) as dose 2, single for covid-19 immunisation. The patient has no medical history and concomitant medications. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (at the age of 49 years old) via an unspecified route of administration in the left arm on 28Jun2021 (Batch/Lot number EW0181) for covid-19 immunization. Two weeks after the second vaccine (Aug2021), she experienced tingling in both hands, hands are blue and purple in color, and heart palpitations. She was seen and treated in the ER, heart attack was ruled out (as reported). She feels funny and symptoms feel worst. The patient was asking if the symptoms may be related to the vaccine. The patient stated that she is starting to feel some symptoms from having the shot. Starting about 2 weeks after the second dose of the vaccine, she has had a lot of tingling in her right hand and her heart has been palpating, symptoms of heart attack (both were reported as worsened). She went to the ER and they said she had a heart attack, treated her with a heparin drip. She waited in the ER for a bed for 24 hours, got a bed to be admitted at 5 o'clock the next day but she left the hospital on her own accord. The insurance company said it was not a heart attack, she stated that her right hand is also a blue or purple color, and that she has circular rash on her right breast, looks like ring worm but it is not. The patient also stated that she just feels funny and has not been right since the vaccinations. The patient thinks the heart attack was maybe on 10Aug2021. The patient stated, "the insurance company said that the chemical came out of the heart with a heart attack, the chemical that starts with a T, states it went from a 9 to a 2. States it explains that in a heart attack that level would not go down like that". The patient wanted to know what other symptoms could be connected with this shot. The outcome of the events "hands blue & purple in color", "circular rash on right breast" and "she just feels funny and has not been right" was unknown while the other events were not recovered.