chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Underdose
Clinical narrative: bleed a lot; saw that a lot of liquid came out/ worried he didn't get the full dose; This is a spontaneous report received from a contactable pharmacist. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said he got the Pfizer vaccine 2nd dose, the pharmacist from there didn't help him. Patient stated, "he bleed a lot and saw that a lot of liquid came out. He was worried he didn't get the full dose." Pharmacist asked if there was any guidance. Outcome of events was unknown.; Sender's Comments: Based solely on chronological connection to the vaccine causality between event bleeding and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The case will be reevaluated should additional 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, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Laboratory test, SARS-CoV-2 test, Streptococcal infection
Clinical narrative: she also tested positive for Covid; she also tested positive for Covid; Streptococcus infection; This is a spontaneous report from Medical Information. A non-contactable consumer (patient herself) reported that a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 26Apr2021, she tested positive for Streptococcus infection and was prescribed with antibiotics. Later that day, she also tested positive for Covid. She said she rescheduled her 2nd dose on 04May2021. Patient said her quarantine period ends on 03May2021, so she wants to know if she can still get the 2nd dose on 4May2021 even if her quarantine period just ended or if she should reschedule it on a later date. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that this patient who is a physician, experienced blood clot on an unspecified date. The outcome of the event was unknown.  Information on batch number has been requested
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous
Clinical narrative: Miscarriage; This is a spontaneous report from a contactable consumer (patient herself). A 30-year-old female patient. A 30-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right deltoid on 14Apr2021 (Batch/Lot Number: Ew0162) as 2nd dose, single for COVID-19 immunisation. Patient had no relevant medical history. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS) received within 2 weeks of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She received an unspecified vaccine on 14Apr2021 (same date) in right arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced miscarriage on 27Apr2021. At 6 weeks there was a heartbeat detected. Patient received her second dose and at 8 weeks there was no heartbeat. Abortion pill was reported as treatment. Event result in Doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Outcome of event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Is currently taking Ampicillian for a urinary tract infaction; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose via an unspecified route of administration on 08Apr2021 for covid-19 immunization.The patient's medical history and concomitant medications were not reported. The patient is currently taking ampicillian for a urinary tract infection on an unspecified date. The patient is scheduled to receive 2nd BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 29Apr2021. Therapeutic measures were taken as a result of is currently taking ampicillian for a urinary tract infection. The outcome of urinary tract infection was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypertension
Clinical narrative: 3-4 weeks after the 2nd dose experienced intermittent  atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 15:00 (Batch/Lot Number: EN6200) as 2ND DOSE, SINGLE for covid-19 immunisation. No pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included Hypothyroid. No known drug allergies. Concomitant medication included thyroid (ARMOUR THYROID) 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. Historical vaccine included BNT162B2 for COVID-19 Immunization [{product=COVID 19, brand=Pfizer, lot_number=EL9262, lot_unknown=False, administration_date=08FEB2021, administration_time=03:00 PM, vaccine_location=Right arm, dose_number=1}. Prior to vaccination, the patient was not diagnosed with COVID-19. Adverse_event was reported as 3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure. Adverse event start date: 29MAR2021, adverse event start time: 07:30 PM. Event treatment included telemetry monitor and 2 High BP Meds. Events resulted in: Doctor or other healthcare professional office/clinic visit. Event outcome was not recovered. The case was reported as Serious: No. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Atrial fibrillation,uncontrolled hypertension. The case will be reassessed once new information is 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
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Investigation, Myocardial necrosis marker, Myocardial necrosis marker increased
Clinical narrative: chest pains; with extremely high cardiac enzyme levels; This is a spontaneous report from a Pfizer-sponsored program,  from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 15Apr2021, the patient began having chest pains and was admitted to the hospital with extremely high cardiac enzyme levels. They could find nothing wrong with heart and was discharged the next day. The patient was hospitalized from 15Apr2021 to 16Apr2021. Outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Seizure
Clinical narrative: seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown  Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, CSF test abnormal, Computerised tomogram, Hypoaesthesia, Inflammation
Clinical narrative: seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown  Information on Lot/Batch number was available. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Paraesthesia
Clinical narrative: seizure; Stroke like event; This is a spontaneous report received from a contactable consumer (Patient) reporting for himself. A 50-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 29Mar2021 01:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced seizure and stroke like event on 22Apr2021 at 11:00. The patient was hospitalized for seizure and stroke like event for 5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Apr2021. Outcome of the events was unknown  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: my uncle had a heart attack a week after getting the vaccine; This is a spontaneous report from a contactable consumer (patient's niece). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her uncle had a heart attack a week after getting the vaccine on an unspecified date with outcome of unknown.  Information on batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19 virus; tested positive for Covid 19 virus; feeling under the weather/feel bad; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 as single dose, second dose via an unspecified route of administration on 20Apr2021 as single dose for covid-19 immunisation. Medical history included seasonal allergies. The patient's concomitant medications were not reported. The patient had received both doses of his Covid 19 vaccine, first dose was 30Mar2021, second dose was about one week ago on 20Apr2021. He was feeling a little under the weather when he received the second vaccine on 20Apr2021 but he had seasonal allergies so he thought that was what he was experiencing. His temperature was taken at the Covid 19 vaccine clinic and he was able to receive his second vaccine. He continued to feel bad and was tested for the Covid 19 virus. He got the results back today, 27Apr2021, and was positive for the Covid 19 virus. That means he had the Covid 19 virus when he received his second Covid 19 vaccine. He was asking what happens if he's already infected with the Covid 19 virus when he receives his Covid 19 vaccine? Is there a reason if he's asymptomatic with the Covid 19 virus and gets the Covid 19 vaccine, does it matter or does he have to get another Covid 19 vaccine? He started having side effects then decided to take a covid test on Sunday (25Apr2021) and positive. He wanted to know if he will have to take another covid vaccine since he tested positive after receiving his second covid vaccine. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Pneumonia, SARS-CoV-2 test
Clinical narrative: diagnosed with Pneumonia; sick; tested positive for the COVID19 virus; tested positive for the COVID19 virus; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient got sick and had been hospitalized and had been diagnosed with Pneumonia. Also, reported patient ended up in the hospital because he got pneumonia. The patient tested positive for the COVID19 virus. The events outcome was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Skin cancer, Vasculitis
Clinical narrative: having Skin Cancer removed; About a week ago, started experiencing a lot of pain from a vasculitis flare up.; a lot of pain from a vasculitis flare up/a lot of pain in various parts of the body; This is a spontaneous report from the Pfizer Sponsor Program. A contactable consumer (patient's daughter) reported that a 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. Medical history included arthritis (had pain sin those areas during cold weather), 2 autoimmune diseases, surgery and shoulder joint pain. The patient's concomitant medications were not reported. Clinical course: patient started experiencing a lot of pain from a vasculitis flare up. It was as if it just happened and was having a lot of pain in various parts of the body in Apr2021. Patient was actually in the care of her vasculitis doctor because she was having skin cancer removed by him. Patient had glasses. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Thrombosis, Ultrasound scan
Clinical narrative: two blood clots in his right calf; It is painful; This is a spontaneous report from a contactable nurse. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in arm left at 10 am on 16Mar2021 (Batch/Lot number was not reported) as 1st dose, single; dose 2 via an unspecified route of administration, administered in arm left at 10 am on 08Apr2021 (Batch/Lot number was not reported) as 2nd dose, single, both for covid-19 immunisation. Medical history included ongoing varicose vein (for years, barely noticeable). No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations received within 4 weeks. The patient's concomitant medications were not reported. The patient experienced two blood clots in his right calf on 27Apr2021, it is painful. The event 'two blood clots in his right calf' was reported as serious and seriousness criteria were medically significant and disability. He said it is better today once he started apixaban (ELIQUIS). He did not know if that was physical or mental. The adverse event required a visit to physician office. The patient underwent lab tests and procedures which included sonogram on leg: unknown results. The outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Myalgia, Paraesthesia
Clinical narrative: Severe pain to muscle and joint; Severe pain to muscle and joint; tingling from shoulder blade to wrist; unable to drive or work; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 09:00 at the age of 64 years old (Lot Number: Er8735) as 1st dose, single for covid-19 immunisation. Medical history was none. Known_allergies was no. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered in the Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 00:15, the patient experienced Severe pain to muscle and joint, tingling from shoulder blade to wrist never went away x 4 weeks unable to extend arm unable to drive or work. The adverse events result in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Treatment received for the adverse events included Ongoing dr neurologist neurontin pain medicine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Malaise, Pain in extremity
Clinical narrative: extreme fatigue; malaise/feel sick; the bottoms of my feet hurt so it's hard to walk; the bottoms of my feet hurt so it's hard to walk; This is a spontaneous report from a contactable other hcp (Patient). A 49-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:15 (Lot Number: er8733) as single dose for covid-19 immunisation at the age of 49-year-old. The patient was not pregnant at time of vaccination. Medical history included herniated disc (l5-s1) and back pain from an unknown date. No known allergies. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced extreme fatigue and malaise/feel sick, the bottoms of feet hurt so it's hard to walk on 28Mar2021 with outcome of not recovered. The events were considered serious as disability. The events resulted in Doctor or other healthcare professional office/clinic visit.  The clinical course was reported as follows: I am having extreme fatigue and malaise. Prior to receiving the vaccine I had NO health issue other than back pain, but now I have extreme fatigue, the bottoms of my feet hurt so it's hard to walk, (and I'm fit) and I feel sick ALL OF THE TIME.  Follow up needed, further information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: About 3 weeks after second does the person tested positive for Covid; About 3 weeks after second does the person tested positive for Covid; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 3 weeks after second does the patient tested positive for covid. The adverse events result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events included monoclonal antibodies. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Dizziness, Fall
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Herpes zoster, Hyperhidrosis
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vomiting
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood pressure measurement, Cold sweat, Fatigue, Hypotension
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Salivary hypersecretion
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hyperhidrosis, Hypotension
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure decreased, Cold sweat, Hypoaesthesia
Clinical narrative: Shingles; blood pressure turned dropping/107/70; Tingling; Throwing up; since of that all he had anaphylactic reaction because he is allergic to Penicillin; his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side; cold and sweaty; cold and sweaty; Headache; Dizziness; he did "fall on the ground"; "creepy"; This is a spontaneous report from a contactable consumer (patient's fiance). A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: EN6206), via an unspecified route of administration, administered in the left arm on 13Mar2021, single for the prevention of corona virus. Medical history included high blood pressure and allergy to penicillin both from an unknown date and unknown if ongoing. The patient's fiance and the patient took their first Pfizer Covid shot on 13March2021 and within 4 minutes the patient started showing symptoms of everything. The patient had his shot on his left arm, his whole left side of his body went numb. He was asked "are you allergic to anything" and he said he cannot have Penicillin. The reporter stated that event on the day of the report, the patient still has the numbness down in his foot, his toe and on his left side but also originally within 4 minutes he was sat down and also within 12 minutes he was throwing up and they could not figure out what was wrong, he did "fall on the ground" (as reported, not further clarified). The patient was experiencing, not as strong but still experiencing, tingly and shingles and originally was numb. The patient is concerned about it. The patient only took the first one because that was on the Saturday and on Monday he went to the doctor and the doctor suggested to not take the second one because his blood pressure turned dropping, he does have the blood pressure and it was 107/70. The reporter said that the patient has allergy and since of that all he had anaphylactic reaction because he is allergic to Penicillin (as reported, pending clarification). He had tingling and shingles after the shot. He was very cold and sweaty and "creepy" (as reported not further clarified). The reporter called the nurse and they took over to have his blood pressure and it was 107/70. The reporter also added that just 4 minutes after the shot he had headache and dizziness and numbness bottom of his left foot and his toe, tingling under his foot and numbness under his toe. The patient did not take any treatment for the events but might take Tylenol for the headache. The outcome of the events his whole left side of his body went numb/still has the numbness down in his foot, his toe and on his left side, shingles, blood pressure turned dropping 107/70, headache and dizziness was not recovered while the outcome of the other events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Myocarditis, Off label use
Clinical narrative: second dose was April 2nd and and her one two weeks earlier; second dose was April 2nd and and her one two weeks earlier; she has myocarditis; Sick for several days; This is a spontaneous report from a contactable consumer (patient's mother). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Batch/Lot Number: Unknown), via an unspecified route of administration on 02Apr2021 at age of 50 years old as 2nd dose, single for COVID-19 immunization. Medical history included mast cell disease (mast cell activation syndrome). The patient's concomitant medications included other medication: "She received chemo every 2 weeks for it." The patient experienced myocarditis, sick for several days, both on an unspecified date in Apr2021. The second dose was 02Apr2021 and other one two weeks earlier. Description: Reporter stated, the oldest daughter (patient) had, well all of this happen, little last when they got Pfizer Covid 19 vaccine, she got her last one 02Apr2021 and she was sick for several days and they finally diagnosed her at the reporting date, they taken her to emergency room then finally she was able to see a cardiologist, she said that she had myocarditis and they were just wondering, the reporter realized that it could possibly be from the vaccine because reporter just saw that on news and reporter was calling because some information about. When probed if start experiencing the side effect after the second shot: Reporter stated, "Actually she didn't right way." When confirmed about the patient, reporter stated, "She was the only one their whole family got this. Just her." Treatment: She went to the emergency room 2 times and saw cardiologist. No." The outcome of events was unknown.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Thrombosis, Vaccination site bruising, Vaccination site discolouration, Vaccination site erythema
Clinical narrative: possible thrombosis reaction; Unexpected bruising near injection site.; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; Bruise was purple and red splotches and has now progressed to mostly yellow/discoloration; minimal pain/stiffness following the shot; minimal pain/stiffness following the shot; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 53-year-old via an unspecified route of administration, administered in Arm Left on 20Apr2021 11:15 (Lot Number: EW0153) at 1st dose, single for covid-19 immunisation.  The patient medical history was not reported. The patient received no 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. Concomitant medication included famotidine (PEPCID AC).  The patient previously took flu shot in Oct2020, prilosec [omeprazole magnesium] for seasonal allergy and experienced drug hypersensitivity.  The patient experienced unexpected bruising near injection site. Bruise was the size of the bandaid, approximately 1" x 2". Bruising had persisted for more than a week now. The patient had never experienced bruising like this with other vaccines. He would like to rule out possible thrombosis reaction before second shot. He did not have bruising at any other locations other than the injection site.  Bruise was purple and red splotches and has now progressed to mostly yellow. He believed the discoloration was a reaction to the vaccine and not the result of the needle. The shot itself was painful but patient felt minimal pain/stiffness following the shot. The event start date was on 20Apr2021. No treatment was received. The outcome was unknown.