chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Gait disturbance, Impaired gastric emptying
Clinical narrative: first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Nasopharyngitis, Nausea, Vomiting
Clinical narrative: first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Neuralgia, Pain in extremity
Clinical narrative: first dose on 18Dec2020/second dose on 05Jan2021; injection arm is hurting a lot.; It feels like nerve pain from my armpit to my fingers (left arm).; my lymph node in my left armpit is swollen because it feels like theres a golf ball pushing; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: el1284), intramuscular on 05Jan2021 at 15:30 at single dose in left arm for covid-19 immunization. Medical history included tachycardia, IBS (Irritable bowel syndrome), and allergies: Sulfa drugs. Concomitant medication included nortriptyline, buspirone, lubiprostone (AMITIZA), probiotics, diltiazem. The patient previously received the first dose bnt162b2 (batch/lot number: eh9899) in left arm on 18Dec2020 for covid-19 immunization. The patient reported that her injection arm was hurting a lot. It felt like nerve pain from her armpit to her fingers (left arm). She believed her lymph node in her left armpit was swollen because it felt like there's a golf ball pushing into her armpit. These events happened on 06Jan2021 at 01:00. These events were reported as non-serious by reporter. The patient did not receive treatment for these events. The outcome of these events was not resolved. The patient was not diagnosed with COVID-19 prior to vaccination, and the patient has not been tested for COVID-19 since the vaccination.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Pharyngeal swelling, Throat irritation
Clinical narrative: dizzy; itchy throat; coughing; swollen throat; This is a spontaneous report from a contactable pharmacist. A 21-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, NDC number: 59267-1000-1; Expiry Date: Mar2021), via an unspecified route of administration on 07Jan2021 11:20 at 0.3 mL, single at left arm for vaccination. Medical history included Cushing's disease (recovering), bipolar disorder from an unknown date and unknown if ongoing. Concomitant medication included lamotrigine (LAMICTAL) for bipolar disorder. On 07Jan2021, looked like after receiving the vaccine about 30 minutes later patient was standing and felt like dizzy. About 15 or 20 more minutes, or 45-50 minutes after received injection, she felt like itchy throat, then itchy throat triggered coughing, then she felt like swollen throat. For the treatment on scene patient was administered 50mg of diphenhydramine hydrochloride (BENADRYL) and when she complained of swollen throat was administered epinephrine (EPI-PEN) 0.3mg injection to right thigh. Then they called EMS who transported her to the hospital where she was admitted to the hospital. Outcome of events was unknown. This report was considered as serious per caused/prolonged hospitalization.  Causality: Cannot jump to that conclusion.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events dizziness, throat irritation, cough and pharyngeal swelling cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: itchy raised red rash started on day 8 after injection, and lasted for 4 days
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: itchy raised red rash started on day 8 after injection, and lasted for 4 days
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Muscular weakness, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Systemic: Chills-Severe, Systemic: Exhaustion-Severe, Systemic: Fever-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Unable to Sleep-Severe, Systemic: Abdominal Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Nausea-Severe, Systemic: Swollen Hands. Couldn't make fist-Severe; symptoms lasted 4 days.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood calcium normal, Blood chloride normal, Blood potassium normal, Blood sodium normal, Blood urea nitrogen/creatinine ratio
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood urea normal, Dizziness, Dry throat, Dyspnoea, Feeling hot
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal, Heart rate increased, Hyperhidrosis
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal swelling, Platelet count increased, Rash, Red blood cell count normal
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Shift to the left, Throat tightness, Urticaria, White blood cell count increased
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Feeling drunk, Hyperhidrosis
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Sinus tachycardia, Swollen tongue, Throat tightness, Tremor
Clinical narrative: Pt got Pfizer injection around 6:19 PM. After 5 min, she c/o feeling dizziness "like drunk/seeing star" as well feeling sob, throat tightness, sweaty hands. Has no PMHx. Not taking any medications Allergies: None. Denies any food allergies.  Has gotten Flu shot yearly w/o any side effects. No prior allergic reaction to vaccines. Temp 98.4, BP 140/92 mm Hg, 142/87 mm Hg, HR 120 /min, 158 /min, RR 24 /min, Oxygen sat % 99 %. Exam: in acute distress, + erythema macular rash noted on forehead/periorbital region. Notice sweaty palms/hand tremors. Throat: a bit swollen tongue. Heart: sinus tachy. Lungs: no stridor, no intercostal retraction seen, clear to auscultation bilaterally, no wheezes, rales. Given Benadryl 50mg QD and Epi-pen (left thigh) and given 2 puff of Proventil inhaler. Pt drank 1-2 cups of water.   Called 911.   After Epi-pen, her HR trended down from 158 - > 120 - > 99 (in 1-2 min). Pt felt better, rash on her forehead/occipital region subsides after 10-15 min. Her shakiness of hand minimal. Her SpO2: 99 % (remains the same)              Still feel a bit tightness of her throat (discomfort when swallowing). Her breathing is stable and talking w/o any discomfort by the time the ambulance came over. Her repeated BP: 142/87, HR: 99. I advised to take her to ER for close monitoring (risk of possible developing another reaction).(NEXT PAGE)
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pyrexia
Clinical narrative: thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced thrombopenia, pulmonary embolism and neutropenia fever on an unspecified date.  The clinical outcome of thrombopenia, pulmonary embolism and neutropenia fever was fatal. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: thrombopenia; pulmonary embolism; neutropenia fever
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Febrile neutropenia, Pulmonary embolism, Thrombocytopenia
Clinical narrative: thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced thrombopenia, pulmonary embolism and neutropenia fever on an unspecified date.  The clinical outcome of thrombopenia, pulmonary embolism and neutropenia fever was fatal. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: thrombopenia; pulmonary embolism; neutropenia fever
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cold sweat, Death, Dyspnoea, Myocardial infarction
Clinical narrative: thrombopenia; pulmonary embolism; neutropenia fever; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced thrombopenia, pulmonary embolism and neutropenia fever on an unspecified date.  The clinical outcome of thrombopenia, pulmonary embolism and neutropenia fever was fatal. The patient died on an unspecified date.  It was unknown if an autopsy was performed.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: thrombopenia; pulmonary embolism; neutropenia fever
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Myocardial infarction, Pyrexia
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an unspecified route of administration in the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization; administered in doctor's office/urgent care.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, the patient experienced heart attack; which resulted in death and was assessed as medically significant. The patient also experienced the associated symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were taken as a result of heart attack, which included "life saving measures" by the paramedics performed upon arrival with no success. The clinical outcome of the event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack; as ruled by the paramedics. It was unknown if an autopsy was performed.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart attack
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Febrile neutropenia, Pulmonary embolism, Thrombocytopenia
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an unspecified route of administration in the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization; administered in doctor's office/urgent care.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, the patient experienced heart attack; which resulted in death and was assessed as medically significant. The patient also experienced the associated symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were taken as a result of heart attack, which included "life saving measures" by the paramedics performed upon arrival with no success. The clinical outcome of the event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack; as ruled by the paramedics. It was unknown if an autopsy was performed.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart attack
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Cold sweat, Death, Dyspnoea, Myocardial infarction
Clinical narrative: Heart attack; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: and Expiration Date: Unknown), via an unspecified route of administration in the left arm on 05Jan2021 at 13:00 at a single dose for COVID-19 immunization; administered in doctor's office/urgent care.  The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jan2021, the patient experienced heart attack; which resulted in death and was assessed as medically significant. The patient also experienced the associated symptoms of cold sweats, chest pain, shortness of breath. Therapeutic measures were taken as a result of heart attack, which included "life saving measures" by the paramedics performed upon arrival with no success. The clinical outcome of the event, heart attack, was fatal. The patient died on 05Jan2021 due to heart attack; as ruled by the paramedics. It was unknown if an autopsy was performed.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart attack
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoacusis, Hypoaesthesia, Paraesthesia, Speech disorder
Clinical narrative: Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Numbness and tingling down left arm into fingers (worst is pinkie and ring fingers), dizziness with blurred vision, hearing sounded like underwater, felt like I had trouble talking. Notified nurse that gave me vaccine, several other nurses came over and helped me into recliner and laid me back and took vitals. Vitals are stable. I quickly began to feel better (within 5 minutes of being reclined). Still had the numbness and tingling. I laid in recliner for 30 minutes, then sat up for 10 minutes before leaving. I drank water and ate 2 rice krispies while in recliner. Numbness and tingling improved, but lingered throughout the day and was gone next morning.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral
Clinical narrative: lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after the second vaccine and she is afraid; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular (left arm) on 06Jan2021 at single dose for covid-19 immunisation. Medical history included blood pressure (abnormal) and blood cholesterol (abnormal) from an unknown date. Concomitant medication included lisinopril (LISINOPRIL) for Blood pressure for 3 years and adenosine (TRICOR) for cholesterol for 6 months; from unspecified dates and ongoing. On 06Jan2021, 50 minutes after the dose, her lips and nose were tingling described as tingling like when a dentist puts your mouth to sleep. It lasted about an hour. She took Cetirizine which she is sure helped. Within the hour of taking Cetirizine it was gone/resolved. She is afraid for the second vaccine. She has heard that you feel sicker after the second vaccine and she is afraid because it is her mouth. She also stated she took Ibuprofen an hour before hand to ward off evil (as reported). She took 400 mg. She asked if there is information on tingling and if it would be worse after the second dose. Outcome of the events lips and nose were tingling was recovered while unknown for "She has heard that you feel sicker after the second vaccine and she is afraid".  Information about batch/lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear, Paraesthesia, Paraesthesia oral
Clinical narrative: lips and nose were tingling; lips and nose were tingling; She has heard that you feel sicker after the second vaccine and she is afraid; This is a spontaneous report from a contactable Nurse reporting for herself. A 65-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, intramuscular (left arm) on 06Jan2021 at single dose for covid-19 immunisation. Medical history included blood pressure (abnormal) and blood cholesterol (abnormal) from an unknown date. Concomitant medication included lisinopril (LISINOPRIL) for Blood pressure for 3 years and adenosine (TRICOR) for cholesterol for 6 months; from unspecified dates and ongoing. On 06Jan2021, 50 minutes after the dose, her lips and nose were tingling described as tingling like when a dentist puts your mouth to sleep. It lasted about an hour. She took Cetirizine which she is sure helped. Within the hour of taking Cetirizine it was gone/resolved. She is afraid for the second vaccine. She has heard that you feel sicker after the second vaccine and she is afraid because it is her mouth. She also stated she took Ibuprofen an hour before hand to ward off evil (as reported). She took 400 mg. She asked if there is information on tingling and if it would be worse after the second dose. Outcome of the events lips and nose were tingling was recovered while unknown for "She has heard that you feel sicker after the second vaccine and she is afraid".  Information about batch/lot number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Patient called and reported today that he had red itchy spots/hives on his legs, back, stomach, and felt like he could not catch his breath and heard whistling sounds with breathing. When asked states he did not take Benadryl because it makes him very sleepy, everything resolved in 3 hours without treatment. Symptoms were approx. 36 hours after vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Patient called and reported today that he had red itchy spots/hives on his legs, back, stomach, and felt like he could not catch his breath and heard whistling sounds with breathing. When asked states he did not take Benadryl because it makes him very sleepy, everything resolved in 3 hours without treatment. Symptoms were approx. 36 hours after vaccine.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Patient called and reported today that he had red itchy spots/hives on his legs, back, stomach, and felt like he could not catch his breath and heard whistling sounds with breathing. When asked states he did not take Benadryl because it makes him very sleepy, everything resolved in 3 hours without treatment. Symptoms were approx. 36 hours after vaccine.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Diarrhoea, Dizziness, Electrocardiogram abnormal
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Full blood count normal, Gait disturbance, Influenza virus test
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza virus test negative, Injection site pain, Metabolic function test, Metabolic function test normal, Nausea
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pallor, Presyncope, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Troponin normal, Ventricular extrasystoles, Vomiting
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase normal, Anion gap, Arthralgia, Aspartate aminotransferase normal, Asthenia
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium decreased, Blood chloride normal
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carbon dioxide normal, Chills, Coronavirus test negative, Dizziness, Fatigue
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Influenza virus test negative, Nausea, Neutrophil percentage increased
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Obesity, Platelet count normal, Presyncope, Protein total normal, Pyrexia
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Shift to the left, Troponin normal, Vomiting, White blood cell count increased
Clinical narrative: 49 yo male was vaccinated 01/08/2021 and reported some dizziness. Saturday morning 01/09/2021 he woke up feeling weak, tired, and had significant nausea. The patient had an episode of vomiting x2 which made him weaker. The patient then had a near-syncopal event, which prompted his wife bringing him in for evaluation. He denies significant fever, chills, headache, cough or congestion. However, at the hospital he reports some joint pain, fevers and chills.  Upon arriving at the ER, BP 126/72, p. 94, resp 18, temp 98.7, pulse ox 98%. HT 6'2", WT 208#, BMI 39.5. Physical exam was otherwise unremarkable. Workup: WBC 10.5, Hgb 15.6, Hct 45.6, Platelet 293,000, left shift w/93% neutrophils. Na 141, Potass 3.5, Chl 105, C
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Full blood count normal, Immediate post-injection reaction, Impaired work ability
Clinical narrative: dizzy; felt like I was going to pass out; shaky; ringing in ears; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via intramuscular route of administration on the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported "almost immediately, dizzy, felt like I was going to pass out, shaky, and ringing in ears" on 30Dec2020 17:00. Events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Ondansetron (ZOFRAN) was given as treatment for nausea and meclizine. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "dizzy, felt like I was going to pass out, shaky, and ringing in ears" and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association.   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 RA, IEC, as appropriate.