chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Bilateral upper and lower extremity paresthesias, left facial paresthesias and numbness, fasciculations in abdomen and face
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Flushing, Pruritus, Vomiting
Clinical narrative: anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Blood pressure increased, Blood pressure measurement, Headache, SARS-CoV-2 test
Clinical narrative: anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia oral, Pain, Paraesthesia oral
Clinical narrative: 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in  1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection  developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for  6 days now.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Hypoaesthesia oral, Laboratory test
Clinical narrative: 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in  1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection  developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for  6 days now.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: 20 minutes post injection developed numbness of the mouth and tongue that lasted for 48 hours then resolved. Myalgias, fatigue and athralgias lasted a week and improved in  1 week in severity but intermittent athrlagias continue to occur. Over 1 month post 2 nd injection  developed numbness of bilateral hands and feet and numbness of the mouth had recurred and is persistent for  6 days now.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Nausea, Throat tightness, Vomiting
Clinical narrative: Immediately after getting the shot I felt nauseous and went to report my symptoms to Dr and other, when I began to vomit in my mouth I ran to the bathroom where I vomited  a lot in my throat and my throat began to tighten and lost consciousness  and i was given the shot of Benadryl and Dr  in medical were taking my vitals and O continue to have difficulty breathing Dr administered the EPIpen in my left leg I began to violently have convulsions until ems workers arrived.  I have fatigue, left side weakness, headaches, brain fog, unable to remember stuff, erratic heart rates blurred vision and shortness of breath.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: Immediately after getting the shot I felt nauseous and went to report my symptoms to Dr and other, when I began to vomit in my mouth I ran to the bathroom where I vomited  a lot in my throat and my throat began to tighten and lost consciousness  and i was given the shot of Benadryl and Dr  in medical were taking my vitals and O continue to have difficulty breathing Dr administered the EPIpen in my left leg I began to violently have convulsions until ems workers arrived.  I have fatigue, left side weakness, headaches, brain fog, unable to remember stuff, erratic heart rates blurred vision and shortness of breath.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate irregular, Hemiparesis, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Immediately after getting the shot I felt nauseous and went to report my symptoms to Dr and other, when I began to vomit in my mouth I ran to the bathroom where I vomited  a lot in my throat and my throat began to tighten and lost consciousness  and i was given the shot of Benadryl and Dr  in medical were taking my vitals and O continue to have difficulty breathing Dr administered the EPIpen in my left leg I began to violently have convulsions until ems workers arrived.  I have fatigue, left side weakness, headaches, brain fog, unable to remember stuff, erratic heart rates blurred vision and shortness of breath.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Throat tightness, Vision blurred, Vomiting
Clinical narrative: Immediately after getting the shot I felt nauseous and went to report my symptoms to Dr and other, when I began to vomit in my mouth I ran to the bathroom where I vomited  a lot in my throat and my throat began to tighten and lost consciousness  and i was given the shot of Benadryl and Dr  in medical were taking my vitals and O continue to have difficulty breathing Dr administered the EPIpen in my left leg I began to violently have convulsions until ems workers arrived.  I have fatigue, left side weakness, headaches, brain fog, unable to remember stuff, erratic heart rates blurred vision and shortness of breath.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Nausea, Pruritus
Clinical narrative: Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Hypotension, Immediate post-injection reaction
Clinical narrative: Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Shortness of breath, itching, dizziness, headache, low blood pressure, hives. These symptoms came on right after the vaccine was administered.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Head injury, Hypoaesthesia, Lip injury, Musculoskeletal stiffness
Clinical narrative: patient reports that 12 hours post vaccine, she became numb and passed out falling to the floor and cutting her head and getting a bloody nose. Since vaccine she frequently faint, has coughing spells, mobility problems from severe weakness, and has had 3 migraines in the last week since the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: patient reports that 12 hours post vaccine, she became numb and passed out falling to the floor and cutting her head and getting a bloody nose. Since vaccine she frequently faint, has coughing spells, mobility problems from severe weakness, and has had 3 migraines in the last week since the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Epistaxis, Fall, Head injury
Clinical narrative: patient reports that 12 hours post vaccine, she became numb and passed out falling to the floor and cutting her head and getting a bloody nose. Since vaccine she frequently faint, has coughing spells, mobility problems from severe weakness, and has had 3 migraines in the last week since the vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Migraine, Mobility decreased, Nasal injury
Clinical narrative: patient reports that 12 hours post vaccine, she became numb and passed out falling to the floor and cutting her head and getting a bloody nose. Since vaccine she frequently faint, has coughing spells, mobility problems from severe weakness, and has had 3 migraines in the last week since the vaccine.
Age: 69.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage
Clinical narrative: I have a big black and blue area where I received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 28Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history was reported as patient had COVID prior vaccination. Concomitant medications was none. Patient just wanted to know that if the vaccine will be effective if the needle went into a vein in the upper arm. patient had a big black and blue area where the shot was received on 28Jan2021. No treatment for adverse event. No other vaccine in four weeks. No COVID tested post vaccination. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 69.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site bruising
Clinical narrative: I have a big black and blue area where I received the shot; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on 28Jan2021 12:00 PM at single dose in left arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history was reported as patient had COVID prior vaccination. Concomitant medications was none. Patient just wanted to know that if the vaccine will be effective if the needle went into a vein in the upper arm. patient had a big black and blue area where the shot was received on 28Jan2021. No treatment for adverse event. No other vaccine in four weeks. No COVID tested post vaccination. The outcome of event was unknown.  Information about batch/lot number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Patient lost consciousness shortly after receiving the vaccine. Patient regained consciousness shortly after, and his vitals were taken. Patient was monitored before leaving the store.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness
Clinical narrative: Patient lost consciousness shortly after receiving the vaccine. Patient regained consciousness shortly after, and his vitals were taken. Patient was monitored before leaving the store.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Erythema, Flushing, Paraesthesia oral, Rosacea
Clinical narrative: I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an allergic reaction because of my allergy history. I sat for 30 minutes. At 12:20 the nurse said my face looked red. she took me to another area to take my blood pressure and said my face looked red and blotchy. at 12:25 2 more nurses came back and asked me how I was feeling and I told them my throat was getting scratchy and tight and felt like it was closing off. the inside of my mouth started feeling tingly/prickly and my tongue felt thick. My throat started closing off more and my lips started getting tingly and prickly. I started losing my voice as my throat was getting really constricted and I was getting shaky. At 12:30 a nurse gave me a half dose of epinephrine and called for an ambulance. At 12:40 the ambulance took me to the ER in the city. Then at 12:50 I arrived at the ER and they took me back and hooked me up to BP and O2 monitors and did blood tests. I was there until 3:30 pm that day. My BP was going up and down the whole time and I was very shaky. ER Doctor told me to NOT take the second vaccine dose and prescribed me an EpiPen.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Throat tightness
Clinical narrative: I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an allergic reaction because of my allergy history. I sat for 30 minutes. At 12:20 the nurse said my face looked red. she took me to another area to take my blood pressure and said my face looked red and blotchy. at 12:25 2 more nurses came back and asked me how I was feeling and I told them my throat was getting scratchy and tight and felt like it was closing off. the inside of my mouth started feeling tingly/prickly and my tongue felt thick. My throat started closing off more and my lips started getting tingly and prickly. I started losing my voice as my throat was getting really constricted and I was getting shaky. At 12:30 a nurse gave me a half dose of epinephrine and called for an ambulance. At 12:40 the ambulance took me to the ER in the city. Then at 12:50 I arrived at the ER and they took me back and hooked me up to BP and O2 monitors and did blood tests. I was there until 3:30 pm that day. My BP was going up and down the whole time and I was very shaky. ER Doctor told me to NOT take the second vaccine dose and prescribed me an EpiPen.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Blood test, Erythema, Nervousness, Oropharyngeal discomfort
Clinical narrative: I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an allergic reaction because of my allergy history. I sat for 30 minutes. At 12:20 the nurse said my face looked red. she took me to another area to take my blood pressure and said my face looked red and blotchy. at 12:25 2 more nurses came back and asked me how I was feeling and I told them my throat was getting scratchy and tight and felt like it was closing off. the inside of my mouth started feeling tingly/prickly and my tongue felt thick. My throat started closing off more and my lips started getting tingly and prickly. I started losing my voice as my throat was getting really constricted and I was getting shaky. At 12:30 a nurse gave me a half dose of epinephrine and called for an ambulance. At 12:40 the ambulance took me to the ER in the city. Then at 12:50 I arrived at the ER and they took me back and hooked me up to BP and O2 monitors and did blood tests. I was there until 3:30 pm that day. My BP was going up and down the whole time and I was very shaky. ER Doctor told me to NOT take the second vaccine dose and prescribed me an EpiPen.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Rash macular, Throat tightness, Tongue disorder
Clinical narrative: I got the shot at 11:45am and at 11:50-12:20 they had me sit in a chair and wait to see if I have an allergic reaction because of my allergy history. I sat for 30 minutes. At 12:20 the nurse said my face looked red. she took me to another area to take my blood pressure and said my face looked red and blotchy. at 12:25 2 more nurses came back and asked me how I was feeling and I told them my throat was getting scratchy and tight and felt like it was closing off. the inside of my mouth started feeling tingly/prickly and my tongue felt thick. My throat started closing off more and my lips started getting tingly and prickly. I started losing my voice as my throat was getting really constricted and I was getting shaky. At 12:30 a nurse gave me a half dose of epinephrine and called for an ambulance. At 12:40 the ambulance took me to the ER in the city. Then at 12:50 I arrived at the ER and they took me back and hooked me up to BP and O2 monitors and did blood tests. I was there until 3:30 pm that day. My BP was going up and down the whole time and I was very shaky. ER Doctor told me to NOT take the second vaccine dose and prescribed me an EpiPen.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient reported reaction about 15 minutes after administration of the Moderna COVID 19 vaccine.  Patient developed left antecubital urticarial rash , and reported feeling anxiety. Patient was given Benadryl 25 mg IM and transferred to Urgent Care for further evaluation. Patient improved and was transferred back to living unit with prescription for Benadryl 25 mg q8h x5 days.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Urticaria
Clinical narrative: Patient reported reaction about 15 minutes after administration of the Moderna COVID 19 vaccine.  Patient developed left antecubital urticarial rash , and reported feeling anxiety. Patient was given Benadryl 25 mg IM and transferred to Urgent Care for further evaluation. Patient improved and was transferred back to living unit with prescription for Benadryl 25 mg q8h x5 days.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aspiration, Death, Insomnia, Seizure
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Feeling cold, Headache
Clinical narrative: extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Oral pain, Vomiting
Clinical narrative: extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Headache
Clinical narrative: extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Neck pain, Oral pain, SARS-CoV-2 test, Vomiting
Clinical narrative: extreme weakness; joint pain in neck; mouth pain; severe heart attack; 10 hrs after shot severe chills; 1 hr later explosive diarrhea; vomiting; severe joint pain in ankles, knees, hips, elbows; severe headache; This is a spontaneous report from a contactable nurse report for self. A 55-year-old female (not pregnant) patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular in left arm on 21Feb2021 10:45 AM at single dose for covid-19 immunisation. The patient's medical history was not reported. No COVID prior vaccination. Concomitant medications in two weeks included atorvastatin, aspirin [acetylsalicylic acid], ergocalciferol (VIT D), cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. Patient was allergy to morphine. Patient received first dose of bnt162b2 (lot number=EL9263) intramuscular in left arm on 30Jan2021 09:30 AM. On 21Feb2021, 1 hr later patient experienced explosive diarrhea and vomiting 1 time, severe joint pain in ankles, knees, hips, elbows, severe headache. 10 hrs after shot patient had severe chills. Next day joint pain in neck and mouth pain along with severe heart attack. On 23Feb2021 had extreme weakness. No treatment received. Patient was recovered from the events. Nasal Swab Covid test post vaccination on 22Feb2021 was Negative.; Sender's Comments: Based on the limited information provided it is unlikely that heart attack was related to suspect product in this patient on atorvastatin and aspirin. Case will be reassessed when additional information is received. 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: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered state of consciousness, Atrial fibrillation, Condition aggravated, Haematoma, Iron deficiency anaemia
Clinical narrative: arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events.  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: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oedema peripheral, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events.  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: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope, Ultrasound Doppler
Clinical narrative: arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events.  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: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematoma, Hot flush, Nausea, Palpitations, Peripheral swelling
Clinical narrative: arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events.  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: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Retching, SARS-CoV-2 test, Syncope
Clinical narrative: arm swelling; had syncopal episodes; nausea; hematoma; hot flashes; palpitations; dry heaving; This is a spontaneous report from a contactable other hcp. An 85-year-old female patient receive second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), at same age, intramuscular in right arm on 23Feb2021 10:45 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) on 27Jan2021 03:15 AM, intramuscular in right arm for covid-19 immunisation. The patient was arrived at emergency room complains of arm swelling at 6pm 23Feb2021, and had syncopal episodes, nausea. lt 'upper ext hematoma', hot flashes, palpitations, and dry heaving, all on 6pm 23Feb2021. Emergency room visit for all events. The patient underwent lab tests and procedures which included post covid-19 rapid screening: negative on 24Feb2021. Patient is not pregnant. Facility type vaccine was Hospital. It is unknown if other vaccine in four weeks or other medications in two weeks. The medication for symptoms was received for all events. The patient was admission to hospital. No COVID prior vaccination. The outcomes of events were unknown.; Sender's Comments: The causal association of the reported events and suspected drug  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINEc cannot be excluded based on temporal relation of drug administration and presentation of events.  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: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chest discomfort, Hypertension, Paraesthesia, Syncope
Clinical narrative: Client's spouse reported almost 24 hours after vaccination episode syncope around 12:00 p.m. the next day  (02/12/2021).
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Client's spouse reported almost 24 hours after vaccination episode syncope around 12:00 p.m. the next day  (02/12/2021).
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Blood test, Chills, Dizziness, Electrocardiogram
Clinical narrative: I have taken the 2nd Moderna Shot that morning. During my sleep i felt bad and i was sweaty middle of the night i headed to restroom. And i have fainted. My wife called 9-1-1 when i was awake, i have noticed my sweat. they did EKG and checked my blood pressure 85/95 95 was too low, my tpical is 80/120. EKG was clean. they took me to the ER . Dr . treated me. Two times EKG has conducted all clean, IV connected. Multiple lab tests have been conducted. My diagnosis was poisoning by vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Hypotension, Pyrexia, Syncope
Clinical narrative: I have taken the 2nd Moderna Shot that morning. During my sleep i felt bad and i was sweaty middle of the night i headed to restroom. And i have fainted. My wife called 9-1-1 when i was awake, i have noticed my sweat. they did EKG and checked my blood pressure 85/95 95 was too low, my tpical is 80/120. EKG was clean. they took me to the ER . Dr . treated me. Two times EKG has conducted all clean, IV connected. Multiple lab tests have been conducted. My diagnosis was poisoning by vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Feeling abnormal, Hyperhidrosis, Syncope
Clinical narrative: I have taken the 2nd Moderna Shot that morning. During my sleep i felt bad and i was sweaty middle of the night i headed to restroom. And i have fainted. My wife called 9-1-1 when i was awake, i have noticed my sweat. they did EKG and checked my blood pressure 85/95 95 was too low, my tpical is 80/120. EKG was clean. they took me to the ER . Dr . treated me. Two times EKG has conducted all clean, IV connected. Multiple lab tests have been conducted. My diagnosis was poisoning by vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: severe back pain, nausea, diarrhea discharged from hospital morning after with famotidine and anti nausea meds tols to follow up with nephrologist in 72 hours. progressively weaker and 3 days later admitted to hospital  next morning embolic stroke, septic, endocarditis, multiorgan failure and DEATH
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood test, Computerised tomogram abdomen, Death
Clinical narrative: severe back pain, nausea, diarrhea discharged from hospital morning after with famotidine and anti nausea meds tols to follow up with nephrologist in 72 hours. progressively weaker and 3 days later admitted to hospital  next morning embolic stroke, septic, endocarditis, multiorgan failure and DEATH
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Electrocardiogram, Embolic stroke, Endocarditis, Gastritis
Clinical narrative: severe back pain, nausea, diarrhea discharged from hospital morning after with famotidine and anti nausea meds tols to follow up with nephrologist in 72 hours. progressively weaker and 3 days later admitted to hospital  next morning embolic stroke, septic, endocarditis, multiorgan failure and DEATH
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, Nausea, Renal failure, Sepsis
Clinical narrative: severe back pain, nausea, diarrhea discharged from hospital morning after with famotidine and anti nausea meds tols to follow up with nephrologist in 72 hours. progressively weaker and 3 days later admitted to hospital  next morning embolic stroke, septic, endocarditis, multiorgan failure and DEATH
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Eye pain, Grip strength decreased, Hyperhidrosis
Clinical narrative: Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Injection site streaking, Loss of consciousness
Clinical narrative: Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Nausea, Pain in extremity, Paraesthesia, Vision blurred
Clinical narrative: Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered.
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness
Clinical narrative: Patient noted weakness in both hands while finishing 15min post-observation time, felt it was abnormal. EMS onsite support provided 100mg diphenhydramine HCL (40mL) PO. Patient/EMS contacted provider, who recommended he be evaluated at ER. Patient was transported to ER for evaluation. Upon following up with local hospital, P.A. noted symptoms did not reflect a vaccine reaction in her opinion and patient was discharged. Patient stopped by several days later to pick up vaccine card and noted was much recovered.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Death, Dizziness, Fall, Headache
Clinical narrative: Patient received his first covid vaccine on 3/3/21 at an unknown time. He later reported to work at 1900 hrs. He complained of a headache and feeling light headed. He was later found unresponsive in a patient's room at 2030 hrs. He has other significant medical history.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Weight increased
Clinical narrative: Patient received his first covid vaccine on 3/3/21 at an unknown time. He later reported to work at 1900 hrs. He complained of a headache and feeling light headed. He was later found unresponsive in a patient's room at 2030 hrs. He has other significant medical history.