chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Malaise, Muscle twitching, Paraesthesia, Peripheral swelling
Clinical narrative: I had tingling after two hours of the vaccination and it stayed up late for two days and then I took Claritin. a couple of days later I had muscle numbness and tingling again and twitchiness in my muscle and lost complete sensation from my arm to my finger. I went to the emergency room and they said i had a reaction to the shot. Few days later I contacted my doctor and they said it will do away because of the vaccination but I had diarrhea and continued for 7 days. My blood pressure was really high and for my blood work everything was normal except the potassium. The doctors sent me to neurologist and they said everything was clear. I am physically ill. I have lost a lot of weight. Sometimes my left hand is suddenly swollen.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: I had tingling after two hours of the vaccination and it stayed up late for two days and then I took Claritin. a couple of days later I had muscle numbness and tingling again and twitchiness in my muscle and lost complete sensation from my arm to my finger. I went to the emergency room and they said i had a reaction to the shot. Few days later I contacted my doctor and they said it will do away because of the vaccination but I had diarrhea and continued for 7 days. My blood pressure was really high and for my blood work everything was normal except the potassium. The doctors sent me to neurologist and they said everything was clear. I am physically ill. I have lost a lot of weight. Sometimes my left hand is suddenly swollen.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Feeling abnormal, Feeling hot, Hyperhidrosis
Clinical narrative: fainting; Rt hand started hurting badly; Parsonage Turner Syndrome; weakness; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm left on 04Aug2021 (at the age of 52-Years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainting, right hand started hurting badly, parsonage turner syndrome and weakness on an unspecified date. Patient had seen by orthopedic and diagnosed with Parsonage Turner Syndrome. He also had weakness and fainting on the fourth day for about three seconds. He thinks was caused from the pain. Patient questioned if he should take the second vaccine or not and If any other individuals reported the same thing. Outcome of the events was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Syncope
Clinical narrative: fainting; Rt hand started hurting badly; Parsonage Turner Syndrome; weakness; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm left on 04Aug2021 (at the age of 52-Years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainting, right hand started hurting badly, parsonage turner syndrome and weakness on an unspecified date. Patient had seen by orthopedic and diagnosed with Parsonage Turner Syndrome. He also had weakness and fainting on the fourth day for about three seconds. He thinks was caused from the pain. Patient questioned if he should take the second vaccine or not and If any other individuals reported the same thing. Outcome of the events was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Neuralgic amyotrophy, Pain in extremity, Syncope
Clinical narrative: fainting; Rt hand started hurting badly; Parsonage Turner Syndrome; weakness; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm left on 04Aug2021 (at the age of 52-Years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainting, right hand started hurting badly, parsonage turner syndrome and weakness on an unspecified date. Patient had seen by orthopedic and diagnosed with Parsonage Turner Syndrome. He also had weakness and fainting on the fourth day for about three seconds. He thinks was caused from the pain. Patient questioned if he should take the second vaccine or not and If any other individuals reported the same thing. Outcome of the events was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin normal, Dermatitis, Rash
Clinical narrative: Dermatitis; Developed a rash on arms, legs, torso and trunk; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 03Feb2021 (Batch/Lot Number: TFN2E1) (at the age of 69-years-old) as SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 14Jan2021 (Batch/Lot Number: EK9231) as SINGLE for covid-19 immunization and both doses were administered at Hospital. Patient medical history included COPD, AFib and High BP from an unknown date and unknown if ongoing and denies for any allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included apixaban (ELIQUIS), carvedilol, prevastatin, valsartan and omeprazole; all taken unspecified indication start date and stop date were not provided. The patient developed a rash on arms, legs, torso and trunk on 09Feb2021 and being treated by dermatologist which resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Also, he developed dermatitis on 23Feb2021, which resulted patient to visit physician office. Patient took steroid shots, antibiotics and steroid creams as a treatment for rash and took triamcinolone and betamethasone topicals for dermatitis. It was reported that the patient still having it on hands and using Betamethasone Right leg last 10 years and 2nd week later rest abdomen and arms were affected and using 4% solution of cortisone. Relevant tests was reported as none. The reporter considered the events as non-serious. The outcome of both the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dermatitis, Rash
Clinical narrative: Dermatitis; Developed a rash on arms, legs, torso and trunk; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 03Feb2021 (Batch/Lot Number: TFN2E1) (at the age of 69-years-old) as SINGLE for covid-19 immunization. Historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in arm left on 14Jan2021 (Batch/Lot Number: EK9231) as SINGLE for covid-19 immunization and both doses were administered at Hospital. Patient medical history included COPD, AFib and High BP from an unknown date and unknown if ongoing and denies for any allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medication included apixaban (ELIQUIS), carvedilol, prevastatin, valsartan and omeprazole; all taken unspecified indication start date and stop date were not provided. The patient developed a rash on arms, legs, torso and trunk on 09Feb2021 and being treated by dermatologist which resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Also, he developed dermatitis on 23Feb2021, which resulted patient to visit physician office. Patient took steroid shots, antibiotics and steroid creams as a treatment for rash and took triamcinolone and betamethasone topicals for dermatitis. It was reported that the patient still having it on hands and using Betamethasone Right leg last 10 years and 2nd week later rest abdomen and arms were affected and using 4% solution of cortisone. Relevant tests was reported as none. The reporter considered the events as non-serious. The outcome of both the events was not recovered.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Computerised tomogram, Coordination abnormal, Dyskinesia, Dysphemia
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electroencephalogram, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test, Magnetic resonance imaging, Muscle spasms, Muscle twitching
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Oral pruritus, Pain in extremity, Speech disorder, Throat irritation, Throat tightness
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Coordination abnormal, Dyskinesia, Dysphemia, Fatigue
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Muscle twitching, Speech disorder
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thinking abnormal
Clinical narrative: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved.  Information on the lot/batch number has been requested.; Sender's Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fatigue, Injection site rash, Injection site swelling
Clinical narrative: rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks; started with hives, around the site then spread within 24 hours around my face, neck, chest, and arms; itching around the injection site radiating to face, neck, and chest within 24 hours; Now was multiple papular rash especially on extremities; Fever 101.4/Fever chills; chills; dizziness; severe headache x 5 days/intracranial pressure pain; pain the site; sore muscles; sore arm side; This is a spontaneous report from a contactable nurse reporting for herself and a consumer. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 13:00 (Lot number: FA6780) administered to left deltoid, at the age of 64 years old as 0.3 mL single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included Autonomic Dysfunction, POTS, A-fib, Hypothyroid, Fibromyalgia, GERD, Hypertension, Sleep Apnea, Cataracts, Hyperhidrosis, High Cholesterol, had Covid virus back on 26Mar2021 prior to vaccine and still with symptoms developed Covid pneumonia and still experiencing symptoms, asthma and a heart ablation. Concomitant mediations were not reported. The patient previously took Codeine, Zoloft, Procardia, Isosorbide and all experienced allergies. On 31Jul2021 13:00, the patient experienced fever 101.4, chills, dizziness, severe headache x 5 days, rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks. Now was multiple papular rash especially on extremities. Fever chills and pain the site. Patient also had the normal side effects, sore arm side and sore muscles on 31Jul2021 13:00. Events were resulted in Emergency room/department or urgent care. Treatment was received for the events included Oral medication, Methylprednisolone 7 day pack and Triamcinolone 0.5% cream. COVID test post vaccination in 2021: Nasal Swab, covid test result: Negative. The outcome of the events were resolving.; Sender's Comments: As there is limited information in the case provided, the causal association between the events rash, vaccination site urticaria, vaccination site pruritus, rash papular and the suspect drug BNT162B2 can-not be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Rash, Rash pruritic, Urticaria
Clinical narrative: rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks; started with hives, around the site then spread within 24 hours around my face, neck, chest, and arms; itching around the injection site radiating to face, neck, and chest within 24 hours; Now was multiple papular rash especially on extremities; Fever 101.4/Fever chills; chills; dizziness; severe headache x 5 days/intracranial pressure pain; pain the site; sore muscles; sore arm side; This is a spontaneous report from a contactable nurse reporting for herself and a consumer. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 13:00 (Lot number: FA6780) administered to left deltoid, at the age of 64 years old as 0.3 mL single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included Autonomic Dysfunction, POTS, A-fib, Hypothyroid, Fibromyalgia, GERD, Hypertension, Sleep Apnea, Cataracts, Hyperhidrosis, High Cholesterol, had Covid virus back on 26Mar2021 prior to vaccine and still with symptoms developed Covid pneumonia and still experiencing symptoms, asthma and a heart ablation. Concomitant mediations were not reported. The patient previously took Codeine, Zoloft, Procardia, Isosorbide and all experienced allergies. On 31Jul2021 13:00, the patient experienced fever 101.4, chills, dizziness, severe headache x 5 days, rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks. Now was multiple papular rash especially on extremities. Fever chills and pain the site. Patient also had the normal side effects, sore arm side and sore muscles on 31Jul2021 13:00. Events were resulted in Emergency room/department or urgent care. Treatment was received for the events included Oral medication, Methylprednisolone 7 day pack and Triamcinolone 0.5% cream. COVID test post vaccination in 2021: Nasal Swab, covid test result: Negative. The outcome of the events were resolving.; Sender's Comments: As there is limited information in the case provided, the causal association between the events rash, vaccination site urticaria, vaccination site pruritus, rash papular and the suspect drug BNT162B2 can-not be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Body temperature, Chills, Dizziness, Headache
Clinical narrative: rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks; started with hives, around the site then spread within 24 hours around my face, neck, chest, and arms; itching around the injection site radiating to face, neck, and chest within 24 hours; Now was multiple papular rash especially on extremities; Fever 101.4/Fever chills; chills; dizziness; severe headache x 5 days/intracranial pressure pain; pain the site; sore muscles; sore arm side; This is a spontaneous report from a contactable nurse reporting for herself and a consumer. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 13:00 (Lot number: FA6780) administered to left deltoid, at the age of 64 years old as 0.3 mL single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included Autonomic Dysfunction, POTS, A-fib, Hypothyroid, Fibromyalgia, GERD, Hypertension, Sleep Apnea, Cataracts, Hyperhidrosis, High Cholesterol, had Covid virus back on 26Mar2021 prior to vaccine and still with symptoms developed Covid pneumonia and still experiencing symptoms, asthma and a heart ablation. Concomitant mediations were not reported. The patient previously took Codeine, Zoloft, Procardia, Isosorbide and all experienced allergies. On 31Jul2021 13:00, the patient experienced fever 101.4, chills, dizziness, severe headache x 5 days, rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks. Now was multiple papular rash especially on extremities. Fever chills and pain the site. Patient also had the normal side effects, sore arm side and sore muscles on 31Jul2021 13:00. Events were resulted in Emergency room/department or urgent care. Treatment was received for the events included Oral medication, Methylprednisolone 7 day pack and Triamcinolone 0.5% cream. COVID test post vaccination in 2021: Nasal Swab, covid test result: Negative. The outcome of the events were resolving.; Sender's Comments: As there is limited information in the case provided, the causal association between the events rash, vaccination site urticaria, vaccination site pruritus, rash papular and the suspect drug BNT162B2 can-not be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia, Rash, Rash papular
Clinical narrative: rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks; started with hives, around the site then spread within 24 hours around my face, neck, chest, and arms; itching around the injection site radiating to face, neck, and chest within 24 hours; Now was multiple papular rash especially on extremities; Fever 101.4/Fever chills; chills; dizziness; severe headache x 5 days/intracranial pressure pain; pain the site; sore muscles; sore arm side; This is a spontaneous report from a contactable nurse reporting for herself and a consumer. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 13:00 (Lot number: FA6780) administered to left deltoid, at the age of 64 years old as 0.3 mL single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included Autonomic Dysfunction, POTS, A-fib, Hypothyroid, Fibromyalgia, GERD, Hypertension, Sleep Apnea, Cataracts, Hyperhidrosis, High Cholesterol, had Covid virus back on 26Mar2021 prior to vaccine and still with symptoms developed Covid pneumonia and still experiencing symptoms, asthma and a heart ablation. Concomitant mediations were not reported. The patient previously took Codeine, Zoloft, Procardia, Isosorbide and all experienced allergies. On 31Jul2021 13:00, the patient experienced fever 101.4, chills, dizziness, severe headache x 5 days, rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks. Now was multiple papular rash especially on extremities. Fever chills and pain the site. Patient also had the normal side effects, sore arm side and sore muscles on 31Jul2021 13:00. Events were resulted in Emergency room/department or urgent care. Treatment was received for the events included Oral medication, Methylprednisolone 7 day pack and Triamcinolone 0.5% cream. COVID test post vaccination in 2021: Nasal Swab, covid test result: Negative. The outcome of the events were resolving.; Sender's Comments: As there is limited information in the case provided, the causal association between the events rash, vaccination site urticaria, vaccination site pruritus, rash papular and the suspect drug BNT162B2 can-not be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks; started with hives, around the site then spread within 24 hours around my face, neck, chest, and arms; itching around the injection site radiating to face, neck, and chest within 24 hours; Now was multiple papular rash especially on extremities; Fever 101.4/Fever chills; chills; dizziness; severe headache x 5 days/intracranial pressure pain; pain the site; sore muscles; sore arm side; This is a spontaneous report from a contactable nurse reporting for herself and a consumer. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 13:00 (Lot number: FA6780) administered to left deltoid, at the age of 64 years old as 0.3 mL single dose for COVID-19 immunization. Facility type vaccine was at Pharmacy or Drug Store. Medical history included Autonomic Dysfunction, POTS, A-fib, Hypothyroid, Fibromyalgia, GERD, Hypertension, Sleep Apnea, Cataracts, Hyperhidrosis, High Cholesterol, had Covid virus back on 26Mar2021 prior to vaccine and still with symptoms developed Covid pneumonia and still experiencing symptoms, asthma and a heart ablation. Concomitant mediations were not reported. The patient previously took Codeine, Zoloft, Procardia, Isosorbide and all experienced allergies. On 31Jul2021 13:00, the patient experienced fever 101.4, chills, dizziness, severe headache x 5 days, rash (started with hives & itching around the injection site radiating to face, neck, and chest within 24 hours. then onto extremities and abdomen, groin, and buttocks. Now was multiple papular rash especially on extremities. Fever chills and pain the site. Patient also had the normal side effects, sore arm side and sore muscles on 31Jul2021 13:00. Events were resulted in Emergency room/department or urgent care. Treatment was received for the events included Oral medication, Methylprednisolone 7 day pack and Triamcinolone 0.5% cream. COVID test post vaccination in 2021: Nasal Swab, covid test result: Negative. The outcome of the events were resolving.; Sender's Comments: As there is limited information in the case provided, the causal association between the events rash, vaccination site urticaria, vaccination site pruritus, rash papular and the suspect drug BNT162B2 can-not be excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Gastrointestinal disorder
Clinical narrative: having a Ulcerative colitis flare up; I got my booster yesterday; Headache; Diarrhea; Achiness; terrible stomach pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0171) via intramuscular, administered in Arm Left on 18Aug2021 10:20 (at the age of 44-year-old) as dose 3, single for covid-19 immunisation. Medical history included colitis ulcerative (she was first diagnosed with Ulcerative Colitis in 2015) and hypothyroidism from an unspecified date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202) via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6200) via an unspecified route of administration on 22Mar2021 as dose 2, single for covid-19 immunisation. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 18Aug2021 10:40 the patient experienced having a Ulcerative colitis flare up, Consumer stated that in the past diagnosed with Ulcerative Colitis and she did not have any issues or any side effects with her first or second dose. It was just with yesterday you know after her shot she had a slight headache and achiness and then this morning she just had really a terrible stomach pain. she was experiencing now a flare up of Ulcerative colitis. It was like combining of her intestines like heading (Not clarified) so it was just like a flare up of the Ulcerative Colitis. Consumer stated that Ulcerative Colitis it has been many years. she would say for 7 to 8 years ago. She states two months ago she was taking a medication called Canasa and her getting up for you right now. It was like a suppository. Consumer stated, she has not taking anything currently but that was the medicine she was prescribed in the past. Consumer stated, she called Gastroenterologist to and left a msg for the nurse and she trying to get a call back from the doctors. It was just really bad stomach pain about 07:45 this morning and then like, she had some Diarrhoea and then it some of side (Not Clarified). The way the doctor explains before happened this like the ulcer and ulcerative colitis with burns of like your Intestinal lining. The adverse events terrible stomach pain, Diarrhoea was result in visit to emergency room/ Physician Office Visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Colitis ulcerative, Diarrhoea, Extra dose administered, Headache
Clinical narrative: having a Ulcerative colitis flare up; I got my booster yesterday; Headache; Diarrhea; Achiness; terrible stomach pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0171) via intramuscular, administered in Arm Left on 18Aug2021 10:20 (at the age of 44-year-old) as dose 3, single for covid-19 immunisation. Medical history included colitis ulcerative (she was first diagnosed with Ulcerative Colitis in 2015) and hypothyroidism from an unspecified date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202) via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6200) via an unspecified route of administration on 22Mar2021 as dose 2, single for covid-19 immunisation. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 18Aug2021 10:40 the patient experienced having a Ulcerative colitis flare up, Consumer stated that in the past diagnosed with Ulcerative Colitis and she did not have any issues or any side effects with her first or second dose. It was just with yesterday you know after her shot she had a slight headache and achiness and then this morning she just had really a terrible stomach pain. she was experiencing now a flare up of Ulcerative colitis. It was like combining of her intestines like heading (Not clarified) so it was just like a flare up of the Ulcerative Colitis. Consumer stated that Ulcerative Colitis it has been many years. she would say for 7 to 8 years ago. She states two months ago she was taking a medication called Canasa and her getting up for you right now. It was like a suppository. Consumer stated, she has not taking anything currently but that was the medicine she was prescribed in the past. Consumer stated, she called Gastroenterologist to and left a msg for the nurse and she trying to get a call back from the doctors. It was just really bad stomach pain about 07:45 this morning and then like, she had some Diarrhoea and then it some of side (Not Clarified). The way the doctor explains before happened this like the ulcer and ulcerative colitis with burns of like your Intestinal lining. The adverse events terrible stomach pain, Diarrhoea was result in visit to emergency room/ Physician Office Visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: having a Ulcerative colitis flare up; I got my booster yesterday; Headache; Diarrhea; Achiness; terrible stomach pain; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN0171) via intramuscular, administered in Arm Left on 18Aug2021 10:20 (at the age of 44-year-old) as dose 3, single for covid-19 immunisation. Medical history included colitis ulcerative (she was first diagnosed with Ulcerative Colitis in 2015) and hypothyroidism from an unspecified date. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6202) via an unspecified route of administration on 01Mar2021 as dose 1, single for covid-19 immunisation and received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6200) via an unspecified route of administration on 22Mar2021 as dose 2, single for covid-19 immunisation. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hypothyroidism. On 18Aug2021 10:40 the patient experienced having a Ulcerative colitis flare up, Consumer stated that in the past diagnosed with Ulcerative Colitis and she did not have any issues or any side effects with her first or second dose. It was just with yesterday you know after her shot she had a slight headache and achiness and then this morning she just had really a terrible stomach pain. she was experiencing now a flare up of Ulcerative colitis. It was like combining of her intestines like heading (Not clarified) so it was just like a flare up of the Ulcerative Colitis. Consumer stated that Ulcerative Colitis it has been many years. she would say for 7 to 8 years ago. She states two months ago she was taking a medication called Canasa and her getting up for you right now. It was like a suppository. Consumer stated, she has not taking anything currently but that was the medicine she was prescribed in the past. Consumer stated, she called Gastroenterologist to and left a msg for the nurse and she trying to get a call back from the doctors. It was just really bad stomach pain about 07:45 this morning and then like, she had some Diarrhoea and then it some of side (Not Clarified). The way the doctor explains before happened this like the ulcer and ulcerative colitis with burns of like your Intestinal lining. The adverse events terrible stomach pain, Diarrhoea was result in visit to emergency room/ Physician Office Visit. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Myocarditis
Clinical narrative: started about 6 hours after - headache, dizzy  at 3 days chest pressure, fast heart beat, rash  Day 7 troponin levels were high at white plains hospital and sent to Montifiore  hospital via ambulance and admitted