chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Feeling abnormal, Gastrointestinal disorder
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Myocarditis, Palpitations
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Arrhythmia, Cardiac stress test, Diastolic dysfunction, Dyspnoea
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Feeling abnormal, Magnetic resonance imaging
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Palpitations, SARS-CoV-2 test, Vertigo
Clinical narrative: myocarditis; arrhythmia has gotten worse; diastolic dysfunction; shortness of breath; heart palpitations; upset stomach; brain fog; vertigo; This is a spontaneous report from a contactable consumer (patient). This consumer reported that a 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6205) at the age of 73-years, via an unspecified route of administration in left arm on 27Feb2021 at single dose for COVID-19 immunization, at public health clinic. Medical history included mildly elevated cholesterol; allergy to sulfa; prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR) to control mildly elevated cholesterol. The patient historically received first single dose of BNT162B2 (lot number: Em9810) in left arm on 06Feb2021 (at the age of 73-years) for COVID-19 Immunization. The patient previously received ciprofloxin and had allergy. It was reported that symptoms began within a few days. 1st was heart palpitations then upset stomach requiring medication, now shortness of breath, at a times brain fog and vertigo. Also more recently the arrhythmia had gotten worse. After ECG, ECHO, Holter, stress test and MRI- diagnosed with myocarditis, diastolic dysfunction and arrhythmia. The events occurred on 06Mar2021. The adverse event result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included starting steroids and rest protocol. On 29Jun2021, COVID-19 PCR test (nasal swab) was negative. Outcome of the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Patient stated he stated he started having joint pain 2 days after receiving dose 1 of Pfizer COVID-19 vaccine. On Oct 4th he started having joint pain in his hands, wrists, neck, knees and ankles. It does respond a little bit to ibuprofen but has not gone away. PT complained of 1 point of some swelling on the right wrist which has resolved. PT met with PCP on 15 Oct and was told to take ibuprofen TID x 1 week. PT had f/u appointment with PCP on 26 Oct and stated that it is actually getting worse instead of better. At the time of f/u it had been over 3 weeks since vaccination. He said that weekend he had suck bad shoulder pain that he was not able to play ball with his child. He states that has resolved with ibuprofen. He is concerned because it seems to be coming more frequent and more severe over time. Impression from PCP: ?This patient should absolutely not receive any more Pfizer Covid vaccination. It would probably be okay for him to take the Johnson and Johnson Covid vaccination but there certainly is a potential for him having a similar response to a different Covid vaccine. There is enough overlap between Moderna and Pfizer that I do not think even a Moderna booster would make sense for this PT. I would expect that if he had another Pfizer Covid vaccine he would likely get worsening issues with polyarthralgia. Joint and muscle pain is a known potential side effect to the Pfizer vaccine. I am going to try him on some steroids and see if that halts the immune response that is causing his joint pain. If his symptoms are getting progressively worse I would like him to f/u with me in 2 weeks. If his symptoms stay the same or gradually improve I would like him to f/u in 1 month. If he keeps having the same symptoms we are going to need to do some blood work for him going forward.? ? Assessment: Adverse effect of vaccine, initial encounter (E949.9)(T50.Z95A; Polyarthralgia (719.49)(M25.50); Shoulder pain, left (719.41)(M25.512).
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Vaccination complication
Clinical narrative: Patient stated he stated he started having joint pain 2 days after receiving dose 1 of Pfizer COVID-19 vaccine. On Oct 4th he started having joint pain in his hands, wrists, neck, knees and ankles. It does respond a little bit to ibuprofen but has not gone away. PT complained of 1 point of some swelling on the right wrist which has resolved. PT met with PCP on 15 Oct and was told to take ibuprofen TID x 1 week. PT had f/u appointment with PCP on 26 Oct and stated that it is actually getting worse instead of better. At the time of f/u it had been over 3 weeks since vaccination. He said that weekend he had suck bad shoulder pain that he was not able to play ball with his child. He states that has resolved with ibuprofen. He is concerned because it seems to be coming more frequent and more severe over time. Impression from PCP: ?This patient should absolutely not receive any more Pfizer Covid vaccination. It would probably be okay for him to take the Johnson and Johnson Covid vaccination but there certainly is a potential for him having a similar response to a different Covid vaccine. There is enough overlap between Moderna and Pfizer that I do not think even a Moderna booster would make sense for this PT. I would expect that if he had another Pfizer Covid vaccine he would likely get worsening issues with polyarthralgia. Joint and muscle pain is a known potential side effect to the Pfizer vaccine. I am going to try him on some steroids and see if that halts the immune response that is causing his joint pain. If his symptoms are getting progressively worse I would like him to f/u with me in 2 weeks. If his symptoms stay the same or gradually improve I would like him to f/u in 1 month. If he keeps having the same symptoms we are going to need to do some blood work for him going forward.? ? Assessment: Adverse effect of vaccine, initial encounter (E949.9)(T50.Z95A; Polyarthralgia (719.49)(M25.50); Shoulder pain, left (719.41)(M25.512).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Chest pain, Dysphagia, Erythema, Eye inflammation
Clinical narrative: facial paralysis; blisters; rash; painful limbs and eyes; painful limbs and eyes; This is a spontaneous report from a contactable consumer (father-in-law of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported.  It was unknown if any other vaccines given the same day or 4 weeks prior or if patient had any problems with vaccines in the past. The patient experienced fa had blisters, rash, severe facial paralysis immediately after receiving the shot. She also had painful limbs and eyes on an unspecified date. She went to the doctor to get the second vaccine and the doctor refused to give it to her. She had been to her primary care provider, as well as an allergist, and neurologist about this as well. Reporter stated this need to be examined by Pfizer and she and Pfizer need to know what was going on. The patient had spoken to a Pfizer nurse over the phone and got no satisfaction. The outcome was not recovered for the reported events.  The information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Hypoaesthesia, Ocular discomfort, Pain, Paraesthesia
Clinical narrative: facial paralysis; blisters; rash; painful limbs and eyes; painful limbs and eyes; This is a spontaneous report from a contactable consumer (father-in-law of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported.  It was unknown if any other vaccines given the same day or 4 weeks prior or if patient had any problems with vaccines in the past. The patient experienced fa had blisters, rash, severe facial paralysis immediately after receiving the shot. She also had painful limbs and eyes on an unspecified date. She went to the doctor to get the second vaccine and the doctor refused to give it to her. She had been to her primary care provider, as well as an allergist, and neurologist about this as well. Reporter stated this need to be examined by Pfizer and she and Pfizer need to know what was going on. The patient had spoken to a Pfizer nurse over the phone and got no satisfaction. The outcome was not recovered for the reported events.  The information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Skin burning sensation, Swelling face, Throat tightness, Urticaria
Clinical narrative: facial paralysis; blisters; rash; painful limbs and eyes; painful limbs and eyes; This is a spontaneous report from a contactable consumer (father-in-law of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported.  It was unknown if any other vaccines given the same day or 4 weeks prior or if patient had any problems with vaccines in the past. The patient experienced fa had blisters, rash, severe facial paralysis immediately after receiving the shot. She also had painful limbs and eyes on an unspecified date. She went to the doctor to get the second vaccine and the doctor refused to give it to her. She had been to her primary care provider, as well as an allergist, and neurologist about this as well. Reporter stated this need to be examined by Pfizer and she and Pfizer need to know what was going on. The patient had spoken to a Pfizer nurse over the phone and got no satisfaction. The outcome was not recovered for the reported events.  The information regarding lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Eye pain, Facial paralysis, Pain in extremity, Rash
Clinical narrative: facial paralysis; blisters; rash; painful limbs and eyes; painful limbs and eyes; This is a spontaneous report from a contactable consumer (father-in-law of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported.  It was unknown if any other vaccines given the same day or 4 weeks prior or if patient had any problems with vaccines in the past. The patient experienced fa had blisters, rash, severe facial paralysis immediately after receiving the shot. She also had painful limbs and eyes on an unspecified date. She went to the doctor to get the second vaccine and the doctor refused to give it to her. She had been to her primary care provider, as well as an allergist, and neurologist about this as well. Reporter stated this need to be examined by Pfizer and she and Pfizer need to know what was going on. The patient had spoken to a Pfizer nurse over the phone and got no satisfaction. The outcome was not recovered for the reported events.  The information regarding lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Insomnia, Malaise, Myalgia, Palpitations
Clinical narrative: Muscle pain everywhere; Very tired; Heart Fibrillations; Could not sleep for 12 hours; 3rd single booster dose; 3rd single booster dose; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   An 82-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 12Oct2021 (Lot Number: FF2590), at the age of 82 years old, as 3rd single booster dose, for COVID-19 immunisation. Medical history included high blood pressure, and allergy. Concomitant medications included amlodipine for hypertension, and montelukast sodium (SINGULAIR) for allergy. The patient received the 1st single dose of BNT162b2 on 27Jan2021 (lot# EL9261) and the 2nd single dose on 01Feb2021 (lot# EL9205), both at the age of 82 years old. The patient had no side effects after the 1st and 2nd doses of BNT162b2. The patient stated that in the evening of 13Oct2021, she could not sleep for 12 hours and when she woke up, she had muscle pain everywhere (on 14Oct2021). She had like heart fibrillations and it took her a long half an hour to get under control. She was very tired the whole day and then that night (unspecified if on 13Oct2021 or 14Oct2021) she had diarrhea for 6 hours. On 15Oct2021 she was feeling fine and she was also fine at the time of the reporting on 16Oct2021. The patient recovered from fibrillation on 13Oct2021, from diarrhea on 14Oct2021, and from all the remaining events on 15Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac fibrillation, Diarrhoea, Fatigue, Immunisation, Insomnia
Clinical narrative: Muscle pain everywhere; Very tired; Heart Fibrillations; Could not sleep for 12 hours; 3rd single booster dose; 3rd single booster dose; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   An 82-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 12Oct2021 (Lot Number: FF2590), at the age of 82 years old, as 3rd single booster dose, for COVID-19 immunisation. Medical history included high blood pressure, and allergy. Concomitant medications included amlodipine for hypertension, and montelukast sodium (SINGULAIR) for allergy. The patient received the 1st single dose of BNT162b2 on 27Jan2021 (lot# EL9261) and the 2nd single dose on 01Feb2021 (lot# EL9205), both at the age of 82 years old. The patient had no side effects after the 1st and 2nd doses of BNT162b2. The patient stated that in the evening of 13Oct2021, she could not sleep for 12 hours and when she woke up, she had muscle pain everywhere (on 14Oct2021). She had like heart fibrillations and it took her a long half an hour to get under control. She was very tired the whole day and then that night (unspecified if on 13Oct2021 or 14Oct2021) she had diarrhea for 6 hours. On 15Oct2021 she was feeling fine and she was also fine at the time of the reporting on 16Oct2021. The patient recovered from fibrillation on 13Oct2021, from diarrhea on 14Oct2021, and from all the remaining events on 15Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Off label use
Clinical narrative: Muscle pain everywhere; Very tired; Heart Fibrillations; Could not sleep for 12 hours; 3rd single booster dose; 3rd single booster dose; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   An 82-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 12Oct2021 (Lot Number: FF2590), at the age of 82 years old, as 3rd single booster dose, for COVID-19 immunisation. Medical history included high blood pressure, and allergy. Concomitant medications included amlodipine for hypertension, and montelukast sodium (SINGULAIR) for allergy. The patient received the 1st single dose of BNT162b2 on 27Jan2021 (lot# EL9261) and the 2nd single dose on 01Feb2021 (lot# EL9205), both at the age of 82 years old. The patient had no side effects after the 1st and 2nd doses of BNT162b2. The patient stated that in the evening of 13Oct2021, she could not sleep for 12 hours and when she woke up, she had muscle pain everywhere (on 14Oct2021). She had like heart fibrillations and it took her a long half an hour to get under control. She was very tired the whole day and then that night (unspecified if on 13Oct2021 or 14Oct2021) she had diarrhea for 6 hours. On 15Oct2021 she was feeling fine and she was also fine at the time of the reporting on 16Oct2021. The patient recovered from fibrillation on 13Oct2021, from diarrhea on 14Oct2021, and from all the remaining events on 15Oct2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal pain, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Extreme soreness in arm; Swelling of sinus tissue; difficulty in breathing; difficulty in swallowing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590), via an unspecified route of administration, administered in left arm on 15Oct2021 at 09:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol (hereditary) and COVID-19 (prior vaccination). The patient had known allergies to Penicillin, Codeine, Sulfates. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. On 15Oct2021 at 10:45 the patient experienced swelling of sinus tissue and at the back of the roof of her mouth causing difficulty in breathing and swallowing, extreme soreness in arm that radiated all the way across shoulder blade and up the left side of her neck and nausea. The patient took a Benadryl at 11:00 am and again at 10:00 pm. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palatal swelling, Pharyngeal swelling, Sinus disorder, Vomiting
Clinical narrative: Extreme soreness in arm; Swelling of sinus tissue; difficulty in breathing; difficulty in swallowing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590), via an unspecified route of administration, administered in left arm on 15Oct2021 at 09:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol (hereditary) and COVID-19 (prior vaccination). The patient had known allergies to Penicillin, Codeine, Sulfates. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. On 15Oct2021 at 10:45 the patient experienced swelling of sinus tissue and at the back of the roof of her mouth causing difficulty in breathing and swallowing, extreme soreness in arm that radiated all the way across shoulder blade and up the left side of her neck and nausea. The patient took a Benadryl at 11:00 am and again at 10:00 pm. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Nausea, Pain in extremity, Swelling
Clinical narrative: Extreme soreness in arm; Swelling of sinus tissue; difficulty in breathing; difficulty in swallowing; Nausea; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590), via an unspecified route of administration, administered in left arm on 15Oct2021 at 09:15 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high cholesterol (hereditary) and COVID-19 (prior vaccination). The patient had known allergies to Penicillin, Codeine, Sulfates. Concomitant medication included pravastatin taken for an unspecified indication, start and stop date were not reported. On 15Oct2021 at 10:45 the patient experienced swelling of sinus tissue and at the back of the roof of her mouth causing difficulty in breathing and swallowing, extreme soreness in arm that radiated all the way across shoulder blade and up the left side of her neck and nausea. The patient took a Benadryl at 11:00 am and again at 10:00 pm. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Atelectasis, Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: Thrombosis and Acute pulmonary embolism without acute cor pulmonale. Shortness of breath, pain in left side and left arm, pain when breathing, cough. Major pain started two days after the shot, resulting in ER visit. Multiple blood clots in both lungs and left arm. Treated with Heparin drip over 48hours then released with 10mg twice daily of eliquis for 7 days, reduced to 5mg twice daily for 23days following. Follow up with hematologist.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Cough, Dyspnoea
Clinical narrative: Thrombosis and Acute pulmonary embolism without acute cor pulmonale. Shortness of breath, pain in left side and left arm, pain when breathing, cough. Major pain started two days after the shot, resulting in ER visit. Multiple blood clots in both lungs and left arm. Treated with Heparin drip over 48hours then released with 10mg twice daily of eliquis for 7 days, reduced to 5mg twice daily for 23days following. Follow up with hematologist.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Flank pain, Pain in extremity, Painful respiration, Pulmonary embolism
Clinical narrative: Thrombosis and Acute pulmonary embolism without acute cor pulmonale. Shortness of breath, pain in left side and left arm, pain when breathing, cough. Major pain started two days after the shot, resulting in ER visit. Multiple blood clots in both lungs and left arm. Treated with Heparin drip over 48hours then released with 10mg twice daily of eliquis for 7 days, reduced to 5mg twice daily for 23days following. Follow up with hematologist.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: Thrombosis and Acute pulmonary embolism without acute cor pulmonale. Shortness of breath, pain in left side and left arm, pain when breathing, cough. Major pain started two days after the shot, resulting in ER visit. Multiple blood clots in both lungs and left arm. Treated with Heparin drip over 48hours then released with 10mg twice daily of eliquis for 7 days, reduced to 5mg twice daily for 23days following. Follow up with hematologist.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable consumer reported for herself.   A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Oct2021 18:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 63 years old. She was not pregnant at the time of vaccination.  Medical history included diabetic. The patient concomitant medications were not reported.  The patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tinnitus on 15Oct2021 07:30 with outcome of not recovered. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report from a contactable consumer reported for herself.   A 63-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Oct2021 18:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation at the age of 63 years old. She was not pregnant at the time of vaccination.  Medical history included diabetic. The patient concomitant medications were not reported.  The patient previously took codeine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced tinnitus on 15Oct2021 07:30 with outcome of not recovered. No treatment was received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Paraesthesia, Throat tightness, Tremor
Clinical narrative: Patient evaluated twice after covid vaccination. C/o shakiness, upper chest tightness, thickness in his throat, nausea, muscle spasm between RIGHT shoulder and neck. He took 2 levsin (under his own direction) and felt his symptoms improve over time.   Normal exam both times besides mild intention tremor in hands. No swelling of mouth, tongue. No palpable swelling of neck. Normal cardiac and lung exams.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Muscle spasms, Nausea, Throat tightness, Tremor
Clinical narrative: Patient evaluated twice after covid vaccination. C/o shakiness, upper chest tightness, thickness in his throat, nausea, muscle spasm between RIGHT shoulder and neck. He took 2 levsin (under his own direction) and felt his symptoms improve over time.   Normal exam both times besides mild intention tremor in hands. No swelling of mouth, tongue. No palpable swelling of neck. Normal cardiac and lung exams.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site paraesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient presents for covid vaccination.  Vaccination administered, and patient was observed after 15 minutes for reaction. After the 15 minutes patient reports left arm tingling and burning. Patient reports tingling down to her fingers. Patient reports arm feels weaker. Took patient's blood pressure and it was 132/70 with pulse of 68. Patient was examined. Having patient stay a couple more minutes. Patient stayed for another couple minutes- patient reports arm feeling better-  Symptoms resolved.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Muscular weakness, Paraesthesia
Clinical narrative: Patient presents for covid vaccination.  Vaccination administered, and patient was observed after 15 minutes for reaction. After the 15 minutes patient reports left arm tingling and burning. Patient reports tingling down to her fingers. Patient reports arm feels weaker. Took patient's blood pressure and it was 132/70 with pulse of 68. Patient was examined. Having patient stay a couple more minutes. Patient stayed for another couple minutes- patient reports arm feeling better-  Symptoms resolved.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Abdominal pain upper, Abdominal tenderness
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest pain, Colonoscopy, Computerised tomogram abdomen abnormal
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Decreased appetite, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymph node pain, Magnetic resonance imaging, Malaise, Nausea, Night sweats
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oesophagogastroduodenoscopy, Pyrexia, Sepsis, Spleen disorder, Splenic infarction
Clinical narrative: Splenic infarction; fevers; shortness of breath; chest pain; night sweats; left upper abdominal pain; lethargy; nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 50-year-old female patient received BNT162B2, via an unspecified route of administration, administered in arm left on 13Sep2021 17:00 (Batch/Lot Number: Fc3184) at the age of 50 years old as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism, gastrooesophageal reflux disease (GERD), COVID-19 prior vaccination. No known allergies: No. The patient was not pregnancy at time of vaccination. Concomitant medication(s) included levothyroxine, omeprazole (PRILOSEC) and venlafaxine hydrochloride (EFFEXOR), all taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: Fa7485), administered in arm left on 23Aug2021 17:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19 (Nasal Swab: negative). The patient experienced splenic infarction, fevers, shortness of breath, chest pain, night sweats, left upper abdominal pain, lethargy and nausea on 13Sep2021 19:00. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and was considered a life threatening illness (immediate risk of death from the event). The patient was hospitalized on unspecified dates in 2021 with duration of hospitalization: 7 days. Therapeutic measures were taken as a result of the events. Outcome of events were not recovered.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event splenic infarction cannot be excluded.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.