chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Vomiting
Clinical narrative: I woke up severely dizzy; I couldn't walk; vomiting; tongue swelled; having an allergic reaction to the Covid vaccine; coughing up mucus; severe body aches; This is a spontaneous report from a contactable consumer (patient). Information were received also from Pfizer-sponsored program COVAX US Support.  A 44-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot#EL9267), via an unspecified route of administration in the left arm on 09Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included asthma, iodine allergy. The patient previously took atropine and sulfur and experienced drug hypersensitivity. The patient was not pregnant. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast (MONTELUKAST), ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT), colecalciferol (VITAMIN D).  The patient experienced dizziness, couldn't walk, vomiting, tongue swelled, allergic reaction to the covid vaccine, coughing up mucus and severe body aches on 10Feb2021 at 00:00 with outcome of recovering. The patient reported that about six hours after the vaccine, she woke up severely dizzy, she couldn't walk and was vomiting. Her husband called the paramedics and She was taken to the hospital. She was at the hospital for 6 hours. Her tongue swelled while she was at the hospital (as reported). The attending physician said that she was having an allergic reaction to the Covid vaccine. She was not been able to go to work this week. She had been coughing up mucus and had had severe body aches. The patient would like to have help paying for the medical bills she had incurred. Events resulted in Emergency room/department or urgent care. The patient received medications as treatment for the events. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.
Age: 88.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Death
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: struggle breathing and body shakes snd high blood pressure
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypertension, Tremor
Clinical narrative: struggle breathing and body shakes snd high blood pressure
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood creatinine increased, Blood culture negative, Blood urea increased, Brain natriuretic peptide increased, Cerebral haemorrhage
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Computerised tomogram head abnormal, Condition aggravated, Culture negative, Death
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Endotracheal intubation, Immunoglobulin therapy, Lung opacity
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Oesophagogastroduodenoscopy, Oxygen saturation decreased, Paralysis, Procalcitonin increased
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pupillary disorder, Pupillary light reflex tests abnormal, Respiratory failure, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular drainage, Viral test negative, White blood cell count increased
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood culture, Brain stem haemorrhage, Brain stem syndrome, Chest X-ray, Chest X-ray abnormal
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Culture, Death, Diarrhoea, Dyspnoea
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Product use issue, SARS-CoV-2 test
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Computerised tomogram head abnormal, Culture throat negative, Death, Diarrhoea
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Endotracheal intubation, General physical health deterioration, Immunoglobulin therapy, Lung opacity
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pupillary light reflex tests, Respiratory failure, SARS-CoV-2 test negative, Troponin increased, Ventricular drainage
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: [COVID-19 mRNA vaccine (Pfizer-BioNtech] treatment under Emergency Use Authorization (EUA)
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary normal, Blood creatine phosphokinase increased, Blood lactic acid, Brain natriuretic peptide increased, Chest X-ray normal
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Computerised tomogram normal, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer increased, International normalised ratio normal, Lipase normal, Lymphadenopathy
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging abnormal, Myocarditis, Nausea, Platelet count decreased, Pyrexia
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Troponin increased, Vomiting
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Brain natriuretic peptide increased, C-reactive protein increased, C-reactive protein normal, Chest discomfort
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Electrocardiogram T wave inversion, Electrocardiogram abnormal
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging heart, Myocarditis, Nausea, Neutrophil percentage increased
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Prohormone brain natriuretic peptide increased, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Troponin increased
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting, White blood cell count increased, White blood cell count normal
Clinical narrative: Shortness of breath, squeezing chest pain 8/10  beginning 11 hrs after receiving 2nd COVID vaccine. Also had fevers, chills, nausea and vomiting which resolved within 48 hrs of vaccine. Chest pain and shortness of breath persisted prompting him to come to Emergency room. On admission his troponin was markedly elevated and he had T wave inversions on his EKG.  His COVID-19 test was negative. Ischemic evaluation was negative. He underwent a cardiac MRI which demonstrated subepicardial hyperenhancement consistent with myocarditis. Infectious and Rheumatologic causes were ruled out. He was treated supportively and discharged with improvement in his symptoms.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was on the 1A list for a covid vaccine, when the appointment was scheduled we had Pfizer on hand. When she presented to the clinic for her vaccine we had Moderna instead of Pfizer. Vaccine was given to patient. Vaccine administrator was not aware that Moderna was for patients over the age of 18. This was patient's first dose of the covid-19 vaccine series. Patient was officially 17 years at 10 months at the time of the first vaccine. No adverse effects noted in the vaccine clinic at time of vaccination or during the observation time afterward. In addition, Moderna was contacted regarding this incident.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was on the 1A list for a covid vaccine, when the appointment was scheduled we had Pfizer on hand. When she presented to the clinic for her vaccine we had Moderna instead of Pfizer. Vaccine was given to patient. Vaccine administrator was not aware that Moderna was for patients over the age of 18. This was patient's first dose of the covid-19 vaccine series. Patient was officially 17 years at 10 months at the time of the first vaccine. No adverse effects noted in the vaccine clinic at time of vaccination or during the observation time afterward. In addition, Moderna was contacted regarding this incident.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Nasal congestion
Clinical narrative: 30 minutes after shot, nose congestion and blood pressure rose to 225/100.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling jittery, Musculoskeletal stiffness, Pain, Pain in extremity, Pharyngeal swelling
Clinical narrative: Pt reports a rash 3 days after receiving vaccine that start as "zit like pimples" around the injection site and then noticed a rash around her bully button that spread to her back and then down both arms as days passed. Pt went to PCP on 02/20/21 and received a steroid shot and reports that rash is starting to clear today 02/25/2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Pt reports a rash 3 days after receiving vaccine that start as "zit like pimples" around the injection site and then noticed a rash around her bully button that spread to her back and then down both arms as days passed. Pt went to PCP on 02/20/21 and received a steroid shot and reports that rash is starting to clear today 02/25/2021.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pustule, Rash
Clinical narrative: Pt reports a rash 3 days after receiving vaccine that start as "zit like pimples" around the injection site and then noticed a rash around her bully button that spread to her back and then down both arms as days passed. Pt went to PCP on 02/20/21 and received a steroid shot and reports that rash is starting to clear today 02/25/2021.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Full blood count, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization.  Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications.  Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment.  The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021.  Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Purpura, Rash, Rash pruritic, Thrombocytopenia
Clinical narrative: Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization.  Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications.  Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment.  The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021.  Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Platelet count decreased, Purpura
Clinical narrative: Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization.  Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications.  Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment.  The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021.  Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 95.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immune thrombocytopenia, Platelet count, White blood cell count
Clinical narrative: Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization.  Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications.  Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment.  The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021.  Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction, Chest pain, Chills, Tremor
Clinical narrative: 2/11/2021 - 2/12/2021 shaking, shivers, and fever 101*F 8AM 2/13/2021 had mild chest pain in the center of the sternum which persisteed 4AM 2/14/2021 Woken by moderate chest pain, cold sweats, and shortness of breath ~5AM 2/14/2021 Travelled to the detached ER, where EKG and troponin were tested, signs of heart attack was observed. ~6AM 2/14/2021 Given Aspirin and Heparin, then transported to hospital 6:30 AM 2/14/2021 Cardiologist performed angiogram, no blockage observed, prescribed aspirin 81mg and Plavix 75mg 2/15/2021 Discharged with declining Troponin: To see cardiologist outpatient 2/25/2021 Visit with cardiologist, recovering well and to continue plavix and aspirin, and return in 2 months for follow-up evaluation, no strenuous excercise.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram normal, Chest pain, Chills, Cold sweat, Computerised tomogram normal
Clinical narrative: 2/11/2021 - 2/12/2021 shaking, shivers, and fever 101*F 8AM 2/13/2021 had mild chest pain in the center of the sternum which persisteed 4AM 2/14/2021 Woken by moderate chest pain, cold sweats, and shortness of breath ~5AM 2/14/2021 Travelled to the detached ER, where EKG and troponin were tested, signs of heart attack was observed. ~6AM 2/14/2021 Given Aspirin and Heparin, then transported to hospital 6:30 AM 2/14/2021 Cardiologist performed angiogram, no blockage observed, prescribed aspirin 81mg and Plavix 75mg 2/15/2021 Discharged with declining Troponin: To see cardiologist outpatient 2/25/2021 Visit with cardiologist, recovering well and to continue plavix and aspirin, and return in 2 months for follow-up evaluation, no strenuous excercise.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Pyrexia, Scan with contrast normal
Clinical narrative: 2/11/2021 - 2/12/2021 shaking, shivers, and fever 101*F 8AM 2/13/2021 had mild chest pain in the center of the sternum which persisteed 4AM 2/14/2021 Woken by moderate chest pain, cold sweats, and shortness of breath ~5AM 2/14/2021 Travelled to the detached ER, where EKG and troponin were tested, signs of heart attack was observed. ~6AM 2/14/2021 Given Aspirin and Heparin, then transported to hospital 6:30 AM 2/14/2021 Cardiologist performed angiogram, no blockage observed, prescribed aspirin 81mg and Plavix 75mg 2/15/2021 Discharged with declining Troponin: To see cardiologist outpatient 2/25/2021 Visit with cardiologist, recovering well and to continue plavix and aspirin, and return in 2 months for follow-up evaluation, no strenuous excercise.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor, Troponin increased
Clinical narrative: 2/11/2021 - 2/12/2021 shaking, shivers, and fever 101*F 8AM 2/13/2021 had mild chest pain in the center of the sternum which persisteed 4AM 2/14/2021 Woken by moderate chest pain, cold sweats, and shortness of breath ~5AM 2/14/2021 Travelled to the detached ER, where EKG and troponin were tested, signs of heart attack was observed. ~6AM 2/14/2021 Given Aspirin and Heparin, then transported to hospital 6:30 AM 2/14/2021 Cardiologist performed angiogram, no blockage observed, prescribed aspirin 81mg and Plavix 75mg 2/15/2021 Discharged with declining Troponin: To see cardiologist outpatient 2/25/2021 Visit with cardiologist, recovering well and to continue plavix and aspirin, and return in 2 months for follow-up evaluation, no strenuous excercise.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphasia, Aphonia, Cough, Dyspnoea
Clinical narrative: Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021  with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea exertional, Fatigue, Fear, Insomnia, Lymphadenopathy
Clinical narrative: Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021  with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pharyngeal swelling, Tonsillar hypertrophy, Tonsillitis
Clinical narrative: Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021  with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphonia, Cough, Dyspnoea
Clinical narrative: Light cough; Shortness of breath; Anaphylaxis; lost voice entirely; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 11Feb2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history was none. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant medications included piroxicam (PAXIL) and lisdexamfetamine mesilate (VYVANSE). Patient did not receive other vaccines in four weeks. The patient experienced light cough on 11Feb2021 at 14:45 with outcome of recovering, shortness of breath on 11Feb2021  with outcome of recovering, anaphylaxis on 11Feb2021 with outcome of recovering, lost voice entirely on 11Feb2021 with outcome of recovering. The events required emergency room visit and physician office visit. The patient was hospitalized due to the events in Feb2021 for 1 day. Events were considered life threatening. Clinical course: light cough after half an hour from vaccination. Within 2 to 3 hours had lost voice entirely and was suffering from shortness of breath. Her primary physician told her to go to the emergency room or he was calling an ambulance because he said it sounded like anaphylaxis and that her life was in danger. Therapeutic measures were taken as a result of the events and included treatment with intravenous (IV) Decadron Pepcid and epinephrine. She received the 2nd dose on 21Feb2021 at 01:15 PM. Patient was not tested for COVID-19 post vaccination.   The information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: Lower lip angioedema within 15min of injection. Dose of benadryl given. Tingling in feet/hands 15min later, resolution of lip symptoms. 3 days later recurrence of the angioedema, treated with benadryl
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Paraesthesia
Clinical narrative: Lower lip angioedema within 15min of injection. Dose of benadryl given. Tingling in feet/hands 15min later, resolution of lip symptoms. 3 days later recurrence of the angioedema, treated with benadryl
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort
Clinical narrative: The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like vomiting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EL9261, via an unspecified route of administration on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Medical history included bypass surgery in Mar, diabetic and seizures from an unknown date and unknown if ongoing. The patient was taking several medications. Patient stated she had the first vaccine (Covid-19 Vaccine by Pfizer) on last Friday and done okay but then she had 10 O'clock in the morning and about 1 O'clock in the morning she woke up with all the pressure across her chest and like under her ribs about 6 inch hold away across and she did feel like vomiting and she was wondering if that was a reaction to that shot and if she should get the second one, she was just kind of concern what she should do it. No treatment was received for the events. The events didn't require Physician Office/ Emergency Room visit. The patient didn't perform any test. The outcome of the events was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Nausea
Clinical narrative: The pressure across my chest and like under my ribs about 6 inch hold away across; I did feel like vomiting; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), Batch/lot number: EL9261, via an unspecified route of administration on 22Jan2021 at single dose in left arm for COVID-19 immunisation. Medical history included bypass surgery in Mar, diabetic and seizures from an unknown date and unknown if ongoing. The patient was taking several medications. Patient stated she had the first vaccine (Covid-19 Vaccine by Pfizer) on last Friday and done okay but then she had 10 O'clock in the morning and about 1 O'clock in the morning she woke up with all the pressure across her chest and like under her ribs about 6 inch hold away across and she did feel like vomiting and she was wondering if that was a reaction to that shot and if she should get the second one, she was just kind of concern what she should do it. No treatment was received for the events. The events didn't require Physician Office/ Emergency Room visit. The patient didn't perform any test. The outcome of the events was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Lip swelling
Clinical narrative: cheeks red and burning; cheeks red and burning; upper lip swelling; This is a spontaneous report from a contactable consumer (patient). This 74-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via an unspecified route of administration in the left arm on 12Jan2021 at single dose for covid-19 immunisation. Medical history included allergic to a lot of antibiotics, always get reactions to drugs. Concomitant medications were unknown. The patient previously received ciprofloxacin (CIPRO) experiencing lip swelled, levofloxacin (LEVAQUIN) experiencing lip swelled, Prednisone experiencing burning cheeks. The patient experienced that her cheeks were red and burning, and upper lip swelling slightly, all on 12Jan2021. And it lasted a little over two hours. The patient was asking if it would be safe to take Benadryl before the 2nd dose of the vaccine. Outcome of all events was recovered on 12Jan2021.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cerebral haemorrhage, Computerised tomogram head abnormal, Headache
Clinical narrative: loss of vision in right eye; a left occipital lobe intraparenchyma hemorrhage; acute subdural hemorrhage posterior left tentorial; headache; This is a spontaneous report from a contactable consumer who reported for himself. A 60-Year-old Male patient received his second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in right arm, 15:00 on 15Feb2021 for COVID-19 immunization. First shot was received 03:00PM on 27Jan2021 at right arm (lot EL3247). Medical history included end stage renal disease (ESRD), hypertension (HTN), coronary artery disease (CAD). Patient had known allergies to Lisinopril and Norvasc. Concomitant medications in two weeks included hydralazine, metoprolol, acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX), and atorvastatin calcium (LIPITOR). The patient developed severe headache and loss of vision in right eye on 16Feb2021 (day post vaccine), started at 09:00 PM. CT scan showed a left occipital lobe intraparenchyma hemorrhage and 1-acute subdural hemorrhage posterior left tentorial. The patient received unspecified treatment on ICU admission. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab was performed on 19Feb2021 and 20Feb2021 and no result was provided. The patient had not recovered from the events.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness, Cerebral haemorrhage, Computerised tomogram, Headache, SARS-CoV-2 test
Clinical narrative: loss of vision in right eye; a left occipital lobe intraparenchyma hemorrhage; acute subdural hemorrhage posterior left tentorial; headache; This is a spontaneous report from a contactable consumer who reported for himself. A 60-Year-old Male patient received his second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in right arm, 15:00 on 15Feb2021 for COVID-19 immunization. First shot was received 03:00PM on 27Jan2021 at right arm (lot EL3247). Medical history included end stage renal disease (ESRD), hypertension (HTN), coronary artery disease (CAD). Patient had known allergies to Lisinopril and Norvasc. Concomitant medications in two weeks included hydralazine, metoprolol, acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX), and atorvastatin calcium (LIPITOR). The patient developed severe headache and loss of vision in right eye on 16Feb2021 (day post vaccine), started at 09:00 PM. CT scan showed a left occipital lobe intraparenchyma hemorrhage and 1-acute subdural hemorrhage posterior left tentorial. The patient received unspecified treatment on ICU admission. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab was performed on 19Feb2021 and 20Feb2021 and no result was provided. The patient had not recovered from the events.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Subdural haemorrhage
Clinical narrative: loss of vision in right eye; a left occipital lobe intraparenchyma hemorrhage; acute subdural hemorrhage posterior left tentorial; headache; This is a spontaneous report from a contactable consumer who reported for himself. A 60-Year-old Male patient received his second single dose of bnt162b2 (Pfizer-BioNTech Covid-19 vaccine, lot number EN5318) in right arm, 15:00 on 15Feb2021 for COVID-19 immunization. First shot was received 03:00PM on 27Jan2021 at right arm (lot EL3247). Medical history included end stage renal disease (ESRD), hypertension (HTN), coronary artery disease (CAD). Patient had known allergies to Lisinopril and Norvasc. Concomitant medications in two weeks included hydralazine, metoprolol, acetylsalicylic acid (ASPIRIN), clopidogrel bisulfate (PLAVIX), and atorvastatin calcium (LIPITOR). The patient developed severe headache and loss of vision in right eye on 16Feb2021 (day post vaccine), started at 09:00 PM. CT scan showed a left occipital lobe intraparenchyma hemorrhage and 1-acute subdural hemorrhage posterior left tentorial. The patient received unspecified treatment on ICU admission. The events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Nasal Swab was performed on 19Feb2021 and 20Feb2021 and no result was provided. The patient had not recovered from the events.