chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Headache, Lymphadenopathy, Muscular weakness, Nausea
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Nervousness, Pain in extremity, Peripheral swelling, Thyroid mass
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Oropharyngeal pain, Pain in extremity, Peripheral swelling, Thyroid mass
Clinical narrative: mass on left side of thyroid; Sore throat; left arm soreness and swelling after first dose; left arm soreness and swelling after first dose; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 17:10 (Lot Number: EN6199) as single dose on left arm for covid-19 immunization. The patient medical history included COVID-19. Concomitant medications included estrogens conjugated, medroxyprogesterone acetate (PREMPRO) taken for menopause from 2019 and ongoing. The patient left arm became swollen and sore after first dose on 10Mar2021, mass on left side of thyroid on 11Mar2021, sore throat on 11Mar2021. There was no treatment received for the adverse event. The patient did not received any other medications within 2 weeks of vaccination. There was no vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient was diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included CT/CAT Scan on 03Apr2021: a mass on her left thyroid, 40x36x31mm and it is definitely deviating her trachea. Caller stated that she is going to the doctor tomorrow to try to get a biopsy of this mass. The outcome of event mass on left side of thyroid was not recovered, the event left arm became swollen and sore outcome was recovered on 13 Mar 2021, sore throat was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ammonia normal, Blood chloride increased, Blood creatinine normal, Blood glucose increased, Blood sodium increased
Clinical narrative: I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; This is a spontaneous report from a contactable Nurse (Registered nurse with title of Infection Preventionist). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an acute CVA and was sent him to the hospital he had acute Cerebrovascular accident (CVA), he had a right artery occlusion, he passed away. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Sender's Comments: The information currently available is very limited. There is no sufficient evidence that the reported events may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion; patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood urea increased, Carotid artery stenosis, Cerebrovascular accident, Haematocrit decreased, Haemoglobin increased
Clinical narrative: I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; This is a spontaneous report from a contactable Nurse (Registered nurse with title of Infection Preventionist). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an acute CVA and was sent him to the hospital he had acute Cerebrovascular accident (CVA), he had a right artery occlusion, he passed away. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Sender's Comments: The information currently available is very limited. There is no sufficient evidence that the reported events may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion; patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary mass, Red blood cell count decreased, Vertebral artery occlusion
Clinical narrative: I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; This is a spontaneous report from a contactable Nurse (Registered nurse with title of Infection Preventionist). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an acute CVA and was sent him to the hospital he had acute Cerebrovascular accident (CVA), he had a right artery occlusion, he passed away. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Sender's Comments: The information currently available is very limited. There is no sufficient evidence that the reported events may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion; patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away; This is a spontaneous report from a contactable Nurse (Registered nurse with title of Infection Preventionist). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 (Lot Number: EL9269; Expiration Date: 01May2021) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an acute CVA and was sent him to the hospital he had acute Cerebrovascular accident (CVA), he had a right artery occlusion, he passed away. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed.; Sender's Comments: The information currently available is very limited. There is no sufficient evidence that the reported events may be related to administration of BNT162B2. Of note, medical history and concomitant medications were not provided to determine pre-existing risk factors or conditions that may have led to the events. Case will be re-assess once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion; patient had an acute CVA and was sent him to the hospital he had acute CVA, he had a right artery occlusion
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Band neutrophil count increased, Blood bilirubin increased
Clinical narrative: Acute liver failure leading to death on 4/24
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pH decreased, Diarrhoea, Dizziness postural, Endotracheal intubation, Haemophagocytic lymphohistiocytosis
Clinical narrative: Acute liver failure leading to death on 4/24
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatic failure, Hypotension, International normalised ratio increased, Jaundice, Myalgia
Clinical narrative: Acute liver failure leading to death on 4/24
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Platelet count decreased, Renal failure, Serum ferritin normal, White blood cell count increased
Clinical narrative: Acute liver failure leading to death on 4/24
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute hepatic failure, Death, Laboratory test normal
Clinical narrative: Acute liver failure leading to death on 4/24
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Cardiac assistance device user, Death, Dyspnoea, Endotracheal intubation
Clinical narrative: Safety manager of recipients work facility verbalized recipient received vaccine between 1300-1400 hrs. At 1700 recipient reported to their medical clinic reporting vomiting and not feeling well. Recipient vitals were stable and refused hospital or EMS care. Recipients brother was called to come pick recipient up due to not feeling well. At 1945 the nurse rounded back to check on recipient as the brother had not made it to the facility to pick recipient up. The recipient was found laying down, foaming at mouth, eyes rolled back in the head and unresponsive. EMS was initiated and CPR started. Recipient was pronounced deceased and transported for autopsy. EMS verbalized they thought there was a GI bleed due to blood and the amount of blood when the recipient was intubated.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Resuscitation, Vomiting
Clinical narrative: Safety manager of recipients work facility verbalized recipient received vaccine between 1300-1400 hrs. At 1700 recipient reported to their medical clinic reporting vomiting and not feeling well. Recipient vitals were stable and refused hospital or EMS care. Recipients brother was called to come pick recipient up due to not feeling well. At 1945 the nurse rounded back to check on recipient as the brother had not made it to the facility to pick recipient up. The recipient was found laying down, foaming at mouth, eyes rolled back in the head and unresponsive. EMS was initiated and CPR started. Recipient was pronounced deceased and transported for autopsy. EMS verbalized they thought there was a GI bleed due to blood and the amount of blood when the recipient was intubated.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Death, Endotracheal intubation, Eye movement disorder, Foaming at mouth
Clinical narrative: Safety manager of recipients work facility verbalized recipient received vaccine between 1300-1400 hrs. At 1700 recipient reported to their medical clinic reporting vomiting and not feeling well. Recipient vitals were stable and refused hospital or EMS care. Recipients brother was called to come pick recipient up due to not feeling well. At 1945 the nurse rounded back to check on recipient as the brother had not made it to the facility to pick recipient up. The recipient was found laying down, foaming at mouth, eyes rolled back in the head and unresponsive. EMS was initiated and CPR started. Recipient was pronounced deceased and transported for autopsy. EMS verbalized they thought there was a GI bleed due to blood and the amount of blood when the recipient was intubated.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Malaise, Resuscitation, Unresponsive to stimuli, Vomiting
Clinical narrative: Safety manager of recipients work facility verbalized recipient received vaccine between 1300-1400 hrs. At 1700 recipient reported to their medical clinic reporting vomiting and not feeling well. Recipient vitals were stable and refused hospital or EMS care. Recipients brother was called to come pick recipient up due to not feeling well. At 1945 the nurse rounded back to check on recipient as the brother had not made it to the facility to pick recipient up. The recipient was found laying down, foaming at mouth, eyes rolled back in the head and unresponsive. EMS was initiated and CPR started. Recipient was pronounced deceased and transported for autopsy. EMS verbalized they thought there was a GI bleed due to blood and the amount of blood when the recipient was intubated.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Injection site paraesthesia, Throat irritation
Clinical narrative: Tingling at injection site, throat, and tongue. Benadryl and solumedrol given. Released with husband in stable condition.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Tingling at injection site, throat, and tongue. Benadryl and solumedrol given. Released with husband in stable condition.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Chills, Dysphagia, Feeling abnormal
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Muscle swelling, Musculoskeletal stiffness, Myalgia, Oropharyngeal pain
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, White blood cell count increased
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Chest pain, Hepatitis acute, Myalgia
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Pulmonary oedema, Red blood cell sedimentation rate increased, Systemic inflammatory response syndrome, Urticaria
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: patient admitted 4/23 for a multitude of symptoms and signs suggestive of a multisystem autoimmune inflammatory disorder of unclear etiology. Her past medical history is relevant for mild intermittent asthma, history of recurrent idiopathic urticaria, history of migraine headaches, hypothyroidism on supplemental levothyroxine, history of bipolar affective disorder on antipsychotropic medications (lamotrigine) and ADHD on stimulant medication (Focalin).  Notably, the patient received a Johnson and Johnson COVID19 vaccine on 4/10. She reports current symptom onset on 4/17. Symptoms include pleuritic type chest pain, myalgias, arthralgias, diffuse interstitial edema, urticaria and objectively evidence of diffuse inflammation manifested by rising leukocytosis 16,000, CRP 9.3 from 5.7 just days ago, ESR 71 from 34 just several days ago, and new acute hepatitis. Pt admitted to the hospital and hospitalist states "Unclear etiology definitively but the clinical features all developed approximately 1 week after administration of the Janssen/Johnson & Johnson COVID-19 adenovirus vaccine which raises suspicion for this vaccine setting off the disease process" and "Strongly recommend consideration for reporting of possible adverse reaction to the Johnson Johnson vaccine".
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Feeling abnormal, Pallor, Unresponsive to stimuli
Clinical narrative: After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood test abnormal, Computerised tomogram normal, Dizziness, Eye movement disorder
Clinical narrative: After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Seizure, Snoring, Urinary tract infection, Urine analysis
Clinical narrative: After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: lymph node under her left arm hurts, red and swollen.; arm was swollen at the side of the injection; This is a spontaneous report from a Contactable Consumer (reported for himself).  This 65-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EL9462) via an unspecified route of administration as a single dose on 14Feb2021 1130AM in the left arm, for Covid-19 immunization. Medical history included thyroid. He did not have any family medical history. Concomitant medications included Methimazole 5 mg once at night. By the night of 14Feb2021, his arm was swollen at the side of the injection. On 16Feb2021 from morning, he had a lymph node under his left arm that hurt, and it was red and swollen. It was hurting worse at the time of this report. He was scheduled to receive the second dose on 07Mar2021. The patient had no history of previous immunization with the Pfizer vaccine. There were no vaccines administered on same day of the BNT162B2 or within 4 weeks prior to it. He did not have any relevant test done. The patient recovered from the event arm swollen at the side of the injection on 15Feb2021. The outcome of the event of lymph node under his left arm that hurt, and it was red and swollen was not recovered.  No further information was available.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: lymph node under her left arm hurts, red and swollen.; arm was swollen at the side of the injection; This is a spontaneous report from a Contactable Consumer (reported for himself).  This 65-year-old male patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: EL9462) via an unspecified route of administration as a single dose on 14Feb2021 1130AM in the left arm, for Covid-19 immunization. Medical history included thyroid. He did not have any family medical history. Concomitant medications included Methimazole 5 mg once at night. By the night of 14Feb2021, his arm was swollen at the side of the injection. On 16Feb2021 from morning, he had a lymph node under his left arm that hurt, and it was red and swollen. It was hurting worse at the time of this report. He was scheduled to receive the second dose on 07Mar2021. The patient had no history of previous immunization with the Pfizer vaccine. There were no vaccines administered on same day of the BNT162B2 or within 4 weeks prior to it. He did not have any relevant test done. The patient recovered from the event arm swollen at the side of the injection on 15Feb2021. The outcome of the event of lymph node under his left arm that hurt, and it was red and swollen was not recovered.  No further information was available.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Gastrointestinal pain, Headache, Myalgia
Clinical narrative: injection site pain and soreness; Myalgia; fatigue; Headache; GI cramps; Nausea; Fever 102; This is a spontaneous report from a contactable Pharmacist (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on an unspecified date at single dose for covid-19 immunization. Past drug history includes syeda for polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. On an unknown date, the patient experienced injection site pain and soreness, myalgia, fatigue, headache, GI cramps, nausea, fever 102. Patient took acetaminophen for symptoms. It was reported that event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection site pain and soreness; Myalgia; fatigue; Headache; GI cramps; Nausea; Fever 102; This is a spontaneous report from a contactable Pharmacist (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) on an unspecified date at single dose for covid-19 immunization. Past drug history includes syeda for polycystic ovarian syndrome (PCOS). The patient's concomitant medications were not reported. On an unknown date, the patient experienced injection site pain and soreness, myalgia, fatigue, headache, GI cramps, nausea, fever 102. Patient took acetaminophen for symptoms. It was reported that event took place after use of product. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling. The outcome of event was unknown.  Information about Lot/Batch is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167410 same reporter/drug/AE with different patient
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Epistaxis, Eye swelling
Clinical narrative: Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; General weakess; insomnia; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 68-years-old female patient (Non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:45, as SINGLE DOSE for COVID-19 immunisation. Medical history included colostomy, osteoporosis and seizure (Grand Mal Seizures). The patient had no known allergies. Concomitant medications included felbamate (FELBATOL); levothyroxine sodium (SYNTHROID), lisinopril (ZESTRIL); calcium carbonate (OSCAL [CALCIUM CARBONATE]) and vitamin c [ASCORBIC ACID]). On 21Jan2021, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in Arm Left, as SINGLE DOSE for COVID-19 immunisation. Patient not received COVID prior vaccination. Patient not tested for COVID post vaccination. On 21Feb2021 (13:00), the patient experienced racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; general weakness; insomnia. Patient not received treatment for the events. At the time of this report event outcome was recovering.  No Follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Insomnia, Nausea
Clinical narrative: Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; General weakess; insomnia; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 68-years-old female patient (Non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:45, as SINGLE DOSE for COVID-19 immunisation. Medical history included colostomy, osteoporosis and seizure (Grand Mal Seizures). The patient had no known allergies. Concomitant medications included felbamate (FELBATOL); levothyroxine sodium (SYNTHROID), lisinopril (ZESTRIL); calcium carbonate (OSCAL [CALCIUM CARBONATE]) and vitamin c [ASCORBIC ACID]). On 21Jan2021, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in Arm Left, as SINGLE DOSE for COVID-19 immunisation. Patient not received COVID prior vaccination. Patient not tested for COVID post vaccination. On 21Feb2021 (13:00), the patient experienced racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; general weakness; insomnia. Patient not received treatment for the events. At the time of this report event outcome was recovering.  No Follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus
Clinical narrative: Racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; General weakess; insomnia; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 68-years-old female patient (Non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in Arm Left on 21Feb2021 13:45, as SINGLE DOSE for COVID-19 immunisation. Medical history included colostomy, osteoporosis and seizure (Grand Mal Seizures). The patient had no known allergies. Concomitant medications included felbamate (FELBATOL); levothyroxine sodium (SYNTHROID), lisinopril (ZESTRIL); calcium carbonate (OSCAL [CALCIUM CARBONATE]) and vitamin c [ASCORBIC ACID]). On 21Jan2021, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in Arm Left, as SINGLE DOSE for COVID-19 immunisation. Patient not received COVID prior vaccination. Patient not tested for COVID post vaccination. On 21Feb2021 (13:00), the patient experienced racing heart within 10 minutes; vicelike headache; extreme nausea; pain in fingers and toes; bloody nose; pain in hips; swollen eyes; itching at injection site; no appetite; general weakness; insomnia. Patient not received treatment for the events. At the time of this report event outcome was recovering.  No Follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: There is a decrease in pain in the shoulder; This is a spontaneous report from a Pfizer-sponsored program and a contactable male consumer (patient) reported. An unspecified age male patient received BNT162B2 (Pfizer Covid-19 vaccine, formulation: solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history concomitant medications were not reported. The patient said that there is a decrease in pain in the shoulder with the tear in his rotator cup. Took Tylenol after first dose. The outcome of the event was unknown  Information on the Batch/Lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Mammogram, Mammogram abnormal
Clinical narrative: Abnormal mammogram requiring repeat imaging and ultrasound; Severe bloody nose four hours; This is a spontaneous report from a contactable consumer(patient). A 59-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3302), via an unspecified route of administration at Arm Left on 13-FEB-2021 15:15 at the 59 years old at single dose for COVID-19 immunization.  The medical history included Rheumatoid arthritis and Penicillin allergy.The concomitant medications were etanercept(ENBREL), duloxetine, estradiol(ESTROGEN). The patient experienced Abnormal mammogram requiring repeat imaging and ultrasound on 13-FEB-2021. The patient experienced Severe bloody nose four hours after vaccine was administered (first one in her life) on 13-FEB-2021. There was Physician Office Visit due to the events. There was no treatment received for the events. There was no other vaccine in four weeks. There was no Covid  prior vaccination. There was no Covid tested post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Dizziness, Eye pain, Headache
Clinical narrative: I had a temperature of 100.4; eye ache; headache; dizziness; no appetite; scratchy throat; This is a spontaneous report received from a contactable consumer (reporting on herself). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN6201 and Expiration Date was not report-ed), via an unspecified route of administration in Arm Right on an unspecified date as single dose for COVID-19 immunization. Medical history included essential hypertension from an unknown date. The patient's concomitant medications were not reported. Patient calling regarding the side effects that she had from the Second dose of the BNT162B2. she had a temperature of a100.4, eye ache, headache, dizziness, no appetite, scratchy throat. Patient was 78-year-old. When ask lot number patient said for the second dose. she guess this was what you EN6201. Patient was left handed so received vaccine on her right arm. Patient saying on other medication that she don't take it on a regular basis. And saying sorry to say she is a bad patient. Patient took Advil for the temperature and she just put cold compresses on my eye and on my head. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia
Clinical narrative: I had a temperature of 100.4; eye ache; headache; dizziness; no appetite; scratchy throat; This is a spontaneous report received from a contactable consumer (reporting on herself). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EN6201 and Expiration Date was not report-ed), via an unspecified route of administration in Arm Right on an unspecified date as single dose for COVID-19 immunization. Medical history included essential hypertension from an unknown date. The patient's concomitant medications were not reported. Patient calling regarding the side effects that she had from the Second dose of the BNT162B2. she had a temperature of a100.4, eye ache, headache, dizziness, no appetite, scratchy throat. Patient was 78-year-old. When ask lot number patient said for the second dose. she guess this was what you EN6201. Patient was left handed so received vaccine on her right arm. Patient saying on other medication that she don't take it on a regular basis. And saying sorry to say she is a bad patient. Patient took Advil for the temperature and she just put cold compresses on my eye and on my head. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nasopharyngitis, Oropharyngeal pain, Pain
Clinical narrative: headaches; runny nose; cold symptoms; body aches; generalized weakness; mild sore throat; This is a spontaneous report from a contactable physician. A 66-years-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy and rhinitis allergic that may have caused or increased his symptoms and concomitant medications were not reported. Family medical history included granddaughter had the same allergic rhinitis and colds too. On an unspecified date, the patient experienced headaches, runny nose, cold symptoms, body aches, generalized weakness and mild sore throat. Patient was scheduled for the 2nd dose on 05Mar2021. The outcome of the events was recovering for weakness and rest all recovered.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headaches; runny nose; cold symptoms; body aches; generalized weakness; mild sore throat; This is a spontaneous report from a contactable physician. A 66-years-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. Medical history included seasonal allergy and rhinitis allergic that may have caused or increased his symptoms and concomitant medications were not reported. Family medical history included granddaughter had the same allergic rhinitis and colds too. On an unspecified date, the patient experienced headaches, runny nose, cold symptoms, body aches, generalized weakness and mild sore throat. Patient was scheduled for the 2nd dose on 05Mar2021. The outcome of the events was recovering for weakness and rest all recovered.