chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual field defect, Vitreous floaters
Clinical narrative: BLEEDING IN EYES; RETINAL TEAR OR DETACHED RETINA; RETINAL TEAR OR DETACHED RETINA; INCREDIBLY PAINFUL INJECTION; REALLY TIRED; This spontaneous report received from a patient concerned a 65 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no eye problem in the past.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced incredibly painful shot upon administration, immediately the patient was really tired. Three hours after the vaccination, his vision became cloudy and blurry. He then fell asleep. On 05-APR-2021, the patient experienced no peripheral vision. On 06-APR-2021, the patient woke up and had a little improvement in cloudiness but the patient stated that about 20 percent of his vision was still cloudy/blurry. The patient experienced pressure behind eyes, right eye distortion. The patient began to see bright flashes and round floaters. On 06-APR-2021, the patient experienced bleeding in eyes, retinal tear and detached retina that affected the patient's ability to work. On 07-APR-2021, morning, he was then referred to an eye specialist for ongoing eye issues. He went to see physician. He had been back to the eye specialist 2 additional times since then with ongoing eye issues. He had been told he has bleeding in his eyes, a retina tear or detached retina and still no peripheral vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from incredibly painful injection on 05-APR-2021, had not recovered from retinal tear or detached retina and bleeding in eyes and the outcome of really tired was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509138-Covid-19 vaccine ad26.cov2.s-Eye heamorrhage, Retinal tear ,Retinal detachment. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Fatigue, Injection site pain, Retinal detachment, Retinal tear
Clinical narrative: BLEEDING IN EYES; RETINAL TEAR OR DETACHED RETINA; RETINAL TEAR OR DETACHED RETINA; INCREDIBLY PAINFUL INJECTION; REALLY TIRED; This spontaneous report received from a patient concerned a 65 year old white not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no eye problem in the past.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient experienced incredibly painful shot upon administration, immediately the patient was really tired. Three hours after the vaccination, his vision became cloudy and blurry. He then fell asleep. On 05-APR-2021, the patient experienced no peripheral vision. On 06-APR-2021, the patient woke up and had a little improvement in cloudiness but the patient stated that about 20 percent of his vision was still cloudy/blurry. The patient experienced pressure behind eyes, right eye distortion. The patient began to see bright flashes and round floaters. On 06-APR-2021, the patient experienced bleeding in eyes, retinal tear and detached retina that affected the patient's ability to work. On 07-APR-2021, morning, he was then referred to an eye specialist for ongoing eye issues. He went to see physician. He had been back to the eye specialist 2 additional times since then with ongoing eye issues. He had been told he has bleeding in his eyes, a retina tear or detached retina and still no peripheral vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from incredibly painful injection on 05-APR-2021, had not recovered from retinal tear or detached retina and bleeding in eyes and the outcome of really tired was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210509138-Covid-19 vaccine ad26.cov2.s-Eye heamorrhage, Retinal tear ,Retinal detachment. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea)  I took Tylenol for the fever.  However after that first 24 hours, the adverse reaction began.  I had constant dizziness, veritgo type symptoms and extreme fatigue.  I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks.  I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist.  I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine.  I was even prescribed a 5 day prednisone course which did not relieve the dizziness.  I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms.  I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained.  I have not been able to drive or care for my 2 year old or work during this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Blood test, Chills, Dizziness, Ear discomfort
Clinical narrative: within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea)  I took Tylenol for the fever.  However after that first 24 hours, the adverse reaction began.  I had constant dizziness, veritgo type symptoms and extreme fatigue.  I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks.  I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist.  I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine.  I was even prescribed a 5 day prednisone course which did not relieve the dizziness.  I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms.  I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained.  I have not been able to drive or care for my 2 year old or work during this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Head discomfort, Inflammation, Nausea
Clinical narrative: within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea)  I took Tylenol for the fever.  However after that first 24 hours, the adverse reaction began.  I had constant dizziness, veritgo type symptoms and extreme fatigue.  I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks.  I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist.  I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine.  I was even prescribed a 5 day prednisone course which did not relieve the dizziness.  I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms.  I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained.  I have not been able to drive or care for my 2 year old or work during this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pyrexia, Tinnitus, Vertigo
Clinical narrative: within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea)  I took Tylenol for the fever.  However after that first 24 hours, the adverse reaction began.  I had constant dizziness, veritgo type symptoms and extreme fatigue.  I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks.  I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist.  I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine.  I was even prescribed a 5 day prednisone course which did not relieve the dizziness.  I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms.  I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained.  I have not been able to drive or care for my 2 year old or work during this time.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Head discomfort, Nystagmus
Clinical narrative: within 12 hours of receiving my vaccine I had the usual symptoms (chills, aches, fever, nausea)  I took Tylenol for the fever.  However after that first 24 hours, the adverse reaction began.  I had constant dizziness, veritgo type symptoms and extreme fatigue.  I have now suffered with the vertigo and dizziness non-stop for the past 6 and a half weeks.  I went to three primary care doctors in my family practice, I saw 2 ENT's, my endichrinologist and my recenetly a neurologist.  I had a complete blood work up and various exams as well as a visit to the Urgent care and all of the medical professionals I have seen had said that this is an inflammatory reaction to the vaccine.  I was even prescribed a 5 day prednisone course which did not relieve the dizziness.  I have tried antihistamines, vitamin c, ibuprofen, and nothing can take away the symptoms.  I have also had ear fullness and pressure in my head with occasional tinnitus, and very foggy brained.  I have not been able to drive or care for my 2 year old or work during this time.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carditis, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Immunoglobulin therapy, Magnetic resonance imaging heart
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial fibrosis, Myocarditis, Troponin increased
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adenovirus test, Antibody test, Antinuclear antibody, C-reactive protein, Chest X-ray
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Complement factor C3, Complement factor C4, Cytomegalovirus test negative, Double stranded DNA antibody
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Epstein-Barr virus test, Fibrosis, Full blood count
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: HIV test negative, Hyperhidrosis, Immunoglobulin therapy, Inflammation, Intensive care
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pain, Pyrexia, Red blood cell sedimentation rate, Serum ferritin
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Troponin
Clinical narrative: Pt is a 18 y.o. male presenting with chest pain x 2 days after getting COVID shot. Now with EKG reportedly showing STE per PMD. Assoc with tactile fever, body aches, diaphoresis. Got Pfizer Vaccine on Saturday (3 days ago) - no sign pmhx   Vital signs at exam notable for tachycardia Physical Exam significant for Tachycardic, RR CTAB Abdomen soft ntnd  no PMH who presents with new onset chest pain. Presented to his PCP office today and was found to have diffuse ST elevation, concerning for pericarditis. Pt sent by his PCP to the emergency department and pedi cardiology notified. Otherwise, pt has been in his usual state of health. Received his second dose of the covid vaccine on Saturday.    In the ED his initial vitals were Temp: 37 °C, Pulse: (!) 98, Resp: 20, SpO2: 98 %. He was noted to be tachycardic but otherwise stable. Received toradol. Labs drawn included CBC, CMP, troponin, CXR, MISC anti-bodies, ESR, CRP.   Admitted to PCICU for close monitoring given diffuse ST elevation on EKG and elevated troponin, concerning for myopericarditis likely post-COVID vaccine vs viral in etiology. Started on motrin 600mg q6, and protonix for GI ppx with serial EKG and troponin monitoring. Cardiac MRI 5/5 shows signs of inflammation and a small area of fibrosis. Rheumatology was consulted for treatment recommendations, pt received 1x IVIG and 2x IV solumedrol. CRP was downtrending; C3/C4, ferritin, ANA, ds-DNA Ab and ENA wnl. ID was consulted for recommendations wrt viral workup, EBV serologies suggest possible re-activation of prior EBV infection, EBV PCR is pending at time of discharge. Adenovirus, HHV6, HIV, CMV neg.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Product preparation issue
Clinical narrative: PRODUCT STORAGE ERROR; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: 23/JUNE/2021) .5 ml, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced product storage error. On 06-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and poor quality vaccine administered was not reported. This report was non-serious. The Product Quality Complaint Number:90000178730 The suspected product quality complaint has been confirmed to be voided(did not meet PQC criteria) based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT STORAGE ERROR; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A expiry: 23/JUNE/2021) .5 ml, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced product storage error. On 06-MAY-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and poor quality vaccine administered was not reported. This report was non-serious. The Product Quality Complaint Number:90000178730 The suspected product quality complaint has been confirmed to be voided(did not meet PQC criteria) based on the PQC evaluation/investigation performed.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aphasia, Blindness, Gait inability, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE REACTIVATED; This spontaneous report received from a consumer via a company representative (Social media) concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Guillain-Barre. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre reactivation and was hospitalized for a month. It was reported that "Guillain-Barre has woke him up with the vaccine".  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre reactivated was not reported. This report was serious (Hospitalization Caused / Prolonged.; Sender's Comments: V0.20210518047-COVID-19 Vaccine Ad26.COV2.S -Guillain-Barre reactivated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Pain
Clinical narrative: GUILLAIN BARRE REACTIVATED; This spontaneous report received from a consumer via a company representative (Social media) concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Guillain-Barre. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre reactivation and was hospitalized for a month. It was reported that "Guillain-Barre has woke him up with the vaccine".  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre reactivated was not reported. This report was serious (Hospitalization Caused / Prolonged.; Sender's Comments: V0.20210518047-COVID-19 Vaccine Ad26.COV2.S -Guillain-Barre reactivated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE REACTIVATED; This spontaneous report received from a consumer via a company representative (Social media) concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included Guillain-Barre. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced Guillain-Barre reactivation and was hospitalized for a month. It was reported that "Guillain-Barre has woke him up with the vaccine".  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillain-Barre reactivated was not reported. This report was serious (Hospitalization Caused / Prolonged.; Sender's Comments: V0.20210518047-COVID-19 Vaccine Ad26.COV2.S -Guillain-Barre reactivated. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test normal, Deep vein thrombosis, Joint swelling, Liver function test normal
Clinical narrative: BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg.  It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscle tightness, Pain, Pain in extremity, Peripheral swelling, Platelet count normal
Clinical narrative: BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg.  It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan abnormal
Clinical narrative: BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg.  It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Deep vein thrombosis, Headache, Myalgia, Nausea
Clinical narrative: BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg.  It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT); NAUSEA (AFTER VACCINATION); EXTREMELY BAD HEADACHES; MUSCLES ACHES; BODY ACHE; LEG PAIN; This spontaneous report received from a patient concerned a 33 year old hispanic or latino male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered on 02-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the patient experienced post vaccine nausea, extremely bad headaches, muscles aches. On 28-APR-2021, the patient experienced blood clot in lower calf muscles in right leg DVT (deep vein thrombosis). At around 2 weeks ago on 28-Apr-2021 or 29-Apr-2021, he started to feel throbbing pain and tightness in calf area. On an unspecified date in APR-2021, the patient experienced body aches specially in leg, back and arms and felt like it was a strain calf muscles or achilles pain, tightness in calf. At around 1-May-2021 to 2-May-2021, he felt the pain was extremely worse although he did not have any trauma and he did not run that may have caused a muscles strain. He went to emergent care on 5-May-2021, as he does not have a medical insurance. The doctor ordered an ultrasound as the pain he was experiencing was unlikely due to muscles strains as he did not do anything that may have caused it. On same day, laboratory data included: blood test (NR: not provided) all results are normal and diagnostic ultrasound showed DVT in lower right calf muscles in right leg.  It was reported that, he was asked if he reporting those side effect to Janssen would affect him by anyway if he want to proceed into any legal action against Janssen as he experienced a blood clot. he was also asking if Janssen can provide him for the cost. On 08-May-2021, treatment medications included rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea (after vaccination), extremely bad headaches, and muscles aches, had not recovered from blood clot in lower calf muscles in right leg (DVT), and the outcome of body ache and leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515729 -Covid-19 vaccine ad26.cov2.s-BLOOD CLOT IN LOWER CALF MUSCLES IN RIGHT LEG (DVT). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Limb discomfort, Peripheral swelling, Ultrasound scan, Weight bearing difficulty
Clinical narrative: pt developed right upper leg DVT 2 days after receiving second covid vaccine, first administered on 4/7
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: pt developed right upper leg DVT 2 days after receiving second covid vaccine, first administered on 4/7
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Cerebrovascular accident, Echocardiogram, Electrocardiogram
Clinical narrative: STROKE; This spontaneous report received from a consumer concerned a 75year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1476806 expiry: 21-JUN-2021) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-APR-2021, the patient experienced stroke. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517403-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).