chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction, Electrocardiogram, Hyperhidrosis, Myocarditis, Pyrexia
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Troponin
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arteriogram coronary normal, Echocardiogram abnormal, Left ventricular dysfunction, Myocarditis, Troponin increased
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Troponin, Troponin increased
Clinical narrative: Symptoms consistent with myocarditis; EKG showed very subtle diffuse ST elevations; chest pain; dyspnea; Troponin trended to 19; This is a spontaneous report from a contactable physician. A 45-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 08Apr2021 (Batch/Lot number and Expiration date were not reported) as a single dose for COVID-19 immunization. Relevant medical history included chronic back pain, degenerative disc disease, and Clostridium difficile (C. Diff) colitis; the patient had no risk factors for cardiac disease other than obesity; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took cyclobenzaprine and pregabalin (LYRICA) and experienced allergies. It was unknown if the patient had other vaccine in four weeks. The patient had no COVID-19 prior vaccination. On 08Apr2021, 8 hours after the 2nd Pfizer vaccine was received, the patient developed chest pain with dyspnea. It was also reported that on 08Apr2021, troponin trended to 19; electrocardiogram (EKG) showed very subtle diffuse ST elevations; and the symptoms were consistent with myocarditis. All the adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit; an emergency room/department or urgent care; and hospitalization on an unspecified date for 3 days. The patient underwent lab tests and procedures, which included other/Xpert Xpress SARS-CoV-at assay: negative on 10Apr2021 (post vaccination). Therapeutic measures were taken as a result of all the events, which included colchicine and ibuprofen. The patient was recovering from all the events.  Information on the batch/lot number has been requested.; Sender's Comments: Information provided was so limited to prevent a meaningful medical assessment. Other than a temporal association, there was no evidence or argument suggesting a causal relationship for BNT162B2 in the reported events, serious due to hospitalization. Otherwise, this patient did not show risk factors for cardiac disease, except for obesity. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Our patient was given the Pfizer vaccine prior to the age of 16 years at the pharmacy.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Pulmonary embolism, Subclavian vein thrombosis, Ultrasound Doppler
Clinical narrative: Right arm pain with swelling that began on 4/11/21 and progressed to a DVT of the right UE by the time of her evaluation in our office on 4/22/21.  Remote history of DVT due to oral birth control from 12/2008. Hypercoag work up negative then.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary vein thrombosis, Chest pain, Computerised tomogram thorax abnormal, Condition aggravated, Deep vein thrombosis
Clinical narrative: Right arm pain with swelling that began on 4/11/21 and progressed to a DVT of the right UE by the time of her evaluation in our office on 4/22/21.  Remote history of DVT due to oral birth control from 12/2008. Hypercoag work up negative then.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling, Pulmonary vascular disorder, Subclavian vein occlusion
Clinical narrative: Right arm pain with swelling that began on 4/11/21 and progressed to a DVT of the right UE by the time of her evaluation in our office on 4/22/21.  Remote history of DVT due to oral birth control from 12/2008. Hypercoag work up negative then.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Subclavian vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Right arm pain with swelling that began on 4/11/21 and progressed to a DVT of the right UE by the time of her evaluation in our office on 4/22/21.  Remote history of DVT due to oral birth control from 12/2008. Hypercoag work up negative then.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood test, Electrocardiogram, Fatigue, Myalgia
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Dyspnoea, Loss of personal independence in daily activities, Malaise
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Emergency care, Flushing, Injection site pain, Malaise
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fatigue, Injection site pain
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: SHORTNESS OF BREATH; BODY ACHES; DECREASED MOBILITY; EXTREME FATIGUE; PAIN AT INJECTION SITE/LEFT ARM SORE TO TOUCH; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient allergic to triple antibiotic ointment.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 06-APR-2021, the subject experienced pain at injection site/left arm sore to touch. On 07-APR-2021, the subject experienced shortness of breath. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced decreased mobility. On 07-APR-2021, the subject experienced extreme fatigue. On 17-APR-2021, Laboratory data included: Blood test (NR: not provided) within normal limits, and EKG (NR: not provided) within normal limits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site/left arm sore to touch, and had not recovered from shortness of breath, extreme fatigue, body aches, and decreased mobility. This report was non-serious.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Received call from where pt was Hospital Resident expired at hospital 3 hours after receiving vaccine on 4-1-21
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Received call from where pt was Hospital Resident expired at hospital 3 hours after receiving vaccine on 4-1-21
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Diverticulitis, Scan with contrast abnormal, Splenic artery aneurysm
Clinical narrative: DIVERTICULITIS ATTACK; SPLENIC ANEURYSM; JOINT PAIN; This spontaneous report received from a patient concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diverticulitis. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered 1 total on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 the patient had severe joint pain she thought was due to vaccine. On 07-APR-2021, all her internal organs swelled up, the patient had severe abdominal pain and inflammation, diverticulitis, 1 cm splenic aneurism, which was confirmed by a rush computerized tomogram (CT) scan on 14-APR-2021. On 20-APR-2021, the patient goes to the surgeon. The patient believed that the vaccine cause a very severe onset of diverticulitis, one like the patient have never had before. This was the worst attack of diverticulitis the patient has ever had. The patient was on 2 unspecified antibiotics for the diverticulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain on 07-APR-2021, had not recovered from diverticulitis attack, splenic aneurysm, and swelling in abdominal cavity, and the outcome of abdominal pain and inflammation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438696-covid-19 vaccine ad26.cov2.s -Diverticulitis. 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  V0: 20210438696-covid-19 vaccine ad26.cov2.s-splenic aneurysm. 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).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Computerised tomogram, Diverticulitis, Splenic artery aneurysm
Clinical narrative: DIVERTICULITIS ATTACK; SPLENIC ANEURYSM; JOINT PAIN; This spontaneous report received from a patient concerned a 57-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diverticulitis. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered 1 total on 05-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 the patient had severe joint pain she thought was due to vaccine. On 07-APR-2021, all her internal organs swelled up, the patient had severe abdominal pain and inflammation, diverticulitis, 1 cm splenic aneurism, which was confirmed by a rush computerized tomogram (CT) scan on 14-APR-2021. On 20-APR-2021, the patient goes to the surgeon. The patient believed that the vaccine cause a very severe onset of diverticulitis, one like the patient have never had before. This was the worst attack of diverticulitis the patient has ever had. The patient was on 2 unspecified antibiotics for the diverticulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain on 07-APR-2021, had not recovered from diverticulitis attack, splenic aneurysm, and swelling in abdominal cavity, and the outcome of abdominal pain and inflammation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210438696-covid-19 vaccine ad26.cov2.s -Diverticulitis. 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  V0: 20210438696-covid-19 vaccine ad26.cov2.s-splenic aneurysm. 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: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Electrocardiogram, Hypoaesthesia
Clinical narrative: I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a  spontaneous report from a contactable consumer patient.  This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 20Apr2021.Outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia, Transient ischaemic attack, Ultrasound Doppler
Clinical narrative: I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a  spontaneous report from a contactable consumer patient.  This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 20Apr2021.Outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test, Transient ischaemic attack
Clinical narrative: I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a  spontaneous report from a contactable consumer patient.  This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative  on 20Apr2021.Outcome of the events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Ear pain, Fatigue
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Impaired work ability, Lethargy, Loss of personal independence in daily activities, Mass
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Nausea, Night sweats, Pain
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Pyrexia, Sleep disorder
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Swelling face, Taste disorder, Tenderness
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Back pain, Decreased appetite, Diarrhoea, Dyspnoea
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Lethargy, Nausea
Clinical narrative: Patient stated she took the vaccine on Monday 4/5/21 @1600 and within 10 minutes she felt her arm started to go numb and it was swollen (face and neck), radiating back pain and a nodule in neck and pain shooting all throughout the arm, loss of appetite, n/v, sob (no chest pain), lethargic, fever (ranging from 99-103), diarrhea developed within the last week, lost a sense of taste, headache, she can move arm but she's in a lot of pain.As of 4/22/21 patient is just experiencing shooting arm pain, nausea, fever, lethargic, SOB (patient feels exhausted when moving around the house), and started to experience some itchyness as of this morning. Patient took tylenol at least 6 times since she took the vaccine, she stated it helps with the pain but once it wears off the pain comes back.   Advised patient to continue with the tylenol/ibuprofen for the fever and pain, and benadryl to help with itchiness or she can apply benadryl cream/hydrocortisone to help. Also advised her that if her sob continues and it gets worse to seek medical attention (ER or urgent care). 4/25-Patient continues with fever, negative for Covid test, continues with loss of taste, recommended for her to see primary provider.