chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Apnoeic attack, Blood culture positive, CSF culture positive, Chest pain, Culture urine positive
Clinical narrative: From Post mortem report from Hospital: when on 4/10/21, she was in the process of self catheterization and began experiencing difficulty breathing and chest pain. Shortly after she collapsed and was not breathing. EMS arrived and found her apneic and  in pulseless electrical activity.  Resuscitation began and continued upon arrival to the ED.  Aside from a short period of returned pulses, she remained in PEA despite an estimated 45-50 minutes of resuscitation. She died at 11:20am on 4/10/21. - Directly from Pathology report  4.12.21
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspnoea, Enterococcal infection, Escherichia bacteraemia, Pulmonary artery occlusion
Clinical narrative: From Post mortem report from Hospital: when on 4/10/21, she was in the process of self catheterization and began experiencing difficulty breathing and chest pain. Shortly after she collapsed and was not breathing. EMS arrived and found her apneic and  in pulseless electrical activity.  Resuscitation began and continued upon arrival to the ED.  Aside from a short period of returned pulses, she remained in PEA despite an estimated 45-50 minutes of resuscitation. She died at 11:20am on 4/10/21. - Directly from Pathology report  4.12.21
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Renal dysplasia, Respiratory arrest, Resuscitation, SARS-CoV-2 test negative
Clinical narrative: From Post mortem report from Hospital: when on 4/10/21, she was in the process of self catheterization and began experiencing difficulty breathing and chest pain. Shortly after she collapsed and was not breathing. EMS arrived and found her apneic and  in pulseless electrical activity.  Resuscitation began and continued upon arrival to the ED.  Aside from a short period of returned pulses, she remained in PEA despite an estimated 45-50 minutes of resuscitation. She died at 11:20am on 4/10/21. - Directly from Pathology report  4.12.21
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: From Post mortem report from Hospital: when on 4/10/21, she was in the process of self catheterization and began experiencing difficulty breathing and chest pain. Shortly after she collapsed and was not breathing. EMS arrived and found her apneic and  in pulseless electrical activity.  Resuscitation began and continued upon arrival to the ED.  Aside from a short period of returned pulses, she remained in PEA despite an estimated 45-50 minutes of resuscitation. She died at 11:20am on 4/10/21. - Directly from Pathology report  4.12.21
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Musculoskeletal stiffness, Paraesthesia, Paraesthesia oral
Clinical narrative: STRANGE SENSATION TINGLING IN THE RIGHT SIDE OF HEAD, INNER EAR, RIGHT CHEEK, RIGHT SIDE JAW AND ARM TO FINGERTIPS; SENSATION IN THE RIGHT SIDE OF TONGUE; STIFFNESS SHOULDER; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stiffness shoulder. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips. On 09-APR-2021, the subject experienced sensation in the right side of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sensation in the right side of tongue, stiffness shoulder, and strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips, and the outcome of headache, chills and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: STRANGE SENSATION TINGLING IN THE RIGHT SIDE OF HEAD, INNER EAR, RIGHT CHEEK, RIGHT SIDE JAW AND ARM TO FINGERTIPS; SENSATION IN THE RIGHT SIDE OF TONGUE; STIFFNESS SHOULDER; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stiffness shoulder. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips. On 09-APR-2021, the subject experienced sensation in the right side of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sensation in the right side of tongue, stiffness shoulder, and strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips, and the outcome of headache, chills and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: STRANGE SENSATION TINGLING IN THE RIGHT SIDE OF HEAD, INNER EAR, RIGHT CHEEK, RIGHT SIDE JAW AND ARM TO FINGERTIPS; SENSATION IN THE RIGHT SIDE OF TONGUE; STIFFNESS SHOULDER; CHILLS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:20 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced stiffness shoulder. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips. On 09-APR-2021, the subject experienced sensation in the right side of tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sensation in the right side of tongue, stiffness shoulder, and strange sensation tingling in the right side of head, inner ear, right cheek, right side jaw and arm to fingertips, and the outcome of headache, chills and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: VOMITING; CHILLS; FATIGUE; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fatigue, headache, nausea, and fever on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; CHILLS; FATIGUE; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced fatigue. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fatigue, headache, nausea, and fever on APR-2021. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Thrombosis, Ultrasound Doppler
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Chills, Computerised tomogram, Electrocardiogram, Injection site pain
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram head normal, Discomfort, Dizziness
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Headache, Magnetic resonance imaging head abnormal
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Argininosuccinate lyase deficiency, Computerised tomogram head, Ischaemic stroke, Magnetic resonance imaging, Muscular weakness
Clinical narrative: presented to Emergency Department on 4/11/21 for right lower extremity weakness.She had J&J covid vaccine on 4/8/21 at a mass vaccination site. She had some side effect symptoms with mild throbbing headache, body aches, fatigue, chills, feeling foggy.  Her symptoms improved gradually.  On 4/11/21 she woke up and felt fatigued, dizzy and noted weakness to rt lower leg.  She felt like she would fall if she walks - felt heavy but no pain. No other associated weakness or speech difficulty noted. Denied fever, visual change, neck/back pain, chest pain, shortness of breath, abdominal pain, nausea/vomiting, diarrhea, constipation, dysuria, incontinence or sensory deficit. She has a h/o migraine but never had weakness in the past.  She was admitted to the hospital for stroke. The following imaging studies were done: CT of head without contrast showed no acute intracranial process; US vascular carotid showed no stenosis to right and left carotid artery; MRI of the brain showed small acute infarct within the left frontal lobe without evidence for hemorrhagic transformation or mass effect; US of both legs showed no DVT. She was discharged with home health services on 4/12/21. She is currently being followed up by neurologist.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral infarction, Computerised tomogram head, Hemiplegia, Magnetic resonance imaging head
Clinical narrative: STROKE 4 HOURS AFTER VACCINATION; This spontaneous report was received from a patient via social media by a company representative and concerned a male of unspecified age. The patient's height, and weight were not reported. The only reported history was that the patient was a father of 7. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number unknown), dose not reported, on 05-APR-2021 for COVID-19 vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stroke 4 hours after vaccination.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of stroke 4 hours after vaccination was not reported. This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report involved a male patient of unspecified age who experienced stroke 4 hours after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Medical history, concomitant medications, and details of the event were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke
Clinical narrative: STROKE 4 HOURS AFTER VACCINATION; This spontaneous report was received from a patient via social media by a company representative and concerned a male of unspecified age. The patient's height, and weight were not reported. The only reported history was that the patient was a father of 7. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number unknown), dose not reported, on 05-APR-2021 for COVID-19 vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stroke 4 hours after vaccination.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of stroke 4 hours after vaccination was not reported. This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report involved a male patient of unspecified age who experienced stroke 4 hours after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Medical history, concomitant medications, and details of the event were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE 4 HOURS AFTER VACCINATION; This spontaneous report was received from a patient via social media by a company representative and concerned a male of unspecified age. The patient's height, and weight were not reported. The only reported history was that the patient was a father of 7. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, route of administration not reported, batch number unknown), dose not reported, on 05-APR-2021 for COVID-19 vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced stroke 4 hours after vaccination.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of stroke 4 hours after vaccination was not reported. This report was serious (other medically important condition).; Sender's Comments: v0 This spontaneous report involved a male patient of unspecified age who experienced stroke 4 hours after receiving Janssen COVID-19 Vaccine Ad26.COV2.S for prophylactic vaccination. Medical history, concomitant medications, and details of the event were not reported. This case has insufficient information to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound Doppler
Clinical narrative: 4/3/21 woke up with slight pain in right calf, 4/4/21 woke up with severe pain in right calf, went to Urgent Care was diagnosed with DVT 7cm started Eliquis for 3 mos, stopped Low Ogestrel
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Full blood count, Pain in extremity, Ultrasound scan
Clinical narrative: 4/3/21 woke up with slight pain in right calf, 4/4/21 woke up with severe pain in right calf, went to Urgent Care was diagnosed with DVT 7cm started Eliquis for 3 mos, stopped Low Ogestrel
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: 4/3/21 woke up with slight pain in right calf, 4/4/21 woke up with severe pain in right calf, went to Urgent Care was diagnosed with DVT 7cm started Eliquis for 3 mos, stopped Low Ogestrel
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, Ultrasound scan abnormal
Clinical narrative: pt says she very bad body pains with severe legs cramps.  she called her PCP and was instructed to go to the ER.  She went to hospital.  They did blood work and US on legs. She was told she had a blood clot and given a shot for her pain.  She was prescribed blood thinner.  She was released to FU w/ a hematologist.  On 4/16/2021 she saw Dr. She was told to continue blood thinner and scheduled her for another US on 4/26/21.  She will FU in 4 weeks on 5/14/2021.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Muscle spasms, Pain, Thrombosis, Ultrasound scan
Clinical narrative: pt says she very bad body pains with severe legs cramps.  she called her PCP and was instructed to go to the ER.  She went to hospital.  They did blood work and US on legs. She was told she had a blood clot and given a shot for her pain.  She was prescribed blood thinner.  She was released to FU w/ a hematologist.  On 4/16/2021 she saw Dr. She was told to continue blood thinner and scheduled her for another US on 4/26/21.  She will FU in 4 weeks on 5/14/2021.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Angiogram pulmonary abnormal, Chest X-ray normal, Dyspnoea, Echocardiogram
Clinical narrative: SHORTNESS OF BREATH; CHEST PAIN; SEVERE BLOOD CLOTS; This spontaneous report was received from a female patient of unspecified age. 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 administration not reported), dose not reported, on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. On 11-APR-2021, the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the shortness of breath, chest pain and severe blood clots were not reported. This report was serious (caused hospitalization).; Sender's Comments: V0:This  female patient of unspecified age was hospitalized due to shortness of breath and increasing chest pain  an unspecified time after blinded COVID-19 VACCINE Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SAR-CoV-2 virus infection. No concomitant medications, past medical history has been  reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined. At the time of the report the outcome of the event is unknown. Based on the limited information  the event is inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization.  The event is considered not related to the blinded study vaccine. Additional information has been requested for further assessment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Full blood count normal, International normalised ratio normal, Prothrombin time normal, Pulmonary embolism
Clinical narrative: SHORTNESS OF BREATH; CHEST PAIN; SEVERE BLOOD CLOTS; This spontaneous report was received from a female patient of unspecified age. 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 administration not reported), dose not reported, on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. On 11-APR-2021, the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the shortness of breath, chest pain and severe blood clots were not reported. This report was serious (caused hospitalization).; Sender's Comments: V0:This  female patient of unspecified age was hospitalized due to shortness of breath and increasing chest pain  an unspecified time after blinded COVID-19 VACCINE Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SAR-CoV-2 virus infection. No concomitant medications, past medical history has been  reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined. At the time of the report the outcome of the event is unknown. Based on the limited information  the event is inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization.  The event is considered not related to the blinded study vaccine. Additional information has been requested for further assessment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Thrombosis
Clinical narrative: SHORTNESS OF BREATH; CHEST PAIN; SEVERE BLOOD CLOTS; This spontaneous report was received from a female patient of unspecified age. 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 administration not reported), dose not reported, on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. On 11-APR-2021, the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcomes of the shortness of breath, chest pain and severe blood clots were not reported. This report was serious (caused hospitalization).; Sender's Comments: V0:This  female patient of unspecified age was hospitalized due to shortness of breath and increasing chest pain  an unspecified time after blinded COVID-19 VACCINE Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SAR-CoV-2 virus infection. No concomitant medications, past medical history has been  reported. On an unspecified date, within a week of receiving the vaccine, the patient reported that she began experiencing shortness of breath and increasing chest pain. the patient was admitted to the hospital and a diagnosis of severe blood clots was made. After a full work-up, no etiology was determined. At the time of the report the outcome of the event is unknown. Based on the limited information  the event is inconsistent with the causal association to immunization, per the WHO causality classification for adverse events following immunization.  The event is considered not related to the blinded study vaccine. Additional information has been requested for further assessment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dysphagia, Fatigue, Pharyngeal swelling, Pyrexia
Clinical narrative: THROAT SWELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced throat swell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swell on 08-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: THROAT SWELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced throat swell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swell on 08-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary pain, Erythema, Rash, Skin burning sensation
Clinical narrative: LIKE RAZOR BURN (BURNING ON RIGHT UNDERARM); MUCH MORE INFLAMED RIGHT UNDERARM; RASH ON BOTH UNDER ARMS; SEVERE JOINT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe joint pain. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced like razor burn (burning on right underarm). On 10-APR-2021, the subject experienced much more inflamed right underarm. On 10-APR-2021, the subject experienced rash on both under arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe joint pain on 10-APR-2021, and the outcome of rash on both under arms, like razor burn (burning on right underarm) and much more inflamed right underarm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Inflammation, Rash
Clinical narrative: LIKE RAZOR BURN (BURNING ON RIGHT UNDERARM); MUCH MORE INFLAMED RIGHT UNDERARM; RASH ON BOTH UNDER ARMS; SEVERE JOINT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805031, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe joint pain. Treatment medications included: paracetamol. On 10-APR-2021, the subject experienced like razor burn (burning on right underarm). On 10-APR-2021, the subject experienced much more inflamed right underarm. On 10-APR-2021, the subject experienced rash on both under arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe joint pain on 10-APR-2021, and the outcome of rash on both under arms, like razor burn (burning on right underarm) and much more inflamed right underarm was not reported. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Breath sounds abnormal, Chest discomfort, Chills, Diarrhoea
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Nausea, Oropharyngeal pain, Retching, Tachycardia
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest discomfort, Cough, Dizziness, Dyspnoea
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Heart rate increased, Laboratory test, Myalgia, Nausea
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Swelling, White blood cell count increased, X-ray
Clinical narrative: 4/13: rapid heart rate; extreme nausea; shortness of breath; coughing; dizziness; headache treatment/outcome: epipen x2; benadryl IV;  ER monitoring; released 4/14: rapid heart rate; tightening of the chest/difficulty breathing; headaches; muscle pain; joint pain treatment/outcome:  benadryl IV; SoluMedrol; prochlorperazine; lorazepam; ER monitoring & released 4/15: swelling; coughing, headaches;  treatment/outcome: ER Visit - Triage, no admittance. Released.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Pyrexia
Clinical narrative: EXTREMELY TIRED; FEVER; This spontaneous report received from a patient concerned a 30 year 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced extremely tired. On 07-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100-101 F. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely tired, and fever. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: EXTREMELY TIRED; FEVER; This spontaneous report received from a patient concerned a 30 year 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced extremely tired. On 07-APR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 100-101 F. Treatment medications included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely tired, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Burning sensation, Chills, Headache
Clinical narrative: CHILLS; FEVER 103; FELT LIKE CRAP; FELT LIKE BODY WAS ON FIRE; BREATHING WAS BAD; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced felt like rubbish . On APR-2021, the subject experienced felt like body was on fire. On APR-2021, the subject experienced breathing was bad. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103, chills, felt like body was on fire, felt like rubbish and breathing was bad was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS; FEVER 103; FELT LIKE CRAP; FELT LIKE BODY WAS ON FIRE; BREATHING WAS BAD; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced felt like rubbish . On APR-2021, the subject experienced felt like body was on fire. On APR-2021, the subject experienced breathing was bad. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103, chills, felt like body was on fire, felt like rubbish and breathing was bad was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Feeling abnormal, Feeling hot
Clinical narrative: CHILLS; FEVER 103; FELT LIKE CRAP; FELT LIKE BODY WAS ON FIRE; BREATHING WAS BAD; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced felt like rubbish . On APR-2021, the subject experienced felt like body was on fire. On APR-2021, the subject experienced breathing was bad. On 02-APR-2021, the subject experienced chills. On 02-APR-2021, the subject experienced fever 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 103, chills, felt like body was on fire, felt like rubbish and breathing was bad was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Muscle spasms, Nausea, Pruritus
Clinical narrative: ITCHING EARS; ITCHING THROAT; PELVIC CRAMP; CHILLS; POUNDING HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced itching ears. On APR-2021, the subject experienced itching throat. On APR-2021, the subject experienced pelvic cramp. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching ears, itching throat, pelvic cramp, pounding headache and chills was not reported. This report was non-serious.