chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Mobility decreased, Pain, Pyrexia, Seizure
Clinical narrative: WOKE UP WITH PAIN AROUND 5-6 INCH BELOW BELLY BUTTON; HEART BEAT LIKE PAIN; LEFT LEG MIDDLE OF CALF FEELS LIKE CRAMP; BLURRY VISION; FELT PRESSURE BEHIND BOTH  EYES; PAIN IN RIGHT HAND JOINTS FROM SHOULDER BLADE TO MIDDLE FOREARM; SHARP PAIN IN KNUCKLE; FULL BODY CHILLS; HEADACHE; BODY PAIN; SPINE HURTING BAD; CONVULSION; DIFFICULT TO TURN OVER; FEVER; This spontaneous report received from a patient concerned a 30 year old white and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 07-APR-2021 14:16 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination patient had no issues for 12 to 14 hours. On 08-APR-2021, the patient experienced convulsion, body shaking, difficult to turn over, spine hurting bad, and fever. On 08-APR-2021 03:00, the patient experienced full body chills, headache and body pain. On 08-APR-2021 01:00, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 08-APR-2021 19:00, treatment medications included: ibuprofen. On 10-APR-2021, the patient experienced sharp pain in knuckle, pain in right hand joints from shoulder blade to middle forearm. On 12-APR-2021 17:10, the patient experienced blurry vision, felt pressure behind both eyes. On 13-APR-2021, the patient experienced left leg middle of calf feels like cramp, heart beat like pain. On 13-APR-2021 08:00, the patient experienced woke up with pain around 5-6 inch below belly button. Laboratory data on 08-APR-2021 included: Body temperature (NR: not provided) 100.5 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from woke up with pain around 5-6 inch below belly button, body pain, pain in right hand joints from shoulder blade to middle forearm, and headache on APR-2021, and the outcome of full body chills, fever, convulsion, difficult to turn over, sharp pain in knuckle, blurry vision, felt pressure behind both eyes, left leg middle of calf feels like cramp, spine hurting bad and heart beat like pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425698-covid-19 vaccine ad26.cov2.s-convulsion. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal pain, Tremor
Clinical narrative: WOKE UP WITH PAIN AROUND 5-6 INCH BELOW BELLY BUTTON; HEART BEAT LIKE PAIN; LEFT LEG MIDDLE OF CALF FEELS LIKE CRAMP; BLURRY VISION; FELT PRESSURE BEHIND BOTH  EYES; PAIN IN RIGHT HAND JOINTS FROM SHOULDER BLADE TO MIDDLE FOREARM; SHARP PAIN IN KNUCKLE; FULL BODY CHILLS; HEADACHE; BODY PAIN; SPINE HURTING BAD; CONVULSION; DIFFICULT TO TURN OVER; FEVER; This spontaneous report received from a patient concerned a 30 year old white and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 07-APR-2021 14:16 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination patient had no issues for 12 to 14 hours. On 08-APR-2021, the patient experienced convulsion, body shaking, difficult to turn over, spine hurting bad, and fever. On 08-APR-2021 03:00, the patient experienced full body chills, headache and body pain. On 08-APR-2021 01:00, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 08-APR-2021 19:00, treatment medications included: ibuprofen. On 10-APR-2021, the patient experienced sharp pain in knuckle, pain in right hand joints from shoulder blade to middle forearm. On 12-APR-2021 17:10, the patient experienced blurry vision, felt pressure behind both eyes. On 13-APR-2021, the patient experienced left leg middle of calf feels like cramp, heart beat like pain. On 13-APR-2021 08:00, the patient experienced woke up with pain around 5-6 inch below belly button. Laboratory data on 08-APR-2021 included: Body temperature (NR: not provided) 100.5 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from woke up with pain around 5-6 inch below belly button, body pain, pain in right hand joints from shoulder blade to middle forearm, and headache on APR-2021, and the outcome of full body chills, fever, convulsion, difficult to turn over, sharp pain in knuckle, blurry vision, felt pressure behind both eyes, left leg middle of calf feels like cramp, spine hurting bad and heart beat like pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425698-covid-19 vaccine ad26.cov2.s-convulsion. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Arthralgia, Body temperature, Chest pain, Chills
Clinical narrative: WOKE UP WITH PAIN AROUND 5-6 INCH BELOW BELLY BUTTON; HEART BEAT LIKE PAIN; LEFT LEG MIDDLE OF CALF FEELS LIKE CRAMP; BLURRY VISION; FELT PRESSURE BEHIND BOTH  EYES; PAIN IN RIGHT HAND JOINTS FROM SHOULDER BLADE TO MIDDLE FOREARM; SHARP PAIN IN KNUCKLE; FULL BODY CHILLS; HEADACHE; BODY PAIN; SPINE HURTING BAD; CONVULSION; DIFFICULT TO TURN OVER; FEVER; This spontaneous report received from a patient concerned a 30 year old white and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 07-APR-2021 14:16 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination patient had no issues for 12 to 14 hours. On 08-APR-2021, the patient experienced convulsion, body shaking, difficult to turn over, spine hurting bad, and fever. On 08-APR-2021 03:00, the patient experienced full body chills, headache and body pain. On 08-APR-2021 01:00, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 08-APR-2021 19:00, treatment medications included: ibuprofen. On 10-APR-2021, the patient experienced sharp pain in knuckle, pain in right hand joints from shoulder blade to middle forearm. On 12-APR-2021 17:10, the patient experienced blurry vision, felt pressure behind both eyes. On 13-APR-2021, the patient experienced left leg middle of calf feels like cramp, heart beat like pain. On 13-APR-2021 08:00, the patient experienced woke up with pain around 5-6 inch below belly button. Laboratory data on 08-APR-2021 included: Body temperature (NR: not provided) 100.5 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from woke up with pain around 5-6 inch below belly button, body pain, pain in right hand joints from shoulder blade to middle forearm, and headache on APR-2021, and the outcome of full body chills, fever, convulsion, difficult to turn over, sharp pain in knuckle, blurry vision, felt pressure behind both eyes, left leg middle of calf feels like cramp, spine hurting bad and heart beat like pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425698-covid-19 vaccine ad26.cov2.s-convulsion. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Mobility decreased, Muscle spasms, Ocular discomfort, Pain
Clinical narrative: WOKE UP WITH PAIN AROUND 5-6 INCH BELOW BELLY BUTTON; HEART BEAT LIKE PAIN; LEFT LEG MIDDLE OF CALF FEELS LIKE CRAMP; BLURRY VISION; FELT PRESSURE BEHIND BOTH  EYES; PAIN IN RIGHT HAND JOINTS FROM SHOULDER BLADE TO MIDDLE FOREARM; SHARP PAIN IN KNUCKLE; FULL BODY CHILLS; HEADACHE; BODY PAIN; SPINE HURTING BAD; CONVULSION; DIFFICULT TO TURN OVER; FEVER; This spontaneous report received from a patient concerned a 30 year old white and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 07-APR-2021 14:16 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination patient had no issues for 12 to 14 hours. On 08-APR-2021, the patient experienced convulsion, body shaking, difficult to turn over, spine hurting bad, and fever. On 08-APR-2021 03:00, the patient experienced full body chills, headache and body pain. On 08-APR-2021 01:00, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 08-APR-2021 19:00, treatment medications included: ibuprofen. On 10-APR-2021, the patient experienced sharp pain in knuckle, pain in right hand joints from shoulder blade to middle forearm. On 12-APR-2021 17:10, the patient experienced blurry vision, felt pressure behind both eyes. On 13-APR-2021, the patient experienced left leg middle of calf feels like cramp, heart beat like pain. On 13-APR-2021 08:00, the patient experienced woke up with pain around 5-6 inch below belly button. Laboratory data on 08-APR-2021 included: Body temperature (NR: not provided) 100.5 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from woke up with pain around 5-6 inch below belly button, body pain, pain in right hand joints from shoulder blade to middle forearm, and headache on APR-2021, and the outcome of full body chills, fever, convulsion, difficult to turn over, sharp pain in knuckle, blurry vision, felt pressure behind both eyes, left leg middle of calf feels like cramp, spine hurting bad and heart beat like pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425698-covid-19 vaccine ad26.cov2.s-convulsion. 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Seizure, Spinal pain, Vision blurred
Clinical narrative: WOKE UP WITH PAIN AROUND 5-6 INCH BELOW BELLY BUTTON; HEART BEAT LIKE PAIN; LEFT LEG MIDDLE OF CALF FEELS LIKE CRAMP; BLURRY VISION; FELT PRESSURE BEHIND BOTH  EYES; PAIN IN RIGHT HAND JOINTS FROM SHOULDER BLADE TO MIDDLE FOREARM; SHARP PAIN IN KNUCKLE; FULL BODY CHILLS; HEADACHE; BODY PAIN; SPINE HURTING BAD; CONVULSION; DIFFICULT TO TURN OVER; FEVER; This spontaneous report received from a patient concerned a 30 year old white and Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included 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, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 07-APR-2021 14:16 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, after vaccination patient had no issues for 12 to 14 hours. On 08-APR-2021, the patient experienced convulsion, body shaking, difficult to turn over, spine hurting bad, and fever. On 08-APR-2021 03:00, the patient experienced full body chills, headache and body pain. On 08-APR-2021 01:00, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 08-APR-2021 19:00, treatment medications included: ibuprofen. On 10-APR-2021, the patient experienced sharp pain in knuckle, pain in right hand joints from shoulder blade to middle forearm. On 12-APR-2021 17:10, the patient experienced blurry vision, felt pressure behind both eyes. On 13-APR-2021, the patient experienced left leg middle of calf feels like cramp, heart beat like pain. On 13-APR-2021 08:00, the patient experienced woke up with pain around 5-6 inch below belly button. Laboratory data on 08-APR-2021 included: Body temperature (NR: not provided) 100.5 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from woke up with pain around 5-6 inch below belly button, body pain, pain in right hand joints from shoulder blade to middle forearm, and headache on APR-2021, and the outcome of full body chills, fever, convulsion, difficult to turn over, sharp pain in knuckle, blurry vision, felt pressure behind both eyes, left leg middle of calf feels like cramp, spine hurting bad and heart beat like pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210425698-covid-19 vaccine ad26.cov2.s-convulsion. 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: U
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Computerised tomogram, Dyspnoea, Fibrin D dimer, Pain in extremity
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a company representative via social media post and 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: Unknown) dose, start therapy date were not reported, one total dose is administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient reported via social media to have blood clots and to have received the COVID-19 vaccine ad26.cov2.s. No other information provided. There is insufficient information to make a meaningful assessment. Additional information will be requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Ultrasound scan, X-ray
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a company representative via social media post and 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: Unknown) dose, start therapy date were not reported, one total dose is administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient reported via social media to have blood clots and to have received the COVID-19 vaccine ad26.cov2.s. No other information provided. There is insufficient information to make a meaningful assessment. Additional information will be requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a company representative via social media post and 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: Unknown) dose, start therapy date were not reported, one total dose is administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested.  No concomitant medications were reported.  On an unspecified date, the subject experienced blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient reported via social media to have blood clots and to have received the COVID-19 vaccine ad26.cov2.s. No other information provided. There is insufficient information to make a meaningful assessment. Additional information will be requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Thrombosis, Ultrasound Doppler
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Chills, Computerised tomogram, Electrocardiogram, Injection site pain
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident, Chills, Computerised tomogram head normal, Discomfort, Dizziness
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance, Headache, Magnetic resonance imaging head abnormal
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Pain, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Argininosuccinate lyase deficiency, Computerised tomogram head, Ischaemic stroke, Magnetic resonance imaging, Muscular weakness
Clinical narrative: ACUTE ISCHEMIC STROKE; BLOOD CLOT IN LEFT FRONTAL LOBE; CHILLS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a white, not hispanic 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: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in APR-2021 the patient's laboratory data included: CT scan (computed tomography scan), EKG (electrocardiography), MRI (magnetic resonance imaging) (NR: not provided) resulted in stroke/blood clot in the left frontal lobe. The patient experienced acute ischemic stroke on 08-APR-2021 and experienced blood clot in left frontal lobe on an unspecified date in APR-2021. On 08-APR-2021, the patient experienced injection site pain at first and felt ok until she went to sleep. In the middle of the night on 08-APR-2021, the patient experienced headache, chills, nausea and then on 09-APR-2021 and 10-APR-2021, the patient experienced brain fog and a headache. On 11-APR-2021, the patient had no change and sat down to have coffee, when she stood up she was dizzy and had no strength in her right leg and right side of the body. She could not walk and called her healthcare professional and went to the emergency room. The patient was hospitalized on 11-Apr-2021 and was discharged on 12-Apr-2021. The patient was hospitalized for 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left frontal lobe, and acute ischemic stroke, and the outcome of chills and injection site pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a female patient, unspecified age, unspecified ethnicity, who experienced headache and brain fog 2 days after receiving the Janssen COVID-19.  Medical, smoking, and alcohol history and concomitant medications were not reported. Height and weight were not reported. Almost 1 day after receiving the vaccine, the patient experienced headache, chills and nausea. The condition progressed the following day to having brain fog and headache. 3rd day after receiving the vaccine, patient experienced dizziness when standing up, feeling weakness on the right side of the body and  right leg. She sought consult with HCP and went to the ER, where  EKG, MRI and CT Scan (actual results not provided) done revealed blood clot in the left frontal lobe suggestive of acute ischemic stroke. Based on the available information, this is assessed as indterminate per WHO causality classification of adverse events following immunization. Additional information requested.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Electrocardiogram, Heart rate increased, International normalised ratio decreased, Laboratory test
Clinical narrative: ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. 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, UNDERLYING DISEASE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Sinus tachycardia, Vascular device user
Clinical narrative: ELEVATED HEART RATE; CHEST PAIN; FELT FAINT; BODY ACHES; STOMACH UPSET; DIARRHEA; FELT JITTERY; HEADACHE; NAUSEA; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 55 year old white male. The patient's height, and weight were not reported. The patient's past medical history included both knees replacement, both hips replacement, and heart attack, and concurrent conditions included heart problems, circulation problems, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 at 10:15 to left arm for prophylactic vaccination. Concomitant medications included warfarin (5mg) for blood thinner, atorvastatin (80mg), baclofen (10mg), furosemide (40mg, 1 to 2 daily), glyceryl trinitrate, losartan (25mg), midodrine (5mg), oxycodone hydrochloride/paracetamol, potassium, and promethazine (25mg). On 08-APR-2021, the patient had heart rate issue after 45 minutes of vaccine administration, while driving to home and went to sleep for 2 hours. The patient felt faint, body aches, stomach upset, diarrhea, headache, nausea, sore arm at injection site and felt jittery. He told vaccination provider that he was on a blood thinner (warfarin 5mg), and had heart and circulation problems. He also took lorazepam (1mg) as treatment for jitters, which was not helpful for it. His heart rate had been fluctuating down to low 70's and up to 100's since he received the vaccine. On 09-APR-2021, he called his nurse about heart rate and nurse advised him to visit to emergency room (ER) if he experience chest pains. On 10-Apr-2021 at 09:00, the patient visited emergency room due to worsening of the elevated heart rate, and chest pain. The patient felt like he had another heart attack. The patient was admitted to the cardiac floor and medicine was provided to stabilize the heart rate. The patient was hospitalized for 2 days and discharged on 11-APR-2021 with the improvement of heart rate on prescribed medicines and advised if heart rate passed 90 to 100 to went back or felt flutter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt faint, body aches, stomach upset, diarrhea, nausea, and sore arm at injection site on 10-APR-2021, was recovering from elevated heart rate, had not recovered from headache, and felt jittery, and the outcome of chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210420626-covid-19 vaccine ad26.cov2.s-Elevated heart rate, Chest pain. 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, UNDERLYING DISEASE