chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphonia, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 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: 206a21a, and batch number: 206A21A 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 trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Fluid intake reduced, Headache, Insomnia, Oropharyngeal pain
Clinical narrative: COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 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: 206a21a, and batch number: 206A21A 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 trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: COULD NOT DRINK WATER; LOSING HER VOICE/CANT SPEAK MORE; GETS SHORTNESS OF BREATH ON EXERTION; VERY ANXIOUS TO BE CONTACTED; HEAVINESS IN CHEST; HEADACHE; PAIN UNDERNEATH LEFT ARM; TROUBLE BREATHING,FELT LIKE GASPING FOR AIR,SHORTNESS OF BREATH/WINDED EASILY; PAIN IN RIGHT SIDE OF CHEST; TROUBLE SLEEPING; SORE THROAT; This spontaneous report received from a patient concerned a 52 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: 206a21a, and batch number: 206A21A 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 trouble sleeping. On 08-APR-2021, the subject experienced sore throat. On 09-APR-2021, the subject experienced trouble breathing, felt like gasping for air, shortness of breath/winded easily. On 09-APR-2021, the subject experienced pain in right side of chest. On 09-APR-2021, the subject experienced pain underneath left arm. On an unspecified date, the subject experienced could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted, heaviness in chest, and headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 12-APR-2021, had not recovered from pain in right side of chest, trouble breathing ,felt like gasping for air, shortness of breath/winded easily, pain underneath left arm, trouble sleeping, and headache, and the outcome of could not drink water, losing her voice/cant speak more, gets shortness of breath on exertion, very anxious to be contacted and heaviness in chest was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased, COVID-19 pneumonia, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear 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  20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. 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).  20210424651-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: HEART ATTACK; COVID-19 PNEUMONIA; SUSPECTED CLINICAL VACCINATION FAILURE; ELEVATED CREATININE; This spontaneous report received from a consumer concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart failure. He was sick two weeks prior to hospitalization due to congestive heart failure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, 1 total, administered in the beginning of MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included blood pressure and cholesterol medications. On 07-APR-2021, the patient went to the emergency room (ER) and was admitted to the hospital and was diagnosed with COVID-19 pneumonia and heart attack. He had suspected clinical vaccination failure. She reported of a positive COVID-19 test that was taken in the hospital and lab values showed everything as elevated. The reporter (daughter) also stated that her father had no issues with kidneys before but during hospitalization, he had elevated creatinine. During hospitalization, the patient received remdesevir, dexamethasone and was on heparin drip for first 4 days and was on bilevel positive airway pressure (BiPAP) machine and oxygen. He was stable and was going to be discharged from hospital later this afternoon on 13-APR-2021. He was hospitalized for 7 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart attack, and covid-19 pneumonia, and the outcome of elevated creatinine and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused).; Sender's Comments: 20210424651-covid-19 vaccine ad26.cov2.s-Heart attack. This event(s) is considered not related. The event(s) has an unknown/unclear 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  20210424651-covid-19 vaccine ad26.cov2.s- Covid19 Pneumonia. 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).  20210424651-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from a 53-year-old female patient. The patient's height, and weight were not reported. The patient had no known allergies and no medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805029, and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced dizziness. On 05-APR-2021, the patient experienced body aches and headache. Her treatment medication included Tylenol (paracetamol) (date unspecified). On 07-APR-2021, the patient recovered from body aches and on 08-APR-2021, she recovered from the headache. On 11-APR-2021, her COVID-19 antigen test was negative, following which a PCR (polymerase chain reaction) test was done. On 13-APR-2021, the PCR test showed a positive result (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210424819-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Conjunctival haemorrhage, Fatigue, Headache, Injection site pain
Clinical narrative: HEADACHE; INJECTION SITE PAIN; FATIGUE; SUBCONJUNCTIVAL HEMORRHAGE; This spontaneous report received from a consumer concerned a 56 year old male.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 21-MAR-2021  at right arm for prophylactic vaccination. No concomitant medications were reported.  On 21-MAR-2021, the patient had red left eye as per reporter who was HCP the patient experienced subconjunctival hemorrhage. The patient also experienced headache, injection site pain, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the subconjunctival hemorrhage, headache, injection site pain and fatigue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210424915 -COVID-19 VACCINE AD26.COV2.S- subconjunctival hemorrhage. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Coagulation time, Coagulation time shortened, Computerised tomogram, Dizziness, Eosinophil count increased
Clinical narrative: DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Magnetic resonance imaging, Malaise, Mean platelet volume
Clinical narrative: DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Pain, Pain in extremity, Platelet count increased, Swelling face
Clinical narrative: DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: DIZZINESS; FATIGUE; NOT FEELING WELL; ELEVATED PLATELETS; LOW CLOTTING TIME; ELEVATED EOSINOPHILS; LEFT SIDE PAIN STARTING FROM THE LEFT BREAST DOWN TO THE HIP; LEFT FACIAL SWELLING; FACIAL NUMBNESS; LEFT EYE TWITCHING; IMPAIRED VISION IN LEFT EYE; LEFT LEG NUMBNESS; LEFT ARM PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, and other pre-existing medical conditions included the patient was not diabetic, not on blood thinners prior to going to the hospital, and does not take thyroid medications. 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 to the left arm, on 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAR-2021, the subject experienced left side pain starting from the left breast down to the hip. On 27-MAR-2021, the subject experienced left facial swelling. On 27-MAR-2021, the subject experienced facial numbness. On 27-MAR-2021, the subject experienced left eye twitching. On 27-MAR-2021, the subject experienced impaired vision in left eye. On 27-MAR-2021, the subject experienced left leg numbness. On 27-MAR-2021, the subject experienced left arm pain. On 29-MAR-2021, the subject experienced elevated platelets. On 29-MAR-2021, the subject experienced low clotting time. On 29-MAR-2021, the subject experienced elevated eosinophils. On 29-MAR-2021, the subject experienced not feeling well. Laboratory data included: CT scan (NR: not provided) unknown, Clotting time (NR: not provided) LOW, Eosinophil count high (NR: not provided) UNKNOWN, MRI (NR: not provided) unknown, Mean platelet volume (NR: not provided) LOW, and Platelets increased (NR: not provided) 10 times above normal. On 30-MAR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side pain starting from the left breast down to the hip, facial numbness, left eye twitching, impaired vision in left eye, left arm pain, and fatigue on 2021, and dizziness on APR-2021, was recovering from left facial swelling, and not feeling well, had not recovered from left leg numbness, and the outcome of elevated platelets, elevated eosinophils and low clotting time was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arterial thrombosis, Fatigue, Hypoaesthesia, Lymphadenopathy, Pain in extremity
Clinical narrative: BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years 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 administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told  that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine.  On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER.  She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiopulmonary exercise test, Catheterisation cardiac, Computerised tomogram, Coronary artery disease, Echocardiogram
Clinical narrative: BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years 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 administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told  that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine.  On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER.  She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Microvascular coronary artery disease, Pain in extremity, Swelling
Clinical narrative: BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years 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 administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told  that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine.  On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER.  She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination.  Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT FOUND IN RADIAL ARTERY OF RIGHT ARM; SWELLING OF LYMPH NODES ON BOTH SIDES OF NECK; ARM SORENESS PROGRESSED TO ACHING OF RIGHT ARM; NUMB RIGHT ARM; FATIGUE; This spontaneous report was received from a patient and concerned a 51 years 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 administration not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 at her right arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, after receiving vaccine, the patient felt fatigue and right arm soreness where she got the vaccine. The arm soreness progressed to aching and numbness. On 01-APR-2021, the patient noticed swelling of lymph nodes on both sides of her neck. On the same day she was sent to emergency room (ER) and was told  that a blood clot was found in the radial artery of her right arm; diagnostic data not reported. She was given Plavix (clopidogrel) and sent home. On 06-APR-2021, the patient returned to ER because she was not feeling any improvement on her right arm, and it was still hurting. She was told that a surgery was planned to remove the clot but it was later cancelled. She was sent home on the same day with XARELTO (rivaroxaban). At the time of report, the patient had a pending appointment with a surgeon regarding the clot; no date was provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 19-MAR-2021, was recovering from arm soreness progressed to aching of right arm, and numb right arm, and had not recovered from blood clot found in radial artery of right arm, and swelling of lymph nodes on both sides of neck. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 51 years old female patient who had a blood clot in the radial artery of her right arm, 15 days after receiving Jansen COVID-19 vaccine.  On the same day of vaccination, patient experienced fatigue and right arm sore where she got the vaccine. The arm soreness progressed to aching and numbness. 15 days after vaccination, the patient noticed swelling of lymph nodes on both sides of her neck and was sent to ER.  She was told that a blood clot was found in the radial artery of her right arm (diagnostic data not reported) and was treated with Plavix and later with Xarelto. Based on the reported information, the causality of event blood clot in the radial artery of her right arm is considered plausible to the vaccination.  Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Stress at work
Clinical narrative: ULCERATIVE COLITIS FLARE; STRESSFUL TIME AT WORK; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported,1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On MAR-2021, the patient experienced ulcerative colitis flare and stressful time at work. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s, was not applicable. The patient was recovering from ulcerative colitis flare, and the outcome of stressful time at work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210425538-covid-19 vaccine ad26.cov2.s -Ulcerative colitis flare. This event(s) is considered not related. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autopsy, Chills, Death, General physical health deterioration
Clinical narrative: COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: COULD NOT MOVE AND WAS PARALYZED FOR 3 DAYS; HEART RACING; FOGGY; CHILLS; WEAKNESS/NOT HAVING THE STRENGTH; HIGH FEVER(NOT SPECIFIED); FATIGUE; This spontaneous report received from a consumer concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ovarian cancer 4 years ago., hay fever, non alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1865020, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced could not move and was paralyzed for 3 days. On 19-MAR-2021, the subject experienced heart racing. On 19-MAR-2021, the subject experienced foggy. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced weakness/not having the strength. On 19-MAR-2021, the subject experienced high fever (not specified). On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not move and was paralyzed for 3 days on 22-MAR-2021, had not recovered from fatigue, foggy, high fever(not specified), and heart racing, and the outcome of chills and weakness/not having the strength was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.