chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 15-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On an unspecified date, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441627.; Sender's Comments: V0: 20210440724 -covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Chest discomfort, Chills
Clinical narrative: POSSIBLE BLOOD CLOT; INCREASED HEART RATE; CHEST TIGHTNESS; HIGH BLOOD PRESSURE; NECK PAIN; ARM PAIN; HEAD PAIN; BODY SHAKING; CHILLS; HIP JOINT PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, osteoarthritis, fibromyalgia, non smoker, and non alcohol user. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14- MAR-2021, around 9 pm the patient experienced body shaking,   and chills for which she took Theraflu. On 15-MAR-2021, morning the patient experienced high blood pressure, chest tightness and increased heart rate of 156 BPM for which she went to the ER. She also experienced neck pain, arm pain and head pain. lung and chest examination was normal. Laboratory data included: Blood pressure (NR: not provided) increased, Fibrin D dimer (NR: not provided) 780, and Heart rate (NR: not provided) 156 pm. As the- d dimer test result was high, the doctor said she has a blood clot. She was given a shot of Toradol at the ER. On 17-MAR-2021, Laboratory data included: Fibrin D dimer (NR: not provided) 650. On 30-MAR-2021, She had another episode, she was in a lot of pain. She went back to ER. Laboratory data included: CAT scan (NR: not provided) normal. They sent her home and prescribed her Meloxicam. The patient went to see her Cardiologist after that, She stated that her cardiologist didn't do any blood work or mention anything regarding a blood clot.   Treatment medications (dates unspecified) included: ketorolac tromethamine, acetylsalicylic acid, meloxicam, and dextromethorphan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, chest tightness, increased heart rate, body shaking, chills, and  head and neck pain and arm pain on MAR-2021, had not recovered from hip joint pain, back pain, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Fibrin D dimer, Headache, Heart rate, Heart rate increased
Clinical narrative: POSSIBLE BLOOD CLOT; INCREASED HEART RATE; CHEST TIGHTNESS; HIGH BLOOD PRESSURE; NECK PAIN; ARM PAIN; HEAD PAIN; BODY SHAKING; CHILLS; HIP JOINT PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, osteoarthritis, fibromyalgia, non smoker, and non alcohol user. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14- MAR-2021, around 9 pm the patient experienced body shaking,   and chills for which she took Theraflu. On 15-MAR-2021, morning the patient experienced high blood pressure, chest tightness and increased heart rate of 156 BPM for which she went to the ER. She also experienced neck pain, arm pain and head pain. lung and chest examination was normal. Laboratory data included: Blood pressure (NR: not provided) increased, Fibrin D dimer (NR: not provided) 780, and Heart rate (NR: not provided) 156 pm. As the- d dimer test result was high, the doctor said she has a blood clot. She was given a shot of Toradol at the ER. On 17-MAR-2021, Laboratory data included: Fibrin D dimer (NR: not provided) 650. On 30-MAR-2021, She had another episode, she was in a lot of pain. She went back to ER. Laboratory data included: CAT scan (NR: not provided) normal. They sent her home and prescribed her Meloxicam. The patient went to see her Cardiologist after that, She stated that her cardiologist didn't do any blood work or mention anything regarding a blood clot.   Treatment medications (dates unspecified) included: ketorolac tromethamine, acetylsalicylic acid, meloxicam, and dextromethorphan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, chest tightness, increased heart rate, body shaking, chills, and  head and neck pain and arm pain on MAR-2021, had not recovered from hip joint pain, back pain, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Neck pain, Pain in extremity, Thrombosis, Tremor
Clinical narrative: POSSIBLE BLOOD CLOT; INCREASED HEART RATE; CHEST TIGHTNESS; HIGH BLOOD PRESSURE; NECK PAIN; ARM PAIN; HEAD PAIN; BODY SHAKING; CHILLS; HIP JOINT PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, osteoarthritis, fibromyalgia, non smoker, and non alcohol user. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, 1 total, administered on right arm on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14- MAR-2021, around 9 pm the patient experienced body shaking,   and chills for which she took Theraflu. On 15-MAR-2021, morning the patient experienced high blood pressure, chest tightness and increased heart rate of 156 BPM for which she went to the ER. She also experienced neck pain, arm pain and head pain. lung and chest examination was normal. Laboratory data included: Blood pressure (NR: not provided) increased, Fibrin D dimer (NR: not provided) 780, and Heart rate (NR: not provided) 156 pm. As the- d dimer test result was high, the doctor said she has a blood clot. She was given a shot of Toradol at the ER. On 17-MAR-2021, Laboratory data included: Fibrin D dimer (NR: not provided) 650. On 30-MAR-2021, She had another episode, she was in a lot of pain. She went back to ER. Laboratory data included: CAT scan (NR: not provided) normal. They sent her home and prescribed her Meloxicam. The patient went to see her Cardiologist after that, She stated that her cardiologist didn't do any blood work or mention anything regarding a blood clot.   Treatment medications (dates unspecified) included: ketorolac tromethamine, acetylsalicylic acid, meloxicam, and dextromethorphan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure, chest tightness, increased heart rate, body shaking, chills, and  head and neck pain and arm pain on MAR-2021, had not recovered from hip joint pain, back pain, and the outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-possible blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Dizziness, Dyspnoea, Fatigue
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; BODY ACHES; SORE THROAT; COUGH; JOINT PAIN; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD, asthma, and sensitive to drugs, and other pre-existing medical conditions included patient was sensitive to vitamins.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, light headed, body aches, sore throat, cough, joint pain, fatigue, and headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: SHORTNESS OF BREATH; LIGHT HEADED; BODY ACHES; SORE THROAT; COUGH; JOINT PAIN; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD, asthma, and sensitive to drugs, and other pre-existing medical conditions included patient was sensitive to vitamins.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 16-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced light headed. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced sore throat. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, light headed, body aches, sore throat, cough, joint pain, fatigue, and headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Chest X-ray, Culture, Culture throat, Echocardiogram
Clinical narrative: CONFIRMED COVID-19 INFECTION; PASSED OUT TWO TO THREE TIMES; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included alcohol use, and concurrent conditions included high blood pressure, and  patient had no known allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 08-MAR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included valsartan for high blood pressure.  On MAR-2021, the patient passed out two to three times. On 17-MAR-2021, the patient experienced shortness of breath, cough, fatigue, taste changed. On 18-MAR-2021, patient tested positive for covid 19 (coded as confirmed covid-19 infection). On 18-MAR-2021, patient had nasal swab test, mouth swab test, and covid 19 test (result was positive). On 19-MAR-2021, patient had chest X-ray, heart ultrasound and electrocardiogram and there was no problem as per result.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the confirmed covid-19 infection and passed out two to three times was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210441069-covid-19 vaccine ad26.cov2.s-Passed out two to three times, confirmed COVID 19 . 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: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Electrocardiogram, Loss of consciousness, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; PASSED OUT TWO TO THREE TIMES; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included alcohol use, and concurrent conditions included high blood pressure, and  patient had no known allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 08-MAR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included valsartan for high blood pressure.  On MAR-2021, the patient passed out two to three times. On 17-MAR-2021, the patient experienced shortness of breath, cough, fatigue, taste changed. On 18-MAR-2021, patient tested positive for covid 19 (coded as confirmed covid-19 infection). On 18-MAR-2021, patient had nasal swab test, mouth swab test, and covid 19 test (result was positive). On 19-MAR-2021, patient had chest X-ray, heart ultrasound and electrocardiogram and there was no problem as per result.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the confirmed covid-19 infection and passed out two to three times was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210441069-covid-19 vaccine ad26.cov2.s-Passed out two to three times, confirmed COVID 19 . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Retinal artery occlusion, Visual acuity reduced
Clinical narrative: BLINDNESS; RETINAL ARTERY OCCLUSION; VISUAL ACUITY REDUCED; This spontaneous report received from a healthcare professional via VAERS (Vaccine Adverse Event Reporting System, VAERS ID 1201402-1) concerned an 82 year old female. Initial information was processed with additional information received from VAERS on 23-APR-2021. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and anatomical vaccination site was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 20-MAR-2021, the subject experienced blindness in both eyes, retinal artery occlusion and visual acuity reduced (no light perception in the right and counting fingers in the left). She went to the emergency room and was hospitalized.  Work up for other causes (not further specified) was reported as negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness in both eyes, retinal artery occlusion and visual acuity reduced. This report was serious (Hospitalization Caused / Prolonged, Disability Or Permanent Damage).; Sender's Comments: V0:  This 82-year-old female patient of unspecified ethnicity was hospitalized for blindness in both eyes, retinal artery occlusion and visual acuity reduced (no light perception in the right and counting fingers in the left) 14 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: BODY ACHE; CHILLS; NAUSEA; HEADACHE; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body ache, chills, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, nausea, and headache. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood triglycerides, Coronary artery occlusion, Myocardial infarction
Clinical narrative: MYOCARDIAL  INFARCTION; CORONARY ARTERY OCCLUSION; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's past medical history included sinus infection, fever, and left anterior descending artery blockage, and concurrent conditions included increased triglyceride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 at 13:00 to left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included eicosapentaenoic acid ethyl ester used for unknown indication. On 24-MAR-2021 19:10, the patient experienced myocardial infarction, and was hospitalized (date unspecified). On 24-MAR-2021 19:10, the patient experienced coronary artery occlusion. It was reported that on 11-MAR-2021 at 17:00, the patient played basketball for 50 minutes and he had no medical issues. On 25-MAR-2021 at 19:10 the patient played basketball for 30 minutes and he had heart attack with a coronary artery LAD 100% blockage and was treated with a stent procedure right after a visit to the emergency room.  Laboratory data (dates unspecified) included: Triglycerides (NR: not provided) Increased (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from myocardial infarction, and coronary artery occlusion. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-Myocardial infarction, coronary artery occlusion. 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: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Joint swelling, Ultrasound Doppler
Clinical narrative: SWOLLEN LEFT ANKLE (DOUBLE IN SIZE); This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic type 1 with insulin pump, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Not reported, and Doppler ultrasound (NR: not provided) Not reported. On MAR-2021, the subject experienced swollen left ankle (double in size). On 15-MAR-2021, treatment medications included: furosemide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen left ankle (double in size). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: PREMATURE VENTRICULAR CONTRACTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-APR-2021, the patient experienced premature ventricular contraction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of premature ventricular contraction was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: FEELING LIKE COVID SYMPTOMS; This spontaneous report received from a parent concerned a male 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, and batch number were not reported) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced feeling like covid-19 symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling like covid-19 symptoms. This report was non-serious. This case, from the same reporter is linked to 20210438886.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Haemorrhage urinary tract, Pain in extremity, Somnolence
Clinical narrative: BLOOD IN URINE; BLOOD CLOTS IN URINE; SLEEPY; SORE ARM; This spontaneous report received from a patient concerned a male 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: 1808609, expiry: 09-Jun-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the patient got the shot experienced sore arm. On 01-APR-2021, at morning he was very sleepy. On 21-APR-2021, the patient went to the bathroom he had blood in urine and again he noticed there were some clots in the urine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and sleepy, and had not recovered from blood in urine, and blood clots in urine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s.Blood clot in urine and blood in urine. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Blood pressure measurement, Blood test, Dizziness, Electrocardiogram
Clinical narrative: HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hypertension, Monoplegia
Clinical narrative: HIGH BLOOD PRESSURE; BRAIN FOG; FATIGUE; ANAPHYLACTIC SHOCK; PARALYSIS IN LEFT HAND; LIGHTHEADED; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic, and other pre-existing medical conditions included the patient had no known drug or non-drug allergies. The patient had no illness 30 days prior to vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) 1 total dose was administered at left arm on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021 at 14:35, the patient immediately felt tingling in left arm (like ben gay) after vaccination, 10 minutes later he felt tingling in neck and cheek. His left hand turned purple. He became unconscious (he did not remember anything). He had cardiac arrest (patient remembers yelling code). He was taken to emergency room. He thought people in emergency room said anaphylactic shock and gave him epinephrine (patient was not sure). He had paralysis in left hand when he woke up for a few minutes. His blood test and Electrocardiogram were normal. He went home in couple of hours (on 31-MAR-2021). On 02-APR-2021 (two days later) he was light-headed, he went to his doctor. His blood pressure was high, he felt little bit of fatigue and brain fog.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheaded, anaphylactic shock, paralysis in left hand, high Blood pressure, fatigue, and brain fog. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210443005-covid-19 vaccine ad26.cov2.s- anaphylactic shock, paralysis in left hand. 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: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Dyspnoea, Epistaxis
Clinical narrative: SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN  REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. 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 event.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemorrhage, Hot flush, Memory impairment, Muscle spasms
Clinical narrative: SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN  REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. 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 event.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasopharyngitis, Nausea, Neck pain, Pharyngeal swelling
Clinical narrative: SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN  REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. 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 event.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Sensation of blood flow
Clinical narrative: SINUS ACTING UP; HOT FLASHES; LEG CRAMPS; LOOSE BOWELS; DIFFICULTY IN  REMEMBERING; SWELLING INSIDE THROAT; ACHINESS ON SIDES OF NECK; DIZZINESS; NOSE BLEED; ACHINESS ON INSIDE OF LEFT ELBOW AND RIGHT KNEE; NAUSEA; TIREDNESS; MUSCLE ACHES; BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA; SHORTNES OF BREATH; FEELING OF BLOOD RUSHING TO HEAD; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfonamide derivatives, non-steroidal anti-inflammatory drugs (NSAIDs), sulfa antibiotics, penicillin, and cephalexin, asthma, and dry eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 06-APR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 06-APR-2021, the patient felt rush of blood to her head almost causing her to pass out. On 07-Apr-2021 (in morning), she developed muscle aches, shortness of breath, a nosebleed one and hot flashes. She experienced trouble while remembering which was never a problem before. She developed leg cramps, loose bowels (for 1 week), swelling in her throat, achiness on both sides of her neck, dizziness, nausea if she ate something that did not agree with her, tiredness and an unusual blood stain in her underwear near the groin area (but not the private parts). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood present on underwear near the groin area, nose bleed, and achiness on inside of left elbow and right knee on 07-APR-2021, feeling of blood rushing to head, sinus acting up, leg cramps, swelling inside throat, and achiness on sides of neck, loose bowels on 14-APR-2021, dizziness on 11-APR-2021, and nausea on 09-APR-2021, was recovering from muscle aches, and had not recovered from shortness of breath, hot flashes, difficulty in remembering, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid-19 vaccine ad26.cov2.s-BLOOD PRESENT ON UNDERWEAR NEAR THE GROIN AREA. 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 event.
Sex: F
Vaccine: COVID19
Symptoms: Death, Hospitalisation
Clinical narrative: HOSPITALIZATION; DEATH; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 01 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  After receiving the vaccine, on an unspecified date, the patient was hospitalized. The patient died after 6 days of hospitalization. The reason of death was unknown. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fatal. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Hospitalization. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, SARS-CoV-2 test, Thrombosis
Clinical narrative: COVID-19; BRONCHITIS; This spontaneous report received from a consumer (patient's husband) concerned a 43 year old female. The patient's height, and weight were not reported. The patient was not pregnant at the time of report.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered at Left Deltoid on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient was given a dose of the vaccine and she did not show up. On next day 10-APR-2021, she started shivering very badly and was feverish. On 11-APR-2021, the patient also had a headache. On 12-APR-2021, all symptoms gone. The next day on 13-APR-2021 when she got up she had chest tightness and went to doctor due to fever, chills, headache resumed. Since that day was the clot information in the news and they did testing for clot stuff which was all negative. Also the patient diagnosed with bronchitis. After the 13th she had 'on/off' days of experiencing symptoms. On 16-APR-2021, she tested for covid-19 via 'non-rapid' test and the results of test came on the 17th were positive for covid-19 (diarrhea, vomiting, chest tightness, shivering, chills, headache, feverish and nausea). On 17-APR-2021, she developed diarrhea and vomiting. By the 19-APR-2021, they went to the hospital where she received unspecified fluids and pain pills for the fever and to calm her down.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bronchitis and covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210443606 - Covid-19 vaccine ad26.cov2.s-Covid 19. 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 event.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative . 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: Unk) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: TROUBLE BREATHING; NECK PAIN; BLURRY VISION; DIARRHEA; DIZZINESS; COUGH; FEEL SICK; WEAKNESS; NAUSEA; ALLERGIES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included she had no history of allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced allergies. On 11-APR-2021, the subject experienced cough. On 11-APR-2021, the subject experienced feel sick. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced neck pain. On 15-APR-2021, the subject experienced blurry vision. On 17-APR-2021, the subject experienced trouble breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, dizziness, neck pain, blurry vision, trouble breathing, cough, allergies, nausea, diarrhea, and feel sick. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.