chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Disseminated varicella zoster virus infection, Headache
Clinical narrative: HERPES ZOSTER DISSEMINATED; STOMACH/ABDOMINAL PAIN; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chicken pox as a child.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: unknown) dose was not reported,1 total administered on 06-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, the patient experienced headache. On 21-APR-2021,the patient experienced stomach/abdominal pain and it was for two days. On 23-APR-2021, the patient broke out in a rash/shingles/herpes zoster/chickenpox all over legs, inner and outer thighs and in front part of stomach and arms. The patient visited the emergency room was diagnosed with herpes Zoster disseminated. The patient was prescribed with Valaciclovir for the rash and the rash was improving. The patient was waiting for the appointment with the rheumatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach/abdominal pain, and headache on 22-APR-2021, and was recovering from herpes zoster disseminated. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210454708-covid-19 vaccine ad26.cov2.s-herpes zoster disseminated . 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Spinal pain
Clinical narrative: PAIN IN THE TERMINAL END OF SPINAL CORD; SWELLING OF THE RIGHT PELVIC LYMPH NODE; This spontaneous report received from a patient concerned a 76 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, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced swelling of the right pelvic lymph node. On 06-APR-2021, the subject experienced pain in the terminal end of spinal cord. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the terminal end of spinal cord on APR-2021, and had not recovered from swelling of the right pelvic lymph node. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Feeling hot, Hypoaesthesia, Pruritus
Clinical narrative: LEG NUMBNESS; ITCHING ON LEGS AND RIGHT ARM; REDNESS ON LEGS; LEGS(FEET TO ABOVE KNEE AREA) HOT TO TOUCH; BURNING SENSATION; RASH ON RIGHT ARM AND BOTH LEGS; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, the subject experienced leg numbness. On 26-APR-2021, the subject experienced itching on legs and right arm. On 26-APR-2021, the subject experienced redness on legs. On 26-APR-2021, the subject experienced legs (feet to above knee area) hot to touch. On 26-APR-2021, the subject experienced burning sensation. On 26-APR-2021, the subject experienced rash on right arm and both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg numbness, itching on legs and right arm, redness on legs, burning sensation, and rash on right arm and both legs, and the outcome of legs(feet to above knee area) hot to touch was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: LEG NUMBNESS; ITCHING ON LEGS AND RIGHT ARM; REDNESS ON LEGS; LEGS(FEET TO ABOVE KNEE AREA) HOT TO TOUCH; BURNING SENSATION; RASH ON RIGHT ARM AND BOTH LEGS; 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: 1808980, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-APR-2021, the subject experienced leg numbness. On 26-APR-2021, the subject experienced itching on legs and right arm. On 26-APR-2021, the subject experienced redness on legs. On 26-APR-2021, the subject experienced legs (feet to above knee area) hot to touch. On 26-APR-2021, the subject experienced burning sensation. On 26-APR-2021, the subject experienced rash on right arm and both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg numbness, itching on legs and right arm, redness on legs, burning sensation, and rash on right arm and both legs, and the outcome of legs(feet to above knee area) hot to touch was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Bursitis, Electrocardiogram, Fatigue, Hypertension
Clinical narrative: INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and 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 blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mouth swelling, Nausea, Psychomotor hyperactivity, Ultrasound scan
Clinical narrative: INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and 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 blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, X-ray
Clinical narrative: INCREASED BLOOD PRESSURE; SEVERE BURSITIS; TIREDNESS; BLURRY VISION; NUMBNESS ON LEFT SIDE OF FACE AND NECK; SWELLING ON INSIDE OF MOUTH; ANXIETY; FEELING WIRED; NAUSEA; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, and migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: JJ1805029, and 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 blurry vision. On 08-APR-2021, the subject experienced numbness on left side of face and neck. On 08-APR-2021, the subject experienced swelling on inside of mouth. On 08-APR-2021, the subject experienced anxiety. On 08-APR-2021, the subject experienced feeling wired. On 08-APR-2021, the subject experienced nausea. On 09-APR-2021, the subject experienced tiredness. On 25-APR-2021, the subject experienced increased blood pressure. On 25-APR-2021, the subject experienced severe bursitis (arm felt as bugs biting the arm). Laboratory data included: Diagnostic ultrasound (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), EKG (NR: not provided) diagnosed with a severe case of bursitis (units unspecified), and X-ray (NR: not provided) diagnosed with a severe case of bursitis (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, increased blood pressure, and nausea on APR-2021, and tiredness on 11-APR-2021, had not recovered from numbness on left side of face and neck, and swelling on inside of mouth, and the outcome of severe bursitis (arm felt as bugs biting the arm), anxiety and feeling wired was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Platelet count, Ultrasound Doppler
Clinical narrative: DEEP VEIN THROMBOSIS IN RIGHT LEG (PAIN AND SWELLING); This spontaneous report received from a physician concerned a 69 year old White and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included arterial fibrillation, and sedentary lifestyle.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, frequency 1 total, administered on 11-APR-2021 at left arm for prophylactic vaccination. Concomitant medications included apixaban for chronic atrial fibrillation. It was stated by internist that, on 26-APR-2021, the patient experienced deep vein thrombosis in right leg with symptoms pain and swelling, and was hospitalized on unspecified date. On unspecified date doctor was screening patient for covid-19 infection. On 27-APR-2021, Laboratory data included: Platelet count (NR: not provided) 167000. Laboratory data (dates unspecified) included: Duplex ultrasound (NR: not provided) definite clot in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis in right leg (pain and swelling) was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210455157-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep vein thrombosis. 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.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Nausea, Pain
Clinical narrative: ACHES; SLEEPLESS; CHILLS; JOINT PAIN; HIGH FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. 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. 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 aches, sleepless, chills, joint pain, high fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pain, sleepless, high fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ACHES; SLEEPLESS; CHILLS; JOINT PAIN; HIGH FEVER; NAUSEA; This spontaneous report received from a consumer concerned multiple patients. 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. 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 aches, sleepless, chills, joint pain, high fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, aches, joint pain, sleepless, high fever and nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210451296.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN LEG; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the subject experienced numbness in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in leg was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: LOW GRADE FEVER; MUSCLE ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 low grade fever, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever and muscle ache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: FATIGUE; 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: Unknown) 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 fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue. This report was non-serious. This case, from the same reporter is linked to 20210453743.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Thrombosis
Clinical narrative: BLOOD CLOT; SEVERE HEADACHE/ FEEL LIKE A CAP ON HER HEAD; This spontaneous report received from a consumer 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 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot, and severe headache/ felt like a cap on her head. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe headache/ feel like a cap on her head and blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: AER 20210455412-Covid-19 vaccine ad26.cov2.s-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: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Muscle spasms, Pain, Pyrexia
Clinical narrative: EXTREME BODY ACHE; CRAY LEG CRAMP; FEVER; 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. 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 extreme body ache, cray leg cramp, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.9. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extreme body ache, cray leg cramp and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: FEVER; HEADACHE; NO ENERGY; 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: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced no energy. On 27-APR-2021, the subject experienced fever. On 27-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache and no energy was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder, Headache, Nausea
Clinical narrative: STOMACH ISSUES; HEADACHES; NAUSEA; This spontaneous report received from a consumer concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: 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 an unspecified date, the subject experienced stomach issues, headaches, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches, stomach issues, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Post stroke depression, Walking aid user
Clinical narrative: MID-STROKE; BLOOD CLOTS IN BRAIN; POST STROKE DEPRESSION; CANE USER; This spontaneous report received from a consumer (sister) concerned a 69 year old female. The patient's weight, height, and medical history were not reported. Patient was a completely healthy woman and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency once total, dose, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient suffered a mid-stroke. Stroke showed that she suffered from blood clots in her brain. All of this happened after receiving Janssen vaccine. Patient had to walk with a cane (coded as cane user) and had been prescribed medication. Patient had to deal with other issues including depression (coded as post stroke depression) because of her new life long issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mid-stroke, blood clots in brain, cane user and post stroke depression was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210455571-Covid-19 vaccine.ad26.cov2.S-MId-stroke,Blood clots in Brain,Post stroke depression. 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: M
Vaccine: COVID19
Symptoms: Migraine, Thrombosis, Vaccination complication
Clinical narrative: THROMBOSIS (RED PATCHES ON HANDS, ARMS, LEGS AND FEET); SEVERE MIGRAINES; SEVERE VACCINATION REACTION; This spontaneous report received from a patient via a company representative concerned a 3 decade 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: Unknown and expiry date: Unknown) dose, 1 total administered, start therapy date was not reported 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. The patient had a severe vaccination reaction, experienced red patches on hands, arms, legs and feet. The patient had visited the hospital and was diagnosed with thrombosis by the physician. Patient was monitored and later discharged. The patient had reattended hospital for severe migraines, also had contacted centers for disease control and prevention regarding vaccination reaction. The patient was unknown for company representative and had only this information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombosis (red patches on hands, arms, legs and feet), severe migraines and severe vaccination reaction was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210455657- COVID-19 VACCINE Ad26.COV2. S -Thrombosis, severe migraines , severe vaccination reaction. This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nail discolouration, Peripheral swelling, Pruritus, Tremor
Clinical narrative: ITCHY LEGS; LEG SHAKING; SWELLING OF LEGS/FEET; TOENAILS TURNING BLUE; TIRED; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced tired. On 09-APR-2021, the subject experienced swelling of legs/feet. On 09-APR-2021, the subject experienced toenails turning blue. On 28-APR-2021, the subject experienced leg shaking. On an unspecified date, the subject experienced itchy legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, had not recovered from swelling of legs/feet, and the outcome of toenails turning blue, leg shaking and itchy legs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: HEADACHE; FELT TIRED; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-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 APR-2021, the subject experienced headache. On APR-2021, the subject experienced felt tired. On APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, felt tired and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Tremor
Clinical narrative: NEUROLOGICAL SHAKING; LOSS OF APPETITE; WEAKNESS; This spontaneous report received from a consumer concerned a 49 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: 1808941 expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced neurological shaking. On 09-APR-2021, the subject experienced loss of appetite. On 09-APR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neurological shaking, loss of appetite, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; 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 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 chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit disorder, back pain, cigarette smoker, and cough, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: COLD-LIKE SYMPTOMS; COUGH; RIGHT ARM PAIN AT THE INJECTION SITE; FEVER; FATIGUE; HEADACHES; LEFT FOOT NUMBNESS/ NUMBNESS UP TO THE LEFT KNEE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included attention deficit disorder, back pain, cigarette smoker, and cough, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced left foot numbness/ numbness up to the left knee. On 25-MAR-2021, the subject experienced cold-like symptoms. On 25-MAR-2021, the subject experienced cough. On 25-MAR-2021, the subject experienced right arm pain at the injection site. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 2021, had not recovered from right arm pain at the injection site, cold-like symptoms, cough, fatigue, and headaches, and the outcome of left foot numbness/ numbness up to the left knee was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Grip strength decreased, Headache, Somnolence
Clinical narrative: WEIRD FEELING; NO STRENGTH IN HAND; GROGGY HEAD; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced weird feeling. On APR-2021, the subject experienced no strength in hand. On APR-2021, the subject experienced groggy head. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 28-APR-2021, and the outcome of weird feeling, no strength in hand and groggy head was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise, Unresponsive to stimuli
Clinical narrative: DEATH; NON-RESPONSIVE; NOT FEELING WELL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included on blood thinners. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,1 total, batch number: Unknown) dose, start therapy date were not reported 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. The consumer had called and stated that their father had passed away and had received JANSSEN covid 19 vaccine 10 to 12 days before. On 26-Apr-2021 the patient was non responsive, lethargic, seemed out of it and was not feeling well. The patient was on blood thinners. On 27-Apr-2021 the consumer's father had passed away, the consumer was still waiting for the cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 27-APR-2021, and the outcome of non-responsive, not feeling well was not reported. This report was serious (Death, Medically significant).; Sender's Comments: 20210456243-covid-19 vaccine ad26.cov2.s -Death, Non responsive. 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: CAUSE OF DEATH UNKNOWN
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Mass, Muscle spasms, Skin discolouration, Ultrasound scan
Clinical narrative: SORE LUMP TO LEFT CALF AREA; BRUISE ON CALF; BIG BROWN SPOT ON LEFT CALF; LEG SPASM WITH MUSCLE TIGHTNESS AND PAIN TO LEFT SIDE HIP TO KNEE AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bad wiring heart condition, neuropathy, arthritis through out the body, and seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, sacubitril valsartan sodium hydrate for heart condition, and montelukast sodium for seasonal allergies. On 20-APR-2021, the subject experienced leg spasm with muscle tightness and pain to left side hip to knee area. On 23-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) Negative.  On 26-APR-2021, the subject experienced big brown spot on left calf. On 27-APR-2021, the subject experienced sore lump to left calf area. On 27-APR-2021, the subject experienced bruise on calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg spasm with muscle tightness and pain to left side hip to knee area, and bruise on calf on 28-APR-2021, and big brown spot on left calf on 27-APR-2021, and had not recovered from sore lump to left calf area. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: WHITE BLOOD CELL COUNT INCREASE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stage iii myelofibrosis, and penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced white blood cell count increase. Laboratory data included: WBC (NR: not provided) 109.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of white blood cell count increase was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown cause of death. 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 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient received the Janssen COVID-19 vaccine and then died 15 days later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  .; Sender's Comments: V0-20210456256- COVID-19 VACCINE AD26.COV2.s.adverse effect . 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Full blood count, Red blood cell sedimentation rate, Urticaria, White blood cell count
Clinical narrative: HIVES ALL OVER THE BODY; This spontaneous report received from a physician 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced hives all over the body. Laboratory data (dates unspecified) included: CBC (NR: not provided) Normal, Erythrocyte sedimentation rate (NR: not provided) Normal, and WBC (NR: not provided) 10.8. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives all over the body. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: FELT LIKE ARM IS KILLING; INJECTION SITE HURTING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 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 felt like arm is killing, and injection site hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site hurting and felt like arm is killing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: VOMITING; SWEATING; BODY CHILLS; FEVER; HEADACHE; FATIGUE; NAUSEA; 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 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 vomiting, sweating, body chills, fever, headache, fatigue, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body chills, sweating, headache, fatigue, nausea and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: VOMITING; SWEATING; BODY CHILLS; FEVER; HEADACHE; FATIGUE; NAUSEA; 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 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 vomiting, sweating, body chills, fever, headache, fatigue, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body chills, sweating, headache, fatigue, nausea and vomiting was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Headache, Pain in extremity, Ultrasound scan
Clinical narrative: LEFT LEG PAIN; HEADACHES; This spontaneous report received from a parent concerned a 25 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Blood test (NR: not provided) normal, and Diagnostic ultrasound (NR: not provided) no findings. On 11-APR-2021, the subject experienced left leg pain. On 11-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headaches, and left leg pain. This report was non-serious. This case, from the same reporter is linked to 20210456965.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Computerised tomogram, Dizziness
Clinical narrative: DIZZINESS WHEN SUPINE; KNEE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included left knee surgery - complete knee replacement, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2020, Laboratory data included: CAT scan (NR: not provided) unknown.  On 12-APR-2021, the subject experienced knee pain. On 19-APR-2021, the subject experienced dizziness when supine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from knee pain on 28-APR-2021, and had not recovered from dizziness when supine. 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.