chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram normal, Fungal test, Gait disturbance, Haematocrit normal, Haemoglobin normal
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Injection site pain, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Metabolic function test
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Muscle tightness, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Nerve conduction studies normal, Pain, Paraesthesia
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count normal, Protein total increased, Red blood cell count increased, Scan with contrast, Sensory disturbance
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin sensitisation, Thyroxine decreased, Viral test, Vitamin B12 normal, White blood cell count
Clinical narrative: Her symptoms began after she received her second COVID shot on 4/16. She first noted some right arm pain around her injection site. Soon thereafter, she developed left sided neck pain. She describes a pulling sensation associated with stiffening. Moving the neck was difficult, and the pain was severe. The tightness worsened. She became concerned because she had a dystonic reaction to phenothiazine in high school that felt similar. She has also noted involvement of her left leg as well, with stiffness and tightness.  She has had no fevers, no chills, an occasional headache, no vomiting. No loss of consciousness. She has had some nausea associated with the pain. She presented to the emergency department on 4/17 for these symptoms. On 4/18 she developed diffuse skin sensitivity and all over muscle aches that "feel like the flu" - these felt different than the muscle spasms described previously. On 4/19 at approximately 3am she acutely developed weakness in both arms and legs, with associated paresthesia in the feet bilaterally and continued muscle aches. She also reported difficulty swallowing liquids and pills. Muscle pain and spasms responded to baclofen, diphenhydramine, and diazepam, but she continued to have weakness of the bilateral legs with some ability to move them anti-gravity but requiring assistance to walk. Physical and occupational therapy evaluation was performed,  and inpatient rehabilitation is recommended to continue regaining strength.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness
Clinical narrative: Flush, chills, sweating, lightheaded, dizzy, face rash, vomiting
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Flushing, Hyperhidrosis, Rash
Clinical narrative: Flush, chills, sweating, lightheaded, dizzy, face rash, vomiting
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Flush, chills, sweating, lightheaded, dizzy, face rash, vomiting
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pruritus, Rash, Rash maculo-papular, Urticaria
Clinical narrative: MACULOPAPULAR RASH PATCH ON FACE, LEGS, ARMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tendency kidney stones, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and drug abuse or illicit drug use at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021 17:00, the subject experienced maculopapular rash patch on face, legs, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from maculopapular rash patch on face, legs, arms. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash maculo-papular
Clinical narrative: MACULOPAPULAR RASH PATCH ON FACE, LEGS, ARMS; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included tendency kidney stones, alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and drug abuse or illicit drug use at the time of this report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-APR-2021 17:00, the subject experienced maculopapular rash patch on face, legs, arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from maculopapular rash patch on face, legs, arms. This report was non-serious.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Laboratory test, Lung assist device therapy, Oral contraception
Clinical narrative: Hemodynamic collapse at home. Persistent cardiac arrest requiring ECMO. Event believed secondary to pulmonary embolism. Death by neurologic criteria.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Resuscitation
Clinical narrative: Hemodynamic collapse at home. Persistent cardiac arrest requiring ECMO. Event believed secondary to pulmonary embolism. Death by neurologic criteria.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Circulatory collapse, Computerised tomogram thorax abnormal, Death, Lung assist device therapy
Clinical narrative: Hemodynamic collapse at home. Persistent cardiac arrest requiring ECMO. Event believed secondary to pulmonary embolism. Death by neurologic criteria.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Hemodynamic collapse at home. Persistent cardiac arrest requiring ECMO. Event believed secondary to pulmonary embolism. Death by neurologic criteria.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Pulmonary embolism
Clinical narrative: Hemodynamic collapse at home. Persistent cardiac arrest requiring ECMO. Event believed secondary to pulmonary embolism. Death by neurologic criteria.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Pain
Clinical narrative: SUSTAINED INJECTION SITE PAIN WITH THROBBING AND BURNING SENSATION; MILD SORENESS AFTER THE INJECTION; 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced mild soreness after the injection. On 18-APR-2021, the subject experienced sustained injection site pain with throbbing and burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild soreness after the injection and sustained injection site pain with throbbing and burning sensation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: SUSTAINED INJECTION SITE PAIN WITH THROBBING AND BURNING SENSATION; MILD SORENESS AFTER THE INJECTION; 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced mild soreness after the injection. On 18-APR-2021, the subject experienced sustained injection site pain with throbbing and burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild soreness after the injection and sustained injection site pain with throbbing and burning sensation was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site discomfort, Injection site mass
Clinical narrative: PAINFUL LUMP/HARD WHEN PRESS IT HURTS; SORE ARM; ALLERGIC REACTION IN SOFT TISSUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included broken wrist in december and a metal plate was inserted, and concurrent conditions included retired, and seasonal allergy. 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 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction in soft tissue.  Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced painful lump/hard when press it hurts. On 12-APR-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 painful lump/hard when press it hurts, and sore arm, and the outcome of allergic reaction in soft tissue was not reported. This report was non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Injection site mass, Pain in extremity
Clinical narrative: PAINFUL LUMP/HARD WHEN PRESS IT HURTS; SORE ARM; ALLERGIC REACTION IN SOFT TISSUE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included broken wrist in december and a metal plate was inserted, and concurrent conditions included retired, and seasonal allergy. 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 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergic reaction in soft tissue.  Treatment medications included: diphenhydramine hydrochloride. On 12-APR-2021, the subject experienced painful lump/hard when press it hurts. On 12-APR-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 painful lump/hard when press it hurts, and sore arm, and the outcome of allergic reaction in soft tissue was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carotid artery dissection, Carotid artery occlusion, Cerebral artery occlusion
Clinical narrative: Sudden stroke due to blood clot
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Embolic stroke
Clinical narrative: Sudden stroke due to blood clot
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Physical examination, Syncope, Thrombosis
Clinical narrative: Sudden stroke due to blood clot
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Echocardiogram, Electrocardiogram, Hypertension
Clinical narrative: DIDN'T FEEL RIGHT; INCREASED BLOOD PRESSURE; 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) High Blood Pressure. On an unspecified date, the subject experienced didn't feel right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased blood pressure and didn't feel right was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal
Clinical narrative: DIDN'T FEEL RIGHT; INCREASED BLOOD PRESSURE; 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 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced increased blood pressure. Laboratory data included: Blood pressure (NR: not provided) High Blood Pressure. On an unspecified date, the subject experienced didn't feel right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased blood pressure and didn't feel right was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Night sweats, Pulmonary thrombosis, Pyrexia
Clinical narrative: Patient with metastatic invasive ductal carcinoma of the breast, presented to hospital on 3/21 with delirium and fever.  Recent diagnosis of pulmonary embolism.  Patient died on 3/25.  Likely cause of death was multiorgan failure secondary to her CA.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast cancer, Breast cancer metastatic, Condition aggravated, Death, Delirium
Clinical narrative: Patient with metastatic invasive ductal carcinoma of the breast, presented to hospital on 3/21 with delirium and fever.  Recent diagnosis of pulmonary embolism.  Patient died on 3/25.  Likely cause of death was multiorgan failure secondary to her CA.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, Pulmonary embolism, Pyrexia
Clinical narrative: Patient with metastatic invasive ductal carcinoma of the breast, presented to hospital on 3/21 with delirium and fever.  Recent diagnosis of pulmonary embolism.  Patient died on 3/25.  Likely cause of death was multiorgan failure secondary to her CA.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient had PICC line placed on 4/13/21 and received IV antibiotics for prior infection.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood disorder, Central venous catheterisation
Clinical narrative: Systemic: Blood Disorder  (diagnosed by MD)-Severe, Additional Details: Patient had PICC line placed on 4/13/21 and received IV antibiotics for prior infection.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Aphonia, Back pain, Immobile, Kidney infection
Clinical narrative: KIDNEY FAILING/LIVER FAILING/FEELING OF DYING BECAUSE OF VACCINE; KIDNEY INFECTION/PAIN IN BACK LEFT SIDE WHERE KIDNEY AREA; BLADDER INFECTION/PRESSURE IN STOMACH; VOMITING; INFECTION IN THROAT; CAN NOT GET OUT OF THE BED; FEELING VERY SICK; FEVER; This spontaneous report received from a patient concerned a 37 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: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021 (next day of vaccination), the patient developed fever at fever at 102-degree F., vomiting, infection in throat, loss of voice, feeling lot of pressure in stomach, bladder infection, pain in back left side where kidney area, both side of lower back in pain, extreme pain in the kidney, cannot sit up or get out of the bad. He felt like the kidney were not working well. On 08-APR-2021 (Friday night), he went to the hospital and urine sample test was performed (result not received yet). He received treatment with pain shot and lidocaine patches. No physical examination on kidney was done. He felt that he is dying to vaccine and his kidney and liver were failing due to vaccine.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kidney failing/liver failing/feeling of dying because of vaccine, feeling very sick, fever, bladder infection/pressure in stomach, vomiting, infection in throat, kidney infection/pain in back left side where kidney area and can not get out of the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421426-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Kidney infection. 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: M
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Pain in extremity, Renal disorder, Renal failure, Renal pain
Clinical narrative: KIDNEY FAILING/LIVER FAILING/FEELING OF DYING BECAUSE OF VACCINE; KIDNEY INFECTION/PAIN IN BACK LEFT SIDE WHERE KIDNEY AREA; BLADDER INFECTION/PRESSURE IN STOMACH; VOMITING; INFECTION IN THROAT; CAN NOT GET OUT OF THE BED; FEELING VERY SICK; FEVER; This spontaneous report received from a patient concerned a 37 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: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021 (next day of vaccination), the patient developed fever at fever at 102-degree F., vomiting, infection in throat, loss of voice, feeling lot of pressure in stomach, bladder infection, pain in back left side where kidney area, both side of lower back in pain, extreme pain in the kidney, cannot sit up or get out of the bad. He felt like the kidney were not working well. On 08-APR-2021 (Friday night), he went to the hospital and urine sample test was performed (result not received yet). He received treatment with pain shot and lidocaine patches. No physical examination on kidney was done. He felt that he is dying to vaccine and his kidney and liver were failing due to vaccine.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kidney failing/liver failing/feeling of dying because of vaccine, feeling very sick, fever, bladder infection/pressure in stomach, vomiting, infection in throat, kidney infection/pain in back left side where kidney area and can not get out of the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421426-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Kidney infection. 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: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cystitis, Feeling abnormal, Kidney infection, Malaise
Clinical narrative: KIDNEY FAILING/LIVER FAILING/FEELING OF DYING BECAUSE OF VACCINE; KIDNEY INFECTION/PAIN IN BACK LEFT SIDE WHERE KIDNEY AREA; BLADDER INFECTION/PRESSURE IN STOMACH; VOMITING; INFECTION IN THROAT; CAN NOT GET OUT OF THE BED; FEELING VERY SICK; FEVER; This spontaneous report received from a patient concerned a 37 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: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021 (next day of vaccination), the patient developed fever at fever at 102-degree F., vomiting, infection in throat, loss of voice, feeling lot of pressure in stomach, bladder infection, pain in back left side where kidney area, both side of lower back in pain, extreme pain in the kidney, cannot sit up or get out of the bad. He felt like the kidney were not working well. On 08-APR-2021 (Friday night), he went to the hospital and urine sample test was performed (result not received yet). He received treatment with pain shot and lidocaine patches. No physical examination on kidney was done. He felt that he is dying to vaccine and his kidney and liver were failing due to vaccine.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kidney failing/liver failing/feeling of dying because of vaccine, feeling very sick, fever, bladder infection/pressure in stomach, vomiting, infection in throat, kidney infection/pain in back left side where kidney area and can not get out of the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421426-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Kidney infection. 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: M
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Pharyngitis, Pyrexia, Urine analysis, Vomiting
Clinical narrative: KIDNEY FAILING/LIVER FAILING/FEELING OF DYING BECAUSE OF VACCINE; KIDNEY INFECTION/PAIN IN BACK LEFT SIDE WHERE KIDNEY AREA; BLADDER INFECTION/PRESSURE IN STOMACH; VOMITING; INFECTION IN THROAT; CAN NOT GET OUT OF THE BED; FEELING VERY SICK; FEVER; This spontaneous report received from a patient concerned a 37 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: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 22-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021 (next day of vaccination), the patient developed fever at fever at 102-degree F., vomiting, infection in throat, loss of voice, feeling lot of pressure in stomach, bladder infection, pain in back left side where kidney area, both side of lower back in pain, extreme pain in the kidney, cannot sit up or get out of the bad. He felt like the kidney were not working well. On 08-APR-2021 (Friday night), he went to the hospital and urine sample test was performed (result not received yet). He received treatment with pain shot and lidocaine patches. No physical examination on kidney was done. He felt that he is dying to vaccine and his kidney and liver were failing due to vaccine.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the kidney failing/liver failing/feeling of dying because of vaccine, feeling very sick, fever, bladder infection/pressure in stomach, vomiting, infection in throat, kidney infection/pain in back left side where kidney area and can not get out of the bed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210421426-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Kidney infection. 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: 50.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Immune thrombocytopenia, Platelet count decreased
Clinical narrative: Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms.  Went to ER seven days after first noticed symptoms.  Was admitted to ICU with platelet level near 2,000.  Complete blood workup was done and everything was eliminated  except Immune Thrombocytopenic Purpura (ITP).  I was treated intravenously with immunoglobulin and steroids.  On 4/21/21 I was released from the hospital with my platelet level near 49,000.  Following up with hematologist on 4/26/21 for further testing and evaluation.
Age: 50.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Blood test, Contusion, Gingival bleeding, HIV test negative, Hepatitis viral test negative
Clinical narrative: Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms.  Went to ER seven days after first noticed symptoms.  Was admitted to ICU with platelet level near 2,000.  Complete blood workup was done and everything was eliminated  except Immune Thrombocytopenic Purpura (ITP).  I was treated intravenously with immunoglobulin and steroids.  On 4/21/21 I was released from the hospital with my platelet level near 49,000.  Following up with hematologist on 4/26/21 for further testing and evaluation.
Age: 50.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Immune thrombocytopenia, Immunoglobulin therapy, Intensive care, Lip blister, Mouth haemorrhage
Clinical narrative: Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms.  Went to ER seven days after first noticed symptoms.  Was admitted to ICU with platelet level near 2,000.  Complete blood workup was done and everything was eliminated  except Immune Thrombocytopenic Purpura (ITP).  I was treated intravenously with immunoglobulin and steroids.  On 4/21/21 I was released from the hospital with my platelet level near 49,000.  Following up with hematologist on 4/26/21 for further testing and evaluation.
Age: 50.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Petechiae, Platelet count decreased, Rash, Rash erythematous, SARS-CoV-2 antibody test positive
Clinical narrative: Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms.  Went to ER seven days after first noticed symptoms.  Was admitted to ICU with platelet level near 2,000.  Complete blood workup was done and everything was eliminated  except Immune Thrombocytopenic Purpura (ITP).  I was treated intravenously with immunoglobulin and steroids.  On 4/21/21 I was released from the hospital with my platelet level near 49,000.  Following up with hematologist on 4/26/21 for further testing and evaluation.
Age: 50.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Bleeding of the gums began followed by black bloody mouth and lip blisters followed by small red/brown dots all over my lower legs and arms followed by black and blue bruises on legs and arms.  Went to ER seven days after first noticed symptoms.  Was admitted to ICU with platelet level near 2,000.  Complete blood workup was done and everything was eliminated  except Immune Thrombocytopenic Purpura (ITP).  I was treated intravenously with immunoglobulin and steroids.  On 4/21/21 I was released from the hospital with my platelet level near 49,000.  Following up with hematologist on 4/26/21 for further testing and evaluation.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Haemoptysis, Productive cough, SARS-CoV-2 test positive
Clinical narrative: Patient was admitted to the hospital with C/O increased shortness of breath x1 week. Pt has history of COPD, on 4L NC daily, O2  sat 81% on 4L. Pt also C/O productive cough with blood tinged sputum, pt reports diarrhea and states his food tasts like salt.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: Patient was admitted to the hospital with C/O increased shortness of breath x1 week. Pt has history of COPD, on 4L NC daily, O2  sat 81% on 4L. Pt also C/O productive cough with blood tinged sputum, pt reports diarrhea and states his food tasts like salt.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Diarrhoea, Dyspnoea, Haemoptysis, Influenza virus test
Clinical narrative: Patient was admitted to the hospital with C/O increased shortness of breath x1 week. Pt has history of COPD, on 4L NC daily, O2  sat 81% on 4L. Pt also C/O productive cough with blood tinged sputum, pt reports diarrhea and states his food tasts like salt.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Productive cough, Respiratory syncytial virus test, SARS-CoV-2 test positive, Taste disorder
Clinical narrative: Patient was admitted to the hospital with C/O increased shortness of breath x1 week. Pt has history of COPD, on 4L NC daily, O2  sat 81% on 4L. Pt also C/O productive cough with blood tinged sputum, pt reports diarrhea and states his food tasts like salt.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Developed left facial numbness-minor left lower periorbital + cheek with gradual increase and decrease after he left the vaccine clinic. Reaction resolved in 48 hours.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bandaemia, Feeling hot, Hypotension, Lymphocyte count increased, Pain
Clinical narrative: Patient initially reported in separate VAERS to have possible multisystem inflammatory response secondary to vaccine (new rash, fever, hypotension, LFT abnormalities) with symptom onset on evening of vaccination receipt on 4/16. One day into hospitalization, diagnosed with new systolic heart failure felt to be most consistent with acute myocarditis.  Previously no symptoms of HF, working in physical labor one week prior to admission.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sepsis, Systemic inflammatory response syndrome, Tachycardia, White blood cell count increased
Clinical narrative: Patient initially reported in separate VAERS to have possible multisystem inflammatory response secondary to vaccine (new rash, fever, hypotension, LFT abnormalities) with symptom onset on evening of vaccination receipt on 4/16. One day into hospitalization, diagnosed with new systolic heart failure felt to be most consistent with acute myocarditis.  Previously no symptoms of HF, working in physical labor one week prior to admission.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide increased, Echocardiogram, Ejection fraction decreased, Hypotension, Inflammation
Clinical narrative: Patient initially reported in separate VAERS to have possible multisystem inflammatory response secondary to vaccine (new rash, fever, hypotension, LFT abnormalities) with symptom onset on evening of vaccination receipt on 4/16. One day into hospitalization, diagnosed with new systolic heart failure felt to be most consistent with acute myocarditis.  Previously no symptoms of HF, working in physical labor one week prior to admission.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Left ventricular failure, Liver function test abnormal, Mitral valve incompetence, Myocarditis, Pulmonary arterial pressure increased
Clinical narrative: Patient initially reported in separate VAERS to have possible multisystem inflammatory response secondary to vaccine (new rash, fever, hypotension, LFT abnormalities) with symptom onset on evening of vaccination receipt on 4/16. One day into hospitalization, diagnosed with new systolic heart failure felt to be most consistent with acute myocarditis.  Previously no symptoms of HF, working in physical labor one week prior to admission.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Tricuspid valve incompetence, Troponin increased
Clinical narrative: Patient initially reported in separate VAERS to have possible multisystem inflammatory response secondary to vaccine (new rash, fever, hypotension, LFT abnormalities) with symptom onset on evening of vaccination receipt on 4/16. One day into hospitalization, diagnosed with new systolic heart failure felt to be most consistent with acute myocarditis.  Previously no symptoms of HF, working in physical labor one week prior to admission.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood potassium increased, Bradycardia, Cardiac arrest, Coma scale abnormal, Death
Clinical narrative: PER hospital note:  Patient received Covid-19 vaccine on Monday (4/19/21), since then has been feeling fatigued. Per patients husband she was difficult to arouse this morning (4/21/21) and ultimately unresponsive. Patient was transported to hospital via EMS (4/21/21)where she expired a short time later.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemodynamic instability, Hypotension, Hypoxia, Malaise, Pulseless electrical activity
Clinical narrative: PER hospital note:  Patient received Covid-19 vaccine on Monday (4/19/21), since then has been feeling fatigued. Per patients husband she was difficult to arouse this morning (4/21/21) and ultimately unresponsive. Patient was transported to hospital via EMS (4/21/21)where she expired a short time later.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Depressed level of consciousness, Fatigue, Unresponsive to stimuli
Clinical narrative: PER hospital note:  Patient received Covid-19 vaccine on Monday (4/19/21), since then has been feeling fatigued. Per patients husband she was difficult to arouse this morning (4/21/21) and ultimately unresponsive. Patient was transported to hospital via EMS (4/21/21)where she expired a short time later.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cold sweat, Hyperhidrosis, Nausea, Seizure, Vomiting
Clinical narrative: About 2-3 minutes after receiving the vaccine, while sitting in the waiting room, I said I don't feel well to my girlfriend next to me and then don't remember anything until waking up being held up by a nurse - I apparently passed out and jerked my head backwards twice, once hitting the wall. I was seen by paramedics and they determined nothing was wrong but after standing up I had another faint spell and had to lay down again - not before throwing up.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyskinesia, Loss of consciousness, Vomiting
Clinical narrative: About 2-3 minutes after receiving the vaccine, while sitting in the waiting room, I said I don't feel well to my girlfriend next to me and then don't remember anything until waking up being held up by a nurse - I apparently passed out and jerked my head backwards twice, once hitting the wall. I was seen by paramedics and they determined nothing was wrong but after standing up I had another faint spell and had to lay down again - not before throwing up.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Ear swelling, Fatigue, Heart rate increased, Injection site mass
Clinical narrative: METALLIC TASTE; SWELLING OF TONGUE; SWELLING; RED BLEMISHES AROUND EAR; BODY ACHE; DIZZINESS; RASH/MOSQUITO TYPE RED DOT UNDER LEFT EYE AND LEFT EARLOBE; LARGE RED SPOT ON NECK, ALMOST LIKE HIVES; WEAKNESS; FEVER; HEADACHE; INCREASED HEART RATE; SLEPT ONLY 3 HOURS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery, and smoker, and concurrent conditions included seasonal asthma, heart palpitations, overweight, and metallic taste reaction with contrast dyes use with scans. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slept only 3 hours. Laboratory data included: Heart rate (NR: not provided) 118-120. On 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced metallic taste. On 10-APR-2021, the subject experienced swelling of tongue. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced red blemishes around ear. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced rash/mosquito type red dot under left eye and left earlobe. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced large red spot on neck, almost like hives. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, swelling of tongue, and swelling on 10-APR-2021, and dizziness, and weakness on APR-2021, was recovering from rash/mosquito type red dot under left eye and left earlobe, and large red spot on neck, almost like hives, had not recovered from red blemishes around ear, fever, headache, body ache, and increased heart rate, and the outcome of slept only 3 hours was not reported. 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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pyrexia, Rash, Rash erythematous, Sensitive skin
Clinical narrative: METALLIC TASTE; SWELLING OF TONGUE; SWELLING; RED BLEMISHES AROUND EAR; BODY ACHE; DIZZINESS; RASH/MOSQUITO TYPE RED DOT UNDER LEFT EYE AND LEFT EARLOBE; LARGE RED SPOT ON NECK, ALMOST LIKE HIVES; WEAKNESS; FEVER; HEADACHE; INCREASED HEART RATE; SLEPT ONLY 3 HOURS; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included hernia surgery, and smoker, and concurrent conditions included seasonal asthma, heart palpitations, overweight, and metallic taste reaction with contrast dyes use with scans. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slept only 3 hours. Laboratory data included: Heart rate (NR: not provided) 118-120. On 10-APR-2021, the subject experienced increased heart rate. On 10-APR-2021, the subject experienced metallic taste. On 10-APR-2021, the subject experienced swelling of tongue. On 10-APR-2021, the subject experienced swelling. On 10-APR-2021, the subject experienced red blemishes around ear. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced rash/mosquito type red dot under left eye and left earlobe. On 10-APR-2021, the subject experienced weakness. On 10-APR-2021, the subject experienced large red spot on neck, almost like hives. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 98.9. On 11-APR-2021, Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metallic taste, swelling of tongue, and swelling on 10-APR-2021, and dizziness, and weakness on APR-2021, was recovering from rash/mosquito type red dot under left eye and left earlobe, and large red spot on neck, almost like hives, had not recovered from red blemishes around ear, fever, headache, body ache, and increased heart rate, and the outcome of slept only 3 hours was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.