chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dyspnoea, Gait disturbance, Insomnia, Limb discomfort
Clinical narrative: LEG CRAMPING; DIFFICULTY BREATHING; SWELLING OF LEG WITH EDEMA; HEAVY LEG; LOSS OF APPETITE; RASH ON LEFT FOREARM; LOSS OF 5 LBS; DIFFICULTY WALKING; DIFFICULTY SLEEPING WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 170.68 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease (copd), asthma, interstitial lung disease, herniated disc at cervical lumbar, allergy to sulfa medications, back injury, and oxygen 24/7.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced loss of 5 lbs. On APR-2021, the subject experienced difficulty walking. On APR-2021, the subject experienced difficulty sleeping well. On 11-APR-2021, the subject experienced leg cramping. On 11-APR-2021, the subject experienced difficulty breathing. On 11-APR-2021, the subject experienced swelling of leg with edema. On 11-APR-2021, the subject experienced heavy leg. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced rash on left forearm. On 12-APR-2021, Laboratory data included: Ultrasound scan (NR: not provided) No venous clots and no thrombosis. On 20-APR-2021, treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of leg with edema, and heavy leg on 15-APR-2021, and loss of appetite, and rash on left forearm on APR-2021, was recovering from leg cramping, and difficulty breathing, and the outcome of loss of 5 lbs, difficulty walking and difficulty sleeping well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Oedema peripheral, Rash, Ultrasound scan, Weight decreased
Clinical narrative: LEG CRAMPING; DIFFICULTY BREATHING; SWELLING OF LEG WITH EDEMA; HEAVY LEG; LOSS OF APPETITE; RASH ON LEFT FOREARM; LOSS OF 5 LBS; DIFFICULTY WALKING; DIFFICULTY SLEEPING WELL; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 120 pounds, and height was 170.68 centimeters. The patient's concurrent conditions included chronic obstructive pulmonary disease (copd), asthma, interstitial lung disease, herniated disc at cervical lumbar, allergy to sulfa medications, back injury, and oxygen 24/7.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced loss of 5 lbs. On APR-2021, the subject experienced difficulty walking. On APR-2021, the subject experienced difficulty sleeping well. On 11-APR-2021, the subject experienced leg cramping. On 11-APR-2021, the subject experienced difficulty breathing. On 11-APR-2021, the subject experienced swelling of leg with edema. On 11-APR-2021, the subject experienced heavy leg. On 11-APR-2021, the subject experienced loss of appetite. On 11-APR-2021, the subject experienced rash on left forearm. On 12-APR-2021, Laboratory data included: Ultrasound scan (NR: not provided) No venous clots and no thrombosis. On 20-APR-2021, treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling of leg with edema, and heavy leg on 15-APR-2021, and loss of appetite, and rash on left forearm on APR-2021, was recovering from leg cramping, and difficulty breathing, and the outcome of loss of 5 lbs, difficulty walking and difficulty sleeping well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case is assessed as Non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Nodule, Paraesthesia, Skin discolouration
Clinical narrative: NUMBNESS AND TINGLING ON THE BOTTOM OF THE FOOT (ALL LEFT FOOT) ALL THE TIME NOW; 2ND TOE (LEFT FOOT) HAS BEEN DISCOLORED WITH A RING AROUND IT; SWELLING AND HURTING KNOT ON TOP OF FOOT (LEFT FOOT), KNOT ON 3RD TOE, KNOTS ON CALF, THIGH (ALL LEFT SIDE)/ KNOT ON RIGHT ARM; MUSCLE CRAMPS IN CALF; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of known allergies and drug abuse and illicit drug use.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 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced muscle cramps in calf. On 25-MAR-2021, the subject experienced swelling and hurting knot on top of foot (left foot), knot on 3rd toe, knots on calf, thigh (all left side) / knot on right arm. On an unspecified date, the subject experienced numbness and tingling on the bottom of the foot (all left foot) all the time now, and 2nd toe (left foot) has been discolored with a ring around it. Treatment medications (dates unspecified) included: acetylsalicylic acid, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling and hurting knot on top of foot (left foot), knot on 3rd toe, knots on calf, thigh (all left side)/ knot on right arm, numbness and tingling on the bottom of the foot (all left foot) all the time now, and 2nd toe (left foot) has been discolored with a ring around it, and the outcome of muscle cramps in calf was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Computerised tomogram, Feeling abnormal
Clinical narrative: CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild case of covid, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2020, Laboratory data included: Platelet count (NR: not provided) 417K/mcL. On 07-APR-2021, the subject experienced head fogginess. On 08-APR-2021, the subject experienced felt like flu. On 09-APR-2021, the subject experienced chest discomfort. On 09-APR-2021, the subject experienced lymph node in right arm pit swollen. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Platelet count (NR: not provided) 331K/mcL. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) unknown, and Chest X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort on 21-APR-2021, and lymph node in right arm pit swollen on 13-APR-2021, and had not recovered from felt like flu, and head fogginess. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Platelet count
Clinical narrative: CHEST DISCOMFORT; LYMPH NODE IN RIGHT ARM PIT SWOLLEN; FELT LIKE FLU; HEAD FOGGINESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included mild case of covid, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2020, Laboratory data included: Platelet count (NR: not provided) 417K/mcL. On 07-APR-2021, the subject experienced head fogginess. On 08-APR-2021, the subject experienced felt like flu. On 09-APR-2021, the subject experienced chest discomfort. On 09-APR-2021, the subject experienced lymph node in right arm pit swollen. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Normal, and Platelet count (NR: not provided) 331K/mcL. On 16-APR-2021, Laboratory data included: CT scan (NR: not provided) unknown, and Chest X-ray (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest discomfort on 21-APR-2021, and lymph node in right arm pit swollen on 13-APR-2021, and had not recovered from felt like flu, and head fogginess. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased
Clinical narrative: INCREASED HEART RATE; SEVERE CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, 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.  On an unspecified date, about 7 hours after receiving the Johnson & Johnson vaccine shot, patient's heart rate increased rapidly (coded as increased heart rate) and he had severe chest pain, resulting in hospitalization(date unspecified). Patient's discharge papers showed that doctors ran tests but couldn't identify a cause other than the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate and severe chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0.20210444419-covid-19 vaccine ad26.cov2.s-increased heart rate,chest pain. 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). Workflow Notes: V0: completed. Case promoted.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Movement disorder
Clinical narrative: LIMITED USE OF ARM; CANT SLEEP ON THAT SIDE; BAD SORE ON ARM AT INJECTION SITE; 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 limited use of arm, cant sleep on that side, and bad sore on arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad sore on arm at injection site, cant sleep on that side and limited use of arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Lower respiratory tract infection
Clinical narrative: CHEST INFECTION; This spontaneous report received from a patient via a company representative (media inbox) concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included HIV positive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) frequency 1 total, dose was not reported, administered on 05-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 13-APR-2021 (8 days after vaccination), the patient had been fighting a chest infection, meaning coughing up thick yellow phlegm. He was recovering and had no fever, no headache. "He had not been sick, even with a cold for two years. This was an anomaly." Patient travelled for a living literally all international 3 weeks a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chest infection.. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-Chest infection. 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: M
Vaccine: COVID19
Symptoms: Erectile dysfunction, Pain in extremity
Clinical narrative: ARM WAS SORE; ERECTILE DYSFUNCTION; 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 concurrent conditions included nerve related pain in foot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total administered on 08-MAR-2021 around 15:15 p.m. or 15:30 p.m. on left arm for prophylactic vaccination. Concomitant medications included gabapentin for nerve related pain in feet, just over 2 months and  had been slowly increasing the dose (started the 300 mg, 3 times a day, 3 weeks ago). It was reported that, on 08-MAR-2021 after receiving the injection the patient's arm was sore, which lasted no more than 3 days. On an unspecified date in MAR-2021,  he experienced erectile dysfunction that he noticed for a month now. He had notified his doctor about the symptoms. He had not yet taken anything for the symptoms. He provided permission to contact his doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore on 12-MAR-2021, and had not recovered from erectile dysfunction. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210445531-covid-19 vaccine ad26.cov2.s -erectile dysfunction. 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 182070, and expiry: UNKNOWN) dose was not reported, administered 1 total on 14-MAR-2021 around 12:00 PM at right arm for prophylactic vaccination. No concomitant medications were reported.  On 19-APR-2021 the patient had a antibody test for Immunoglobulin M (IGM) and Immunoglobulin G (IGG) antibodies, and the antibody test showed no antibodies. She did the antibody test at home as she was part of a home clinical trial. Test results suggested that the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210445661- covid-19 vaccine ad26.cov2.s-CONFIRMED IMMUNOLOGICAL VACCINE FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Endoscopy, Fatigue, Neuro-ophthalmological test
Clinical narrative: BENIGN VERTIGO/ON AND OFF LIGHTHEADEDNESS/FEELING WEIRD; TIREDNESS/FATIGUE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 62 kilograms, and height was 69 inches. The patient's past medical history included fat removal from chest, and concurrent conditions included gastrooesophageal reflux disease, somewhat of a hypochondriac, penicillin allergy, and alcoholic, and other pre-existing medical conditions included patient had allergy to all NSAIDS (non-steroidal antiinflammatory drugs). patient had no drug abuse or illicit drug usage. patient consumed one small glass of red wine at night as a preventative for blood clots on the recommendation of a friend who is doctor and the alcohol also thins blood. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination.  Concomitant medications included pantoprazole sodium sesquihydrate for gerd.  On APR-2021, Laboratory data included: Endoscopy (NR: not provided) unknown. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 39.5 C. On 10-APR-2021, the subject experienced tiredness/fatigue. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 16-APR-2021, the subject experienced benign vertigo/on and off lightheadedness/feeling weird. On 21-APR-2021, Laboratory data included: Neuro-ophthalmological test (NR: not provided) Benign vertigo. Treatment medications (dates unspecified) included: meclozine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, and tiredness/fatigue on 12-APR-2021, and the outcome of benign vertigo/on and off lightheadedness/feeling weird was not reported. This report was non-serious.; Sender's Comments: MAC- V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vertigo
Clinical narrative: BENIGN VERTIGO/ON AND OFF LIGHTHEADEDNESS/FEELING WEIRD; TIREDNESS/FATIGUE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 27 year old male. The patient's weight was 62 kilograms, and height was 69 inches. The patient's past medical history included fat removal from chest, and concurrent conditions included gastrooesophageal reflux disease, somewhat of a hypochondriac, penicillin allergy, and alcoholic, and other pre-existing medical conditions included patient had allergy to all NSAIDS (non-steroidal antiinflammatory drugs). patient had no drug abuse or illicit drug usage. patient consumed one small glass of red wine at night as a preventative for blood clots on the recommendation of a friend who is doctor and the alcohol also thins blood. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination.  Concomitant medications included pantoprazole sodium sesquihydrate for gerd.  On APR-2021, Laboratory data included: Endoscopy (NR: not provided) unknown. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 39.5 C. On 10-APR-2021, the subject experienced tiredness/fatigue. Laboratory data included: Body temperature (NR: not provided) 38.5 C. On 16-APR-2021, the subject experienced benign vertigo/on and off lightheadedness/feeling weird. On 21-APR-2021, Laboratory data included: Neuro-ophthalmological test (NR: not provided) Benign vertigo. Treatment medications (dates unspecified) included: meclozine, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 11-APR-2021, and tiredness/fatigue on 12-APR-2021, and the outcome of benign vertigo/on and off lightheadedness/feeling weird was not reported. This report was non-serious.; Sender's Comments: MAC- V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gastric disorder, Malaise
Clinical narrative: SHORTNESS OF BREATH; STOMACH ISSUES; NOT FEELING WELL; 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) 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 shortness of breath, stomach issues, and not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shortness of breath, not feeling well and stomach issues was not reported. 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.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Feeling hot, Hypoaesthesia, Musculoskeletal pain
Clinical narrative: I THOUGHT I WAS DYING; BUTT AND LEG NUMB; BUTT PAIN; LEG PAIN; SO HOT; WEAKNESS; DANGEROUS FEVER; 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, start therapy date were not reported for prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced i thought i was dying, butt and leg numb, leg numb, butt pain, leg pain, so hot, weakness, and dangerous fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dangerous fever, so hot, weakness, i thought i was dying, butt numb and leg numb, leg numb, butt pain and leg pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: I THOUGHT I WAS DYING; BUTT AND LEG NUMB; BUTT PAIN; LEG PAIN; SO HOT; WEAKNESS; DANGEROUS FEVER; 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, start therapy date were not reported for prophylactic vaccination. Batch/Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced i thought i was dying, butt and leg numb, leg numb, butt pain, leg pain, so hot, weakness, and dangerous fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dangerous fever, so hot, weakness, i thought i was dying, butt numb and leg numb, leg numb, butt pain and leg pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Vomiting
Clinical narrative: VOMITING; LIGHT HEADEDNESS; WEAKNESS; 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 08-APR-2021 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 vomiting, light headedness, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, light headedness and weakness was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Fatigue, Pharyngeal swelling, Vision blurred
Clinical narrative: DEPRESSED; VERY BLURRY VISION; VERY FATIGUED; SIDE AND MIDDLE OF THROAT SWOLLEN; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimoto's disease, and reading glasses user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included varicella zoster vaccine rge (cho) for prophylactic vaccination. On 02-APR-2021, the subject experienced side and middle of throat swollen. On 02-APR-2021, the subject experienced very fatigued. On 03-APR-2021, the subject experienced very blurry vision. On 04-APR-2021, the subject experienced depressed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side and middle of throat swollen on 03-APR-2021, was recovering from very blurry vision, and had not recovered from very fatigued, and depressed. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: CHILLS/SOME SHIVERS; FELT CRAPPY; FEVER; 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) 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/some shivers, fever, and felt crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills/some shivers, fever, and felt crappy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECT; 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, 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.  On an unspecified date, the subject experienced unspecified side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20210446494.
Sex: U
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: HUGE LUMP THAT SEEMS TO BE GETTIING WORSEOVER TIME/ THERE WAS LOT OF REDNESS/SWELLING/ITCHING/LUMP HURT TO TOUCH OR LAY ON,/IS QUITE HARD; 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, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Batch /Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced huge lump that seems to be getting worse over time/lot of redness/swelling/itching/lump hurt to touch or lay on, /is quite hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from huge lump that seems to be getting worse over time/lot of redness/swelling/itching/lump hurt to touch or lay on,/is quite hard. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVER; CHILLS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, 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 chills. On 02-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced sore arm. On 15-APR-2021, the subject experienced injection site pain. On 23-APR-2021, the subject experienced numbing sensation. On 23-APR-2021, the subject experienced whole arm feels weird. On 23-APR-2021, the subject experienced top of the hand hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, and had not recovered from sore arm, injection site pain, top of the hand hurts, numbing sensation, and whole arm feels weird. This report was non-serious.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NUMBING SENSATION; WHOLE ARM FEELS WEIRD; TOP OF THE HAND HURTS; SORE ARM; INJECTION SITE PAIN; FEVER; CHILLS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, 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 chills. On 02-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced sore arm. On 15-APR-2021, the subject experienced injection site pain. On 23-APR-2021, the subject experienced numbing sensation. On 23-APR-2021, the subject experienced whole arm feels weird. On 23-APR-2021, the subject experienced top of the hand hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 04-APR-2021, and had not recovered from sore arm, injection site pain, top of the hand hurts, numbing sensation, and whole arm feels weird. This report was non-serious.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Blood urine present, Computerised tomogram, Haemorrhage urinary tract, Pain
Clinical narrative: BLOOD CLOTS IN URINE; URINATING BLOOD; FELT ACHY; This spontaneous report received from a patient concerned a 43 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: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered, 1 total, to left arm on 19-MAR-2021 around 06:00 PM for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, 12 hours after vaccination patient felt achy which had resolved in 24 hours. On 20-APR-2021, patient experienced blood clots in urine and had urinating blood lasted till evening of same day. The patient visited emergency room for same symptoms and admitted on 20-APR-2021, discharged around noon on same day. The patient was given with IV fluids and no other medications were administered. The patient had undergone blood test, urine analysis, computerized tomography (CT) scan and results were nothing urgent to consult. The patient had planned to do follow-up with urologist on 28-APR-2021. Laboratory data included: Blood test (NR: not provided) negative, computerized tomography (CT) scan (NR: not provided) negative, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and urinating blood on 20-APR-2021, and felt achy on 21-MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Covid-19 vaccine .Ad26.Cov2.S- Blood clots in urine . 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: BLOOD CLOTS IN URINE; URINATING BLOOD; FELT ACHY; This spontaneous report received from a patient concerned a 43 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: 1805020, and expiry: 25-MAY-2021) dose was not reported, administered, 1 total, to left arm on 19-MAR-2021 around 06:00 PM for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, 12 hours after vaccination patient felt achy which had resolved in 24 hours. On 20-APR-2021, patient experienced blood clots in urine and had urinating blood lasted till evening of same day. The patient visited emergency room for same symptoms and admitted on 20-APR-2021, discharged around noon on same day. The patient was given with IV fluids and no other medications were administered. The patient had undergone blood test, urine analysis, computerized tomography (CT) scan and results were nothing urgent to consult. The patient had planned to do follow-up with urologist on 28-APR-2021. Laboratory data included: Blood test (NR: not provided) negative, computerized tomography (CT) scan (NR: not provided) negative, and Urinalysis (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and urinating blood on 20-APR-2021, and felt achy on 21-MAR-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Covid-19 vaccine .Ad26.Cov2.S- Blood clots in urine . 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: Abdominal pain upper, Chills, Headache, Night sweats, Pyrexia
Clinical narrative: CHILLS SOMETIMES COME WITH NIGHT SWEATS; OCCASIONALLY CHILLS; OCCASIONALLY HEADACHE; FEVER; ABDOMINAL PAIN (STOMACH ACHE); This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced abdominal pain (stomach ache). On an unspecified date, the subject experienced chills sometimes come with night sweats, occasionally chills, occasionally headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from abdominal pain (stomach ache), occasionally headache, occasionally chills, and chills sometimes come with night sweats. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling face
Clinical narrative: SWOLLEN FACE; RASH ON NECK THAT IS ITCHY, SORE, FEELS RAW; 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: 1806029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced swollen face. On 15-APR-2021, the subject experienced rash on neck that is itchy, sore, feels raw. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on neck that is itchy, sore, feels raw, and swollen face. This report was non-serious.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: ACHY LEGS FROM THE HIP DOWNS THAT FEELS LIKE GOWNING PAINS; HEADACHE; This spontaneous report received from a consumer concerned a 34 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 02-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 23-APR-2021, the subject experienced achy legs from the hip downs that feels like gowning pains. On 23-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and achy legs from the hip downs that feels like gowning pains was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: DIZZINESS; TIRED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tired, and had not recovered from dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Monoplegia, Neutropenia
Clinical narrative: SEVERE CHRONIC NEUTROPENIA; NOT FEELING WELL; SHORTNESS OF BREATH; LEG PARALYSIS AT TIMES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included cancer, chronic obstructive pulmonary disease (copd), and diabetes mellitus (dm). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and  expiry: 25/MAY/2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 30-MAR-2021, the patient experienced shortness of breath. On 30-MAR-2021, the patient experienced leg paralysis at times. On 30-MAR-2021, the patient experienced not feeling well. On an unspecified date, the patient experienced severe chronic neutropenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling well, shortness of breath and leg paralysis at times was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 :-covid vaccine-leg paralysis at times ,severe chronic neutropenia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: ACHES; CHILLS; NAUSEA; This spontaneous report received from a parent concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-APR-2021, the subject experienced aches. On 23-APR-2021, the subject experienced chills. On 23-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fibrin D dimer, Fibrin D dimer increased, Hypertension
Clinical narrative: D-DIMER NUMBERS ELEVATED; EXTREMELY HIGH BLOOD PRESSURE; 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) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced d-dimer numbers elevated. On APR-2021, the subject experienced extremely high blood pressure. Laboratory data included: Blood pressure (NR: not provided) Extremely high, and Fibrin D dimer (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from d-dimer numbers elevated, and extremely high blood pressure. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Pulmonary embolism
Clinical narrative: POSSIBLE PULMONARY EMBOLISM; ELEVATED D-DIMER; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: ER8729, and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 at around 10:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-APR-2021, the patient experienced shortness of breath that worsened with exertion, and at the time of reporting at rest. Patient called her physician (MD) (internist) and went to the office on 23-APR-2021 for some testing. She had an elevated d-dimer level. Laboratory data included: Fibrin D dimer high (NR: not provided) Elevated. The physician treated her for possible pulmonary embolism. On same day she experienced pressure in her chest. At the time of reporting patient had shortness of breath and occasionally some pressure in her chest. Patient did not take any medications for her symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated d-dimer, and possible pulmonary embolism. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous case describes a 55-year-old female who experienced shortness of breath which worsened with exertion 9 days after receiving the Janssen COVID-19 vaccine.  She then experienced chest pressure 16 days after vaccine administration, and saw her physician that day.  D-dimer level was elevated, and the physician treated her for a possible pulmonary embolism.  Medical history and concomitant medications were not provided.  The patient had not recovered from the events.  There are insufficient details in the case to make a meaningful medical assessment. The case will be assessed further when additional information is received.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: BODY ACHES; SLIGHT FEVER; SUPER TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, slight fever, and super tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight fever, body aches, and super tired. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pain
Clinical narrative: DISCOMFORT; BODY ACHES; CHILLS; 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 body aches, discomfort, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, body aches, and discomfort. This report was non-serious.