chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Blister, Dacryostenosis acquired, Fatigue, Fluid retention
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy, Migraine, Pain, Visual impairment
Clinical narrative: 1st shot: fatigue, arm pain, and left armpit pain (duration: a day) 2nd shot: (24 hrs. after shot - duration 2 days) headache, body ache, sore jaw, swollen chest and armpits, gastroinestinal issues, achey joints  2 weeks to the day after 2nd shot: sore, swollen, tender breasts and armpits; next day: mammogram resulting in injury to swollen lymph nodes that were an unknown reaction to the vaccine. It has been over a week now, and doctors are telling me this is going to be a process. I have been to the ER, and have had multiple tests ordered for imaging, but I am awaiting pre-authorization from insurance company. I am a teacher and doubt I will be physically able to return to work this school year.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: lower ext DVT, started on oral anticoagulation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion missed, Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: 03/01/2021: Positive pregnancy test 03/31/2021: 8 weeks gestation based on LMP; US showed fetus measuring 6w1d, fetal heartbeat 81 04/07/2021: 9 weeks gestation based on LMP; US showed fetus measuring 6w1d, no fetal heart tones 04/09/2021: D&C performed for missed abortion
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Moderns COVID-19 Vaccine EUA. Experiencing cramping in both calves.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood pressure increased, Cardiovascular disorder, Computerised tomogram, Facial discomfort
Clinical narrative: WEAK AND HEAVY FEELING ON THE FACE; FEELS LIKE THE CIRCULATION IS LOW; WEAKNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; NUMBNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; COLD LIMBS; ABDOMINAL PAIN; SORE INJECTION SITE; HEADACHE; NECK PAIN; CLOUDY CLEAR URINE; SWOLLEN VEIN ON RIGHT FOOT; HIGHER BP THAN NORMAL; WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced cloudy clear urine. On APR-2021, the subject experienced swollen vein on right foot. On APR-2021, the subject experienced higher bp than normal. On APR-2021, the subject experienced weight loss. On APR-2021, the subject experienced sore injection site. On APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced numbness on the right leg right arm and left foot. On 14-APR-2021, the subject experienced cold limbs. On 14-APR-2021, the subject experienced weak and heavy feeling on the face. On 14-APR-2021, the subject experienced feels like the circulation is low. On 14-APR-2021, the subject experienced weakness on the right leg right arm and left foot. On 19-APR-2021, Laboratory data included: CT scan (NR: not provided) No thrombosis findings, and Laboratory test (NR: not provided) No thrombosis finding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, sore injection site, numbness on the right leg right arm and left foot, cold limbs, cloudy clear urine, swollen vein on right foot, abdominal pain, weak and heavy feeling on the face, higher bp than normal, weight loss, weakness on the right leg right arm and left foot, and feels like the circulation is low. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Injection site pain, Laboratory test, Muscular weakness
Clinical narrative: WEAK AND HEAVY FEELING ON THE FACE; FEELS LIKE THE CIRCULATION IS LOW; WEAKNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; NUMBNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; COLD LIMBS; ABDOMINAL PAIN; SORE INJECTION SITE; HEADACHE; NECK PAIN; CLOUDY CLEAR URINE; SWOLLEN VEIN ON RIGHT FOOT; HIGHER BP THAN NORMAL; WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced cloudy clear urine. On APR-2021, the subject experienced swollen vein on right foot. On APR-2021, the subject experienced higher bp than normal. On APR-2021, the subject experienced weight loss. On APR-2021, the subject experienced sore injection site. On APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced numbness on the right leg right arm and left foot. On 14-APR-2021, the subject experienced cold limbs. On 14-APR-2021, the subject experienced weak and heavy feeling on the face. On 14-APR-2021, the subject experienced feels like the circulation is low. On 14-APR-2021, the subject experienced weakness on the right leg right arm and left foot. On 19-APR-2021, Laboratory data included: CT scan (NR: not provided) No thrombosis findings, and Laboratory test (NR: not provided) No thrombosis finding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, sore injection site, numbness on the right leg right arm and left foot, cold limbs, cloudy clear urine, swollen vein on right foot, abdominal pain, weak and heavy feeling on the face, higher bp than normal, weight loss, weakness on the right leg right arm and left foot, and feels like the circulation is low. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Peripheral coldness, Urine abnormality, Vasodilatation, Weight decreased
Clinical narrative: WEAK AND HEAVY FEELING ON THE FACE; FEELS LIKE THE CIRCULATION IS LOW; WEAKNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; NUMBNESS ON THE RIGHT LEG RIGHT ARM AND LEFT FOOT; COLD LIMBS; ABDOMINAL PAIN; SORE INJECTION SITE; HEADACHE; NECK PAIN; CLOUDY CLEAR URINE; SWOLLEN VEIN ON RIGHT FOOT; HIGHER BP THAN NORMAL; WEIGHT LOSS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included raynaud, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced cloudy clear urine. On APR-2021, the subject experienced swollen vein on right foot. On APR-2021, the subject experienced higher bp than normal. On APR-2021, the subject experienced weight loss. On APR-2021, the subject experienced sore injection site. On APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced numbness on the right leg right arm and left foot. On 14-APR-2021, the subject experienced cold limbs. On 14-APR-2021, the subject experienced weak and heavy feeling on the face. On 14-APR-2021, the subject experienced feels like the circulation is low. On 14-APR-2021, the subject experienced weakness on the right leg right arm and left foot. On 19-APR-2021, Laboratory data included: CT scan (NR: not provided) No thrombosis findings, and Laboratory test (NR: not provided) No thrombosis finding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, sore injection site, numbness on the right leg right arm and left foot, cold limbs, cloudy clear urine, swollen vein on right foot, abdominal pain, weak and heavy feeling on the face, higher bp than normal, weight loss, weakness on the right leg right arm and left foot, and feels like the circulation is low. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest discomfort, Chest pain, Dizziness
Clinical narrative: LOST NIGHT VISION; HAD A SHARP PAIN IN THE SIDE OF HEAD; HURT SHOULDER; HAD A SHARP PAIN IN THE SIDE OF JAW; SLIGHT CHEST PAIN; CHEST HEAVINESS; STABBING PAIN IN BACK; LIGHT-HEADNESS; PAIN IN HIPS; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots, and other pre-existing medical conditions included sick for at least 6 weeks, started with a fever for several days. 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 10-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 difficulty breathing. On APR-2021, the subject experienced slight chest pain. On APR-2021, the subject experienced chest heaviness. On APR-2021, the subject experienced stabbing pain in back. On APR-2021, the subject experienced light-headness. On APR-2021, the subject experienced pain in hips. On 10-APR-2021, the subject experienced hurt shoulder. On 10-APR-2021, the subject experienced had a sharp pain in the side of jaw. On 10-APR-2021, the subject experienced had a sharp pain in the side of head. On 11-APR-2021, the subject experienced lost night vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, and stabbing pain in back, and the outcome of pain in hips, had a sharp pain in the side of head, had a sharp pain in the side of jaw, lost night vision, slight chest pain, chest heaviness, light-headness and hurt shoulder 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: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Limb injury, Night blindness, Pain in jaw
Clinical narrative: LOST NIGHT VISION; HAD A SHARP PAIN IN THE SIDE OF HEAD; HURT SHOULDER; HAD A SHARP PAIN IN THE SIDE OF JAW; SLIGHT CHEST PAIN; CHEST HEAVINESS; STABBING PAIN IN BACK; LIGHT-HEADNESS; PAIN IN HIPS; DIFFICULTY BREATHING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included blood clots, and other pre-existing medical conditions included sick for at least 6 weeks, started with a fever for several days. 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 10-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 difficulty breathing. On APR-2021, the subject experienced slight chest pain. On APR-2021, the subject experienced chest heaviness. On APR-2021, the subject experienced stabbing pain in back. On APR-2021, the subject experienced light-headness. On APR-2021, the subject experienced pain in hips. On 10-APR-2021, the subject experienced hurt shoulder. On 10-APR-2021, the subject experienced had a sharp pain in the side of jaw. On 10-APR-2021, the subject experienced had a sharp pain in the side of head. On 11-APR-2021, the subject experienced lost night vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty breathing, and stabbing pain in back, and the outcome of pain in hips, had a sharp pain in the side of head, had a sharp pain in the side of jaw, lost night vision, slight chest pain, chest heaviness, light-headness and hurt shoulder 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: U
Vaccine: COVID19
Symptoms: Chills, Hyperaesthesia, Pain, Pyrexia
Clinical narrative: SENSITIVE HANDS; BODY ACHED; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sensitive hands, body ache, chills, and body ached. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive hands, body ache, chills, and body ached. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; SORENESS; FATIGUE; This spontaneous report received from a patient concerned a 38 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: 1805021, and expiry: UNKNOWN) dose was not reported, 1 total administered on 13-MAR-2021 at right deltoid as prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, after vaccination patient had a little soreness and some fatigue for first two days. The patient experienced cold and felt run down for past week because patient was exposed to neighbor on 18-Apr-2021 who was tested positive for COVID-19. On 23-APR-2021, patient got tested for COVID-19 and received positive results for same on 24-Apr-2021. It was stated that patient felt run down, fatigue and common cold. The patient also had some chest congestion, but did not have any consistent cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, and fatigue on 15-MAR-2021, had not recovered from suspected covid 19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. Sender's Comments: V0:-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Pain, Pain in extremity
Clinical narrative: NUMBNESS AND TINGLING IN ARM; IT STARTED IN HER LEFT PINKY AND RADIATED UP THE LEFT ARM. IT HURT FOR A FEW HOURS; BRAIN HURT; SHAKINESS; BODY PAIN; CHILLS; EXHAUSTION; SEIZURES; This spontaneous report received from a health care professional concerned a 19 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, 1 total, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On 09-APR-2021, the patient experienced seizures, confusion, pale appearance and nausea after forty five minutes patient was okay. The patient was drove back home and slept for 7 hours then experienced exhaustion. The next morning on 10-APR-2021, the patient's  brain hurt to work and experienced body pain, shakiness, chills. Ten days later on 19-APR-2021, the patient experienced numbness and tingling in left arm. It was started in left pinky finger and radiated up the left arm. It was hurt for a few hours (just 1 episode). health care professional has ordered tests but they had not been completed yet. The patient was seen by a pediatric neurologist on 22-APR-2021 for evaluation of seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures, exhaustion, chills, body pain, shakiness, brain hurt, numbness and tingling in arm, It started in her left pinky and radiated up the left arm, It hurt for a few hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210450038- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizures. 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Seizure, Tremor
Clinical narrative: NUMBNESS AND TINGLING IN ARM; IT STARTED IN HER LEFT PINKY AND RADIATED UP THE LEFT ARM. IT HURT FOR A FEW HOURS; BRAIN HURT; SHAKINESS; BODY PAIN; CHILLS; EXHAUSTION; SEIZURES; This spontaneous report received from a health care professional concerned a 19 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, 1 total, administered on 09-APR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and it has been requested.  No concomitant medications were reported.  On 09-APR-2021, the patient experienced seizures, confusion, pale appearance and nausea after forty five minutes patient was okay. The patient was drove back home and slept for 7 hours then experienced exhaustion. The next morning on 10-APR-2021, the patient's  brain hurt to work and experienced body pain, shakiness, chills. Ten days later on 19-APR-2021, the patient experienced numbness and tingling in left arm. It was started in left pinky finger and radiated up the left arm. It was hurt for a few hours (just 1 episode). health care professional has ordered tests but they had not been completed yet. The patient was seen by a pediatric neurologist on 22-APR-2021 for evaluation of seizures. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizures, exhaustion, chills, body pain, shakiness, brain hurt, numbness and tingling in arm, It started in her left pinky and radiated up the left arm, It hurt for a few hours was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210450038- JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Adnexa uteri pain, Breast swelling, Chills, Menstrual disorder
Clinical narrative: SHARP OVARIAN PAIN; BAD HORMONAL ACNE; SWOLLEN BOOBS; MENSTRUAL BLEEDING FOR 7 DAYS STRAIGHT; FLU-LIKE CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sharp ovarian pain, bad hormonal acne, swollen boobs, menstrual bleeding for 7 days straight, flu-like chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like chills, fever, sharp ovarian pain, bad hormonal acne, swollen boobs and menstrual bleeding for 7 days straight was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SHARP OVARIAN PAIN; BAD HORMONAL ACNE; SWOLLEN BOOBS; MENSTRUAL BLEEDING FOR 7 DAYS STRAIGHT; FLU-LIKE CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sharp ovarian pain, bad hormonal acne, swollen boobs, menstrual bleeding for 7 days straight, flu-like chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like chills, fever, sharp ovarian pain, bad hormonal acne, swollen boobs and menstrual bleeding for 7 days straight was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Muscle twitching, Nausea, Pyrexia
Clinical narrative: BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. 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.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: BULGING VEINS IN LOWER LEGS; MUSCLE TWITCHING; NAUSEA; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. On 01-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced muscle twitching. On 10-APR-2021, the subject experienced bulging veins in lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 03-APR-2021, nausea on APR-2021, and headache on 05-APR-2021, was recovering from muscle twitching, and had not recovered from bulging veins in lower legs. 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: Arthralgia, Asthenia, Cardiac discomfort, Chest pain, Dyspnoea
Clinical narrative: CHEST PAIN; PAIN IN SHOULDER; SLEPT ALL THE DAY; TOTALLY TIRED, FATIGUE; LOSS OF ENERGY; HARD TO BREATH; FELT VERY DIFFERENT LIKE SOMETHING WAS TIGHT IN HEART; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included slightly elevated cholesterol/high cholesterol, and stomach acidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included cholesterol, and ergocalciferol.  On 2021, the subject experienced hard to breath. On 2021, the subject experienced felt very different like something was tight in heart. On 2021, the subject experienced loss of energy. On 14-MAR-2021, the subject experienced slept all the day. On 14-MAR-2021, the subject experienced totally tired, fatigue. On 20-MAR-2021, the subject experienced chest pain. On 20-MAR-2021, the subject experienced pain in shoulder. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from totally tired, fatigue, chest pain, pain in shoulder, and hard to breath, and the outcome of slept all the day, loss of energy and felt very different like something was tight in heart was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: CHEST PAIN; PAIN IN SHOULDER; SLEPT ALL THE DAY; TOTALLY TIRED, FATIGUE; LOSS OF ENERGY; HARD TO BREATH; FELT VERY DIFFERENT LIKE SOMETHING WAS TIGHT IN HEART; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's past medical history included slightly elevated cholesterol/high cholesterol, and stomach acidity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included cholesterol, and ergocalciferol.  On 2021, the subject experienced hard to breath. On 2021, the subject experienced felt very different like something was tight in heart. On 2021, the subject experienced loss of energy. On 14-MAR-2021, the subject experienced slept all the day. On 14-MAR-2021, the subject experienced totally tired, fatigue. On 20-MAR-2021, the subject experienced chest pain. On 20-MAR-2021, the subject experienced pain in shoulder. Treatment medications (dates unspecified) included: omeprazole. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from totally tired, fatigue, chest pain, pain in shoulder, and hard to breath, and the outcome of slept all the day, loss of energy and felt very different like something was tight in heart was not reported. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a consumer concerned a multiple females patient's of unspecified age. The patient's weight, height, and medical history were not reported.  The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown) dose, 1 total 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 after vaccination, the patient's experienced pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210446568.; Sender's Comments: V0: 20210450133-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Pulmonary embolism. This event 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Asthenopia, Chest discomfort, Chest pain, Contusion
Clinical narrative: BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Headache, Limb injury
Clinical narrative: BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Platelet count, Skin discolouration
Clinical narrative: BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLACK TOE; STUBBED HER RIGHT SMALL TOE; SEVERE HEADACHE; CHEST PRESSURE; CHEST PAIN; SORE ARM; NECK PAIN; MUSCLE ACHES; EXTREME TIREDNESS; SHORTNESS OF BREATH; HEAVY AND TIRED EYE; MULTIPLE BRUISE; BLURRED VISION IN LEFT EYE; FUNNY EYES; COUGHING; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 in march 2020, and concurrent conditions included migraine on the right or left side of her head, and sinus problem. he patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included mecobalamin.  On APR-2021, the subject experienced shortness of breath. On APR-2021, the subject experienced heavy and tired eye. On APR-2021, the subject experienced multiple bruise. On APR-2021, the subject experienced blurred vision in left eye. On APR-2021, the subject experienced funny eyes. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced neck pain. On APR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced extreme tiredness. Laboratory data included: Platelet count (NR: not provided) Normal. On 08-APR-2021, the subject experienced sore arm. On 10-APR-2021, the subject experienced chest pressure. On 10-APR-2021, the subject experienced chest pain. On 14-APR-2021, the subject experienced stubbed her right small toe. On 14-APR-2021, the subject experienced severe headache. On 15-APR-2021, the subject experienced black toe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pressure, and chest pain on 11-APR-2021, and heavy and tired eye, blurred vision in left eye, funny eyes, coughing, black toe, stubbed her right small toe, sore arm, severe headache, muscle aches, and extreme tiredness on APR-2021, had not recovered from multiple bruise, and the outcome of shortness of breath and neck pain was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Feeling hot, Haematoma, Malaise
Clinical narrative: HEMATOMA  ALL OVER THE BODY/RIGHT LEG AND RIGHT ARM/LEFT LEG/NECK; NOT FEELING WELL; BURNING SENSATION INSIDE BODY; FEELING HOT; PAIN IN LEFT LEG AND FROM THE KNEE DOWN TO FOOT; FEELING TIRED; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stenosis of back, and hypothyroidism.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid. On APR-2021, the subject experienced pain in left leg and from the knee down to foot. On APR-2021, the subject experienced feeling tired. On 10-APR-2021, the subject experienced burning sensation inside body. On 10-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced not feeling well. On 19-APR-2021, the subject experienced hematoma all over the body/right leg and right arm/left leg/neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation inside body, and feeling hot on 11-APR-2021, had not recovered from hematoma all over the body/right leg and right arm/left leg/neck, pain in left leg and from the knee down to foot, and not feeling well, and the outcome of feeling tired 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: HEMATOMA  ALL OVER THE BODY/RIGHT LEG AND RIGHT ARM/LEFT LEG/NECK; NOT FEELING WELL; BURNING SENSATION INSIDE BODY; FEELING HOT; PAIN IN LEFT LEG AND FROM THE KNEE DOWN TO FOOT; FEELING TIRED; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stenosis of back, and hypothyroidism.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine for thyroid. On APR-2021, the subject experienced pain in left leg and from the knee down to foot. On APR-2021, the subject experienced feeling tired. On 10-APR-2021, the subject experienced burning sensation inside body. On 10-APR-2021, the subject experienced feeling hot. On 11-APR-2021, the subject experienced not feeling well. On 19-APR-2021, the subject experienced hematoma all over the body/right leg and right arm/left leg/neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation inside body, and feeling hot on 11-APR-2021, had not recovered from hematoma all over the body/right leg and right arm/left leg/neck, pain in left leg and from the knee down to foot, and not feeling well, and the outcome of feeling tired 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.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site.  His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: DIARRHEA; LETHARGIC; GENERALISED ACHING; HEADACHE; SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; BLOOD CLOT FROM THIGH TO CALF; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included paralyzed on left side from a previous injury and not very active. 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 1 total administered on 06-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient had blow-out diarrhea, lethargic, body aches, headache. On APR-2021, the patient experienced leg pain (started week ago), swelling at injection site and redness at injection site.  His left foot was swollen, and called physician to check for blood clot or break. The doctor said that the test showed a blood clot from his thigh all the way down to his calf that was a medical emergency. Reporter thinks there was a possibility that they were already exposed to COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot from thigh to calf, diarrhea, lethargic, generalised aching, headache, swelling at injection site and redness at injection site was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210450241- COVID-19 VACCINE Ad26.COV2. S -Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).