chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Pallor, Physical examination, Testicular swelling
Clinical narrative: SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A 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 numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan, Urine analysis, Vision blurred
Clinical narrative: SWEATING; LIPS TURNED INTO PALE; VISION BLURRED; NO ENERGY; STRESSFUL HEADACHE; NUMBNESS IN THE GROIN AREA AND LEFT TESTICLES; SWOLLEN LEFT TESTICLE; FEEL EXTREME PAIN; FEELING SENSATION IN DEEP INSIDE BODY AND WAS NOT SUPERFICIAL/FEELING WAS GOING TOWARD LEFT SIDE OF PELVIS/FEELING BLOOD BEATS IN LOWER PART AREA; LEFT SIDE OF LOWER ABDOMEN AROUND THE WAISTLINE SWOLLEN; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, and concurrent conditions included non alcohol user, and smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 043A21A 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 numbness in the groin area and left testicles. On APR-2021, the subject experienced swollen left testicle. On APR-2021, the subject experienced feel extreme pain. On APR-2021, the subject experienced feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area. On APR-2021, the subject experienced left side of lower abdomen around the waistline swollen. On APR-2021, the subject experienced stressful headache. Treatment medications included: morphine, and oxycodone hydrochloride. On 03-APR-2021, the subject experienced sweating. On 03-APR-2021, the subject experienced lips turned into pale. On 03-APR-2021, the subject experienced vision blurred. On 03-APR-2021, the subject experienced no energy. On 30-APR-2021, Laboratory data included: Diagnostic ultrasound (NR: not provided) no sign of infection, Physical examination (NR: not provided) no sign of infection, and Urine analysis (NR: not provided) no sign of infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vision blurred, and the outcome of numbness in the groin area and left testicles, sweating, swollen left testicle, lips turned into pale, no energy, feel extreme pain, feeling sensation in deep inside body and was not superficial/feeling was going toward left side of pelvis/feeling blood beats in lower part area, stressful headache and left side of lower abdomen around the waistline swollen was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait inability
Clinical narrative: UNABLE TO WALK AND WAS ON WHEELCHAIR; FELT SMALL 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 past medical history included tibial plateau fracture surgery, and concurrent conditions included allergic to penicillin, allergic to sulfas, allergy to macrolide, and deep vein thrombosis. The patient experienced allergy when treated with codeine, gliclazide, and diazepam.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. Concomitant medications included cannabis sativa, celecoxib, gabapentin, and paracetamol.  On 06-MAY-2021, the subject experienced unable to walk and was on wheelchair. On 06-MAY-2021, the subject experienced felt small tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unable to walk and was on wheelchair, and the outcome of felt small tired was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Scan, Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT LEG; This spontaneous report received from a patient concerned a 48 year old, White and Hispanic or Latino female. The patient's height, weight and medical history were not reported. The patient had no blood clots in the past or no recent trauma and surgery. The patient was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm, on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the patient came into the hospital with swelling in left leg, a lot of heat and a lot of pain. In emergency room (ER) they did scans and tests and it was found that the patient had a blood clot in left leg. The patient has to stay in the hospital for 24 hours until the blood clot was resolved.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot in left leg. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0;20210516127- covid-19 vaccine ad26.cov2.s-Blood Clot in left leg. 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Headache, Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: LEFT HAND SORE; LEFT CHEST MUSCLE SORE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 62 year old Asian (Not hispanic or latino) male. The patient's height, and weight were not reported. The patient had no history of covid-19 on test.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 09-APR-2021, the patient experienced headache (right side of head, sometimes in left side) but no fever. Six weeks later, his antibody test was performed. On 05-MAY-2021, no antibody (coded as: suspected immunological vaccine failure) found in the test. On 06-MAY-2021, he had left chest muscle sore. He also developed left hand sore. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and left chest muscle sore, had not recovered from suspected immunological vaccine failure, and the outcome of left hand sore was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000178890. The suspected product quality complaint has been confirmed to be void: No based on the PQC evaluation/investigation performed. This case, is linked to 20210516564 (same reporter).; Sender's Comments: V0: 20210516323- Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine 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: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: LEFT HAND SORE; LEFT CHEST MUSCLE SORE; SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; HEADACHE; This spontaneous report received from a patient concerned a 62 year old Asian (Not hispanic or latino) male. The patient's height, and weight were not reported. The patient had no history of covid-19 on test.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: unknown) dose was not reported, 1 total administered on 26-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  On 09-APR-2021, the patient experienced headache (right side of head, sometimes in left side) but no fever. Six weeks later, his antibody test was performed. On 05-MAY-2021, no antibody (coded as: suspected immunological vaccine failure) found in the test. On 06-MAY-2021, he had left chest muscle sore. He also developed left hand sore. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and left chest muscle sore, had not recovered from suspected immunological vaccine failure, and the outcome of left hand sore was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000178890. The suspected product quality complaint has been confirmed to be void: No based on the PQC evaluation/investigation performed. This case, is linked to 20210516564 (same reporter).; Sender's Comments: V0: 20210516323- Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: BLOOD IN STOOL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 in total administered on 06-MAY-2021, around 14:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform the follow up to request batch number. No concomitant medications were reported.  On 07-MAY-2021, the patient had blood in stools in the morning and later on day of reporting. The patient had visited physician office for blood in stool. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516537-covid-19 vaccine ad26.cov2. s-blood in stool. 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: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasal congestion
Clinical narrative: NASAL CONGESTION; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight was 52.3 kilograms, and height was not reported. The patient's concurrent conditions included seasonal allergies, and secondary pulmonary hypertension. The patient received epoprostenol sodium (injection, intravenous, batch number: MM254M0101 expiry: UNKNOWN) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ambrisentan for drug used for unknown indication, and tadalafil non-company for drug used for unknown indication. On an unspecified date, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. The outcome of nasal congestion was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Eye pain, Eyelid pain, Headache, Injection site pain
Clinical narrative: LEFT EYE AND EYE BALL HURTS; LEFT EYE LID HURTS TO BLINK; EYE LID CRAMPS; HEADACHE ACCOMPANIED WITH DISCOMFORT WITH LIGHT (COULD NOT LOOK AT THE LIGHT); HEADACHE MIGRATES FROM ONE SIDE TO ANOTHER AND TO TOP OF HEAD; PAIN IN LEFT SHOULDER ON SITE OF THE VACCINE FOR WHOLE MONTH AND LONGER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included border line diabetic, breast cancer, and eye lid cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pain in left shoulder on site of the vaccine for whole month and longer. On 03-APR-2021, the subject experienced headache migrates from one side to another and to top of head. On 06-MAY-2021, the subject experienced left eye and eye ball hurts. On 06-MAY-2021, the subject experienced left eye lid hurts to blink. On 06-MAY-2021, the subject experienced eye lid cramps. On 06-MAY-2021, the subject experienced headache accompanied with discomfort with light (could not look at the light). Treatment medications (dates unspecified) included: paracetamol, menthol/methyl salicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in left shoulder on site of the vaccine for whole month and longer, and had not recovered from headache migrates from one side to another and to top of head, left eye and eye ball hurts, headache accompanied with discomfort with light (could not look at the light), eye lid cramps, and left eye lid hurts to blink. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: LEFT EYE AND EYE BALL HURTS; LEFT EYE LID HURTS TO BLINK; EYE LID CRAMPS; HEADACHE ACCOMPANIED WITH DISCOMFORT WITH LIGHT (COULD NOT LOOK AT THE LIGHT); HEADACHE MIGRATES FROM ONE SIDE TO ANOTHER AND TO TOP OF HEAD; PAIN IN LEFT SHOULDER ON SITE OF THE VACCINE FOR WHOLE MONTH AND LONGER; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included border line diabetic, breast cancer, and eye lid cramps. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced pain in left shoulder on site of the vaccine for whole month and longer. On 03-APR-2021, the subject experienced headache migrates from one side to another and to top of head. On 06-MAY-2021, the subject experienced left eye and eye ball hurts. On 06-MAY-2021, the subject experienced left eye lid hurts to blink. On 06-MAY-2021, the subject experienced eye lid cramps. On 06-MAY-2021, the subject experienced headache accompanied with discomfort with light (could not look at the light). Treatment medications (dates unspecified) included: paracetamol, menthol/methyl salicylate, and acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain in left shoulder on site of the vaccine for whole month and longer, and had not recovered from headache migrates from one side to another and to top of head, left eye and eye ball hurts, headache accompanied with discomfort with light (could not look at the light), eye lid cramps, and left eye lid hurts to blink. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: PAIN AT INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAY-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Hypersomnia, Malaise, Pain in extremity, Polymenorrhoea
Clinical narrative: EARLY MENSTRUAL PERIOD (12 DAYS AFTER PREVIOUS PERIOD); 8 DAYS OF HEAVY BLEEDING; SLEPT ALMOST THE ENTIRE DAY; VERY SORE ARM; FELT RUN DOWN FOR ABOUT A WEEK; 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: 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 very sore arm. On 10-APR-2021, the subject experienced felt run down for about a week. On 11-APR-2021, the subject experienced slept almost the entire day. On 17-APR-2021, the subject experienced 8 days of heavy bleeding. On 06-MAY-2021, the subject experienced early menstrual period (12 days after previous period). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 8 days of heavy bleeding on 24-APR-2021, slept almost the entire day on 11-APR-2021, very sore arm on 13-APR-2021, and felt run down for about a week on 17-APR-2021, and the outcome of early menstrual period (12 days after previous period) 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: COVID-19 pneumonia, SARS-CoV-2 test
Clinical narrative: COVID-19 PNEUMONIA; This spontaneous report received from a consumer (patient's wife) from a traditional media article via a company representative, concerned a male patient of unspecified age, race and ethnicity. 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 administration was not reported, batch number and expiry were unknown) dose was not reported, 1 total, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 01-APR-2021, the patient felt sick, had a stuffy and sore throat, cough, fatigue and then he started to run a fever. On the same day, the patient was tested positive for coronavirus disease (COVID-19) and also developed pneumonia (COVID-19 pneumonia). On an unknown date, the patient was hospitalized and was fighting for his life. At the time of report, the patient's condition was critical and was on medications (unspecified) for his condition. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19 pneumonia. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000178844.; Sender's Comments: V0; 20210516810-covid-19 vaccine ad26.cov2.s-COVID-19 pneumonia. 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: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hydrocephalus, Hypertension
Clinical narrative: HYDROCEPHALUS PRESSURE INCREASED; HIGH BLOOD PRESSURE; This spontaneous report received from a patient via social media concerned a 61 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included hydrocephalus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced hydrocephalus pressure increased, and high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hydrocephalus pressure increased and high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516875-covid-19 vaccine ad26.cov2.s -Hydrocephalus pressure increased. This event(s) is considered not related. The event(s) has an unknown/unclear 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: UNDERLYING DISEASE
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 09-MAY-2021, the subject experienced sore arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arms was not reported. This report was non-serious. This case, involving the same patient is linked to 20210519312.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache
Clinical narrative: PAIN IN THE ARMPIT; TIRED; HEADACHE; CHILLS; 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 pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAY-2021, the subject experienced chills. On 08-MAY-2021, the subject experienced tired. On 08-MAY-2021, the subject experienced headache. On 09-MAY-2021, the subject experienced pain in the armpit. The action taken with covid-19 vaccine  was not applicable. The patient recovered from chills, tired, and headache, and had not recovered from pain in the armpit. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Formication, Headache
Clinical narrative: GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Illusion, Palpitations
Clinical narrative: GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine  was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DEEP VEIN THROMBOSIS  LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient developed deep vein thrombosis (DVT) on leg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of deep vein thrombosis leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210517421- COVID-19 VACCINE AD26.COV2.S  Deep vein thrombosis leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: PASSED AWAY BECAUSE OF CLOT; This spontaneous report received from a consumer concerned a patient of Unspecified Race, ethnic origin, 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, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient passed away because of clot. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210517449- covid-19 vaccine ad26.cov2.s-thrombosis. 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).; Reported Cause(s) of Death: CLOT
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN LEFT CALF; This spontaneous report received from a patient via a company representative through social media concerned a male of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced blood clot in left calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in left calf was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;0210517568-covid-19 vaccine ad26.cov2.-Blood clot in left calf. 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: Malaise
Clinical narrative: FEELING UNWELL; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine (suspension for injection, intramuscular, 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 feeling unwell. The action taken with covid-19 vaccine was not applicable. The outcome of feeling unwell was not reported. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electrocardiogram, Hypoaesthesia, Peripheral swelling
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Full blood count, Hypertension, Lacrimation increased
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound scan, Vision blurred
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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: 58.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Fatigue, Hypoaesthesia, Peripheral swelling
Clinical narrative: BLOOD CLOTS IN LUNGS; NUMBNESS IN HANDS AND FEET; SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 58 year old white male. Initial information was processed along with the additional information received on 11-MAY-2021  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered to right deltoid on 09-APR-2021 around 13:00 for prophylactic vaccination. No concomitant medications were reported.  After receiving the vaccination on 09-APR-2021, the patient went home and slept for 6 hours. One week after vaccination, on 12-APR-2021 the patient experienced swelling in hands and feet. Two weeks after, on 19-APR-2021 the patient experienced numbness in hands and feet. On 21-APR-2021, the patient went to the emergency room (ER) and was given the tests, laboratory data included: Blood test (NR: not provided) unknown, CAT scan (NR: not provided) blood clots in lungs, and EKG (NR: not provided) unknown. The patient experienced blood clots in lungs and was hospitalized. On 22-APR-2021, laboratory data included: Sonogram (NR: not provided) results awaiting and will get records on wednesday.  As of 22-APR-2021 the patient was started on blood thinner. Treatment medications included: apixaban (Eliquis) 2 a day. On an unspecified date in APR-2021 while in the hospital the patient was on oxygen (unspecified indication). The patient was discharged on 22-APR-2021 and the duration of hospitalization was 1 day. The patient was released with a prescription of Eliquis for 3 months. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in hands and feet, numbness in hands and feet, and blood clots in lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210518013 -COVID-19 VACCINE AD26.COV2.S- Blood Clots in lungs . 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).