chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS TOOK QUITE A WHILE  TO GET OVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 side effects took quite a while to get over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects took quite a while to get over was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: ARM HURTS; LITTLE FEVER/FELT LIKE CAUGHT THE FLU; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 10-JUL-2021, the subject experienced little fever/felt like caught the flu. On an unspecified date, the subject experienced arm hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little fever/felt like caught the flu, and had not recovered from arm hurts. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: ARM WAS SORE FOR A DAY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: esketamine hydrochloride ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced arm was sore for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm was sore for a day. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: SLOW IMPROVEMENTS STARTED FEELING TINGLING IN HER TOES LIKE NERVES WERE COMING BACK TO LIFE AND ALMOST BACK TO NORMAL AS GO FOR WALKS AGAIN VACCINE WAS ABLE TO DO A RESET ON IMMUNE SYSTEM; This spontaneous report received from a parent via a company representative concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included red/purple toes, swollen toes, blistered toes, scaly toes, and painful toes, and other pre-existing medical conditions included patient suffered for a solid year with what was referred to as covid toes and her toes couldn't bend and looked like they had frostbite half the time. 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 APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced slow improvements started feeling tingling in her toes like nerves were coming back to life and almost back to normal as go for walks again vaccine was able to do a reset on immune system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slow improvements started feeling tingling in her toes like nerves were coming back to life and almost back to normal as go for walks again vaccine was able to do a reset on immune system was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose increased, Chills, Headache
Clinical narrative: SLIGHT MIGRAINE; RECURRENT SWEATING; ACHES AND PAIN; JAW HURT; FEELS SENSITIVE IN THE SKIN AND THE NECK ON THE RIGHT SIDE OF THE FACE; BLOOD GLUCOSE LEVEL OUT OF WHACK; RECURRENT SHIVERING; WEAKNESS; HEADACHE/RIGHT TEMPLE IS SENSITIVE ALONG WITH THE VEINS ON THE RIGHT SIDE ABOVE THE EYE BROW; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included accident, and concurrent conditions included diabetic, arthritis pain, and lesion on his hip, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced slight migraine. On 16-MAY-2021, the subject experienced recurrent sweating. On 16-MAY-2021, the subject experienced aches and pain. On 16-MAY-2021, the subject experienced jaw hurt. On 16-MAY-2021, the subject experienced feels sensitive in the skin and the neck on the right side of the face. On 16-MAY-2021, the subject experienced blood glucose level out of whack. On 16-MAY-2021, the subject experienced recurrent shivering. On 16-MAY-2021, the subject experienced weakness. On 16-MAY-2021, the subject experienced headache/right temple is sensitive along with the veins on the right side above the eye brow. Laboratory data included: Blood glucose (NR: not provided) 228 mg/dL. On 09-JUN-2021, Laboratory data included: Hip X-ray (NR: not provided) did not find anything wrong, and Laboratory test (NR: not provided) did not find anything wrong. On 12-JUL-2021, Laboratory data included: Blood glucose (NR: not provided) 179 mg/dL. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 115 mg/dL. Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, headache/right temple is sensitive along with the veins on the right side above the eye brow, recurrent sweating, jaw hurt, aches and pain, recurrent shivering, slight migraine, feels sensitive in the skin and the neck on the right side of the face, and blood glucose level out of whack. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Laboratory test, Migraine, Pain, Pain in jaw
Clinical narrative: SLIGHT MIGRAINE; RECURRENT SWEATING; ACHES AND PAIN; JAW HURT; FEELS SENSITIVE IN THE SKIN AND THE NECK ON THE RIGHT SIDE OF THE FACE; BLOOD GLUCOSE LEVEL OUT OF WHACK; RECURRENT SHIVERING; WEAKNESS; HEADACHE/RIGHT TEMPLE IS SENSITIVE ALONG WITH THE VEINS ON THE RIGHT SIDE ABOVE THE EYE BROW; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included accident, and concurrent conditions included diabetic, arthritis pain, and lesion on his hip, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced slight migraine. On 16-MAY-2021, the subject experienced recurrent sweating. On 16-MAY-2021, the subject experienced aches and pain. On 16-MAY-2021, the subject experienced jaw hurt. On 16-MAY-2021, the subject experienced feels sensitive in the skin and the neck on the right side of the face. On 16-MAY-2021, the subject experienced blood glucose level out of whack. On 16-MAY-2021, the subject experienced recurrent shivering. On 16-MAY-2021, the subject experienced weakness. On 16-MAY-2021, the subject experienced headache/right temple is sensitive along with the veins on the right side above the eye brow. Laboratory data included: Blood glucose (NR: not provided) 228 mg/dL. On 09-JUN-2021, Laboratory data included: Hip X-ray (NR: not provided) did not find anything wrong, and Laboratory test (NR: not provided) did not find anything wrong. On 12-JUL-2021, Laboratory data included: Blood glucose (NR: not provided) 179 mg/dL. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 115 mg/dL. Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, headache/right temple is sensitive along with the veins on the right side above the eye brow, recurrent sweating, jaw hurt, aches and pain, recurrent shivering, slight migraine, feels sensitive in the skin and the neck on the right side of the face, and blood glucose level out of whack. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin, X-ray of pelvis and hip
Clinical narrative: SLIGHT MIGRAINE; RECURRENT SWEATING; ACHES AND PAIN; JAW HURT; FEELS SENSITIVE IN THE SKIN AND THE NECK ON THE RIGHT SIDE OF THE FACE; BLOOD GLUCOSE LEVEL OUT OF WHACK; RECURRENT SHIVERING; WEAKNESS; HEADACHE/RIGHT TEMPLE IS SENSITIVE ALONG WITH THE VEINS ON THE RIGHT SIDE ABOVE THE EYE BROW; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included accident, and concurrent conditions included diabetic, arthritis pain, and lesion on his hip, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced slight migraine. On 16-MAY-2021, the subject experienced recurrent sweating. On 16-MAY-2021, the subject experienced aches and pain. On 16-MAY-2021, the subject experienced jaw hurt. On 16-MAY-2021, the subject experienced feels sensitive in the skin and the neck on the right side of the face. On 16-MAY-2021, the subject experienced blood glucose level out of whack. On 16-MAY-2021, the subject experienced recurrent shivering. On 16-MAY-2021, the subject experienced weakness. On 16-MAY-2021, the subject experienced headache/right temple is sensitive along with the veins on the right side above the eye brow. Laboratory data included: Blood glucose (NR: not provided) 228 mg/dL. On 09-JUN-2021, Laboratory data included: Hip X-ray (NR: not provided) did not find anything wrong, and Laboratory test (NR: not provided) did not find anything wrong. On 12-JUL-2021, Laboratory data included: Blood glucose (NR: not provided) 179 mg/dL. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 115 mg/dL. Treatment medications (dates unspecified) included: cefalexin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, headache/right temple is sensitive along with the veins on the right side above the eye brow, recurrent sweating, jaw hurt, aches and pain, recurrent shivering, slight migraine, feels sensitive in the skin and the neck on the right side of the face, and blood glucose level out of whack. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS IN TOES IN THE RIGHT FOOT; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included hypercholesterolemia, and concurrent conditions included hypothyroidism, hypersensitivity to bees wax, no alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. family history of gout. she consumes biological food for about 40 years. The patient experienced drug allergy when treated with loracarbef.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUL-2021, the subject experienced numbness in toes in the right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in toes in the right foot. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: JANSSEN VACCINE TAKEN AFTER TWO DOSES OF PFIZER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with bnt 162 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 24-JUL-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced janssen vaccine taken after two doses of pfizer. On 12-JUL-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the janssen vaccine taken after two doses of pfizer and off label use was not reported. This report was non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: ITCHINESS WITH BURNING SENSATION; WORSE RASH ON ARMS, LEGS, CHEST, NECK, BACK AND ALL OVER BODY; FEVER; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, 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: 1808982, expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced fever. On 10-JUL-2021, the subject experienced worse rash on arms, legs, chest, neck, back and all over body. Treatment medications included: paracetamol. On 12-JUL-2021, the subject experienced itchiness with burning sensation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 10-JUL-2021, and had not recovered from worse rash on arms, legs, chest, neck, back and all over body, and itchiness with burning sensation. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: TINGLING IN LEFT LEG WHICH WAS PROGRESSED TO LEFT ARM; PAIN IN THE LEFT HIP JOINT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced tingling in left leg which was progressed to left arm, and pain in the left hip joint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in the left hip joint and tingling in left leg which was progressed to left arm was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Eye pain, Fatigue, Nausea
Clinical narrative: DARK ORANGE URINE; BOTH EYES HURTING; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 11-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUL-2021, the subject experienced dark orange urine. On 11-JUL-2021, the subject experienced both eyes hurting. On 11-JUL-2021, the subject experienced nausea. On 11-JUL-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dark orange urine, both eyes hurting, nausea, and tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Biliary dilatation, Blood test, Colonoscopy
Clinical narrative: DILATION OF BILE DUCT; ACHING ALL OVER; FATTY LIVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient did not have any prior problems. The patient had no gall bladder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A) dose was not reported, 1 total, administered on 25-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was very very ill, described as on 26-MAY-2021, the patient experienced severe pain all over radiating into breast bone. On 31-MAY-2021, the patient was taken to emergency room (ER) as pain was so severe that patient could hardly breath. By then it was more than aching all over. The blood work looked good as of 31-MAY-2021. She had normal ALT/AST (Alanine aminotransferase/ Aspartate aminotransferase) as of 31-MAY-2021. By 06-JUN-2021, the patient was taken at ER because she had pain all over, was given ibuprofen and Tylenol and she did not get any better. The pain was so severe that it was up into her breast bone. The hospital did Computerized tomogram Scan and thought it was colitis. Then she had a Esophagogastroduodenoscopy and colonoscopy to see what was going on. The colonoscopy found nothing, though esophagus and stomach was bright red, might be they thought it was gastritis. She was given medicine for it. The ultrasound found that she had dilation of bile duct on 17-JUN-2021, and since she had no gall bladder that was odd. In JUN-2021, the gastrologist doctor diagnosed her to have a fatty liver which they did not know about. By the 15-JUN-2021, her liver enzymes were way up (abnormal liver enzymes). On 29-JUN-2021, ALT was 59 and AST was 41 which was double what it should be. Her liver had been totally affected.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dilation of bile duct, and aching all over, and the outcome of fatty liver was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210725320-covid-19 vaccine ad26.cov2.s-dilation of bile duct. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hepatic enzyme, Hepatic steatosis, Oesophagogastroduodenoscopy, Pain
Clinical narrative: DILATION OF BILE DUCT; ACHING ALL OVER; FATTY LIVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient did not have any prior problems. The patient had no gall bladder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A) dose was not reported, 1 total, administered on 25-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was very very ill, described as on 26-MAY-2021, the patient experienced severe pain all over radiating into breast bone. On 31-MAY-2021, the patient was taken to emergency room (ER) as pain was so severe that patient could hardly breath. By then it was more than aching all over. The blood work looked good as of 31-MAY-2021. She had normal ALT/AST (Alanine aminotransferase/ Aspartate aminotransferase) as of 31-MAY-2021. By 06-JUN-2021, the patient was taken at ER because she had pain all over, was given ibuprofen and Tylenol and she did not get any better. The pain was so severe that it was up into her breast bone. The hospital did Computerized tomogram Scan and thought it was colitis. Then she had a Esophagogastroduodenoscopy and colonoscopy to see what was going on. The colonoscopy found nothing, though esophagus and stomach was bright red, might be they thought it was gastritis. She was given medicine for it. The ultrasound found that she had dilation of bile duct on 17-JUN-2021, and since she had no gall bladder that was odd. In JUN-2021, the gastrologist doctor diagnosed her to have a fatty liver which they did not know about. By the 15-JUN-2021, her liver enzymes were way up (abnormal liver enzymes). On 29-JUN-2021, ALT was 59 and AST was 41 which was double what it should be. Her liver had been totally affected.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dilation of bile duct, and aching all over, and the outcome of fatty liver was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210725320-covid-19 vaccine ad26.cov2.s-dilation of bile duct. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: DILATION OF BILE DUCT; ACHING ALL OVER; FATTY LIVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient did not have any prior problems. The patient had no gall bladder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A) dose was not reported, 1 total, administered on 25-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was very very ill, described as on 26-MAY-2021, the patient experienced severe pain all over radiating into breast bone. On 31-MAY-2021, the patient was taken to emergency room (ER) as pain was so severe that patient could hardly breath. By then it was more than aching all over. The blood work looked good as of 31-MAY-2021. She had normal ALT/AST (Alanine aminotransferase/ Aspartate aminotransferase) as of 31-MAY-2021. By 06-JUN-2021, the patient was taken at ER because she had pain all over, was given ibuprofen and Tylenol and she did not get any better. The pain was so severe that it was up into her breast bone. The hospital did Computerized tomogram Scan and thought it was colitis. Then she had a Esophagogastroduodenoscopy and colonoscopy to see what was going on. The colonoscopy found nothing, though esophagus and stomach was bright red, might be they thought it was gastritis. She was given medicine for it. The ultrasound found that she had dilation of bile duct on 17-JUN-2021, and since she had no gall bladder that was odd. In JUN-2021, the gastrologist doctor diagnosed her to have a fatty liver which they did not know about. By the 15-JUN-2021, her liver enzymes were way up (abnormal liver enzymes). On 29-JUN-2021, ALT was 59 and AST was 41 which was double what it should be. Her liver had been totally affected.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dilation of bile duct, and aching all over, and the outcome of fatty liver was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210725320-covid-19 vaccine ad26.cov2.s-dilation of bile duct. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Cough, Discomfort, Headache, Muscle spasms
Clinical narrative: BEEN IN BED FOR A WEEK; BODY PAIN; CRAMPS; COUGH; ALL TYPES OF DISCOMFORTS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 been in bed for a week, body pain, cramps, cough, all types of discomforts, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from been in bed for a week, and the outcome of body pain, cramps, headache, cough and all types of discomforts was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BEEN IN BED FOR A WEEK; BODY PAIN; CRAMPS; COUGH; ALL TYPES OF DISCOMFORTS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 been in bed for a week, body pain, cramps, cough, all types of discomforts, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from been in bed for a week, and the outcome of body pain, cramps, headache, cough and all types of discomforts was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMBNESS MAINLY IN MY ARMS AND HANDS, SOMETIMES IN MY LEGS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid, and cyanocobalamin/pyridoxine hydrochloride/thiamine mononitrate. On an unspecified date, the subject experienced numbness mainly in my arms and hands, sometimes in my legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness mainly in my arms and hands, sometimes in my legs was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Illness
Clinical narrative: HEART WEAK; REAL SICK; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 24-APR-2021, the patient experienced weak heart, was really sick, and hospitalized on unspecified date. The patient was on pacemaker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart weak, and the outcome of real sick was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210725335-Covid-19 vaccine ad26.cov2.s- Heart weak, Real sick . 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: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia, Pain in extremity
Clinical narrative: ACHE IN LEFT ARM AND PAIN RUNNING DOWN TO LEFT ARM; SORE ARM AT INJECTION SITE; REDUCED SLEEP; This spontaneous report received from a patient via a company representative concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included bisacodyl, and docusate sodium. On JUL-2021, the subject experienced reduced sleep. On JUL-2021, the subject experienced sore arm at injection site. On 08-JUL-2021, the subject experienced ache in left arm and pain running down to left arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ache in left arm and pain running down to left arm, and sore arm at injection site, and the outcome of reduced sleep was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Painful respiration, Pyrexia, Speech disorder
Clinical narrative: DIFFICULTY IN BREATHING; PAIN IN BREATHING; DIFFICULTY SPEAKING; TEMPERATURE 39 DEGREE CELCIUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 12-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, the subject experienced difficulty in breathing. On 12-JUL-2021, the subject experienced pain in breathing. On 12-JUL-2021, the subject experienced difficulty speaking. On 12-JUL-2021, the subject experienced temperature 39 degree celcius. Laboratory data included: Body temperature (NR: not provided) 39 degree celcius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty in breathing, pain in breathing, and difficulty speaking, and the outcome of temperature 39 degree celcius was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Urticaria
Clinical narrative: HIVES INSIDE THE MOUTH WHICH HURTS AND SOMETIMES OPEN UP AND BLEED; FEVER 99.7; HEADACHES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included psoriasis, and psoriatic arthritis, and concurrent conditions included asthma, and antibiotic allergy, and other pre-existing medical conditions included patient have allergies to lots of outdoor stuff, kind of antibiotic. patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced hives inside the mouth which hurts and sometimes open up and bleed. On 06-APR-2021, the subject experienced fever 99.7. On 06-APR-2021, the subject experienced headaches. Laboratory data included: Body temperature (NR: not provided) Fever 99.7. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 99.7 on 27-JUN-2021, and headaches on 12-APR-2021, and had not recovered from hives inside the mouth which hurts and sometimes open up and bleed. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Imaging procedure, Injection site pain, Joint stiffness
Clinical narrative: LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal.  On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: LEFT ELBOW STIFFNESS; JOINT PAIN; LEFT ARM SORENESS AT INJECTION SITE; LEFT ELBOW MUSCLE PAIN; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 200.4 pounds, and height was 67.5 inches. The patient's concurrent conditions included asthma-like attacks, palpitations, anaphylaxis-like reactions, formaldehyde allergy, and cat dander allergy, and other pre-existing medical conditions included patient had a 98 squares test on her back & breathing test. Pin sticks on arm to check for other allergies. The patient experienced drug allergy when treated with nickel, and fluoxetine hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma-like attacks, epinephrine for palpitations, metoprolol for palpitations, and loratadine. On 21-JUN-2021, Laboratory data included: Imaging procedure (NR: not provided) Normal.  On 09-JUL-2021, the subject experienced shortness of breath. On 11-JUL-2021, the subject experienced left elbow stiffness. On 11-JUL-2021, the subject experienced joint pain. On 11-JUL-2021, the subject experienced left arm soreness at injection site. On 11-JUL-2021, the subject experienced left elbow muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 09-JUL-2021, and left arm soreness at injection site on 12-JUL-2021, and had not recovered from left elbow stiffness, left elbow muscle pain, and joint pain. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING IN LEFT FOOT; LEFT LEG FELT HEAVY; PAIN IN LEFT FOOT; NO STRENGTH IN LEFT LEG; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tingling in left foot. On MAY-2021, the subject experienced left leg felt heavy. On MAY-2021, the subject experienced pain in left foot. On MAY-2021, the subject experienced no strength in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg felt heavy, no strength in left leg, tingling in left foot, and pain in left foot. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria, Haemorrhage urinary tract, Headache, Renal pain, SARS-CoV-2 test
Clinical narrative: BLOOD CLOTS IN URINE; BLOOD IN URINE; STABBING BACKPAIN IN THE KIDNEY AREA ON THE RIGHT SIDE; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 09-JUL-2021) dose was not reported, frequency 1 total administered on 05-JUN-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 6-Jun-2021 the patient complaint of a severe headache at 2 am, followed by severe stabbing back pain in the kidney area on the right side and blood in urine. The blood started to clot after an hour. The patient went to the hospital emergency room (ER) twice once at night and the other in the evening. After four days due to persistent clotting, he visited a urologist where a catheter was inserted to help to empty the clots. On 18-Jun-2021, he was admitted to another hospital ER because the bleeding could not be stopped. He was hospitalized for 9 days. In order to stop the bleeding and clotting, a stent was placed in the kidney by a surgeon. On unspecified date in JUN-2021 Laboratory data included: Laboratory test COVID-19 virus test (NR: not provided) negative. The patient was discharged from hospital and came home on 26-Jun-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clots in urine, and stabbing backpain in the kidney area on the right side on 26-JUN-2021, and was recovering from blood in urine, and severe headache. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210725558-covid-19 vaccine ad26.cov2.s-Blood clots in urine, Blood in Urine ,Stabbing back pain in the kidney area on the right side. 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: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Poor quality sleep, Pruritus, Skin abrasion
Clinical narrative: SKIN ABRADED; AWAKE LAST NIGHT BECAUSE OF INTENSE ITCHING; ITCHING OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; REDNESS OF KNEECAP, QUAD, LOWER QUAD ON BOTH LEGS, BOTH SIDES OF HIP NEAR PELVIC BONE, BICEP, LOWER ABDOMEN; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 178 pounds, and height was 69 inches. The patient's concurrent conditions included alcohol user, non smoker, and eczema, and other pre-existing medical conditions included the patient had no known allergy. The patient was normally healthy, had no medical conditions. The patient took no medications. The patient did not have any history of drug abuse or illicit drug use. The patient took vitamin b for men. The patient was previously treated with alprazolam, and zinc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On 12-JUN-2021, the subject experienced redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen. On an unspecified date, the subject experienced skin abraded, and awake last night because of intense itching. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and redness of kneecap, quad, lower quad on both legs, both sides of hip near pelvic bone, bicep, lower abdomen, and the outcome of skin abraded and awake last night because of intense itching was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: RECEIVED THE VACCINE TWICE/VACCINE OVERDOSE; This spontaneous report received from a pharmacist concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included cataracts, fracture of lower leg, pruritic rash, and pterygium, and concurrent conditions included allergic rhinitis, chronic pain, hypertension, nicotine dependence, osteoarthritis of knee, tobacco use/smoker, rosacea, non dependent alcohol abuse, and alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. the patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: 07-AUG-2021) dose was not reported, administered on 23-JUN-2021, and dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. The first dose batch number was not reported and has been requested. No concomitant medications were reported.  On 12-JUL-2021, the subject experienced received the vaccine twice/vaccine overdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received the vaccine twice/vaccine overdose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Malaise
Clinical narrative: MATERNAL EXPOSURE DURING PREGNANCY; CHILLS; FEELING UNWELL; JOINT PAIN; SORE ARM; FATIGUE; HEADACHE; This solicited pregnancy report received from a consumer concerned a 38 year old female. The patient was enrolled in a non-company sponsored study. The patient's weight was 68.93 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 10-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 MAR-2021, the patient experienced maternal exposure during pregnancy. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced feeling unwell. On MAR-2021, the patient experienced joint pain. On MAR-2021, the patient experienced sore arm. On MAR-2021, the patient experienced fatigue. On MAR-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fatigue, feeling unwell, headache, joint pain, sore arm and maternal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related, and between covid-19 vaccine ad26.cov2.s, and chills, feeling unwell, joint pain, sore arm, fatigue, and headache was related.  This report was non-serious.