chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Illness, Throat irritation
Clinical narrative: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy colon, Chills, Colitis ulcerative, Colonoscopy abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Constipation, Diarrhoea, Dizziness, Gastritis, Malaise
Clinical narrative: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Oesophagogastroduodenoscopy abnormal, Pain, Thrombosis
Clinical narrative: SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash pruritic, Swelling face
Clinical narrative: SWELLING IN THE FACE, VERY  SWOLLEN; LITTLE ITCHINESS, RASH SPREADING BIGGER AND BIGGER, SPREADING ON FACE, EAR, NECK AND ALL OVER HER BODY LEG, THIGH,  BACK, RASH BEING RED, ITCHY, ALL OVER HER BODY AND GETS WORSE WITH FRICTION; SEVERE ALLERGIC REACTION; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy at the time of vaccination. The patient experienced allergic reaction when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-AUG-2021, the patient experienced swelling in the face, very swollen. On 20-AUG-2021, the patient experienced little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. On 20-AUG-2021, the patient experienced severe allergic reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe allergic reaction, swelling in the face, very swollen, and little itchiness, rash spreading bigger and bigger, spreading on face, ear, neck and all over her body leg, thigh, back, rash being red, itchy, all over her body and gets worse with friction. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: POSITIVE COVID TEST AFTER TAKING VACCINE; This spontaneous report received from a patient concerned a 44 year old female. 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, intramuscular, 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 28-AUG-2021, the patient experienced positive covid test after taking vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from positive covid test after taking vaccine. This report was non-serious. This report was associated with product quality complaint: 90000191409.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20210852596.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM IN BOTH LUNGS; 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) 1 total, dose was administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (within a month after vaccination), the patient had pulmonary embolism in both lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism in both my lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210859993-covid-19 vaccine ad26.cov2.s-Pulmonary embolism in both my 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).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Malaise, Pyrexia
Clinical narrative: COULDN'T SLEEP AT NIGHT; WHOLE BODY FELT LIKE IT GOT HIT BY A CAR; FEELING SICK; MASSIVE FEVER; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced couldn't sleep at night, whole body felt like it got hit by a car, feeling sick, and massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep at night, whole body felt like it got hit by a car, feeling sick, and massive fever. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON HER LEGS THEN APPEARED ON ARM, CHEST, FEET / RASH ALL OVER BODY; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included: multiple sclerosis, and concurrent conditions included: alcohol use, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug or non-drug allergies. The patient had no 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, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, Laboratory data included: Skin biopsy (NR: not provided) Unknown. On 07-AUG-2021, the patient experienced rash on her legs then appeared on arm, chest, feet / rash all over body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on her legs then appeared on arm, chest, feet / rash all over body. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: ANXIETY ABOUT THE SHOT; ARM PAIN; TINGLING IN FINGERS OF LEFT HAND (SAME SIDE AS SHOT); HEADACHE; MORE TIRED THAN NORMAL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 27-AUG-2021, the patient experienced arm pain. On 27-AUG-2021, the patient experienced tingling in fingers of left hand (same side as shot). On 27-AUG-2021, the patient experienced headache. On 27-AUG-2021, the patient experienced more tired than normal. On an unspecified date, the patient experienced anxiety about the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm pain, headache, tingling in fingers of left hand (same side as shot), and more tired than normal, and the outcome of anxiety about the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210860475.
Sex: F
Vaccine: COVID19
Symptoms: ACTH stimulation test, Antibody test, Bedridden, Haemoptysis, Liver function test
Clinical narrative: SHE WAS STILL IN BED; USES A WALKER TO GET AROUND; BLOTCHY SKIN/VITILIGO; DARKENING OF SKIN/DISCOLORATION OF SKIN; SKIN STARTED TANNING; COUGHED UP BLOOD CLOT; FELT SOMETHING TICKLING; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 240 pounds, and height was 60 inches. The patient's concurrent conditions included: alcohol non user, non smoker, penicillin allergy, erythromycin allergy, sulfa allergy, hypertension, fungus flare up, and pain, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam for drug used for unknown indication, melatonin for drug used for unknown indication, paracetamol for drug used for unknown indication, tizanidine for drug used for unknown indication, vitamins nos for drug used for unknown indication, ketoconazole for fungal infection, enalapril for hypertension, furosemide for hypertension, and tramadol for pain.  On MAR-2021, the patient experienced coughed up blood clot. On MAR-2021, the patient experienced felt something tickling. On MAY-2021, the patient experienced blotchy skin/vitiligo. On MAY-2021, the patient experienced darkening of skin/discoloration of skin. On MAY-2021, the patient experienced skin started tanning. On an unspecified date, the patient experienced she was still in bed, and uses a walker to get around. Laboratory data (dates unspecified) included: ACTH stimulation test (NR: not provided) Unknown, Antibody test (NR: not provided) Unknown, and Liver function test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from darkening of skin/discoloration of skin, skin started tanning, blotchy skin/vitiligo, and she was still in bed, and the outcome of coughed up blood clot, felt something tickling and uses a walker to get around was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Sensory disturbance, Skin discolouration, Tanning, Walking aid user
Clinical narrative: SHE WAS STILL IN BED; USES A WALKER TO GET AROUND; BLOTCHY SKIN/VITILIGO; DARKENING OF SKIN/DISCOLORATION OF SKIN; SKIN STARTED TANNING; COUGHED UP BLOOD CLOT; FELT SOMETHING TICKLING; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was 240 pounds, and height was 60 inches. The patient's concurrent conditions included: alcohol non user, non smoker, penicillin allergy, erythromycin allergy, sulfa allergy, hypertension, fungus flare up, and pain, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam for drug used for unknown indication, melatonin for drug used for unknown indication, paracetamol for drug used for unknown indication, tizanidine for drug used for unknown indication, vitamins nos for drug used for unknown indication, ketoconazole for fungal infection, enalapril for hypertension, furosemide for hypertension, and tramadol for pain.  On MAR-2021, the patient experienced coughed up blood clot. On MAR-2021, the patient experienced felt something tickling. On MAY-2021, the patient experienced blotchy skin/vitiligo. On MAY-2021, the patient experienced darkening of skin/discoloration of skin. On MAY-2021, the patient experienced skin started tanning. On an unspecified date, the patient experienced she was still in bed, and uses a walker to get around. Laboratory data (dates unspecified) included: ACTH stimulation test (NR: not provided) Unknown, Antibody test (NR: not provided) Unknown, and Liver function test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from darkening of skin/discoloration of skin, skin started tanning, blotchy skin/vitiligo, and she was still in bed, and the outcome of coughed up blood clot, felt something tickling and uses a walker to get around was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Therapeutic response unexpected
Clinical narrative: BLOOD PRESSURE DROPPED AND NORMAL / LOW NORMAL NOW AND HAS REMAINED THERE A STEADY 115/70 BEFORE IT FLUCTUATES 150/100; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included atenolol. On MAY-2021, the patient experienced blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100. Laboratory data included: Blood pressure (NR: not provided) 115/70 mmHg. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 150/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood pressure dropped and normal / low normal now and has remained there a steady 115/70 before it fluctuates 150/100 was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59 year old male. 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: 1808609 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient's laboratory data included: SARS-CoV-2 antibody test (NR: not provided) negative with an index of less than 0.01 or normal (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210860141 -COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Myelitis transverse, Rash
Clinical narrative: TRANSVERSE MYELITIS; RASH IN CHEST AREA AND BACK OF RIGHT ARM; HYPERSENSITIVITY; This spontaneous report received from a patient via a company representative concerned a 4 decade old white and non Hispanic or Latino female.  The patient's height, and weight were not reported. 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: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 19-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 23-MAR-2021, the patient experienced hypersensitivity, rash in chest area and back of right arm, strange sensation of having clothes on covering her whole body even when not wearing clothes, stiff neck and arm and could not feel feet for about one month. Patient's current doctor mentioned that it might be transverse myelitis. On an unspecified date in AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative, and X-ray (NR: not provided) Negative. The patient had multiple X-rays and blood tests that had a negative result and as per the health care professional (HCP) nothing was wrong. As of 28-AUG-2021 (currently), the patient was experiencing numbness in both hands. Patient had a physician office visit for adverse events.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from transverse myelitis, and the outcome of hypersensitivity and rash in chest area and back of right arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210860147-COVID-19 VACCINE AD26.COV2.S-Transverse myelitis. 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: Chills, Feeling abnormal, Headache
Clinical narrative: FELT LIKE CRAP; CHILLS; HEADACHE; 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. No concomitant medications were reported.  On an unspecified date, the patient experienced felt like crap, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like crap, chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HAS NOT STOPPED BEING SORE; 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: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced arm has not stopped being sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm has not stopped being sore. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Full blood count, Joint swelling, Platelet count
Clinical narrative: LITTLE INFLAMMATION ON BOTH ANKLES; ANKLE LITTLE SWOLLEN; RED DOTS ON BOTH LOWER LEGS BELOW THE KNEE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgery 3 months ago, and concurrent conditions included: high blood pressure, high cholesterol, penicillin allergy, non-alcohol user, and non smoker, and other pre-existing medical conditions included: 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, batch number: Unk) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced little inflammation on both ankles. On 27-AUG-2021, the patient experienced ankle little swollen. On 27-AUG-2021, the patient experienced red dots on both lower legs below the knee. On 30-AUG-2021, Laboratory data included: Blood test (NR: not provided) Awaiting results, CBC (NR: not provided) Awaiting results, and Platelet count (NR: not provided) Awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red dots on both lower legs below the knee, little inflammation on both ankles, and ankle little swollen. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: LITTLE INFLAMMATION ON BOTH ANKLES; ANKLE LITTLE SWOLLEN; RED DOTS ON BOTH LOWER LEGS BELOW THE KNEE; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: knee replacement surgery 3 months ago, and concurrent conditions included: high blood pressure, high cholesterol, penicillin allergy, non-alcohol user, and non smoker, and other pre-existing medical conditions included: 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, batch number: Unk) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-AUG-2021, the patient experienced little inflammation on both ankles. On 27-AUG-2021, the patient experienced ankle little swollen. On 27-AUG-2021, the patient experienced red dots on both lower legs below the knee. On 30-AUG-2021, Laboratory data included: Blood test (NR: not provided) Awaiting results, CBC (NR: not provided) Awaiting results, and Platelet count (NR: not provided) Awaiting results. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red dots on both lower legs below the knee, little inflammation on both ankles, and ankle little swollen. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Therapy non-responder
Clinical narrative: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 225 pounds, and height was 66 inches. The patient's concurrent conditions included endometrial cancer, penicillin allergy. The patient had no daily medication. The patient was on chemotherapy before and after receiving the vaccine. The patient stated that garlic caused her to be ill and nauseated. The patient experienced drug allergy when treated with codeine, hydrocodone bitartrate/paracetamol, and oxycodone hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021, the patient tested negative for antibody test (confirmed immunological vaccine failure) which she described as blood test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000191551.; Sender's Comments: V0:20210860335 -covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY,UNDERLYING DISEASE (CHEMOTHERAPY)  SPECIAL SITUATIONS
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Muscular weakness
Clinical narrative: LOWER BACK PAIN (STILL PRESENT BUT NOT AS BAD AS IT WAS); SEVERE MUSCLE WEAKNESS  AND GOT WORSE WITH TIME; CHILLS; SEVERE BODY FATIGUE AND GOT WORSE WITH TIME; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 205 pounds, and height was 74 inches. The patient's concurrent conditions included: stress, blood pressure, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included: Patient had no medical history and no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included methyldopa for stress, and blood pressure.  On 06-AUG-2021, the patient experienced lower back pain (still present but not as bad as it was). On 06-AUG-2021, the patient experienced severe muscle weakness and got worse with time. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced severe body fatigue and got worse with time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-AUG-2021, recovered with sequelae from severe muscle weakness and got worse with time on AUG-2021, was recovering from lower back pain (still present but not as bad as it was), and had not recovered from severe body fatigue and got worse with time. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: BREAKTHROUGH INFECTION; This spontaneous report received from a patient via a company representative concerned a 30 year old female. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breakthrough infection was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Infectious mononucleosis, Influenza, Pain, Pain in extremity
Clinical narrative: FEELS LIKE SHE HAS MONO AGAIN; LEFT SIDE AND SPLEEN SWELLING; LEFT SIDE PAIN; FEELING CRAPPY; FLU SYMPTOMS/HEADACHE/CHILLS/LOW GRADE FEVER/ACHY; ARM PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced flu symptoms/headache/chills/low grade fever/achy. On 27-AUG-2021, the patient experienced arm pain. On 28-AUG-2021, the patient experienced left side and spleen swelling. On 28-AUG-2021, the patient experienced left side pain. On 28-AUG-2021, the patient experienced feeling crappy. On 30-AUG-2021, the patient experienced feels like she has mono again. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu symptoms/headache/chills/low grade fever/achy, and had not recovered from arm pain, feeling crappy, left side pain, left side and spleen swelling, and feels like she has mono again. This report was non-serious. This case, from the same reporter is linked to 20210860099.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Splenomegaly
Clinical narrative: FEELS LIKE SHE HAS MONO AGAIN; LEFT SIDE AND SPLEEN SWELLING; LEFT SIDE PAIN; FEELING CRAPPY; FLU SYMPTOMS/HEADACHE/CHILLS/LOW GRADE FEVER/ACHY; ARM PAIN; This spontaneous report received from a consumer concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced flu symptoms/headache/chills/low grade fever/achy. On 27-AUG-2021, the patient experienced arm pain. On 28-AUG-2021, the patient experienced left side and spleen swelling. On 28-AUG-2021, the patient experienced left side pain. On 28-AUG-2021, the patient experienced feeling crappy. On 30-AUG-2021, the patient experienced feels like she has mono again. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu symptoms/headache/chills/low grade fever/achy, and had not recovered from arm pain, feeling crappy, left side pain, left side and spleen swelling, and feels like she has mono again. This report was non-serious. This case, from the same reporter is linked to 20210860099.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 26-AUG-2021, he did an antibody test and it was negative test (confirmed immunological vaccine failure). After received the vaccine he had no side effects at all. The patient's arm was not even hurting from the injection. He could not even tell which arm he got the vaccine. He drove for a couple of hours to get the vaccine and on his way back he drank a couple of bottles of electrolytes as he was advised that this will help after getting the vaccine. The patient's doctor suggested to get another shot of Pfizer Covid-19 vaccine which he received on August 26th, 2021. The patient was not on any other medications other than OTC pain killers and vitamins. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000191530. This case, from the same reporter is linked to 20210860607 and 20210860781.; Sender's Comments: V0; 20210860500-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Skin mass
Clinical narrative: LUMPS UNDER SKIN; ITCHING; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps under skin, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps under skin and itching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity
Clinical narrative: LUMPS UNDER SKIN; ITCHING; 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced lumps under skin, and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lumps under skin and itching was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia
Clinical narrative: LETHARGY; FEVER; 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 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 APR-2021, the patient experienced lethargy. On APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and fever on APR-2021. This report was non-serious.