chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: INCAPACITATED; FATIGUE; VOMITED; FAINTED; FLUSHING FROM ARMS UP TO THE NECK AND THEN INTO THE FACE; BED RIDDEN; This spontaneous report received from a patient concerned a 69 year old white and not Hispanic or Latino 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 (suspension for injection, route of admin not reported, batch number: 1802070 expiry: 23-AUG-2021) dose was not reported,1 total, administered on 10-MAR-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the patient within twenty minutes of receiving the shot experienced flushing from arms, up to the neck and then into the face, fainted, after being revived patient vomited. On 11-MAR-2021, the patient experienced fatigue and incapacitated. On an unspecified date in MAR-2021, the patient experienced bed ridden for three days and no change in patient lifestyle. The action taken with covid-19 vaccine was not applicable. The patient recovered from fainted, flushing from arms up to the neck and then into the face, and vomited on 11-MAR-2021, incapacitated, and fatigue on 18-MAR-2021, and bed ridden. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210944286 -JANSSEN COVID-19 VACCINE fainted -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: Medication error
Clinical narrative: MEDICATION ERROR; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight was 68.95 kilograms, and height was 166 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, administered on 02-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 patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Cold sweat, Dizziness, Heart rate
Clinical narrative: LIGHTHEADED FOR 15 MINUTES AFTER VACCINATION; FOREHEAD WAS CLAMMY; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: gout, and rheumatoid arthritis, and other pre-existing medical conditions included: patient did not have allergies to medications, food or other products. The patient did not have any adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A and expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 10:45 for prophylactic vaccination.  Concomitant medications included allopurinol.  On 21-SEP-2021, the patient experienced lightheaded for 15 minutes after vaccination. On 21-SEP-2021, the patient experienced forehead was clammy. Laboratory data included: Blood glucose (NR: not provided) 132, Blood pressure (NR: not provided) normal, Heart rate (NR: not provided) elevated, and Vital signs measurement (NR: not provided) Stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded for 15 minutes after vaccination, and forehead was clammy on 21-SEP-2021. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vital signs measurement
Clinical narrative: LIGHTHEADED FOR 15 MINUTES AFTER VACCINATION; FOREHEAD WAS CLAMMY; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: gout, and rheumatoid arthritis, and other pre-existing medical conditions included: patient did not have allergies to medications, food or other products. The patient did not have any adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A and expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 10:45 for prophylactic vaccination.  Concomitant medications included allopurinol.  On 21-SEP-2021, the patient experienced lightheaded for 15 minutes after vaccination. On 21-SEP-2021, the patient experienced forehead was clammy. Laboratory data included: Blood glucose (NR: not provided) 132, Blood pressure (NR: not provided) normal, Heart rate (NR: not provided) elevated, and Vital signs measurement (NR: not provided) Stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded for 15 minutes after vaccination, and forehead was clammy on 21-SEP-2021. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Cold sweat, Dizziness, Heart rate increased
Clinical narrative: LIGHTHEADED FOR 15 MINUTES AFTER VACCINATION; FOREHEAD WAS CLAMMY; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: gout, and rheumatoid arthritis, and other pre-existing medical conditions included: patient did not have allergies to medications, food or other products. The patient did not have any adverse event following any previous vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A and expiry: UNKNOWN) dose was not reported, administered on 21-SEP-2021 10:45 for prophylactic vaccination.  Concomitant medications included allopurinol.  On 21-SEP-2021, the patient experienced lightheaded for 15 minutes after vaccination. On 21-SEP-2021, the patient experienced forehead was clammy. Laboratory data included: Blood glucose (NR: not provided) 132, Blood pressure (NR: not provided) normal, Heart rate (NR: not provided) elevated, and Vital signs measurement (NR: not provided) Stable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheaded for 15 minutes after vaccination, and forehead was clammy on 21-SEP-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Nausea, Rash
Clinical narrative: FLUSHING; RASH; NAUSEA; HEADACHE; This spontaneous report received from a pharmacist concerned multiple patients.  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: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced flushing. On 23-SEP-2021, the patient experienced rash. On 23-SEP-2021, the patient experienced nausea. On 23-SEP-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushing, rash, nausea, and headache on 23-SEP-2021. This report was non-serious. This case, from the same reporter is linked to 20210555373.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion
Clinical narrative: HAVE PACEMAKER; This spontaneous report received from a consumer concerned multiple (3) patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter stated that "3 others that got your shot the same day, now have pacemakers". The action taken with covid-19 vaccine was not applicable. The outcome of have pacemaker was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210946882.; Sender's Comments: V0: 20210946715-Covid-19 vaccine Have pacemaker. 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: Expired product administered
Clinical narrative: ADMINISTERED THE VACCINE TWO DAYS PAST EXPIRATION DATE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced administered the vaccine two days past expiration date. The action taken with covid-19 vaccine was not applicable. The outcome of administered the vaccine two days past expiration date was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Body temperature increased, Chest X-ray, Chest discomfort
Clinical narrative: CALVES SWOLLEN; HEART RACING; CALVES TENSE; FEELING BAD; HEAVINESS IN CHEST, ESPECIALLY IN HORIZONTAL POSITION; LEGS HURTING; HANDS SHAKING; WORSENING BREATHING PROBLEM; TIREDNESS; ALLERGY; ELEVATED TEMPERATURE; SNEEZING; RUNNING NOSE; STRONG COUGH; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pcos (polycystic ovarian syndrome), hashimoto's disease, insulin resistance, non smoker, and non alcoholic, and other pre-existing medical conditions included: The Patient stated that she ate healthy, exercise regularly. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for hashimoto's disease, and metformin for insulin resistance. On AUG-2021, the patient experienced running nose. On AUG-2021, the patient experienced strong cough. On AUG-2021, the patient experienced sneezing. On AUG-2021, the patient experienced worsening breathing problem. On AUG-2021, the patient experienced tiredness. On AUG-2021, the patient experienced allergy. On AUG-2021, the patient experienced elevated temperature. Laboratory data included: Body temperature (NR: not provided) elevated. Treatment medications included: paracetamol. On an unspecified date, the patient experienced calves swollen, heart racing, hands shaking, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and legs hurting. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, COVID-19 virus test (NR: not provided) Negative, Chest X-ray (NR: not provided) everything looked normal, and EEG (NR: not provided) Normal. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, elevated temperature, strong cough, legs hurting, calves swollen, heart racing, hands shaking, worsening breathing problem, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and allergy, and the outcome of sneezing and running nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Electroencephalogram, Fatigue, Feeling abnormal
Clinical narrative: CALVES SWOLLEN; HEART RACING; CALVES TENSE; FEELING BAD; HEAVINESS IN CHEST, ESPECIALLY IN HORIZONTAL POSITION; LEGS HURTING; HANDS SHAKING; WORSENING BREATHING PROBLEM; TIREDNESS; ALLERGY; ELEVATED TEMPERATURE; SNEEZING; RUNNING NOSE; STRONG COUGH; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pcos (polycystic ovarian syndrome), hashimoto's disease, insulin resistance, non smoker, and non alcoholic, and other pre-existing medical conditions included: The Patient stated that she ate healthy, exercise regularly. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for hashimoto's disease, and metformin for insulin resistance. On AUG-2021, the patient experienced running nose. On AUG-2021, the patient experienced strong cough. On AUG-2021, the patient experienced sneezing. On AUG-2021, the patient experienced worsening breathing problem. On AUG-2021, the patient experienced tiredness. On AUG-2021, the patient experienced allergy. On AUG-2021, the patient experienced elevated temperature. Laboratory data included: Body temperature (NR: not provided) elevated. Treatment medications included: paracetamol. On an unspecified date, the patient experienced calves swollen, heart racing, hands shaking, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and legs hurting. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, COVID-19 virus test (NR: not provided) Negative, Chest X-ray (NR: not provided) everything looked normal, and EEG (NR: not provided) Normal. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, elevated temperature, strong cough, legs hurting, calves swollen, heart racing, hands shaking, worsening breathing problem, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and allergy, and the outcome of sneezing and running nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Muscle tightness, Pain in extremity, Palpitations, Peripheral swelling
Clinical narrative: CALVES SWOLLEN; HEART RACING; CALVES TENSE; FEELING BAD; HEAVINESS IN CHEST, ESPECIALLY IN HORIZONTAL POSITION; LEGS HURTING; HANDS SHAKING; WORSENING BREATHING PROBLEM; TIREDNESS; ALLERGY; ELEVATED TEMPERATURE; SNEEZING; RUNNING NOSE; STRONG COUGH; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pcos (polycystic ovarian syndrome), hashimoto's disease, insulin resistance, non smoker, and non alcoholic, and other pre-existing medical conditions included: The Patient stated that she ate healthy, exercise regularly. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for hashimoto's disease, and metformin for insulin resistance. On AUG-2021, the patient experienced running nose. On AUG-2021, the patient experienced strong cough. On AUG-2021, the patient experienced sneezing. On AUG-2021, the patient experienced worsening breathing problem. On AUG-2021, the patient experienced tiredness. On AUG-2021, the patient experienced allergy. On AUG-2021, the patient experienced elevated temperature. Laboratory data included: Body temperature (NR: not provided) elevated. Treatment medications included: paracetamol. On an unspecified date, the patient experienced calves swollen, heart racing, hands shaking, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and legs hurting. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, COVID-19 virus test (NR: not provided) Negative, Chest X-ray (NR: not provided) everything looked normal, and EEG (NR: not provided) Normal. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, elevated temperature, strong cough, legs hurting, calves swollen, heart racing, hands shaking, worsening breathing problem, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and allergy, and the outcome of sneezing and running nose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Sneezing, Tremor
Clinical narrative: CALVES SWOLLEN; HEART RACING; CALVES TENSE; FEELING BAD; HEAVINESS IN CHEST, ESPECIALLY IN HORIZONTAL POSITION; LEGS HURTING; HANDS SHAKING; WORSENING BREATHING PROBLEM; TIREDNESS; ALLERGY; ELEVATED TEMPERATURE; SNEEZING; RUNNING NOSE; STRONG COUGH; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pcos (polycystic ovarian syndrome), hashimoto's disease, insulin resistance, non smoker, and non alcoholic, and other pre-existing medical conditions included: The Patient stated that she ate healthy, exercise regularly. 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 AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included levothyroxine sodium for hashimoto's disease, and metformin for insulin resistance. On AUG-2021, the patient experienced running nose. On AUG-2021, the patient experienced strong cough. On AUG-2021, the patient experienced sneezing. On AUG-2021, the patient experienced worsening breathing problem. On AUG-2021, the patient experienced tiredness. On AUG-2021, the patient experienced allergy. On AUG-2021, the patient experienced elevated temperature. Laboratory data included: Body temperature (NR: not provided) elevated. Treatment medications included: paracetamol. On an unspecified date, the patient experienced calves swollen, heart racing, hands shaking, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and legs hurting. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal, COVID-19 virus test (NR: not provided) Negative, Chest X-ray (NR: not provided) everything looked normal, and EEG (NR: not provided) Normal. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, elevated temperature, strong cough, legs hurting, calves swollen, heart racing, hands shaking, worsening breathing problem, calves tense, feeling bad, heaviness in chest, especially in horizontal position, and allergy, and the outcome of sneezing and running nose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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 and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021 (a week ago), the patient was diagnosed with covid infection (suspected clinical vaccination failure) and had never been so sick and the patient was hit with headache, aches, pains, and freezing chills (suspected covid-19 infection). All the patient could do was pray for relief. It was lasted for three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with regulatory authority: 90000194664.; Sender's Comments: V0: 20210947219-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: RHEUMATOID ARTHRITIS FLARE; This spontaneous report received from a patient concerned a 6 decade old female of unknown race and ethnicity. 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, expiry: Unknown) dose, start therapy date were not reported, 1 total administered 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: adalimumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced rheumatoid arthritis flare and was off humira while pandemic happened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rheumatoid arthritis flare was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210947413-covid-19 vaccine ad26.cov2.s- rheumatoid arthritis flare. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a physician via a company representative concerned a 40 year old female of unknown race and ethnicity. 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, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient received vaccine 6 months ago, then had very mild 4 to 5 days bout of Covid-19. It was reported that the patient had Polymerase chain reaction (PCR) positive (confirmed covid-19 infection and confirmed clinical vaccination failure) and became well. Reporter wanted to know if patient should get booster and if so or if between the original vaccine and the confirmed illness was he likely to be as immunized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210947468-Covid-19 vaccine ad26.cov2.-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Presyncope
Clinical narrative: DIZZINESS; ALMOST PASSED OUT; BAD PAIN IN BACK OF HEAD; NAUSEATED; This spontaneous report received from a consumer via a company representative concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy, seasonal allergies, non alcoholic, and non smoker, and other pre-existing medical conditions included: Patient did not had any 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: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 23-SEP-2021 13:30 for prophylactic vaccination. Concomitant medications included lacosamide for epilepsy, and levetiracetam for epilepsy. On 23-SEP-2021, the patient experienced dizziness. On 23-SEP-2021, the patient experienced almost passed out. On 23-SEP-2021, the patient experienced bad pain in back of head. On 23-SEP-2021, the patient experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad pain in back of head on 23-SEP-2021, was recovering from dizziness, and the outcome of nauseated and almost passed out was not reported. This report was non-serious. This case, from the same reporter is linked to 20210326737.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis, Colitis ulcerative, Nephrolithiasis
Clinical narrative: KIDNEY STONES; COLITIS ULCERATIVE AGGRAVATED; COLITIS; This spontaneous report received from a patient concerned a 42 year old male of unspecified race and ethnicity. 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 was not reported) dose was not reported, frequency 1 total, administered on 04-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced kidney stones, colitis ulcerative aggravated, and colitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from colitis ulcerative aggravated, had not recovered from colitis, and the outcome of kidney stones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210947670-COVID-19 VACCINE AD26.COV2.S-Kidney stones, colitis ulcerative aggravated. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VERY LITTLE RESPONSE; 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 an unspecified date, the patient experienced very little response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very little response was not reported. This report was non-serious. This case, from the same reporter is linked to 20210948137.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Off label use
Clinical narrative: EXTRA DOSE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a pharmacist 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, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 05-APR-2021, and dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number for second dose was not reported and has been requested. No concomitant medications were reported. On 23-SEP-2021, the patient experienced extra dose administered. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extra dose administered and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Complicated appendicitis
Clinical narrative: GANGRENOUS APPENDIX; ADVERSE REACTION TO COVID VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 11-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.  It was reported that within 6 weeks after vaccination, the patient had symptoms (adverse reaction to covid vaccine) and then had an emergency surgery for a gangrenous appendix. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gangrenous appendix and adverse reaction to covid vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210948253-covid-19 vaccine ad26.cov2.s-Gangrenous appendix. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: COVID 19 VACCINE GIVEN 6 HOURS AND 23 MINUTES AFTER THE FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a health care professional 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 15:13 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced covid 19 vaccine given 6 hours and 23 minutes after the first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 vaccine given 6 hours and 23 minutes after the first puncture of the vial was not reported. This report was non-serious.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: SHORTNESS OF BREATH, LOST HIS BREATH AND UNABLE TO TAKE DEEP BREATHS; This spontaneous report received from a patient concerned an 82 year old male. The patient's height, and weight were not reported. The patient's past medical history included: loss of muscle control, and concurrent conditions included: allergy. 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced shortness of breath, lost his breath and unable to take deep breaths. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, lost his breath and unable to take deep breaths on 07-APR-2021. This report was non-serious.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 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: 202A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-SEP-2021, the patient experienced administration of expired vaccine. On 23-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949990.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 40 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: 043A21A expiry: 19-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210949322, 20210949808, 20210949974, 20210949996, 20210950004, 20210950006 and 20210950120.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient 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, expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient as recently as 1 month ago (AUG-2021) tested PCR positive (COVID-19 PCR test) for Covid (confirmed covid-19 and confirmed clinical vaccination failure). He was only having mild case and reported that it was not the kind that puts patient in the hospital, some mild fatigue and coughing were his chief complaints.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20210949780-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: GOT PERIOD OR SPOTTING A LOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was skipping placebo of birth control so had never get period for years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and 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 got period or spotting a lot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got period or spotting a lot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Lymph node pain, Lymphadenopathy
Clinical narrative: PAINFUL LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; FEELING BAD; RASH ON  ARM; SWOLLEN LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; CHILLS; 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 was not reported, administered on 07-SEP-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 07-SEP-2021, the patient experienced chills. On 07-SEP-2021, the patient experienced headache. On 08-SEP-2021, the patient experienced painful lymph node in the arm where vaccine shot was given. On 08-SEP-2021, the patient experienced feeling bad. On 08-SEP-2021, the patient experienced rash on arm. On 08-SEP-2021, the patient experienced swollen lymph node in the arm where vaccine shot was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, swollen lymph node in the arm where vaccine shot was given, rash on arm, painful lymph node in the arm where vaccine shot was given and feeling bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: PAINFUL LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; FEELING BAD; RASH ON  ARM; SWOLLEN LYMPH NODE IN THE ARM WHERE VACCINE SHOT WAS GIVEN; CHILLS; 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 was not reported, administered on 07-SEP-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 07-SEP-2021, the patient experienced chills. On 07-SEP-2021, the patient experienced headache. On 08-SEP-2021, the patient experienced painful lymph node in the arm where vaccine shot was given. On 08-SEP-2021, the patient experienced feeling bad. On 08-SEP-2021, the patient experienced rash on arm. On 08-SEP-2021, the patient experienced swollen lymph node in the arm where vaccine shot was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, headache, swollen lymph node in the arm where vaccine shot was given, rash on arm, painful lymph node in the arm where vaccine shot was given and feeling bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex with unspecified 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) dose, start therapy date were not reported, 1 total 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. As per the reporter, "Cousin had JnJ vaccine four months later and had been diagnosed with Guillan Barre." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210949880.; Sender's Comments: V0- 20210949856- covid-19 vaccine ad26.cov2.s Guillain barre syndrome. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Medication error
Clinical narrative: EXPIRED VACCINE ADMINISTRATION; This spontaneous report received from a health care professional 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: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administration was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a physician concerned a 35 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: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Injection site pain, Myalgia, Pyrexia
Clinical narrative: BONE ACHES; SITE SORENESS; MUSCLE ACHE; LIGHT 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: 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 bone aches, site soreness, muscle ache, and light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches, site soreness, muscle ache, and light fever. This report was non-serious. This case, from the same reporter is linked to 20210949856.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Influenza like illness, Injection site pain
Clinical narrative: FLU LIKE SYMPTOMS; MILD DIZZINESS; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 210 pounds, and height was 69 inches. The patient's concurrent conditions included: alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no pre-existing medical history and did not receive any medication. He had no known drug or non-drug allergies and had no drug abuse or illicit use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-MAR-2021, the patient experienced pain at injection site. On 19-MAR-2021, the patient experienced flu like symptoms. On 19-MAR-2021, the patient experienced mild dizziness. Laboratory data included: Body temperature (NR: not provided) 100.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms, mild dizziness, and pain at injection site on 21-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pain in extremity, Tenderness
Clinical narrative: COULD NOT SLEEP; SORE TO TOUCH; ACHE GOES FROM SHOULDER TO THE ELBOW; DULL ACHY PAIN THAT FELT LIKE DEEP IN THE MUSCLE OF THE SAME SIDE THAT WAS INJECTED; This spontaneous report received from a patient concerned a 61 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 had no known allergies. The patient did not have history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, treatment medications included: paracetamol. On 21-SEP-2021, the patient experienced dull achy pain that felt like deep in the muscle of the same side that was injected. On 21-SEP-2021, the patient experienced sore to touch. On 21-SEP-2021, the patient experienced ache goes from shoulder to the elbow. On 23-SEP-2021, the patient experienced could not sleep. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dull achy pain that felt like deep in the muscle of the same side that was injected, could not sleep, ache goes from shoulder to the elbow, and sore to touch. This report was non-serious.