chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: This spontaneous report was received from literature: DELAYED DIAGNOSIS OF HISTOPLASMOSIS IN A PATIENT WITH A PROSTHETIC AORTIC VALVE. JACC. 2022 MAR 08; 79/9 Supplement A. This report concerned a 50 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: congenital aortic valve disease (The patient had post bioprosthetic AV replacement (AVR) in 2014). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 1 total, 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, post vaccination the patient was presented with 6 months of flu-like illness, pancytopenia, and suspected transient ischemic attack. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Negative. From detailed workup laboratory investigations revealed myelodysplastic syndrome and positive urine histoplasmosis antigen. Chest computed tomographic angiography (CTA) provided demonstrated a 16x16 mm left lower lobe pulmonary nodule with central cavitation suspicious for pulmonary histoplasmosis. Transesophageal echocardiography (TEE) showed bulky thickening of the prosthetic leaflets with suspected vegetation causing severe prosthetic aortic stenosis. Head and neck CTA showed no mycotic aneurysms. Intraoperative findings included a very large vegetation with near-total obstruction of the aortic valve and circumferential necrotic tissue of the aortic root. Treatment medications (dates unspecified) included: Amphotericin B and underwent redo AV replacement. The authors concluded that despite its rare incidence, histoplasmosis should remain on the differential for infective endocarditis in patients presenting with systemic illness and prosthetic valves. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the histoplasmosis, myelodysplastic syndrome, suspected transient ischemic attack and infective endocarditis with histoplasmosis was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:20220409335-Covid-19 vaccine ad26.cov2.s-Myelodysplastic syndrome, Suspected transient ischemic attack. 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). Therefore, this event(s) is considered unassessable. 20220409335-Covid-19 vaccine ad26.cov2.s-Histoplasmosis, Infective endocarditis with histoplasmosis. 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: UNDERLYING DISEASE (Myelodysplastic syndrome). Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Electrocardiogram, Vascular stent thrombosis, Vital signs measurement
Clinical narrative: STENT THROMBOSIS; This spontaneous report was received from literature. This report concerned a 54 year old adult male of an unspecified race and ethnicity The objective of this study was to describe evidence of thrombotic events after Janssen & Janssen COVID-19 vaccine. Although the vaccine is effective to prevent serious COVID-19 infections. The patient's height, and weight were not reported. The patient's past medical history included: coronary artery disease (PCI) (percutaneous coronary intervention) to the left anterior descending artery (LAD) six years prior presented with substernal chest discomfort.), and stent, and concurrent conditions included: hypertension, hyperlipidemia, and type two diabetes mellitus The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after 3 weeks of vaccination, the patient experienced substernal chest discomfort for three hours, vital signs were in normal limits, and his electrocardiogram showed two-to-three-millimeter ST elevation across the precordial leads with reciprocal ST (Stent thrombosis) depressions. The patient was brought emergently to the cardiac catheterization lab where coronary angiography revealed a large thrombus within the previously placed LAD (left anterior descending artery) stent. The patient underwent aspiration thrombectomy, balloon angioplasty and stenting of the LAD (left anterior descending artery). The patient was discharged in good condition on dual-antiplatelet therapy after three days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stent thrombosis. The authors emphasized on the possibly related temporal relationship of stent thrombosis with Janssen & Janssen COVID-19 vaccine by providing the evidence of an case study so that we can learn more about the 2019 coronavirus and the COVID-19 vaccines.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220409369-COVID-19 Vaccine Ad26.CoV2.S- STENT THROMBOSIS. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, concomitant medications, height, weight and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Apr 10, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient had blurred vision for 3 days. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Inappropriate schedule of product administration, Off label use
Clinical narrative: STOMACH PAIN; DIARRHEA; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; 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, and batch number were not reported) dose, start therapy date were not reported, and dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 26-MAR-2021, the patient experienced off label use, and inappropriate schedule of vaccine administered. On 28-MAR-2021, the patient experienced stomach pain, and diarrhea. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, stomach pain, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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. On an unspecified date, the patient had suspected Covid-19 infection and patient was in intensive care for Covid which leads to suspected clinical vaccination failure. Patient was hospitalized (date unspecified for unspecified days). It was reported that the patient was in intensive care for Covid and received the J&J Jab 5 weeks before. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected Covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000225871. Sender's Comments: V0: 20220409590- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related. 20220409590- Covid-19 vaccine ad26.cov2.s-suspected Covid-19 infection. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Illness, Loss of personal independence in daily activities, Tremor
Clinical narrative: EXTRAORDINARY GOT SICK; TREMORS; CANNOT STAND UP; CANNOT FUNCTION; This spontaneous report received from a parent 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced extraordinary got sick, tremors, cannot stand up, and cannot function. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extraordinary got sick, tremors, cannot stand up and cannot function was not reported. This report was non-serious. This case, from the same reporter is linked to 20220410434.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: FELT PAIN SIMILAR TO STRAINED MUSCLE LOWER RIB CAGE AND HIP MUSCLE SAME SIDE; BODY ACHES; BY 48 HOURS APPETITE GONE; CHILLS DEVELOPED FOR 3 TO 4 HOURS; TOTAL LACK OF ENERGY; FEVER (99 PLUS) FOR 3 TO 4 HOURS; DULL LONG LASTING HEADACHE; This spontaneous report received from a patient via a company representative concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was above average health and did not take daily meds. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt pain similar to strained muscle lower rib cage and hip muscle same side, body aches, by 48 hours appetite gone, chills developed for 3 to 4 hours, total lack of energy, fever (99 plus) for 3 to 4 hours, and dull long lasting headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt pain similar to strained muscle lower rib cage and hip muscle same side, chills developed for 3 to 4 hours, and fever (99 plus) for 3 to 4 hours, was recovering from by 48 hours appetite gone, and total lack of energy, and had not recovered from body aches, and dull long lasting headache. This report was non-serious. This case, involving the same patient is linked to 20210427557.
Sex: M
Vaccine: COVID19
Symptoms: Muscle strain, Pain, Pyrexia
Clinical narrative: FELT PAIN SIMILAR TO STRAINED MUSCLE LOWER RIB CAGE AND HIP MUSCLE SAME SIDE; BODY ACHES; BY 48 HOURS APPETITE GONE; CHILLS DEVELOPED FOR 3 TO 4 HOURS; TOTAL LACK OF ENERGY; FEVER (99 PLUS) FOR 3 TO 4 HOURS; DULL LONG LASTING HEADACHE; This spontaneous report received from a patient via a company representative concerned a 74 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was above average health and did not take daily meds. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt pain similar to strained muscle lower rib cage and hip muscle same side, body aches, by 48 hours appetite gone, chills developed for 3 to 4 hours, total lack of energy, fever (99 plus) for 3 to 4 hours, and dull long lasting headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 plus. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt pain similar to strained muscle lower rib cage and hip muscle same side, chills developed for 3 to 4 hours, and fever (99 plus) for 3 to 4 hours, was recovering from by 48 hours appetite gone, and total lack of energy, and had not recovered from body aches, and dull long lasting headache. This report was non-serious. This case, involving the same patient is linked to 20210427557.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. The patient's height, weight, medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. The batch number was not reported. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced complication. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of complication: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced coupled side effects. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: SUSPECTED GUILLAIN BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, 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, and batch number and expiry date were not reported) 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. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected guillain barre syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected guillain barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220410424-COVID-19 VACCINE AD26.COV2.S -Guillain-Barre syndrome.These event are labeled per RSI and are therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Illness, Loss of personal independence in daily activities, Tremor
Clinical narrative: CANNOT FUNCTION; CANNOT STAND UP; TREMORS; EXTRAORDINARY GOT SICK; This spontaneous report received from a parent 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cannot function, cannot stand up, tremors, and extraordinary got sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot function, cannot stand up, tremors and extraordinary got sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220410180.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Nasopharyngitis
Clinical narrative: KIND OF LIKE COLD SYMPTOM; SEVERE CRAMPING IN LEFT FOOT THAT WAS GONE OVERNIGHT; 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, and batch number were not reported) dose was not reported, administered on 15-MAY-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 MAY-2021, the patient experienced kind of like cold symptom, and severe cramping in left foot that was gone overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from kind of like cold symptom, and severe cramping in left foot that was gone overnight on MAY-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced problems with vaccine (more sleep than ever off and on). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: ALLERGIC TO ONE OF THE COMPONENTS IN THE VACCINE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced allergic to one of the components in the vaccine. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergic to one of the components in the vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS OF THE VACCINE; 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions of the vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: not reported) dose: not reported, on Apr 12, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced somewhat of an adverse reaction. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN RIGHT ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included Blood clots. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered on an unspecified date 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 blood clots in right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots in right arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220411946- covid-19 vaccine ad26.cov2.s Blood clots in right arm. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Nonspecific reaction
Clinical narrative: BAD REACTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. On an unspecified date, following vaccination with first dose of covid-19 vaccine ad26.cov2.s, the patient experienced bad reaction and had a bad flu and the patient had to go to the ER (emergency room) where the doctor recommend the patient to used Tylenol and that really helped the patient a lot (dose number in series 1). It was reported that the patient used Tylenol for years and it did not disappoint the patient (dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. 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, following vaccination with second dose of covid-19 vaccine ad26.cov2.s, the patient had bad reaction (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction was not reported. This report was non-serious. This case, involving the same patient is linked to 20220408757 (dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: STILL HAD PAIN IN ARMS; HEADACHE IN THE FRONT OF HEAD; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced still had pain in arms, and headache in the front of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still had pain in arms, and headache in the front of head. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Rash, Sensory loss
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient's arms doesn't feel well at all/started not to feel well and legs starting to have a rash. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch/lot number: not reported) dose, start therapy date: not reported, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced side effects with the COVID-19 vaccine. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: THREW UP; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced threw up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of threw up was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included loperamide hydrochloride. On an unspecified date, the patient experienced diarrhea.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of diarrhea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, 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, batch number were not reported, expiry Unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20220412702-COVID-19 VACCINE AD26.COV2.S-Died. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Knee operation, Off label use, Vaccination site pain
Clinical narrative: This spontaneous report received from a patient via other company (RA) concerned a 50 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1). On an unspecified date, the patient received second dose with Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered for prophylactic vaccination. The patient received third dose booster with covid-19 vaccine ad26.cov2.s (dose number in series 2), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose was not reported, 1 total administered on DEC-2021 for prophylactic vaccination which was off label use, and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were not reported) dose and frequency were not reported from an unspecified date to 2021 for ankylosing spondylitis. No concomitant medications were reported.  On DEC-2021, the patient experienced vaccination site pain, and arm hurt for a week (dose number in series 2). On FEB-2022, the patient experienced right knee surgery (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from vaccination site pain and arm hurt for a week, and the outcome of right knee surgery, off label use and inappropriate schedule of vaccine administered was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220413065- Covid-19 vaccine ad26.cov2.s-right knee surgery. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: NATURE OF EVENT. Therefore, this event(s) is considered not related.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Decreased appetite, Headache, Infection, Intracardiac thrombus
Clinical narrative: This spontaneous report received from a consumer concerned a 54-year-old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient had no known allergies and concurrent conditions included: diabetic and hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 22-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JAN-2022 (Day of vaccination) the patient felt like his head was hurting (Head pain) that continued for a few days afterwards. He figured it would just pass. On an unknown date within a week (JAN-2022) he was in the hospital and they said he had two strokes (Stroke). The doctors thought he might have had a blood clot in his heart (Cardiac thrombosis) but patient did not want to have a camera go up inside him. After three weeks (FEB-2022) he was sent to rehab where he developed an infection that required him to be sent back to the hospital. He was discharged yesterday (06-APR-2022). Number of days of hospitalization was unknown. He currently had difficulty walking by himself and had absolutely no appetite (Appetite absent). He was suffering from short term memory loss and did not seem to be able to make the right decisions. He kept saying no to everything. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from had two strokes, and lack of appetite, and the outcome of developed an infection, felt like head was hurting and blood clot in heart was not reported. This report was serious (Hospitalization Caused / Prolonged). Sender's Comments: V0. 20220414413-Covid-19 vaccine ad26.cov2.s -blood clot in his heart, developed an infection. 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). Therefore, this event(s) is considered unassessable. 20220414413-Covid-19 vaccine ad26.cov2.s - had two strokes. 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: MEDICAL HISTORY (Diabetes and Hypertension). Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: This spontaneous report received from a patient, concerned a patient of unspecified age and gender. Medical history, weight, height, concomitant medications and concurrent conditions reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot number: not reported) dose: not reported, on Mar 11, 2021, for immunization. Unable to perform follow-up to request batch/lot numbers. On an unspecified date, patient experienced itchiness. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome: not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Oxygen saturation decreased, SARS-CoV-2 test, Scan, Vaccination failure
Clinical narrative: This spontaneous report received from a patient concerned a 74 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 previously received Covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855194, and expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 04-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JAN-2022, the patient had a sore throat (dose number in series 2). On 03-JAN-2022, she went to the clinic and underwent polymerase chain reaction (PCR) Covid-19 test, the test came out positive (confirmed Covid-19 infection) which led to confirmed clinical vaccination failure (dose number in series 2). On JAN-2022, she started with a lot of coughing and decreased oxygen, laboratory data included: Oxygen saturation decreased (NR: not provided) decreased, so she returned to the clinic and they did a scan which was negative for clots, and positive for pneumonia (dose number in series 2). On 07-JAN-2022, the patient was administered with steroids and monoclonal antibody. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from Covid-19 pneumonia, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000225106. Sender's Comments: V0: 20220414785-COVID-19 VACCINE AD26.COV2.S-COVID-19 pneumonia. 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). Therefore, this event(s) is considered unassessable. 20220414785-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Swelling
Clinical narrative: ISSUES ON ANKLE; TERRIBLE SWELLING; 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. The patient's pre-existing medical conditions included: The patient had no history of ankle issues in the entire life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced terrible swelling. On an unspecified date, the patient experienced issues on ankle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible swelling and issues on ankle was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex 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, route of admin not reported, batch number: Unknown, expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had stroke. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of  stroke was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220414885- Covid-19 vaccine ad26.cov2.s- stroke. 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). Therefore, this event(s) is considered unassessable.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: This spontaneous report received from a patient concerned a 65 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Previously patient could see better with his right eye. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: unknown) dose was not reported, 1 in total administered to left arm on 03-AUG-2021 for prophylactic vaccination. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 05-AUG-2021, two days after the vaccination patient started complaining about a decline in vision with his right eye and since then his vision has not improved and he cannot able to read. His doctor told him that it could be a cataract, but the eye specialist said that his cataract was minor. Patient was upset on how his vision declined after the vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minor cataract of right eye. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220414931- Covid-19 vaccine ad26.cov2.s - minor cataract of right eye. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Hypoaesthesia, Injection site pain, Tremor
Clinical narrative: LIGHTHEADEDNESS; WOBBLING UNSTEADY WHEN WALKING; FELT SHAKY; FELT NUMBNESS AROUND RIGHT EAR; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient had no known allergies. The patient never had a reaction to a vaccine (flu shot and other). The patient's concurrent conditions included: The patient had drug abuse or illicit drug usage of penicillin medication that increases Serotonin such as Tramodol (pain medications). The patient was previously treated with Spikevax (Moderna (elasomeran)) (Dose Number in Series 1) (route of administration, dose, batch number and expiry not reported) dose, start therapy date were not reported for prophylactic vaccination. The patient had fever and chills following vaccination with first dose of Spikevax (Moderna (elasomeran)) (Dose Number in Series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose Number in Series 2) (suspension for injection, route of admin not reported, batch number: 1855190, and expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 07-APR-2022 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2022, the patient experienced lightheadedness and then started feeling numbness around right ear, pain at injection site afterwards, felt that the injection was given very high on the arm. She also felt shaky and wobbling when walking (Dose Number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site, and the outcome of lightheadedness, felt numbness around right ear, wobbling unsteady when walking and felt shaky was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: WAS NOT FEELING VERY GOOD; CHILLS; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced was not feeling very good, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the was not feeling very good and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rhinorrhoea
Clinical narrative: SHINGLES; RUNNY NOSE; 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced shingles, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shingles and runny nose was not reported. This report was non-serious.