chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st in Jul2019, never followed for 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on right deltoid in July 2019). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not applicable for this report. The patient was never followed up for her second dose and till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient stated she would speak to her health care professional before deciding on if she should take the second dose.  The reporter consented to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Laboratory test, Vasculitis
Clinical narrative: VASCULAR INFLAMMATION; This spontaneous report received from a health care professional concerned a 68 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no underlying health conditions and never had coronavirus disease-19 (COVID-19), and ruled out risk factors including no genetic variants for increased risk in underlying health conditions confirmed by medical testing and no increased risk for blood clotting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced vascular inflammation. Laboratory data (dates unspecified) included: IgG (NR: not provided) negative, robust, and Laboratory test (NR: not provided) no conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vascular inflammation. This report was non-serious. This case, from the same reporter is linked to 20211032197.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure, Viral test
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's concurrent condition is blood pressure, and had not known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on left arm on 22-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, the patient experienced Soreness, Nausea, Diarrhea, Fever, Headaches, Sinus Congestion, and loss of smell (confirmed covid-19 infection). On the same date, COVID-19 virus test result was performed and result was Positive which suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. on an unspecified date patient experienced soreness as well. The outcome of the confirmed covid-19 infection, suspected clinical vaccination failure was not reported. This case, from the same reporter is linked to 20211043553 and 20211043252. This report was associated with product quality complaint.; Sender's Comments: V0: 20211043945-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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 34 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not an unhealthy and overweight person with pre existing conditions. The patient was healthy and had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: Unknown) dose was not reported, 1 total administered on an unspecified date in APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-OCT-2021, the patient tested positive for covid-19 (confirmed covid-19 infection and confirmed clinical vaccination failure). The patient had symptoms that were not mild but closely resembled a bad case of the flu. The patient also stated that, the patient would certainly not be getting your vaccine (vax) or any booster in the future. 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: 90000198826.; Sender's Comments: V0: 20211046440-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: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Septic shock
Clinical narrative: SEPTIC SHOCK; ACUTE HYPOXIC RESPIRATORY FAILURE; This spontaneous report was received from literature:  This report concerned an 88 year old male of unknown race and ethnic origin. The objective of this study was to describe fatal and non-fatal possible Adverse Events after COVID-19 vaccine administration. The patient's height, and weight were not reported. The patient's past medical history included: congestive heart failure, and cerebrovascular accident, and concurrent conditions included: hypertension, diabetes mellitus type 2, and multiple sclerosis. 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, one total administered 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 septic shock, and acute hypoxic respiratory failure and was hospitalized (date unspecified). Number of hospitalization days were not reported. On an unspecified date, the patient died from septic shock, and acute hypoxic respiratory failure. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The authors concluded that although reported adverse events (AEs) were not necessarily caused by the vaccination, this study provided further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. The study also supported prior data that serious AEs post vaccination were much lower than primary COVID-19 infections. Also, need for further studies to investigate causalities between vaccines and reported AEs across all age groups was highlighted. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211045466.; Sender's Comments: 20211048130-covid-19 vaccine ad26.cov2.s-septic shock, and acute hypoxic respiratory failure. 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).; Reported Cause(s) of Death: SEPTIC SHOCK; ACUTE HYPOXIC RESPIRATORY FAILURE
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYSIS; This spontaneous report received from a consumer concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. 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 was paralyzed (paralysis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211048907-COVID-19 VACCINE AD26.COV2.S-Paralysis. 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: M
Vaccine: COVID19
Symptoms: Brain death, Brain operation, Cerebral infarction, Death, Laboratory test
Clinical narrative: COLLAPSING; EMERGENCY BRAIN SURGERY; BRAIN DEAD; CEREBRAL INFARCTION; DEATH; This spontaneous report received from a consumer (news article) via a company representative concerned a 57 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: heart valve surgery (33 years ago). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: unknown) dose was not reported, 01 total, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On 06-OCT-2021 the patient was collapsed and rushed to a hospital. He was diagnosed with a cerebral infarction there and underwent emergency brain surgery, but was eventually declared brain dead. Number of days hospitalized and discharge information was not reported. It was unknown if an autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on 10-OCT-2021, and the outcome of brain dead, collapsing, cerebral infarction and emergency brain surgery was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211048955-COVID-19 VACCINE AD26.COV2.S-death, brain dead, cerebral infarction, collapsing, emergency brain surgery. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: COLLAPSING; EMERGENCY BRAIN SURGERY; BRAIN DEAD; CEREBRAL INFARCTION; DEATH; This spontaneous report received from a consumer (news article) via a company representative concerned a 57 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: heart valve surgery (33 years ago). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: unknown) dose was not reported, 01 total, administered on 17-SEP-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On 06-OCT-2021 the patient was collapsed and rushed to a hospital. He was diagnosed with a cerebral infarction there and underwent emergency brain surgery, but was eventually declared brain dead. Number of days hospitalized and discharge information was not reported. It was unknown if an autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from unknown cause of death on 10-OCT-2021, and the outcome of brain dead, collapsing, cerebral infarction and emergency brain surgery was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0 20211048955-COVID-19 VACCINE AD26.COV2.S-death, brain dead, cerebral infarction, collapsing, emergency brain surgery. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood pressure measurement, Hypertension, Pulmonary embolism, Syncope
Clinical narrative: ATRIAL FIBRILLATION; MULTIPLE LARGE EMBOLISM IN BOTH LUNGS; SYNCOPE; BLOOD PRESSURE HAD BEEN UP; This spontaneous report received from a consumer via a company representative concerned a 62 year old, male. The patient's height, and weight were not reported. Patient had no known drug allergies and medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  In FEB-2021 primary medical doctor (PMD) noticed patient's blood pressure had been up, laboratory data (dates unspecified) included: Blood pressure (NR: not provided) slightly elevated and has been monitoring it since then. Patient had a follow up appointment with primary medical doctor on 24-AUG-2021. On the 25-AUG-2021 when patient was moving in the lawn noticed a bit short of breath. Patient had yet to begin taking low dose antihypertensive medication. Reporter and patient was taking routine walks multiple times a week without incident. On 09-SEP-2021 patient was unable to complete routine walk due to being severely short of breath. Later that same evening, patient passed out (syncope) and was taken to the local emergency room where was admitted and diagnosed with atrial fibrillation and multiple large embolism in both lungs. Patient was admitted on 09-SEP-2021 and discharged on 12-SEP-2021. Patient was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 09-SEP-2021, and had not recovered from multiple large embolism in both lungs, atrial fibrillation, and blood pressure had been up.  This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20211049442-COVID-19 VACCINE AD26.COV2.S-multiple large embolism in both lungs, atrial fibrillation, syncope. 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: Disability, Gastrointestinal disorder, Multiple organ dysfunction syndrome
Clinical narrative: ALL OF HER ORGANS FAILED EXCEPT FOR HER HEART; DISABLED NOW; LOST ALL BUT 90 CC OF HER SMALL INTESTINE LEFT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient was hospitalized for 30 days. All of her organs failed except for her heart and had lost all but 90 CC of her small intestine left. It was reported that, patient had hospital bills over million dollars. Now, patient was disabled with only 90 CC of her small intestine left.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from all of her organs failed except for her heart, disabled now, and lost all but 90 cc of her small intestine left. This report was serious (Hospitalization Caused / Prolonged, and Disability Or Permanent Damage).; Sender's Comments: V0: 20211049832-covid-19 vaccine ad26.cov2.s- All of her organs failed except for her heart, lost all but 90 CC of her small intestine left, disabled now. 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: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose were not reported, 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 died from an unknown cause of death. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211049949-covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Dysgeusia, Hypoaesthesia oral, Lip pain, Mouth ulceration
Clinical narrative: LOSS OF TASTE (NO TASTE FOR COFFEE); FUNNY OR ROTTEN SMELL; SORES ON BOTH OUTER LIPS; LEAD TASTE IN MOUTH; SORES INSIDE MOUTH; SORES ON OUTSIDE OF MOUTH; NUMBNESS IN MOUTH; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the patient experienced loss of taste (no taste for coffee). On 15-MAY-2021, the patient experienced funny or rotten smell. On 15-MAY-2021, the patient experienced sores on both outer lips. On 15-MAY-2021, the patient experienced lead taste in mouth. On 15-MAY-2021, the patient experienced sores inside mouth. On 15-MAY-2021, the patient experienced sores on outside of mouth. On 15-MAY-2021, the patient experienced numbness in mouth. Treatment medications (dates unspecified) included: ethanol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste (no taste for coffee), funny or rotten smell, sores on both outer lips, lead taste in mouth, sores inside mouth, numbness in mouth, and sores on outside of mouth. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parosmia, Stomatitis
Clinical narrative: LOSS OF TASTE (NO TASTE FOR COFFEE); FUNNY OR ROTTEN SMELL; SORES ON BOTH OUTER LIPS; LEAD TASTE IN MOUTH; SORES INSIDE MOUTH; SORES ON OUTSIDE OF MOUTH; NUMBNESS IN MOUTH; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the patient experienced loss of taste (no taste for coffee). On 15-MAY-2021, the patient experienced funny or rotten smell. On 15-MAY-2021, the patient experienced sores on both outer lips. On 15-MAY-2021, the patient experienced lead taste in mouth. On 15-MAY-2021, the patient experienced sores inside mouth. On 15-MAY-2021, the patient experienced sores on outside of mouth. On 15-MAY-2021, the patient experienced numbness in mouth. Treatment medications (dates unspecified) included: ethanol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste (no taste for coffee), funny or rotten smell, sores on both outer lips, lead taste in mouth, sores inside mouth, numbness in mouth, and sores on outside of mouth. This report was non-serious.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse reaction, Ageusia, Cheilitis, Dysgeusia, Hypoaesthesia oral
Clinical narrative: LOSS OF TASTE (NO TASTE FOR COFFEE); FUNNY OR ROTTEN SMELL; SORES ON BOTH OUTER LIPS; LEAD TASTE IN MOUTH; SORES INSIDE MOUTH; SORES ON OUTSIDE OF MOUTH; NUMBNESS IN MOUTH; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAY-2021, the patient experienced loss of taste (no taste for coffee). On 15-MAY-2021, the patient experienced funny or rotten smell. On 15-MAY-2021, the patient experienced sores on both outer lips. On 15-MAY-2021, the patient experienced lead taste in mouth. On 15-MAY-2021, the patient experienced sores inside mouth. On 15-MAY-2021, the patient experienced sores on outside of mouth. On 15-MAY-2021, the patient experienced numbness in mouth. Treatment medications (dates unspecified) included: ethanol/thymol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of taste (no taste for coffee), funny or rotten smell, sores on both outer lips, lead taste in mouth, sores inside mouth, numbness in mouth, and sores on outside of mouth. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: PARALYSIS; This spontaneous report received from a consumer via twitter concerned a patient of unspecified age, sex, race and ethic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was healthy before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 experienced paralysis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211050086-covid-19 vaccine ad26.cov2.s-paralysis. 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: Rash, Rash pruritic
Clinical narrative: RASH SIMILAR TO DARK PURPLE/RED ITCHY AND BURNING SPOTS ALL OVER THE BODY; PAINFUL RASH; This spontaneous report received from a consumer 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, and batch number were not reported) 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 rash similar to dark purple/red itchy and burning spots all over the body, and painful rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash similar to dark purple/red itchy and burning spots all over the body and painful rash was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049049.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CRAWLING UPS THE STEPS LIKE A DOG WITH BLOOD CLOTS; This spontaneous report received from a consumer 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, 1 total administered , 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 number No concomitant medications were reported. On an unspecified date, the reporter stated that '' she had heard of someone "crawling up the steps like a dog with blood clots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crawling ups the steps like a dog with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211050432-covid-19 vaccine ad26.cov2.s-crawling ups the steps like a dog with blood clots. This event(s) is considered unassessable. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 53.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Psoriasis
Clinical narrative: PSORIASIS ON WRIST, SLEEVE, ELBOWS AND LEGS; TIREDNESS; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: Unknown) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis, and moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis on wrist, sleeve, elbows and legs, and tiredness. 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 tiredness, and had not recovered from psoriasis on wrist, sleeve, elbows and legs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: LARGE BRUISE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced large bruise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from large bruise. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Diplopia, Pain in extremity
Clinical narrative: FOGGY EYED IN THE LEFT EYE/WAS SEEING DOUBLE SOME DAYS; WHEN USED WRISTS A LOT OF PAIN; WHEN USED HANDS  A LOT OF PAIN; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for covid-19 vaccination. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. 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 foggy eyed in the left eye/was seeing double some days, when used wrists a lot of pain, and when used hands a lot of pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient had not recovered from when used hands a lot of pain, and when used wrists a lot of pain, and the outcome of foggy eyed in the left eye/was seeing double some days was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal pain, COVID-19
Clinical narrative: COVID VIRUS; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for covid-19 vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe ulcerative colitis. No concomitant medications were reported. On 2021, the patient experienced abdominal pain. On SEP-2021, the patient experienced covid virus. 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 abdominal pain, and was recovering from covid virus. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Exostosis, Tendonitis
Clinical narrative: FOOT EXOSTOSIS; ACHILLES TENDONITIS; This spontaneous report received from a consumer via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease. No concomitant medications were reported.  On an unspecified date, the patient experienced foot exostosis, and achilles tendonitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from foot exostosis, and achilles tendonitis. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: FEELING TIRED; ARM HURT; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 20-JUL-2021 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 leflunomide.  On JUL-2021, the patient experienced arm hurt. On an unspecified date, the patient experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm hurt, and was recovering from feeling tired. This report was non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: VIth nerve paralysis
Clinical narrative: ACUTE ABDUCENS NERVE PALSY OF SIXTH CRANIAL NERVE; This spontaneous report received from a parent concerned a 24 year old male of unspecified race and ethnicity. The patient's weight was 175 pounds, and height was 72 inches. The patient's past medical history included: covid-19 positive (In March 2021), and other pre-existing medical conditions included: Patient had no known allergies. 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, 1 total, administered on 19-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-OCT-2021, the patient experienced double vision in his left eye. Consumer reported that, patient complained of double vision in his left eye for about 6 weeks, so patient went to see an optometrist. On 26-OCT-2021, patient was diagnosed with acute abducens nerve palsy of sixth cranial nerve. Consumer reported that, on 27-OCT-2021 patient was referred to ophthalmologist and scheduled for an Magnetic resonance imaging (MRI). Consumer reported that, patient had a Covid-19 in MAR-2021, so was unsure about diagnosis was due to vaccine or tumor, stroke (aneurysm) or increased cranial pressure. Patient had no other adverse effects after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute abducens nerve palsy of sixth cranial nerve was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211051676.; Sender's Comments: V0: 20211051664- Covid-19 vaccine ad26.cov2.s- acute abducens nerve palsy of sixth cranial nerve. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia, Vasodilatation
Clinical narrative: SWOLLEN TEMPLE VEINS; DIZZINESS; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 swollen temple veins, dizziness, low grade fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen temple veins, dizziness, low grade fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blister, Erythema, Stomatitis
Clinical narrative: BLISTERS THAT COMES AND GO; INSIDE OF MOUTH, NOSE AND CHEEK WAS RED; MOUTH IRRITATION; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blisters that comes and go, inside of mouth, nose and cheek was red, and mouth irritation. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) Nothing came up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blisters that comes and go, inside of mouth, nose and cheek was red and mouth irritation was not reported. This report was non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE WAS ADMINISTERED PAST THE RECOMMENDED STORAGE TIME (VACCINE WAS REFRIGERATED OVER NIGHT BEFORE BEING ADMINISTERED); This spontaneous report received from a health care professional concerned a 29 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: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 26-OCT-2021 10:40 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced vaccine was administered past the recommended storage time (vaccine was refrigerated over night before being administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered past the recommended storage time (vaccine was refrigerated over night before being administered) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052091.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effect was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211052814.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE REFRIGERATED OVER NIGHT BEFORE BEING ADMINISTERED; INCORRECTLY STORED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 56 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: 1822811 and expiry: 20-MAR-2022) dose was not reported, administered on 26-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the patient experienced vaccine refrigerated over night before being administered. On 26-OCT-2021, the patient experienced incorrectly stored vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine refrigerated over night before being administered and incorrectly stored vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211051934.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Irritability, Pain, Pyrexia
Clinical narrative: BRAIN FOG; VERY HEAVY FEELING; FEELING GRUMPY; LOTS OF ACHES AND PAINS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 brain fog, very heavy feeling, feeling grumpy, lots of aches and pains, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the brain fog, lots of aches and pains, fever, very heavy feeling and feeling grumpy was not reported. This report was non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Condition aggravated, Fatigue, Laboratory test
Clinical narrative: TIRED; FLARE OF CONGESTION, SINUS, RED EYES; FEVER; RED EYES; CONGESTION IN HEAD AND EARS/ SINUS ISSUES; CHEST PAIN/TWINGE OF PAIN IN UPPER CHEST; RACING HEART; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included: no thyriod gland, and concurrent conditions included: high cholesterol, non alcoholic, non smoker, trees allergy, grass allergy, ragweed allergy, pollen allergy, and latex allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: 23-AUG-2021) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. Concomitant medications included levocetirizine dihydrochloride for allergy, montelukast sodium for allergy, rosuvastatin calcium for high cholesterol, and levothyroxine sodium for thyroidectomy. On MAR-2021, the patient experienced red eyes. On MAR-2021, the patient experienced congestion in head and ears/ sinus issues. On MAR-2021, the patient experienced chest pain/twinge of pain in upper chest. On MAR-2021, the patient experienced racing heart. Laboratory data included: Blood test (NR: not provided) no significant findings, and Laboratory test (NR: not provided) no significant findings. On 05-MAR-2021, the patient experienced fever. On AUG-2021, the patient experienced flare of congestion, sinus, red eyes. On an unspecified date, the patient experienced tired. Treatment medications (dates unspecified) included: paracetamol, methylprednisolone, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red eyes, and congestion in head and ears/ sinus issues on JUN-2021, chest pain/twinge of pain in upper chest, flare of congestion, sinus, red eyes on OCT-2021, and fever on 09-MAR-2021, and the outcome of tired and racing heart was not reported. This report was non-serious.