chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Multiple allergies, Nausea, Neck pain, Vision blurred
Clinical narrative: TROUBLE BREATHING; NECK PAIN; BLURRY VISION; DIARRHEA; DIZZINESS; COUGH; FEEL SICK; WEAKNESS; NAUSEA; ALLERGIES; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included she had no history of allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13/JUN/2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced allergies. On 11-APR-2021, the subject experienced cough. On 11-APR-2021, the subject experienced feel sick. On 11-APR-2021, the subject experienced weakness. On 11-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced diarrhea. On 13-APR-2021, the subject experienced dizziness. On 15-APR-2021, the subject experienced neck pain. On 15-APR-2021, the subject experienced blurry vision. On 17-APR-2021, the subject experienced trouble breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, dizziness, neck pain, blurry vision, trouble breathing, cough, allergies, nausea, diarrhea, and feel sick. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805029, expiry: Unknown) frequency one total, dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that since 15-APR-2021, she had head cold with congestion and runny nose. On 18-APR-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection and outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality compliant: 90000177213.; Sender's Comments: V0:20210444534-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: M
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: ACUTE KIDNEY FAILURE; This spontaneous report received from a consumer concerned a male patient of an unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number was not reported and has been requested) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced acute kidney failure (severe side effects including vomiting, stomachache, headache) and he was hospitalized in ICU for two days (date unspecified). Doctors refused to report that events as vaccine-related issue.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of acute kidney failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210444537-covid-19 vaccine ad26.cov2.s-Acute kidney failure. 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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED ADVERSE REACTIONS; This spontaneous report received other pharmaceutical company (Pfizer, Inc.) via online article 'The Covid-19 vaccines are highly effective, and the chance of an adverse reaction is rare', concerned multiple patients (unspecified number). The patients' weight, height, and medical history were not reported.  The patients received vaccination with 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 patients experienced unspecified adverse reactions and an unspecified vaccination site in the state of Iowa paused vaccinations.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient outcome for unspecified adverse reactions was not reported. This report was non-serious. This case, for same reporter, was linked to 20210415305
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Haemoptysis, Oropharyngeal pain
Clinical narrative: PHLEGM WITH BLOOD; COUGH; SORE THROAT; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced sore throat. On 17-APR-2021, the subject experienced phlegm with blood. On 17-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat on 15-APR-2021, and had not recovered from cough, and phlegm with blood. This report was non-serious.; Sender's Comments: MAC Comment: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anger, Crying, Insomnia, Irritability, Rash
Clinical narrative: SEIZURES; DID NOT SLEEP WELL; IRRITABILITY; ANGER; CRYING; BAD RASH ON HIS BOTTOM; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia, deafness, and seizures. 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, administered on 06-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included unspecified seizures medications. On 06-Apr-2021, after receiving the vaccine the patient did not sleep well, since then extra seizures. The patient has had an inaudible seizure for several years. On 21-APR-2021, the patient slept through the night, irritability. The patient was totally different, angry, crying a lot, had rash, one on his bottom and bad one there. The patient took seizures medicine three times a day. The patient did not have any further information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the did not sleep well, seizures, irritability, anger, crying and bad rash on his bottom was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : - Covid-19 vaccine ad26.cov2.s-SEIZURES- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: SEIZURES; DID NOT SLEEP WELL; IRRITABILITY; ANGER; CRYING; BAD RASH ON HIS BOTTOM; This spontaneous report received from a consumer concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included quadriplegia, deafness, and seizures. 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, administered on 06-APR-2021 on left arm for prophylactic vaccination. Concomitant medications included unspecified seizures medications. On 06-Apr-2021, after receiving the vaccine the patient did not sleep well, since then extra seizures. The patient has had an inaudible seizure for several years. On 21-APR-2021, the patient slept through the night, irritability. The patient was totally different, angry, crying a lot, had rash, one on his bottom and bad one there. The patient took seizures medicine three times a day. The patient did not have any further information.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the did not sleep well, seizures, irritability, anger, crying and bad rash on his bottom was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : - Covid-19 vaccine ad26.cov2.s-SEIZURES- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Angiopathy, Asthenia, Chills, Fatigue, Feeling cold
Clinical narrative: COMPLETELY UNRESPONSIVE; PROMINENT VEINS IN HANDS; WEAK; TIRED; COLD; SHIVERING; BEGAN A PERIOD THE DAY SHE GOT THE INJECTION, THEN IT STOPPED AD BEGAN AGAIN; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 about 10 hours after receiving the vaccine, the patient was cold and shivering (cold on the inside) and later became completely unresponsive, began a period the day she got the injection, then it stopped ad began again. At 1: 15 a.m. (date unspecified) she was sent to hospital. She received lab testing and imaging and she woke up within 5-6 hours. The results were inconclusive. On 11-APR-2021, the patient experienced feeling weak and tired, her veins were prominent in hands. She received unknown medication while in the hospital. She has not followed up with primary care physician nor has she been back to the hospital since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely unresponsive, and cold and shivering on 11-APR-2021, and began a period the day she got the injection, then it stopped ad began again on 14-APR-2021, was recovering from weak and tired, and the outcome of prominent veins in hands was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s -completely unresponsive,  began a period the day she got the injection, then it stopped ad began again. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage, Unresponsive to stimuli
Clinical narrative: COMPLETELY UNRESPONSIVE; PROMINENT VEINS IN HANDS; WEAK; TIRED; COLD; SHIVERING; BEGAN A PERIOD THE DAY SHE GOT THE INJECTION, THEN IT STOPPED AD BEGAN AGAIN; This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 about 10 hours after receiving the vaccine, the patient was cold and shivering (cold on the inside) and later became completely unresponsive, began a period the day she got the injection, then it stopped ad began again. At 1: 15 a.m. (date unspecified) she was sent to hospital. She received lab testing and imaging and she woke up within 5-6 hours. The results were inconclusive. On 11-APR-2021, the patient experienced feeling weak and tired, her veins were prominent in hands. She received unknown medication while in the hospital. She has not followed up with primary care physician nor has she been back to the hospital since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from completely unresponsive, and cold and shivering on 11-APR-2021, and began a period the day she got the injection, then it stopped ad began again on 14-APR-2021, was recovering from weak and tired, and the outcome of prominent veins in hands was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s -completely unresponsive,  began a period the day she got the injection, then it stopped ad began again. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-APR-2021, the subject experienced suspected covid-19 infection. On 21-APR-2021, the subject experienced suspected clinical vaccination failure. 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 non-serious.; Sender's Comments: v0-Medical assessment comment not required as per standard operating procedures, as case was assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Laboratory test, Visual impairment
Clinical narrative: LIGHTHEADEDNESS; HEADACHE; ANXIETY; VISUAL DISTURBANCE; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included hiccoughing, and concurrent conditions included speech slurred, non alcohol consumer, and non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included iron for used for unknown indication. On 07-APR-2021, the subject experienced anxiety. On 07-APR-2021, the subject experienced visual disturbance. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced lightheadedness. On 22-APR-2021, Laboratory data included: Lab test (NR: not provided) No results available (units unspecified). Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from visual disturbance, lightheadedness, and headache on 08-APR-2021, and had not recovered from anxiety. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure since case is assessed as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Computerised tomogram, Dyspnoea, Erythema
Clinical narrative: DIFFICULTY BREATHING(LOW OXYGEN); ELEVATED D-DIMER; INABILITY TO MOVE; LOW BODY TEMPERATURE; TINGLY FACE; RED FACE; FELT BAD AND AWFUL; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction, and concurrent conditions included fibromyalgia. The patient did not had previous history of allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1605018,expiry: unknown) dose was not reported,1 total administered on 20-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported.   On 20-MAR-2021, 20 minutes after vaccination, the patient's felt her face red and tingly and it went away. On 29-APR-2021, nine days after receiving the vaccine, the patient woke up not able to breathe or move and had a temperature of 94 degree F. The patient went to hospital and had low oxygen, an elevated d-dimer and had no evidence of blood clots in CT (computed tomography) scan. The patient was treated in ER (emergency room) with epinephrine, steroids, diphenhydramine (Benadryl) and a unspecified nebulizer and then she could breathe. The patient's physician tested her d-dimer for second time following the patient's visit to the hospital and it was elevated, but not as high. The patient had history of fibromyalgia and mysterious health condition but it was reported that she did not have anything like what she experienced after vaccination and she felt really bad and super awful. The patient was not feeling great, but better and can breathe again at the time of this report; her oxygen level also was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing(low oxygen) on 2021, and red face, was recovering from felt bad and awful, had not recovered from elevated d-dimer, and the outcome of tingly face, inability to move and low body temperature was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210446229- covid-19 vaccine ad26.cov2.s -Difficulty breathing(Oxygen). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Fibrin D dimer, Fibrin D dimer increased, Mobility decreased, Oxygen saturation
Clinical narrative: DIFFICULTY BREATHING(LOW OXYGEN); ELEVATED D-DIMER; INABILITY TO MOVE; LOW BODY TEMPERATURE; TINGLY FACE; RED FACE; FELT BAD AND AWFUL; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction, and concurrent conditions included fibromyalgia. The patient did not had previous history of allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1605018,expiry: unknown) dose was not reported,1 total administered on 20-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported.   On 20-MAR-2021, 20 minutes after vaccination, the patient's felt her face red and tingly and it went away. On 29-APR-2021, nine days after receiving the vaccine, the patient woke up not able to breathe or move and had a temperature of 94 degree F. The patient went to hospital and had low oxygen, an elevated d-dimer and had no evidence of blood clots in CT (computed tomography) scan. The patient was treated in ER (emergency room) with epinephrine, steroids, diphenhydramine (Benadryl) and a unspecified nebulizer and then she could breathe. The patient's physician tested her d-dimer for second time following the patient's visit to the hospital and it was elevated, but not as high. The patient had history of fibromyalgia and mysterious health condition but it was reported that she did not have anything like what she experienced after vaccination and she felt really bad and super awful. The patient was not feeling great, but better and can breathe again at the time of this report; her oxygen level also was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing(low oxygen) on 2021, and red face, was recovering from felt bad and awful, had not recovered from elevated d-dimer, and the outcome of tingly face, inability to move and low body temperature was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210446229- covid-19 vaccine ad26.cov2.s -Difficulty breathing(Oxygen). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: DIFFICULTY BREATHING(LOW OXYGEN); ELEVATED D-DIMER; INABILITY TO MOVE; LOW BODY TEMPERATURE; TINGLY FACE; RED FACE; FELT BAD AND AWFUL; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included anaphylaxis reaction, and concurrent conditions included fibromyalgia. The patient did not had previous history of allergy to vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1605018,expiry: unknown) dose was not reported,1 total administered on 20-MAR-2021 to the right arm for prophylactic vaccination. No concomitant medications were reported.   On 20-MAR-2021, 20 minutes after vaccination, the patient's felt her face red and tingly and it went away. On 29-APR-2021, nine days after receiving the vaccine, the patient woke up not able to breathe or move and had a temperature of 94 degree F. The patient went to hospital and had low oxygen, an elevated d-dimer and had no evidence of blood clots in CT (computed tomography) scan. The patient was treated in ER (emergency room) with epinephrine, steroids, diphenhydramine (Benadryl) and a unspecified nebulizer and then she could breathe. The patient's physician tested her d-dimer for second time following the patient's visit to the hospital and it was elevated, but not as high. The patient had history of fibromyalgia and mysterious health condition but it was reported that she did not have anything like what she experienced after vaccination and she felt really bad and super awful. The patient was not feeling great, but better and can breathe again at the time of this report; her oxygen level also was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing(low oxygen) on 2021, and red face, was recovering from felt bad and awful, had not recovered from elevated d-dimer, and the outcome of tingly face, inability to move and low body temperature was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210446229- covid-19 vaccine ad26.cov2.s -Difficulty breathing(Oxygen). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a healthcare professional (patient's wife) concerned a 40-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (stable at the time of report). The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on right deltoid on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date (couple of weeks before this report), the patient and his wife had been to a restaurant. On 14-APR-2021, the patient experienced nasal congestion which resolved on 17-APR-2021. On 21-APR-2021, the patient experienced cough and his wife recognized it as COVID cough'. On the same day, the patient was tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was described by his wife as a breakthrough infection (suspected COVID-19 infection and suspected clinical vaccination failure). The patient's wife mentioned that she thinks her husband probably caught the infection at the restaurant they had been to earlier. The reporter (wife) stated that the patient's symptoms were very mild, he had no fever and did not need an HCP consultation or any medication to treat the symptoms.  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 unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-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: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Dehydration, Dyspnoea
Clinical narrative: DEHYDRATION; UPPER GASTROINTESTINAL PAIN, STOMACH ISSUE; LOSS OF APPETITE; WEAKNESS; NAUSEOUS; HEADACHE/ MIGRAINE LIKE HEADACHE; MUSCLE ACHES; FATIGUE; VOMITING; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, immediately after vaccination the patient experienced headache, muscle aches, fatigue. On 12-APR-2021, the patient went to urgent care which the patient was determined to have dehydration. The patient had been given 2 bags of IVs and nausea medication. Patient was having constant headaches and was feeling weak, nauseous, also had upper gastrointestinal pain, loss of appetite and migraine-like headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shortness of breath, weakness, fatigue, and muscle aches on APR-2021, was recovering from loss of appetite, had not recovered from nauseous, and upper gastrointestinal pain, stomach issue, and the outcome of dehydration and headache was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-Dehydration. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Vomiting
Clinical narrative: DEHYDRATION; UPPER GASTROINTESTINAL PAIN, STOMACH ISSUE; LOSS OF APPETITE; WEAKNESS; NAUSEOUS; HEADACHE/ MIGRAINE LIKE HEADACHE; MUSCLE ACHES; FATIGUE; VOMITING; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, immediately after vaccination the patient experienced headache, muscle aches, fatigue. On 12-APR-2021, the patient went to urgent care which the patient was determined to have dehydration. The patient had been given 2 bags of IVs and nausea medication. Patient was having constant headaches and was feeling weak, nauseous, also had upper gastrointestinal pain, loss of appetite and migraine-like headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, shortness of breath, weakness, fatigue, and muscle aches on APR-2021, was recovering from loss of appetite, had not recovered from nauseous, and upper gastrointestinal pain, stomach issue, and the outcome of dehydration and headache was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-Dehydration. 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: Pulmonary embolism
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report received from a consumer and concerned a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, 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 pulmonary embolism. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210450133.; Sender's Comments: V0: 20210446568-COVID-19 VACCINE AD26.COV2.S-PULMONARY EMBOLISM . This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This solicited report received from a patient  from Janssen  for STELARA Crohns concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was treated with ustekinumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of suspected covid-19 infection was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and suspected covid-19 infection as possible; and between ustekinumab, and suspected covid-19 infection as possible.  This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Thrombocytopenia, Thrombosis
Clinical narrative: RARE BLOOD CLOT; LOW PLATELETS; This spontaneous report received from a consumer concerned about 50 years old female. The reporter obtained the information from news/media. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unknown date in APR-2021 after vaccination, the patient experienced severe headache, abdominal pain, leg pain and shortness of breath. The patient developed a rare blood clot and low platelets on an unspecified date in APR-2021, within two weeks of receiving JANSSEN COVID-19 vaccine. The patient was hospitalized on an unspecified date in APR-2021. On APR-2021, the patient died from blood clot. The reporter was not sure whether the events was related to the vaccination. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of rare blood clot on APR-2021, and had not recovered from low platelets. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This female patient in her 50s was reported to have developed a rare blood clot and low platelets within two weeks of receiving JANSSEN COVID-19 vaccine.  On an unspecified date, symptoms reported were severe headache, abdominal pain, leg pain and shortness of breath.  The patient was hospitalized on an unspecified date and subsequently died from blood clot.  It was not known if autopsy was performed.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.; Reported Cause(s) of Death: BLOOD CLOT
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTTING; This spontaneous report received via traditional media from a patient concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expire date: Unknown ) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clotting and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clotting was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210447114-Covid-19 vaccine ad26.cov2.s- BLOOD CLOTTING These events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood triglycerides, Dry mouth, Fatigue, Feeling abnormal, Lip dry
Clinical narrative: FEELING ABNORMAL; DRY MOUTH; DRY LIPS; FATIGUE; This spontaneous report received from a consumer via Regulatory Authority concerned a 73 year old male. The patient's height, and weight were not reported. The patient's past medical history included surgery, knee replacement, and back surgery, and concurrent conditions included type 2 diabetes mellitus, aortic aneurysm, alcohol use, cigar smoker, and high cholesterol. The patient had no known allergies. On an unspecified date in 2019, the patient underwent coronary stent placement. The patient was also prescribed with overdose and experienced product odor abnormal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included pantoprazole for acid reflux (esophageal), lisinopril for blood pressure high, pancreatin for gastrointestinal disorder therapy, allopurinol for gout, acetylsalicylic acid for heart disorder, propranolol for heart disorder, evolocumab for high cholesterol, alprazolam for panic attack, clonazepam for panic attack, and post-traumatic stress disorder, topiramate for post-traumatic stress disorder, alogliptin for type 2 diabetes mellitus, glipizide for type 2 diabetes mellitus, and metformin for type 2 diabetes mellitus. On FEB-2021, Laboratory data included: Triglycerides (NR: not provided) 240 (Unspecified unit).  On 06-MAR-2021 after vaccination, the patient felt abnormal and had dry mouth and dry lips. The patient also experienced fatigue. Laboratory data (dates unspecified) included: Triglycerides (NR: not provided) Baseline 1000. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, feeling abnormal, dry mouth and dry lips was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 - 20210447135-covid-19 vaccine ad26.cov2.s -Feeling abnormal, Dry mouth, Dry lips. 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). 20210447135-covid-19 vaccine ad26.cov2.s -Fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cardiac flutter, Dyspnoea, Fatigue, Headache
Clinical narrative: SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING OF HEART; This spontaneous report received from a patient concerned a 74 year old  female. The patient's weight was 266 pounds, and height was 62 inches. The patient's past medical history included concussion in 2019, spinal injuries, anaphylaxis shock after medicine took for bone and swelling, and concurrent conditions included non alcohol user, non-smoker, and reaction to iv dye, fluttering of the heart, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with steroids for swelling.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered one total, on 08-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included roprinolil, atorvastatin, lisinopril , propranolol , salbutamol sulfate(inhaler) as needed, oxybutynin, and paracetamol as needed, all drugs were used for unknown indications. On 09-APR-2021, the patient experienced worsening of fluttering of heart, tiredness. On 10-APR-2021, the patient experienced left arm soreness. On 13-APR-2021, the patient experienced headache. On 17-APR-2021, the patient experienced stomach cramps and recovered on 21-APR-2021. On 19-APR-2021, the patient experienced shortness of breath. It was reported that patient had experienced shortness of breath before shot but not as often. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from stomach cramps on 21-APR-2021, and was recovering from headache, worsening of fluttering of heart, left arm soreness, shortness of breath, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: v0:20210447945: covid-19 vaccine ad26.cov2.s -Worsening of fluttering of heart. 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: MEDICAL HISTORY
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SHORTNESS OF BREATH; STOMACH CRAMPS; HEADACHE; LEFT ARM SORENESS; TIREDNESS; WORSENING OF FLUTTERING OF HEART; This spontaneous report received from a patient concerned a 74 year old  female. The patient's weight was 266 pounds, and height was 62 inches. The patient's past medical history included concussion in 2019, spinal injuries, anaphylaxis shock after medicine took for bone and swelling, and concurrent conditions included non alcohol user, non-smoker, and reaction to iv dye, fluttering of the heart, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient was previously treated with steroids for swelling.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered one total, on 08-APR-2021 in left arm for prophylactic vaccination. Concomitant medications included roprinolil, atorvastatin, lisinopril , propranolol , salbutamol sulfate(inhaler) as needed, oxybutynin, and paracetamol as needed, all drugs were used for unknown indications. On 09-APR-2021, the patient experienced worsening of fluttering of heart, tiredness. On 10-APR-2021, the patient experienced left arm soreness. On 13-APR-2021, the patient experienced headache. On 17-APR-2021, the patient experienced stomach cramps and recovered on 21-APR-2021. On 19-APR-2021, the patient experienced shortness of breath. It was reported that patient had experienced shortness of breath before shot but not as often. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from stomach cramps on 21-APR-2021, and was recovering from headache, worsening of fluttering of heart, left arm soreness, shortness of breath, and tiredness. This report was serious (Other Medically Important Condition).; Sender's Comments: v0:20210447945: covid-19 vaccine ad26.cov2.s -Worsening of fluttering of heart. 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: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and dose was not reported, batch number: unknown) administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the patient experienced suspected immunological vaccine failure. On unspecified date patient went to the doctor to do Laboratory test for detection of antibodies which was found as negative. Patient was upset about it and wants to know about how this was happened. Patient also states that company would contact with her to know the details of event occurred. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious. (Other Medically Important condition) This report was associated with product quality complaint: 90000177573.; Sender's Comments: V0:20210448211-Covid-19 vaccine ad26.cov2.s-suspected immunological vaccination 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).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Erythema, Fatigue, Feeling hot
Clinical narrative: GLASSY EYES; CHILLS; STOMACH DISCOMFORT; FATIGUE; SWELLING AT INJECTION SITE; LUMP; PAINFUL; REDNESS; WARM; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced lump. On 12-APR-2021, the subject experienced painful. On 12-APR-2021, the subject experienced redness. On 12-APR-2021, the subject experienced warm. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced swelling at injection site. On 21-APR-2021, the subject experienced stomach discomfort. On 22-APR-2021, the subject experienced glassy eyes. On 22-APR-2021, the subject experienced chills. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm, and swelling at injection site on 21-APR-2021, and chills on 23-APR-2021, was recovering from stomach discomfort, fatigue, and glassy eyes, and had not recovered from lump, painful, and redness. This report was non-serious.