chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: CAN'T WALK AFTER GETTING THE VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine 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 and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced can't walk after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can't walk after getting the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211058708.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race, and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that after getting initial dose of Janssen covid 19 vaccine, on an unspecified date patient was diagnosed with covid (suspected covid-19 infection). Reportedly the symptoms were mild. On an unspecified date, the patient had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0 - 20211058684 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: Body temperature, Breast pain, Dizziness, Feeling abnormal, Headache
Clinical narrative: COLD; FEEL LIKE FAINTING; DYING; SETLHABI ON LEFT BOOBIE; HIGH FEVER AND TEMPERATURE; POUNDING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cold, dying, setlhabi on left boobie, high fever and temperature, pounding headache, and feel like fainting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and temperature, dying, pounding headache, setlhabi on left boobie, cold and feel like fainting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: COLD; FEEL LIKE FAINTING; DYING; SETLHABI ON LEFT BOOBIE; HIGH FEVER AND TEMPERATURE; POUNDING HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced cold, dying, setlhabi on left boobie, high fever and temperature, pounding headache, and feel like fainting. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever and temperature, dying, pounding headache, setlhabi on left boobie, cold and feel like fainting was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: WHOLE FAMILY HAD HORRIBLE REACTIONS TO THE SHOT; 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 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 whole family had horrible reactions to the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of whole family had horrible reactions to the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20211059062.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: HEADACHE; FATIGUE; 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue. This report was non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: A PUNCTURED JANSSEN COVID-19 VACCINE VIAL WAS USED 40 MINS PAST ITS 6 HOURS TIME RANGE; POTENTIAL ADMINISTRATION ERROR EXPIRED JANSSEN COVID-19 VACCINE; This spontaneous report received from a pharmacist concerned a 65 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: 1822809 and expiry: 07-MAR-2022) dose was not reported, administered on 27-OCT-2021 15:45 for prophylactic vaccination. No concomitant medications were reported. On 27-OCT-2021, the patient experienced potential administration error expired janssen covid-19 vaccine. On an unspecified date, the patient experienced a punctured janssen covid-19 vaccine vial was used 40 mins past its 6 hours time range. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potential administration error expired janssen covid-19 vaccine and a punctured janssencovid-19 vaccine vial was used 40 mins past its 6 hours time range was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations, Pyrexia, Thinking abnormal
Clinical narrative: HEART WAS POUNDING OUT OF CHEST; COULD NOT BREATHE; THOUGHT WAS GOING TO DIE; FEVER; This spontaneous report received from a consumer concerned a 70 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, 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 heart was pounding out of chest, could not breathe, thought was going to die, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart was pounding out of chest, could not breathe, fever and thought was going to die was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Colonoscopy, Culture, Discomfort, Endoscopy upper gastrointestinal tract
Clinical narrative: RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Herpes virus test, Malaise, Pain, Pyrexia
Clinical narrative: RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, SARS-CoV-2 test, Sexually transmitted disease test, Vaginal ulceration
Clinical narrative: RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Eyelid rash, Fatigue, Headache, Pain
Clinical narrative: RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Sexually transmitted disease test, Vaginal ulceration
Clinical narrative: RASH UNDER THE EYES/ LITTLE BUMPS AND SOME REDNESS ON THE UPPER CHEEK; VAGINAL ULCERS/LITTLE TENDER IN VAGINAL AREA/VAGINAL SORES AND SEVERE PAIN DURING URINATION; UNCOMFORTABLE; BODYACHES; CHILLS; GENERAL MALAISE; FEVER; SEVERE HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 symptoms, 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: 204A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 15:35 for prophylactic vaccination. No concomitant medications were reported. On 19-AUG-2021, the patient experienced bodyaches. On 19-AUG-2021, the patient experienced chills. On 19-AUG-2021, the patient experienced general malaise. On 19-AUG-2021, the patient experienced fever. On 19-AUG-2021, the patient experienced severe headache. On 20-AUG-2021, the patient experienced vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination. On 20-AUG-2021, the patient experienced uncomfortable. On 22-AUG-2021, the patient experienced rash under the eyes/ little bumps and some redness on the upper cheek. On 23-AUG-2021, Laboratory data included: Culture (NR: not provided) Negative, Herpes virus test (NR: not provided) Negative, and Sexually transmitted disease test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative, Colonoscopy (NR: not provided) Not reported, and Endoscopy upper gastrointestinal tract (NR: not provided) Not reported. Treatment medications (dates unspecified) included: lidocaine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bodyaches, chills, and general malaise on 21-AUG-2021, and severe headache on 26-AUG-2021, had not recovered from fever, and the outcome of rash under the eyes/ little bumps and some redness on the upper cheek, vaginal ulcers/little tender in vaginal area/vaginal sores and severe pain during urination and uncomfortable was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: HIV test, Urinary tract infection
Clinical narrative: UTI(URINARY TRACT INFECTION); This spontaneous report received from a consumer 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 was not reported, administered on 22-OCT-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 OCT-2021, the patient experienced uti (urinary tract infection). Laboratory data included: HIV test (NR: not provided) Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of uti(urinary tract infection) was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Constipation, Fatigue, Gastrointestinal disorder, Heart rate irregular
Clinical narrative: LOOSE 10 LBS/DROPPED BELOW 100LBS; DIFFICULTY GAINING BACK THE WEIGHT; FATIGUE; HEART PALPITATIONS; INTESTINAL PROBLEMS; CONSTIPATION; LACK OF CONTROL OF BOWELS; LEG SWELLING; STRONG IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: soy allergy, and other pre-existing medical conditions included: The patient had unspecified dietary related allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2072A12 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart palpitations. On 12-APR-2021, the patient experienced intestinal problems. On 12-APR-2021, the patient experienced constipation. On 12-APR-2021, the patient experienced lack of control of bowels. On 12-APR-2021, the patient experienced leg swelling. On 12-APR-2021, the patient experienced strong irregular heart beat. On 12-APR-2021, the patient experienced fatigue. On an unspecified date, the patient experienced loose 10 lbs/dropped below 100lbs, and difficulty gaining back the weight. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) No blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, intestinal problems, constipation, lack of control of bowels, leg swelling, strong irregular heart beat, and fatigue, and the outcome of loose 10 lbs/dropped below 100lbs and difficulty gaining back the weight was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Palpitations, Peripheral swelling, Weight decreased, Weight gain poor
Clinical narrative: LOOSE 10 LBS/DROPPED BELOW 100LBS; DIFFICULTY GAINING BACK THE WEIGHT; FATIGUE; HEART PALPITATIONS; INTESTINAL PROBLEMS; CONSTIPATION; LACK OF CONTROL OF BOWELS; LEG SWELLING; STRONG IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: soy allergy, and other pre-existing medical conditions included: The patient had unspecified dietary related allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2072A12 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart palpitations. On 12-APR-2021, the patient experienced intestinal problems. On 12-APR-2021, the patient experienced constipation. On 12-APR-2021, the patient experienced lack of control of bowels. On 12-APR-2021, the patient experienced leg swelling. On 12-APR-2021, the patient experienced strong irregular heart beat. On 12-APR-2021, the patient experienced fatigue. On an unspecified date, the patient experienced loose 10 lbs/dropped below 100lbs, and difficulty gaining back the weight. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) No blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, intestinal problems, constipation, lack of control of bowels, leg swelling, strong irregular heart beat, and fatigue, and the outcome of loose 10 lbs/dropped below 100lbs and difficulty gaining back the weight was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Pyrexia
Clinical narrative: HORRIBLE REACTIONS; FEVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight was 100 pounds, and height was 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced horrible reactions, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of horrible reactions was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: BAD REACTION TO VACCINE; This spontaneous report received from a parent concerned an adult male. The patient's weight was 100 pounds, and height was 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 bad reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad reaction to vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211058812.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a patient concerned a 78 year old white male of unspecified ethnic origin. The patient's weight was 194 pounds, and height was 68 inches. The patient's concurrent conditions included: alcohol user, nonsmoker, blood pressure abnormal, and cholesterol abnormal, and other pre-existing medical conditions included: The patient had no known allergies, did not have any drug abuse/illicit drug use and had taken blood pressure pills, cholesterol pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported , batch number: 202A2, expiry: Unknown) dose was not reported, 01 total administered to left arm on 02-MAY-2021 for prophylactic vaccination. Concomitant medications included fish oil for unknown indication.  Patient stated that about a month later, on an unspecified date in JUN-2021, he was walking to the pharmacy, and on the way home he pulled a muscle in his left leg, which continued for about a month. He then went to the emergency room and was diagnosed with a blood clot and was not admitted to the hospital. The patient had been on treatment medication (dates unspecified) Xarelto (rivaroxaban) for 3 months. Reportedly, on an unspecified date his right leg got sore and was still sore at the time of report. His primary care physician (PCP) was aware of his symptoms. He also stated that, he was first started on an unspecified another pill and then his PCP switched him to Xarelto for 3 months. Reportedly, on unspecified date patient also felt very painful to walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211059076-covid-19 vaccine ad26.cov2.s-Blood clot. 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: Body temperature, Headache, Malaise, Pain, Pyrexia
Clinical narrative: ACHES; GENERAL MALAISE; EQUIVALENT OF A HANGOVER AND DULL HEADACHE; 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 aches, general malaise, equivalent of a hangover and dull headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from equivalent of a hangover and dull headache, and fever, and the outcome of general malaise and aches was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED AFTER THE 30 MINUTES OUTSIDE OF EXPIRY TIME (VIAL PUNCTURED AT 9 AM AND ADMINISTERED AT 3.30 PM); This spontaneous report received from a health care professional concerned a 37 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: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 28-OCT-2021, the patient experienced vaccine administered after the 30 minutes outside of expiry time (vial punctured at 9 am and administered at 3.30 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the 30 minutes outside of expiry time (vial punctured at 9 am and administered at 3.30 pm) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: DRUG EXPOSURE VIA BREAST MILK; 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's parent 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 drug exposure via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from drug exposure via breast milk. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Nausea, Pain in extremity, Pyrexia
Clinical narrative: LEGS LOOK RED; CHILLING EFFECT; PAINING IN LEG; FACE HAS RASH; FEVER; NAUSEA; 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: 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 or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced legs look red, chilling effect, paining in leg, face has rash, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chilling effect, fever, and nausea, and the outcome of paining in leg, legs look red and face has rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: LEGS LOOK RED; CHILLING EFFECT; PAINING IN LEG; FACE HAS RASH; FEVER; NAUSEA; 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: 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 or lot number. No concomitant medications were reported. On an unspecified date, the patient experienced legs look red, chilling effect, paining in leg, face has rash, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chilling effect, fever, and nausea, and the outcome of paining in leg, legs look red and face has rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Malaise
Clinical narrative: DIZZY; DO NOT FEEL GOOD; WEAKNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-OCT-2021, the patient experienced dizzy. On 27-OCT-2021, the patient experienced do not feel good. On 27-OCT-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizzy, weakness, and do not feel good. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hypersomnia
Clinical narrative: SLEPT A LOT WHOLE WEEKEND; CHILLS; TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, 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 slept a lot whole weekend, chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, slept a lot whole weekend and tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; 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 unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Ear discomfort, Eye pain, Fatigue
Clinical narrative: DISRUPTED SLEEP (10 DAYS); SHORTNESS OF BREATH; CHEST PAIN; PAIN BEHIND EAR (GENERALIZED PAIN); SWELLING IN HEAD AND BEHIND EAR; PRESSURE BEHIND EYE; PRESSURE BEHIND EAR; RASH ON SCALP AND FOREHEAD; HEADACHE ON LEFT SIDE OF HEAD (BACK OF HEAD GENERAL PAIN); GENERALIZED FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions prior to taking vaccine. 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 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced disrupted sleep (10 days). On OCT-2021, the patient experienced shortness of breath. On OCT-2021, the patient experienced chest pain. On OCT-2021, the patient experienced pain behind ear (generalized pain). On OCT-2021, the patient experienced swelling in head and behind ear. On OCT-2021, the patient experienced pressure behind eye. On OCT-2021, the patient experienced pressure behind ear. On OCT-2021, the patient experienced rash on scalp and forehead. On OCT-2021, the patient experienced headache on left side of head (back of head general pain). On OCT-2021, the patient experienced generalized fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the disrupted sleep (10 days), shortness of breath, chest pain, headache on left side of head (back of head general pain), generalized fatigue, pain behind ear (generalized pain), swelling in head and behind ear, pressure behind eye, rash on scalp and forehead and pressure behind ear was not reported. This report was non-serious. This case, from the same reporter is linked to 20211059166.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Rash, Sleep disorder, Swelling
Clinical narrative: DISRUPTED SLEEP (10 DAYS); SHORTNESS OF BREATH; CHEST PAIN; PAIN BEHIND EAR (GENERALIZED PAIN); SWELLING IN HEAD AND BEHIND EAR; PRESSURE BEHIND EYE; PRESSURE BEHIND EAR; RASH ON SCALP AND FOREHEAD; HEADACHE ON LEFT SIDE OF HEAD (BACK OF HEAD GENERAL PAIN); GENERALIZED FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical conditions prior to taking vaccine. 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 15-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced disrupted sleep (10 days). On OCT-2021, the patient experienced shortness of breath. On OCT-2021, the patient experienced chest pain. On OCT-2021, the patient experienced pain behind ear (generalized pain). On OCT-2021, the patient experienced swelling in head and behind ear. On OCT-2021, the patient experienced pressure behind eye. On OCT-2021, the patient experienced pressure behind ear. On OCT-2021, the patient experienced rash on scalp and forehead. On OCT-2021, the patient experienced headache on left side of head (back of head general pain). On OCT-2021, the patient experienced generalized fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the disrupted sleep (10 days), shortness of breath, chest pain, headache on left side of head (back of head general pain), generalized fatigue, pain behind ear (generalized pain), swelling in head and behind ear, pressure behind eye, rash on scalp and forehead and pressure behind ear was not reported. This report was non-serious. This case, from the same reporter is linked to 20211059166.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site oedema
Clinical narrative: edema in his left arm where he got the shot in.; It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004PL1A and 040C21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus in 2000 and Enlarged prostate in 1999. Concurrent medical conditions included Allergy to antibiotic and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, DOXAZOSIN MESYLATE for Enlarged prostate, CANAGLIFLOZIN HEMIHYDRATE, METFORMIN HYDROCHLORIDE (INVOKANA DUO) and METFORMIN for Type 2 diabetes mellitus.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.). At the time of the report, VACCINATION SITE OEDEMA (edema in his left arm where he got the shot in.) and VACCINATION SITE MASS (It is a soft mass/rather large/frightening/it is shrinking but it is still not gone after a month.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient stated that Soft mass in Left Arm Tricep, not painful.  It has been 30 plus days. The lump has reduced in size but has not gone away.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Added patient demographics, other relevant history and concomitant medications, updated dose details.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Wheezing
Clinical narrative: Tightness of chest; Wheezing; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue). At the time of the report, CHEST DISCOMFORT (Tightness of chest), WHEEZING (Wheezing) and FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.   This case was linked to MOD-2021-359055 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years received  the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose). On 19-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years received  the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The expiration date was 13 Nov 2021. Patient had not exhibited any adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up was received and the  reporter details, patient demographics were updated.