chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dry eye, Eyelid ptosis, Fatigue, Feeling abnormal, Gastrointestinal sounds abnormal
Clinical narrative: HEAD PRESSURE; HEART PALPITATIONS; FEELING OF A RUSH TO THE HEAD AFTER EATING; DRY EYES; RINGING IN THE EARS; MYALGIA; GI ISSUES LIKE BUBBLING STOMACH; FATIGUE; STIFFNESS IN THE NECK/ MUSCLE TIGHTNESS IN THE JAW; DROOPING RIGHT EYE LID; CHEST PRESSURE; ANXIETY; DIZZINESS AFTER GOING FOR A WALK; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. 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 batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness after going for a walk. On 2021, the subject experienced anxiety. On 2021, the subject experienced headache. On APR-2021, the subject experienced drooping right eye lid. On APR-2021, the subject experienced chest pressure. On APR-2021, the subject experienced stiffness in the neck/ muscle tightness in the jaw. Laboratory data included: Blood test (NR: not provided) NOT REPORTED. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced gi issues like bubbling stomach. On 09-APR-2021, the subject experienced myalgia. On 18-APR-2021, Laboratory data included: Blood test (NR: not provided) did not find any specific signs causing his symptoms, and CT scan (NR: not provided) did not find any specific signs causing his symptoms. On 25-APR-2021, the subject experienced ringing in the ears. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) also found nothing unusual. On an unspecified date, the subject experienced head pressure, heart palpitations, feeling of a rush to the head after eating, and dry eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from gi issues like bubbling stomach, feeling of a rush to the head after eating, and dizziness after going for a walk, had not recovered from fatigue, myalgia, head pressure, heart palpitations, chest pressure, anxiety, and ringing in the ears, and the outcome of dry eyes, stiffness in the neck/ muscle tightness in the jaw, drooping right eye lid and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Musculoskeletal stiffness, Myalgia, Palpitations
Clinical narrative: HEAD PRESSURE; HEART PALPITATIONS; FEELING OF A RUSH TO THE HEAD AFTER EATING; DRY EYES; RINGING IN THE EARS; MYALGIA; GI ISSUES LIKE BUBBLING STOMACH; FATIGUE; STIFFNESS IN THE NECK/ MUSCLE TIGHTNESS IN THE JAW; DROOPING RIGHT EYE LID; CHEST PRESSURE; ANXIETY; DIZZINESS AFTER GOING FOR A WALK; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. 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 batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness after going for a walk. On 2021, the subject experienced anxiety. On 2021, the subject experienced headache. On APR-2021, the subject experienced drooping right eye lid. On APR-2021, the subject experienced chest pressure. On APR-2021, the subject experienced stiffness in the neck/ muscle tightness in the jaw. Laboratory data included: Blood test (NR: not provided) NOT REPORTED. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced gi issues like bubbling stomach. On 09-APR-2021, the subject experienced myalgia. On 18-APR-2021, Laboratory data included: Blood test (NR: not provided) did not find any specific signs causing his symptoms, and CT scan (NR: not provided) did not find any specific signs causing his symptoms. On 25-APR-2021, the subject experienced ringing in the ears. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) also found nothing unusual. On an unspecified date, the subject experienced head pressure, heart palpitations, feeling of a rush to the head after eating, and dry eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from gi issues like bubbling stomach, feeling of a rush to the head after eating, and dizziness after going for a walk, had not recovered from fatigue, myalgia, head pressure, heart palpitations, chest pressure, anxiety, and ringing in the ears, and the outcome of dry eyes, stiffness in the neck/ muscle tightness in the jaw, drooping right eye lid and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: HEAD PRESSURE; HEART PALPITATIONS; FEELING OF A RUSH TO THE HEAD AFTER EATING; DRY EYES; RINGING IN THE EARS; MYALGIA; GI ISSUES LIKE BUBBLING STOMACH; FATIGUE; STIFFNESS IN THE NECK/ MUSCLE TIGHTNESS IN THE JAW; DROOPING RIGHT EYE LID; CHEST PRESSURE; ANXIETY; DIZZINESS AFTER GOING FOR A WALK; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. 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 batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness after going for a walk. On 2021, the subject experienced anxiety. On 2021, the subject experienced headache. On APR-2021, the subject experienced drooping right eye lid. On APR-2021, the subject experienced chest pressure. On APR-2021, the subject experienced stiffness in the neck/ muscle tightness in the jaw. Laboratory data included: Blood test (NR: not provided) NOT REPORTED. On 07-APR-2021, the subject experienced fatigue. On 08-APR-2021, the subject experienced gi issues like bubbling stomach. On 09-APR-2021, the subject experienced myalgia. On 18-APR-2021, Laboratory data included: Blood test (NR: not provided) did not find any specific signs causing his symptoms, and CT scan (NR: not provided) did not find any specific signs causing his symptoms. On 25-APR-2021, the subject experienced ringing in the ears. On 26-APR-2021, Laboratory data included: Blood test (NR: not provided) also found nothing unusual. On an unspecified date, the subject experienced head pressure, heart palpitations, feeling of a rush to the head after eating, and dry eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from gi issues like bubbling stomach, feeling of a rush to the head after eating, and dizziness after going for a walk, had not recovered from fatigue, myalgia, head pressure, heart palpitations, chest pressure, anxiety, and ringing in the ears, and the outcome of dry eyes, stiffness in the neck/ muscle tightness in the jaw, drooping right eye lid and headache was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This spontaneous report received from a consumer via a company representative 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 admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient died from blood clot. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0. 20210514012-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).; Reported Cause(s) of Death: BLOOD CLOT
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS IN LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, start therapy date were not reported 1 total for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On an unspecified date, on 2021, the patient experienced blood clots in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in legs. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210515265-covid-19 vaccine ad26.cov2.s-thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Hypoaesthesia, Muscle spasms, Muscular weakness
Clinical narrative: THROMBOSIS IN RIGHT HAND MIDDLE FINGER KNUCKLE; RIGHT ARM AND HAND COLD; RIGHT ARM AND HAND NUMB,LEFT HAND NUMB; WEAK LEFT HAND AND WEAK LEGS; CRAMP IN INNER MIDDLE FOOT LEFT FOOT; PAIN ALL OVER BODY; CHILLS; FEVER; HAND AND LEG STIFFNESS,STIFF NECK; RED/BLUE BRUISE; This spontaneous report received from a patient concerned a 38 year old white and Hispanic or Latino 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 and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced red/blue bruise. On 03-MAY-2021, the patient experienced pain all over body, hand and leg stiffness for 10 minutes, stiff neck, chills and fever. On 04-MAY-2021, the patient experienced cramp in inner middle foot left foot. On 09-MAY-2021, the patient experienced thrombosis in right hand middle finger knuckle, right arm and hand cold, right arm and hand numb, left hand numb and weak left hand and weak legs.  Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramp in inner middle foot left foot on 04-MAY-2021, pain all over body on MAY-2021, and chills, and fever on 03-MAY-2021, was recovering from right arm and hand cold, right arm and hand numb, left hand numb, and weak left hand and weak legs, had not recovered from thrombosis in right hand middle finger knuckle, and hand and leg stiffness, stiff neck, and the outcome of red/blue bruise was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516231-covid-19 vaccine ad26.cov2.s - thrombosis in right hand middle finger in Hispanic or Latino patient. 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Peripheral coldness, Pyrexia, Thrombosis
Clinical narrative: THROMBOSIS IN RIGHT HAND MIDDLE FINGER KNUCKLE; RIGHT ARM AND HAND COLD; RIGHT ARM AND HAND NUMB,LEFT HAND NUMB; WEAK LEFT HAND AND WEAK LEGS; CRAMP IN INNER MIDDLE FOOT LEFT FOOT; PAIN ALL OVER BODY; CHILLS; FEVER; HAND AND LEG STIFFNESS,STIFF NECK; RED/BLUE BRUISE; This spontaneous report received from a patient concerned a 38 year old white and Hispanic or Latino 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 and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the patient experienced red/blue bruise. On 03-MAY-2021, the patient experienced pain all over body, hand and leg stiffness for 10 minutes, stiff neck, chills and fever. On 04-MAY-2021, the patient experienced cramp in inner middle foot left foot. On 09-MAY-2021, the patient experienced thrombosis in right hand middle finger knuckle, right arm and hand cold, right arm and hand numb, left hand numb and weak left hand and weak legs.  Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramp in inner middle foot left foot on 04-MAY-2021, pain all over body on MAY-2021, and chills, and fever on 03-MAY-2021, was recovering from right arm and hand cold, right arm and hand numb, left hand numb, and weak left hand and weak legs, had not recovered from thrombosis in right hand middle finger knuckle, and hand and leg stiffness, stiff neck, and the outcome of red/blue bruise was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516231-covid-19 vaccine ad26.cov2.s - thrombosis in right hand middle finger in Hispanic or Latino patient. 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old white Not Hispanic or Latino female. The patient's height, and weight were not reported. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 08-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient had an antibody test with the SARS-COV-2 IgM and IgG  which showed no antibodies. On 08-MAY-2021, the patient had an antibody test with the SARS-COV-2 IgM and IgG which showed no antibodies (confirmed immunological vaccine failure). It was reported that, the bars for IgG and IgM did not appear and only the control bar lit up and the patient discovered that the test kit expired on 29-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516298-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED AFTER COMPLICATION FROM THE JOHNSON AND JOHNSON COVID-19 VACCINE; This spontaneous report received from a patient via a company representative 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 admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the patient died after complication from the Johnson & Johnson COVID-19 vaccine. The cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0;20210516437-covid-19 vaccine ad26.cov2.-Died after complication from the Johnson & Johnson COVID-19 vaccine. 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.; Reported Cause(s) of Death: DIED
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Nausea, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: SWOLLEN FACE; RASH WENT DOWN THE BODY TO THE KNEES; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: amoxicillin/clavulanic acid ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On APR-2021, the subject experienced rash went down the body to the knees. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. Laboratory data included: Blood test (NR: not provided) High inflammatory markers present (markers unspecified), and COVID-19 virus test (NR: not provided) Negative. On 11-APR-2021, the subject experienced swollen face. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash went down the body to the knees, and swollen face, and the outcome of nausea and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Swelling face
Clinical narrative: SWOLLEN FACE; RASH WENT DOWN THE BODY TO THE KNEES; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: amoxicillin/clavulanic acid ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On APR-2021, the subject experienced rash went down the body to the knees. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. Laboratory data included: Blood test (NR: not provided) High inflammatory markers present (markers unspecified), and COVID-19 virus test (NR: not provided) Negative. On 11-APR-2021, the subject experienced swollen face. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash went down the body to the knees, and swollen face, and the outcome of nausea and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: NOT FEELING WELL; 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 ustekinumab (form of admin and route of admin were not reported, batch number: Unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. 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 Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ustekinumab was not reported. The patient was recovering from not feeling well. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Mean platelet volume increased, Thrombosis
Clinical narrative: CLOTTING; MPV IS HIGH; This spontaneous report received from a patient via a company representative concerned to patient of unspecified age and gender with unknown race and ethnicity. The patient's weight, height, and medical history were not reported. Patient reported that last year Mean Platelet Volume MPV was in the normal range.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the patient performed yearly bloodwork and physical test which showed Mean Platelet Volume (MPV) was high and it lead to clotting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the MPV was high and clotting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210517660-covid-19 vaccine ad26.cov2-MPV was high and clotting. This 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: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Feeling hot, Headache, Hypervigilance
Clinical narrative: PAIN IN BASE OF SKULL/NECK; COUGHED UP MUCUS; FELT HOT; ACHY BACK AND SHOULDERS; FELT LIKE SINUS INFECTION AROUND MY EYES/FOREHEAD; FELT SICK, UNWELL; HEADACHE; NAUSEA ON AND OFF; BODY TEMPERATURE OF 97.6F; A LITTLE STUFFINESS; EXTRA AWARE FEELING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anaphylactic to bee stings, and allergy to pollen. 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 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced extra aware feeling. On 28-APR-2021, the subject experienced a little stuffiness. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.6 F. On 04-MAY-2021, the subject experienced pain in base of skull/neck. On 04-MAY-2021, the subject experienced coughed up mucus. On 04-MAY-2021, the subject experienced felt hot. On 04-MAY-2021, the subject experienced achy back and shoulders. On 04-MAY-2021, the subject experienced felt like sinus infection around my eyes/forehead. On 04-MAY-2021, the subject experienced felt sick, unwell. On 04-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced nausea on and off. On 04-MAY-2021, the subject experienced body temperature of 97.6f. Treatment medications (dates unspecified) included: arnica montana, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra aware feeling on 27-APR-2021, a little stuffiness on 29-APR-2021, and coughed up mucus on 05-MAY-2021, was recovering from felt sick, unwell, headache, pain in base of skull/neck, nausea on and off, achy back and shoulders, and felt like sinus infection around my eyes/forehead, and the outcome of felt hot and body temperature of 97.6f was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Nausea, Neck pain, Pain
Clinical narrative: PAIN IN BASE OF SKULL/NECK; COUGHED UP MUCUS; FELT HOT; ACHY BACK AND SHOULDERS; FELT LIKE SINUS INFECTION AROUND MY EYES/FOREHEAD; FELT SICK, UNWELL; HEADACHE; NAUSEA ON AND OFF; BODY TEMPERATURE OF 97.6F; A LITTLE STUFFINESS; EXTRA AWARE FEELING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anaphylactic to bee stings, and allergy to pollen. 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 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced extra aware feeling. On 28-APR-2021, the subject experienced a little stuffiness. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.6 F. On 04-MAY-2021, the subject experienced pain in base of skull/neck. On 04-MAY-2021, the subject experienced coughed up mucus. On 04-MAY-2021, the subject experienced felt hot. On 04-MAY-2021, the subject experienced achy back and shoulders. On 04-MAY-2021, the subject experienced felt like sinus infection around my eyes/forehead. On 04-MAY-2021, the subject experienced felt sick, unwell. On 04-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced nausea on and off. On 04-MAY-2021, the subject experienced body temperature of 97.6f. Treatment medications (dates unspecified) included: arnica montana, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra aware feeling on 27-APR-2021, a little stuffiness on 29-APR-2021, and coughed up mucus on 05-MAY-2021, was recovering from felt sick, unwell, headache, pain in base of skull/neck, nausea on and off, achy back and shoulders, and felt like sinus infection around my eyes/forehead, and the outcome of felt hot and body temperature of 97.6f was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Sinusitis
Clinical narrative: PAIN IN BASE OF SKULL/NECK; COUGHED UP MUCUS; FELT HOT; ACHY BACK AND SHOULDERS; FELT LIKE SINUS INFECTION AROUND MY EYES/FOREHEAD; FELT SICK, UNWELL; HEADACHE; NAUSEA ON AND OFF; BODY TEMPERATURE OF 97.6F; A LITTLE STUFFINESS; EXTRA AWARE FEELING; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anaphylactic to bee stings, and allergy to pollen. 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 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced extra aware feeling. On 28-APR-2021, the subject experienced a little stuffiness. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.6 F. On 04-MAY-2021, the subject experienced pain in base of skull/neck. On 04-MAY-2021, the subject experienced coughed up mucus. On 04-MAY-2021, the subject experienced felt hot. On 04-MAY-2021, the subject experienced achy back and shoulders. On 04-MAY-2021, the subject experienced felt like sinus infection around my eyes/forehead. On 04-MAY-2021, the subject experienced felt sick, unwell. On 04-MAY-2021, the subject experienced headache. On 04-MAY-2021, the subject experienced nausea on and off. On 04-MAY-2021, the subject experienced body temperature of 97.6f. Treatment medications (dates unspecified) included: arnica montana, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extra aware feeling on 27-APR-2021, a little stuffiness on 29-APR-2021, and coughed up mucus on 05-MAY-2021, was recovering from felt sick, unwell, headache, pain in base of skull/neck, nausea on and off, achy back and shoulders, and felt like sinus infection around my eyes/forehead, and the outcome of felt hot and body temperature of 97.6f was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: INCOMPLETE DOSE ADMINISTERED; NEEDLE FAILURE; This spontaneous report received from a pharmacist . 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) 0.1 ml, administered on 11-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAY-2021, the subject experienced incomplete dose administered. On 11-MAY-2021, the subject experienced needle failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incomplete dose administered and needle failure was not reported. This report was non-serious.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 09-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 10-APR-2021, the subject experienced confirmed covid-19 infection. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive. On 12-APR-2021, Laboratory data included: COVID-19 molecular test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: VACCINATION FAILURE; POSITIVE COVID-19 TEST RESULT; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hashimotos ,Allergic to antibiotics allergy, socially alcohol user, and non-smoker. On 26-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported,1 total administered  possibly on left arm for prophylactic vaccination. Concomitant medications included levothyroxine sodium/ Synthroid 125 mcg for thyroid, pantoprazole sodium sesquihydrate, and pravastatin sodium/ Pravacol. On 09-May-2021 or 10-May-2021, the patient was unsure about the exact date of symptom onset, since symptom onset coincided with allergy season, the patient experienced shortness of breath and extreme tiredness. On 12-MAY-2021, the patient tested positive for Covid-19 on 15 minute rapid test ( Binax 15 minute rapid test).  The patient reported that she did not had any reaction or side effects post vaccination. The patient questioned if her lack of reaction post vaccination was  correlated to reduced effectiveness of the vaccine. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the positive covid-19 test result and vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210523305-covid-19 vaccine ad26.cov2- vaccination failure. 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: SPECIAL SITUATIONS
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: EXHAUSTED; ACHY; LOW GRADE FEVER; This spontaneous report received from a parent concerned a 27 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: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-APR-2021, the subject experienced achy. On 30-APR-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) Around 99.9. On 01-MAY-2021, the subject experienced exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and low grade fever on 02-MAY-2021, and had not recovered from exhausted. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE WAS GIVEN 2.5 HOURS AFTER IT WAS DRAWN IN A SYRINGE AND KEPT AT ROOM TEMPERATURE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: Unk) dose was not reported, administered on 12-MAY-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 12-MAY-2021, the subject experienced vaccine was given 2.5 hours after it was drawn in a syringe and kept at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was given 2.5 hours after it was drawn in a syringe and kept at room temperature was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rheumatoid arthritis
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis since an unknown date. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE for an unknown indication.   In September 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MYALGIA (body aches). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) (seriousness criterion medically significant). On 30-Mar-2021, MYALGIA (body aches) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthristis flare up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other relevant history included no tobacco use and alcohol use. Laboratory data for lab test and blood work included unknown. Treatment for the events were not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Coronavirus test
Clinical narrative: patient got pneumonia and was tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (patient got pneumonia and was tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Overweight.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 PNEUMONIA (patient got pneumonia and was tested positive for covid) (seriousness criterion hospitalization). At the time of the report, COVID-19 PNEUMONIA (patient got pneumonia and was tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Coronavirus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.  She went to get the Moderna vaccine about 3 weeks ago.  About 4 days after her shot, she got pneumonia.  She was rushed to the hospital.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury
Clinical narrative: Acute kidney failure, unspecified
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Acute kidney injury, Hyponatraemia, Hypoosmolar state
Clinical narrative: Hypo-osmolality and hyponatremia Acute kidney failure, unspecified abdominal pain
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Approximately 3 days after 1st shot I became ill and was diagnosed with Shingles  due to small rash on arm. Several days before my 2nd shot I felt much better and assumed the Shingles bout was over. Then, 3 days after 2nd shot I once again got ill with Shingles and that bout lasted 6 weeks. I have since encountered two other individuals who had the same experience.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury
Clinical narrative: N17.9 - Acute kidney failure, unspecified
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Hypersensitivity
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Additional Details: GAVE WATER AFTER PATIENT EXPERIENCED DIZZINESS-PT WAS DEHYDRATED. PATIENT RECOVERED SHORTLY AFTER RECEIVING WATER. WE HAD PATIENT WAIT FOR ANOTHER 15 MINUTES AFTER INITIALLY DRINKING WATER.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Muscle spasms, Wheezing
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Diarrhea-Medium, Systemic: Weakness-Medium, Additional Details: Pt also reported shortness of breath, wheezing and muscle cramps
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: red inflamed sore at injection site. lasted a week. applied ice pack.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Mild, Additional Details: Patient started experiencing lymph node swelling (" knot" - as per patient)on left collar bone  05/07/21 . The patient still feels the 'knot" but is not limiting patient from performing daily activities. Recommended patient to contact primary physician to make a shared clinical decision on receiving second dose . Patient is also given contact info for moderna
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient has a known history of allergic reactions to vaccines (delayed onset after the vaccine has been given). Patient was watched/monitored for 30 minutes on 5/4/21 with no signs/symptoms of an adverse reaction. Patient presented on 5/13 with a large rash around the injection site 10 days after administration.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: chills tired ache headache
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Nausea, Pyrexia, Rash
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Fever-Medium, Systemic: Nausea-Medium, Additional Details: pt experienced fever , rash ,and nausea
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: Decreased appetite, Diarrhoea, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative
Clinical narrative: Reported fever tmax 104 degrees (F) within 30 hours of receiving his 6 month vaccines. Also diarrhea, decreased oral intake. He was seen in local emergency department on 5/11/21. He was then seen in pediatric clinic on 5/13/21, diagnosed with otitis media then. He is improving, not fully recovered yet, still had fever.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Reported fever tmax 104 degrees (F) within 30 hours of receiving his 6 month vaccines. Also diarrhea, decreased oral intake. He was seen in local emergency department on 5/11/21. He was then seen in pediatric clinic on 5/13/21, diagnosed with otitis media then. He is improving, not fully recovered yet, still had fever.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Mild
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Mild
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram ambulatory, Gait inability, Magnetic resonance imaging, Pyrexia
Clinical narrative: chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Tinnitus, Vertigo, Vestibular disorder, Vestibular function test
Clinical narrative: chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: chills/fever/spinning/dizzy/dropped at work so left and went to urgent care where they did a rapid covid test which was neg/ said to go to the ER/ I waited until next day when I seem to get worse ans ended up in the Emergency room having a hard time breathing/vomiting/dizzy/and couldnt even walk/after several test and keeping me overnight, i was diagnosed with vertigo and came home the tinnitus began and i still have i was sent home on meclizine and zofran.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, headache, fever, aches
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever and fatigue the evening of the vaccine. The next morning seemed fine. By 2pm the next day began to feel tired. By 2:30pm fever and fatigue returned.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: Systemic: Extreme pain in left leg (8 on pain scale), starting 1 week after shot, limited mobility due to pain in limb. Pain began to subside in about another week and then numbness from the knee to thigh began-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: Pt has had a hx of surgery in left arm, no arm problems after shot. 1 week s/p vaccine extreme pain in left leg began, limiting mobility. Pain brokethu APAP extra stregnth, and cycles of icing/heating/elevation. 1 week after pain sx, pain began to subside but numbness from the knee and thigh began. Pt is following up with her orthopedic MD. Pt states there has been no preceding injury in the leg.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19 on 05/13/2021
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt recovered after a few minutes of sweating and feeling nauseous.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Shakiness-Medium