chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Nausea, Pain in extremity, Peripheral swelling, Sinus congestion
Clinical narrative: ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: ROCKHARD TUMORS IN BREAST; CONGESTION; CANNOT STAND UP; DIZZINESS; SHAKING; SWELLING OF FEET; CANNOT EAT MUCH; SICK; CANNOT WALK; VOMITING; FALL; LEGS HURT; NO STRENGTH; TROUBLE HOLDING THINGS; HEADACHE; TIRED; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient stated that she had breast cancer before and undergone chemo radiation last year. she stated that her left breast is missing. She was on chemo radiation per three week. The patient stated that she had been through two rotator cuff surgeries with joints replacement and metal screws in 2011 and her concurrent conditions included non alcoholic, and non smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered 1 total on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced congestion, she was unable to stand and shaking up, she felt dizziness and fall. The patient also experienced swelling of her feet, she was not eating much and feeling sick, with difficulty in walking and was vomiting. She was not doing good as she noticed large rock-hard tumors had popped up in her breast after covid shot, her legs were crumbled, she had no strength and experienced trouble in holding things even had headache, felt tired and nauseous. The patient stated that she don't drive she don't use caffeine, her limb was crippled. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cannot stand up, dizziness, shaking, swelling of feet, legs hurt, headache, congestion, tired, cannot eat much, sick, nausea, no strength, trouble holding things, cannot walk, vomiting, rock-hard tumors in breast and fall was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521006- Covid-19 vaccine ad26.cov2.s-Rock hard tumors in breast. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination complication
Clinical narrative: REACTION TO COVID VACCINE; This spontaneous report received from a patient concerned a 45 year old female of unspecified race and ethnicity. The patient's weight was 88.2 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. The patient received epoprostenol sodium (form of admin unknown, intravenous, batch number: MM248M0101 expiry: 30-JUN-2022) 1.5 mg, frequency, and therapy dates were not reported for drug used for unknown indication. Concomitant medications included macitentan and warfarin for drug used for unknown indication.  On an unspecified date, the patient experienced reaction to covid vaccine, and was hospitalized on 07-MAY-2021. On an unspecified date, the patient died from reaction to covid vaccine. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of epoprostenol sodium was not changed. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210521894-COVID-19 VACCINE AD26.COV2.S-REACTION TO COVID VACCINE. This event(s) is considered not related. 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).; Reported Cause(s) of Death: REACTION TO COVID VACCINE
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dizziness, Electrocardiogram, Fatigue
Clinical narrative: BACK PAIN; PAIN IN LEFT SIDE OF CHEST; ARMS PAIN; BODY PAIN/EXCRUCIATING PAIN; FELT SO SICK; CHILLS; NAUSEA; TIREDNESS/EXHAUSTED; BURNING SENSATION ON RIGHT ARM; COLD AS INSIDE AN IGLOO; DIZZINESS; ABDOMINAL PAIN; PAIN IN THE BONES OF THE CHEST; BURNING SENSATION ON RIGHT ARM THAT EXTENDED TO ABDOMEN; SWEATING; HEAVINESS IN RIGHT ARM; TIGHTNESS ON THE RIGHT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 158 pounds, and height was 159 centimeters. The patient's concurrent conditions included hereditary condition called g6pd, type 2 diabetes, osteoporosis, allergy to sulfa based meds, allergy to soy, non smoker, non alcohol user, and tetracycline allergy, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported. On 2021, the subject experienced tightness on the right arm. On 2021, the subject experienced sweating. On 2021, the subject experienced heaviness in right arm. On 27-APR-2021, the subject experienced abdominal pain. On 27-APR-2021, the subject experienced pain in the bones of the chest. On 27-APR-2021, the subject experienced burning sensation on right arm that extended to abdomen. On 27-APR-2021, the subject experienced dizziness. On 27-APR-2021, the subject experienced cold as inside an igloo. On 27-APR-2021, the subject experienced felt so sick. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced nausea. On 27-APR-2021, the subject experienced tiredness/exhausted. On 27-APR-2021, the subject experienced burning sensation on right arm. On 10-MAY-2021, the subject experienced body pain/excruciating pain. On 11-MAY-2021, the subject experienced back pain. On 11-MAY-2021, the subject experienced pain in left side of chest. On 11-MAY-2021, the subject experienced arms pain. Laboratory data included: Chest X-ray (NR: not provided) Negative for heart attack, and ECG (NR: not provided) Negative for heart attack. Treatment medications (dates unspecified) included: ketorolac tromethamine, paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from abdominal pain, chills, pain in the bones of the chest, dizziness, tiredness/exhausted, nausea, body pain/excruciating pain, and cold as inside an igloo, and the outcome of burning sensation on right arm that extended to abdomen, felt so sick, pain in left side of chest, arms pain, heaviness in right arm, burning sensation on right arm, sweating, back pain and tightness on the right arm 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 considered non serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Nausea, Pain, Pain in extremity
Clinical narrative: BACK PAIN; PAIN IN LEFT SIDE OF CHEST; ARMS PAIN; BODY PAIN/EXCRUCIATING PAIN; FELT SO SICK; CHILLS; NAUSEA; TIREDNESS/EXHAUSTED; BURNING SENSATION ON RIGHT ARM; COLD AS INSIDE AN IGLOO; DIZZINESS; ABDOMINAL PAIN; PAIN IN THE BONES OF THE CHEST; BURNING SENSATION ON RIGHT ARM THAT EXTENDED TO ABDOMEN; SWEATING; HEAVINESS IN RIGHT ARM; TIGHTNESS ON THE RIGHT ARM; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight was 158 pounds, and height was 159 centimeters. The patient's concurrent conditions included hereditary condition called g6pd, type 2 diabetes, osteoporosis, allergy to sulfa based meds, allergy to soy, non smoker, non alcohol user, and tetracycline allergy, and other pre-existing medical conditions included there was no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with acetylsalicylic acid. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prevention of covid-19 disease. No concomitant medications were reported. On 2021, the subject experienced tightness on the right arm. On 2021, the subject experienced sweating. On 2021, the subject experienced heaviness in right arm. On 27-APR-2021, the subject experienced abdominal pain. On 27-APR-2021, the subject experienced pain in the bones of the chest. On 27-APR-2021, the subject experienced burning sensation on right arm that extended to abdomen. On 27-APR-2021, the subject experienced dizziness. On 27-APR-2021, the subject experienced cold as inside an igloo. On 27-APR-2021, the subject experienced felt so sick. On 27-APR-2021, the subject experienced chills. On 27-APR-2021, the subject experienced nausea. On 27-APR-2021, the subject experienced tiredness/exhausted. On 27-APR-2021, the subject experienced burning sensation on right arm. On 10-MAY-2021, the subject experienced body pain/excruciating pain. On 11-MAY-2021, the subject experienced back pain. On 11-MAY-2021, the subject experienced pain in left side of chest. On 11-MAY-2021, the subject experienced arms pain. Laboratory data included: Chest X-ray (NR: not provided) Negative for heart attack, and ECG (NR: not provided) Negative for heart attack. Treatment medications (dates unspecified) included: ketorolac tromethamine, paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from abdominal pain, chills, pain in the bones of the chest, dizziness, tiredness/exhausted, nausea, body pain/excruciating pain, and cold as inside an igloo, and the outcome of burning sensation on right arm that extended to abdomen, felt so sick, pain in left side of chest, arms pain, heaviness in right arm, burning sensation on right arm, sweating, back pain and tightness on the right arm 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 considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Mechanical ventilation
Clinical narrative: ON A VENTILATOR; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. 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 date: unknown) dose, start therapy date were not reported 1 in total administered 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, following vaccination, the patient was put on a ventilator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a ventilator was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210523218-covid-19 vaccine ad26.cov2.s -On a ventilator . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: LEGS WERE RUBBERY; TIRED FEELING FROM BOTTOM TO MY NECK/ARMS AND CHEST TIRED; HAD SHORTNESS OF BREATH; VERY LIGHT-HEADED/VERY DIZZY; FEEL BEAT UP; NO ENERGY; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, chronic bronchitis, macular degeneration, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 20UA21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included rivaroxaban for atrial fibrillation, atorvastatin, calcium carbonate/colecalciferol, diltiazem, dofetilide, ergocalciferol, and spironolactone.  On 2021, the subject experienced feel beat up. On 2021, the subject experienced no energy. On 29-APR-2021, the subject experienced very light-headed/very dizzy. On 30-APR-2021, the subject experienced legs were rubbery. On 30-APR-2021, the subject experienced tired feeling from bottom to my neck/arms and chest tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from very light-headed/very dizzy on 2021, and tired feeling from bottom to my neck/arms and chest tired on 05-MAY-2021, was recovering from feel beat up, and the outcome of legs were rubbery, no energy and had shortness of breath 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: Sensory disturbance
Clinical narrative: LEGS WERE RUBBERY; TIRED FEELING FROM BOTTOM TO MY NECK/ARMS AND CHEST TIRED; HAD SHORTNESS OF BREATH; VERY LIGHT-HEADED/VERY DIZZY; FEEL BEAT UP; NO ENERGY; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation, chronic bronchitis, macular degeneration, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 20UA21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included rivaroxaban for atrial fibrillation, atorvastatin, calcium carbonate/colecalciferol, diltiazem, dofetilide, ergocalciferol, and spironolactone.  On 2021, the subject experienced feel beat up. On 2021, the subject experienced no energy. On 29-APR-2021, the subject experienced very light-headed/very dizzy. On 30-APR-2021, the subject experienced legs were rubbery. On 30-APR-2021, the subject experienced tired feeling from bottom to my neck/arms and chest tired. The action taken with covid-19 vaccine was not applicable. The patient recovered from very light-headed/very dizzy on 2021, and tired feeling from bottom to my neck/arms and chest tired on 05-MAY-2021, was recovering from feel beat up, and the outcome of legs were rubbery, no energy and had shortness of breath 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Hot flush
Clinical narrative: FLUTTERING FEELING AROUND HEART; HOT FLASHES; This spontaneous report received from a patient concerned a 60 year old Not Hispanic or Latino African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, menopause and other pre-existing medical conditions included the patient had drug allergies. past unremarkable history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, 1 in total administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced hot flashes and On 07-APR-2021 experienced cardiac flutter and fast beating of heart. She stated hot flashes symptoms come and go and sometimes had this feeling after eating peppermint candy, unknown if she had peppermint candy before receiving the Janssen COVID-19 vaccine. Her medical doctor was not yet notified and she had not treated her symptoms with any over the counter medications. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes and cardiac flutter. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210523500-Covid-19 vaccine ad26.cov2.s -Fluttering feeling around heart. 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: Abdominal pain, Abdominal pain upper, Constipation, Dyschezia
Clinical narrative: CONSTIPATION; STOMACH CRAMPS; ABDOMINAL PAIN; TROUBLE DEFECATING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto's disease. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 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 2021, the subject experienced trouble defecating. On 28-APR-2021, the subject experienced constipation. On 28-APR-2021, the subject experienced stomach cramps. On 28-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from stomach cramps, abdominal pain, and constipation, and the outcome of trouble defecating 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: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 50 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: Unknown) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Reporter stated that on 22-Apr-2021, patient took an antibody test (semi-quantitative spike protein test) post vaccination which came negative. On 10-May-2021, patient repeated antibody test which was also negative. On 22-APR-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On 10-MAY-2021, Laboratory data included: Antibody test (NR: not provided) Negative. 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: 20210524105-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: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Neuralgia, Neuritis, Vomiting
Clinical narrative: NEURALGIA; NEURITIS; VOMITING; DIZZINESS; HEADACHE; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: XD955 and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced headache. On 11-MAY-2021, the subject experienced neuralgia. On 11-MAY-2021, the subject experienced neuritis. On 11-MAY-2021, the subject experienced vomiting. On 11-MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache, vomiting, dizziness, neuralgia and neuritis 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.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: GIVEN EXPIRED DOSE OF VACCINATION; This spontaneous report received from a pharmacist concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced given expired dose of vaccination. The action taken with covid-19 vaccine  was not applicable. The outcome of the given expired dose of vaccination was not reported. This report was non-serious.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: GIVEN EXPIRED DOSE OF VACCINATION; This spontaneous report received from a pharmacist concerned a 57 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 04-JUL-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced given expired dose of vaccination. The action taken with covid-19 vaccine  was not applicable. The outcome of the given expired dose of vaccination was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fall
Clinical narrative: PATIENT FELL AT HOME AFTER VACCINATION; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 70.5 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) 10 mg, every 1 day, frequency, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: ZE019B0101) dose, start therapy date were not reported, for prophylactic vaccination. Concomitant medications included riociguat. On an unspecified date, the subject experienced subject fell at home after vaccination. The action taken with covid-19 vaccine was not applicable; and dose of macitentan was not changed. The outcome of patient fell at home after vaccination was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Hypokinesia
Clinical narrative: BELLS PALSY; INDEX AND MIDDLE  FINGER NOT FUNCTIONING / BENDING PROPERLY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-MAY-2021, the patient experienced index and middle finger not functioning and not bending properly. On 07-MAY-2021, the patient experienced loss of facial muscle activity, loss of mouth muscle activity (Bells palsy) and was unable to suck on a straw. No medications were taken at that time. Patient consulted a health care provider who refereed a neurologist. The neurologists after seeing also referred the patient to the emergency department to get a computed tomography scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy, and index and middle finger not functioning / bending properly. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210527130- Covid-19 vaccine ad26.cov2.s-Bell's palsy. 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: Chills, Fatigue, Myalgia
Clinical narrative: CHILLS; WIPED OUT FOR TWO DAYS; WOKE UP WITH MUSCLE ACHE FROM ALL SHIVERING; 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  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, wiped out for two days, and woke up with muscle ache from all shivering. The action taken with covid-19 vaccine  was not applicable. The outcome of the wiped out for two days, chills and woke up with muscle ache from all shivering was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Migraine, Pyrexia
Clinical narrative: MIGRAINE; BAD COLD UNCONTROLLABLE CHILLS; FEVER OF 101.7; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient never had a positive covid-19 test but the whole family was sick in JAN-2020 and had all the symptoms of covid-19.The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced migraine. On 13-MAY-2021, the subject experienced bad cold uncontrollable chills. On 13-MAY-2021, the subject experienced fever of 101.7. On 13-MAY-2021 19:30, Laboratory data included: Body temperature (NR: not provided) 101.7 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from migraine, and fever of 101.7 on 15-MAY-2021, and the outcome of bad cold uncontrollable chills 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 as non serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; MIGRAINE HEADACHE; FEVER; EXTREME FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 56 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAY-2021, the subject experienced body ache. On 07-MAY-2021, the subject experienced migraine headache. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced extreme fatigue. On 07-MAY-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAY-2021, had not recovered from fever, extreme fatigue, and body ache, and the outcome of migraine headache was not reported. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Headache, Hypoaesthesia oral, Insomnia
Clinical narrative: LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN'T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn't sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn't sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Neck pain, Odynophagia, Pharyngeal swelling, Swelling
Clinical narrative: LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN'T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn't sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn't sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Pain, Peripheral swelling
Clinical narrative: SWELLING OF LEFT ARM; LEFT SIDE CHEST BROKEN VEIN; LYMPH GLAND CLOSEST TO VACCINE SWELLED UP; SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, dermatomyositis, antisynthetase syndrome, interstitial lung disease, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any known drug history. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced soreness. On 12-MAY-2021, the subject experienced lymph gland closest to vaccine swelled up. On 13-MAY-2021, the subject experienced left side chest broken vein. On 16-MAY-2021, the subject experienced swelling of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, lymph gland closest to vaccine swelled up, left side chest broken vein, and swelling of left arm. 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pain, Headache, Oropharyngeal pain
Clinical narrative: SORE THROAT; PINK EYE; HEADACHE; RIGHT EYE PAIN; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, and non alcohol consumer, 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: Unk) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. The Batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced right eye pain. On 14-MAY-2021, the subject experienced sore throat. On 14-MAY-2021, the subject experienced pink eye. On 14-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right eye pain, sore throat, and headache, and the outcome of pink eye was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vein discolouration
Clinical narrative: VEIN WAS TURNING PURPLE APPEARING BLACK AND DARK (BLACK GROWTH ON THE WRIST); RAISED SMALL BUMPS ON LEFT WRIST; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's 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: 042B21A, expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced raised small bumps on left wrist. On 10-MAY-2021, the subject experienced vein was turning purple appearing black and dark. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein was turning purple appearing black and dark, and the outcome of raised small bumps on left wrist was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 20 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: 201a21a, expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210530455.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain in extremity
Clinical narrative: PAIN IN NECK; JOINT PAIN/ MIDDLE FINGER JOINT PAIN; PAIN IN BOTH CHINS,SHOULDER, FOREARMS AND HANDS; PAIN IN BOTH ANKLES; HEADACHE; This spontaneous report received from a patient via a company representative concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included chin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, the subject experienced pain in neck. On 2021, the subject experienced joint pain/ middle finger joint pain. On 2021, the subject experienced pain in both chins, shoulder, forearms and hands. On 2021, the subject experienced pain in both ankles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain/ middle finger joint pain, pain in neck, pain in both ankles, pain in both chins, shoulder, forearms and hands, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Feeling abnormal, Headache, Insomnia
Clinical narrative: FEELS WORSE; FEELING AWFUL; FEELING SICK; CHILLS; NAUSEA; HEADACHE; BODY ACHES; DID NOT SLEEP WELL; This spontaneous report received from a consumer 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 14-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body aches. On 14-MAY-2021, the subject experienced did not sleep well. On 14-MAY-2021, the subject experienced feeling sick. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced feels worse. On 15-MAY-2021, the subject experienced feeling awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, body aches, headache, nausea, chills, did not sleep well, and feels worse, and the outcome of feeling awful was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain
Clinical narrative: FEELS WORSE; FEELING AWFUL; FEELING SICK; CHILLS; NAUSEA; HEADACHE; BODY ACHES; DID NOT SLEEP WELL; This spontaneous report received from a consumer 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 14-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body aches. On 14-MAY-2021, the subject experienced did not sleep well. On 14-MAY-2021, the subject experienced feeling sick. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced feels worse. On 15-MAY-2021, the subject experienced feeling awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, body aches, headache, nausea, chills, did not sleep well, and feels worse, and the outcome of feeling awful was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product label issue
Clinical narrative: PACKAGE INSERT IS BLANK ON BOTH SIDES; This spontaneous report received from a patient concerned a 53 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, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced package insert is blank on both sides. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from package insert is blank on both sides. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Chills, Headache, Nausea
Clinical narrative: BODY ACHE; ARMPIT PAIN; ARMPIT SWELLING; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 150 pounds, and height was 168 centimeters. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body ache. On 14-MAY-2021, the subject experienced armpit pain. On 14-MAY-2021, the subject experienced armpit swelling. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 degree F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, nausea, headache, and fever on 14-MAY-2021, and was recovering from armpit pain, and armpit swelling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: BODY ACHE; ARMPIT PAIN; ARMPIT SWELLING; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 150 pounds, and height was 168 centimeters. The patient's concurrent conditions included alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, drug abuse/illicit drug use. the patient was not pregnant at the time of reporting. no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body ache. On 14-MAY-2021, the subject experienced armpit pain. On 14-MAY-2021, the subject experienced armpit swelling. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 14-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.8 degree F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, nausea, headache, and fever on 14-MAY-2021, and was recovering from armpit pain, and armpit swelling. This report was non-serious.