chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vomiting
Clinical narrative: RANDOM VAGINAL SPOTTING; SWOLLEN LIP; NAUSEA; VOMITING (THREW UP TWICE); FELT "FUZZY"; CHILLS; FEVER; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. The patient's past medical history included nausea, and vomiting, and concurrent conditions included acne, and allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included spironolactone for acne, and cetirizine hydrochloride for allergies. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced felt "fuzzy". On 11-APR-2021, the subject experienced vomiting (threw up twice). On 11-APR-2021, the subject experienced nausea. On 12-APR-2021, the subject experienced swollen lip. On 13-APR-2021, the subject experienced random vaginal spotting. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt "fuzzy", vomiting (threw up twice), and nausea on 11-APR-2021, swollen lip on 12-APR-2021, and chills, and fever on 10-APR-2021, and had not recovered from random vaginal spotting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Disturbance in attention, Fatigue
Clinical narrative: DIFFICULTY IN CONCENTRATING; EXHAUSTED/FATIGUE; INJECTION SITE PAIN; NAUSEA; CHILLS; LOST SENSE OF SMELL; LOST SENSE OF TASTE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced lost sense of smell. On 11-APR-2021, the subject experienced lost sense of taste. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced difficulty in concentrating. On 14-APR-2021, the subject experienced exhausted/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea, had not recovered from lost sense of smell, lost sense of taste, difficulty in concentrating, and exhausted/fatigue, and the outcome of injection site pain was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea
Clinical narrative: DIFFICULTY IN CONCENTRATING; EXHAUSTED/FATIGUE; INJECTION SITE PAIN; NAUSEA; CHILLS; LOST SENSE OF SMELL; LOST SENSE OF TASTE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced lost sense of smell. On 11-APR-2021, the subject experienced lost sense of taste. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced injection site pain. On 11-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced difficulty in concentrating. On 14-APR-2021, the subject experienced exhausted/fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea, had not recovered from lost sense of smell, lost sense of taste, difficulty in concentrating, and exhausted/fatigue, and the outcome of injection site pain was not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nausea
Clinical narrative: FOGGY FEELING IN HEAD; FATIGUE; NAUSEA; 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 sulfonamide allergy, non smoker, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced foggy feeling in head. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, nausea, and foggy feeling in head. This report was non-serious.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Lethargy, Malaise, Nausea, Vertigo
Clinical narrative: VERTIGO; LETHARGY; FEELING SICK; HEADACHE; NAUSEA; This spontaneous report received from a patient 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: prednisone ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 19-MAR-2021 for an unspecified indication. No concomitant medications were reported. On MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced lethargy. On MAR-2021, the subject experienced feeling sick. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with prednisone was not reported. The outcome of the headache, nausea, vertigo, lethargy and feeling sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Upper respiratory tract infection
Clinical narrative: UPPER RESPIRATORY INFECTION; MIGRAINE HEADACHES; EXTREME FATIGUE; 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 administration not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced upper respiratory infection, migraine headaches, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, and the outcome of migraine headaches and upper respiratory infection was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Migraine, Nausea
Clinical narrative: MIGRAINE; STOMACH PAIN; HEADACHE; NAUSEA; 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 APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced migraine. On APR-2021, the subject experienced stomach pain. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, headache, stomach pain and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: ASTHMA ATTACK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced asthma attack. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma attack on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZY AND LIGHTHEADEDNESS; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy and lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizzy and lightheadedness was not reported. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nasopharyngitis
Clinical narrative: COLD/MUCUS CONGESTION/COUGHING GREEN MUCUS/FEELING SICK/TIRED/NO ENERGY/SLUGGISH; MIGRAINE/SEVERE POUNDING HEADACHE; This spontaneous report received from a parent concerned a 24 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 and batch number: 1A05031 expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish. On 10-APR-2021, the subject experienced migraine/severe pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold/mucus congestion/coughing green mucus/feeling sick/tired/no energy/sluggish and migraine/severe pounding headache was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: LEG RASH; HEADACHE; This spontaneous report received from a patient concerned a 61 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: 042A27A, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included isosorbide. On 02-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced leg rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and leg rash. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: LUMP; This spontaneous report received from a consumer concerned multiple patients. 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-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced lump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lump was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Coagulopathy, Dizziness, Fatigue, Headache
Clinical narrative: CLOTTING DISORDER; CHILLS; HEADACHE; FEVER; FATIGUE; UNDESCRIBED RESPIRATORY RATE; DIZZINESS; This spontaneous report received from a parent 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced undescribed respiratory rate. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. Laboratory data included: Respiratory rate (NR: not provided) undescribed. On an unspecified date, the subject experienced clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, and undescribed respiratory rate, had not recovered from dizziness, and fatigue, and the outcome of clotting disorder was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Respiration abnormal, Respiratory rate
Clinical narrative: CLOTTING DISORDER; CHILLS; HEADACHE; FEVER; FATIGUE; UNDESCRIBED RESPIRATORY RATE; DIZZINESS; This spontaneous report received from a parent 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced undescribed respiratory rate. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced fatigue. Laboratory data included: Respiratory rate (NR: not provided) undescribed. On an unspecified date, the subject experienced clotting disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, and undescribed respiratory rate, had not recovered from dizziness, and fatigue, and the outcome of clotting disorder was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Head discomfort
Clinical narrative: TINGLING IN  LEFT CHEST; BLURRY; DIZZINESS; BRAIN FOG; PRESSURE AT TEMPLES; HEADACHES; FATIGUE; STRUGGLE AT WORK; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included concussion, and concurrent conditions included hypertension, and menopause.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included naproxen for hypertension. On 19-MAR-2021, the subject experienced struggle at work. On 19-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced pressure at temples. On APR-2021, the subject experienced brain fog. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 15-APR-2021, the subject experienced tingling in left chest. On 15-APR-2021, the subject experienced blurry. On 15-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left chest, blurry, and dizziness on APR-2021, had not recovered from headaches, and the outcome of chills, fatigue, pressure at temples, brain fog and struggle at work was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Paraesthesia, SARS-CoV-2 test, Vision blurred
Clinical narrative: TINGLING IN  LEFT CHEST; BLURRY; DIZZINESS; BRAIN FOG; PRESSURE AT TEMPLES; HEADACHES; FATIGUE; STRUGGLE AT WORK; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included concussion, and concurrent conditions included hypertension, and menopause.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. Concomitant medications included naproxen for hypertension. On 19-MAR-2021, the subject experienced struggle at work. On 19-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced headaches. On 20-MAR-2021, the subject experienced fatigue. On 21-MAR-2021, the subject experienced pressure at temples. On APR-2021, the subject experienced brain fog. On 08-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 13-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On 15-APR-2021, the subject experienced tingling in left chest. On 15-APR-2021, the subject experienced blurry. On 15-APR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in left chest, blurry, and dizziness on APR-2021, had not recovered from headaches, and the outcome of chills, fatigue, pressure at temples, brain fog and struggle at work was not reported. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; 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 penicillin allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with morphine. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-APR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Abdominal pain upper, Back pain, Pain in extremity
Clinical narrative: SEVERE STOMACH PAIN ALL THE WAY DOWN TO CROTCH WHEN SAT DOWN; LOWER BACK PAIN; ABDOMINAL PAIN; MILD STOMACH DISCOMFORT; LEFT LEG PAIN; 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 concurrent conditions included arthritis, and smoker. 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 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced severe stomach pain all the way down to crotch when sat down. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced abdominal pain. On APR-2021, the subject experienced mild stomach discomfort. On APR-2021, the subject experienced left leg pain. Treatment medications (dates unspecified) included: naproxen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe stomach pain all the way down to crotch when sat down, left leg pain, lower back pain, abdominal pain and mild stomach discomfort was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Injection site pain, Oedema, Peripheral swelling, Stool analysis
Clinical narrative: LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included no 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included no 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Electrocardiogram, Injection site pain, Pain, Palpitations
Clinical narrative: LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included no 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling, X-ray
Clinical narrative: LOWER EXTREMITY SWELLING; TACHYCARDIA; INJECTION SITE PAIN; EDEMA; This spontaneous report received from a patient concerned an 85 year old female. The patient's weight was 113 pounds, and height was 62 inches. The patient's concurrent conditions included ulcerative colitis, okra allergies, non smoker, and nonalcohol user, and other pre-existing medical conditions included no 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: Unk) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included infliximab for ulcerative colitis. On 2021, the subject experienced edema. On MAR-2021, Laboratory data included: Blood test (NR: not provided) not reported, and Stool analysis (NR: not provided) Abnormal high. On 18-MAR-2021, the subject experienced injection site pain. On 22-MAR-2021, the subject experienced tachycardia. On 01-APR-2021, the subject experienced lower extremity swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-APR-2021, was recovering from tachycardia, and lower extremity swelling, and the outcome of edema was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Muscle spasms, Myalgia
Clinical narrative: SPORADIC MUSCLE CRAMPING IN LEFT LEG; EXHAUSTION; FEVER 100.4; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 32 year old of unspecified 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced sporadic muscle cramping in left leg. On 12-APR-2021, the subject experienced exhaustion. On 12-APR-2021, the subject experienced fever 100.4. On 12-APR-2021, the subject experienced muscle ache. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion, fever 100.4, muscle ache, and headache on 12-APR-2021, and had not recovered from sporadic muscle cramping in left leg. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SPORADIC MUSCLE CRAMPING IN LEFT LEG; EXHAUSTION; FEVER 100.4; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 32 year old of unspecified 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: 043A21A, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the subject experienced sporadic muscle cramping in left leg. On 12-APR-2021, the subject experienced exhaustion. On 12-APR-2021, the subject experienced fever 100.4. On 12-APR-2021, the subject experienced muscle ache. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100.4 (unit not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion, fever 100.4, muscle ache, and headache on 12-APR-2021, and had not recovered from sporadic muscle cramping in left leg. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: NECK PAIN; ARM PAIN; LEFT SIDE BODY PAIN; HEADACHE; 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 diabetes, blood pressure, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: ibuprofen, and paracetamol. On 13-APR-2021, the subject experienced neck pain. On 13-APR-2021, the subject experienced arm pain. On 13-APR-2021, the subject experienced left side body pain. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, neck pain, arm pain, and left side body pain. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea exertional, Electrocardiogram, Erythema, Headache
Clinical narrative: CHEST PAIN/BURNING; FACE REDDENING; BLURRED VISION; SORE LEGS; HEADACHES; TROUBLE BREATHING AFTER DOING MANUAL LABOR/SHORTNESS OF BREATH; This spontaneous report received from a patient via a company representative concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and concurrent conditions included high blood pressure, and borderline diabetes, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing after doing manual labor/shortness of breath. On 10-APR-2021, the subject experienced face reddening. On 10-APR-2021, the subject experienced blurred vision. On 10-APR-2021, the subject experienced sore legs. On 10-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced chest pain/burning. Laboratory data included: EKG (NR: not provided) came out fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/burning on 13-APR-2021, and face reddening on 12-APR-2021, and was recovering from trouble breathing after doing manual labor/shortness of breath, headaches, sore legs, and blurred vision. This report was non-serious. This case is a duplicate. Additional information was received from patient on 15-APR-2021. It was determined that it was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: CHEST PAIN/BURNING; FACE REDDENING; BLURRED VISION; SORE LEGS; HEADACHES; TROUBLE BREATHING AFTER DOING MANUAL LABOR/SHORTNESS OF BREATH; This spontaneous report received from a patient via a company representative concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and concurrent conditions included high blood pressure, and borderline diabetes, and other pre-existing medical conditions included patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced trouble breathing after doing manual labor/shortness of breath. On 10-APR-2021, the subject experienced face reddening. On 10-APR-2021, the subject experienced blurred vision. On 10-APR-2021, the subject experienced sore legs. On 10-APR-2021, the subject experienced headaches. On 12-APR-2021, the subject experienced chest pain/burning. Laboratory data included: EKG (NR: not provided) came out fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain/burning on 13-APR-2021, and face reddening on 12-APR-2021, and was recovering from trouble breathing after doing manual labor/shortness of breath, headaches, sore legs, and blurred vision. This report was non-serious. This case is a duplicate. Additional information was received from patient on 15-APR-2021. It was determined that it was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number. Sender's Comments: V0:Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: TIREDNESS; FEVER; SORE AT INJECTION SITE; This spontaneous report received from a patient via a Social media post 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 APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, fever and sore at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Myalgia, Skin discolouration
Clinical narrative: SICK; PURPLE FINGER; JOINT PAIN; MUSCLE ACHE; 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: Unk) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced purple finger. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced muscle ache. On 12-APR-2021, the subject experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the purple finger, muscle ache, joint pain and sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body ache, chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache and nausea was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Discomfort, Fatigue, Pain, Pyrexia
Clinical narrative: MODERATE AND CONSISTENT ABDOMINAL PAIN; BODY ACHES; SOARED; FEVER; REALLY TIRED; This spontaneous report received from a patient concerned a 19 year old male. The patient's weight was 170 pounds, and height was 70 inches. 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: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced body aches. On 31-MAR-2021, the subject experienced soared. On 31-MAR-2021, the subject experienced fever. On 31-MAR-2021, the subject experienced really tired. On 13-APR-2021, the subject experienced moderate and consistent abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, soared, fever, and really tired on 01-APR-2021, and had not recovered from moderate and consistent abdominal pain. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Fatigue, Head discomfort, Hypertension
Clinical narrative: TACHYCARDIA; SHORTNESS OF BREATH; FATIGUE; FULLNESS AT BASE OF SKULL; HIGH BLOOD PRESSURE; ARM DISCOMFORT; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy om hormone replacement, and concurrent conditions included hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced arm discomfort. On 27-MAR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure high (NR: not provided) 170/90 mmHg, 175/102 mmHg. On 28-MAR-2021, the subject experienced fullness at base of skull. On 28-MAR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced tachycardia. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Normal, no PE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fullness at base of skull, and fatigue on 29-MAR-2021, tachycardia on 14-APR-2021, and arm discomfort on 27-MAR-2021, was recovering from shortness of breath, and had not recovered from high blood pressure. This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Tachycardia
Clinical narrative: TACHYCARDIA; SHORTNESS OF BREATH; FATIGUE; FULLNESS AT BASE OF SKULL; HIGH BLOOD PRESSURE; ARM DISCOMFORT; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy om hormone replacement, and concurrent conditions included hypothyroidism, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 26-MAR-2021, the subject experienced arm discomfort. On 27-MAR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure high (NR: not provided) 170/90 mmHg, 175/102 mmHg. On 28-MAR-2021, the subject experienced fullness at base of skull. On 28-MAR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced tachycardia. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Normal, no PE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fullness at base of skull, and fatigue on 29-MAR-2021, tachycardia on 14-APR-2021, and arm discomfort on 27-MAR-2021, was recovering from shortness of breath, and had not recovered from high blood pressure. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Foetal exposure during pregnancy
Clinical narrative: EXPOSURE IN UTERO; This spontaneous pregnancy 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's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. 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 exposure in utero. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure in utero was not reported. This report was non-serious. This parent/child case is linked to 20210427241 (Parent).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Eye pain, Fatigue, Headache
Clinical narrative: PAIN IN WHOLE RIGHT ARM AND BOTH LEGS; PAIN AT INJECTION SITE; FATIGUE; PAIN IN LEFT HIP; SHOOTING PAIN IN HEAD; SWELLING OF BOTH LEGS; PAIN OVER EYES; PAIN IN BRIDGE AND SIDE OF NOSE; STOMACH ACHE; NAUSEA; SEVERE HEADACHE; INSOMNIA; BLEEDING AT INJECTION SITE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included superficial blood clot, and concurrent conditions included no alcohol user, and non smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 17/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced insomnia. On 08-APR-2021, the subject experienced bleeding at injection site. On 11-APR-2021, the subject experienced severe headache. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced stomach ache. On 15-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced fatigue. On 15-APR-2021, the subject experienced pain in left hip. On 15-APR-2021, the subject experienced pain in whole right arm and both legs. On 15-APR-2021, the subject experienced shooting pain in head. On 15-APR-2021, the subject experienced swelling of both legs. On 15-APR-2021, the subject experienced pain over eyes. On 15-APR-2021, the subject experienced pain in bridge and side of nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and stomach ache on 11-APR-2021, insomnia on 09-APR-2021, and bleeding at injection site on 08-APR-2021, recovered with sequelae from severe headache on 11-APR-2021, and had not recovered from pain at injection site, fatigue, pain in left hip, shooting pain in head, pain over eyes, pain in bridge and side of nose, pain in whole right arm and both legs, and swelling of both legs. This report was non-serious.