chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Gait inability, Pain
Clinical narrative: BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 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, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tachycardia
Clinical narrative: BLOOD PRESSURE INCREASED 147/60; TACHYCARDIA; ACHINESS; FATIGUE; SEVERE LEG PAIN; UNABLE TO WALK LONG DISTANCES; SORENESS IN ARM; This spontaneous report received from a consumer concerned a 63 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, 1 total dose administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the patient experienced soreness in arm. On APR-2021, the patient experienced unable to walk long distances. On APR-2021, the patient experienced severe leg pain. On 01-APR-2021, the patient experienced fatigue. On 05-APR-2021, the patient experienced achiness. On an unspecified date, the patient experienced blood pressure increased 147/60, and tachycardia and his EKG came back clear on a suspected heart attack. His blood pressure was normally low. On 19-APR-2021, the patient was hospitalized. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 147/60 mmHg, 110/60 mmHg. Treatment medications (dates unspecified) included: sodium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood pressure increased 147/60147/60, had not recovered from soreness in arm, unable to walk long distances, fatigue, achiness, and severe leg pain, and the outcome of tachycardia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Blood pressure increased, Tachycardia, Unable to walk long distances and Achiness. This event(s) are considered unassessable. The event(s) have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0 20210440548-COVID-19 VACCINE AD26.COV2.S-Soreness in arm, Severe leg pain, Fatigue. This event(s) are labeled per RSI and are therefore considered potentially related.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hemiparesis, Loss of consciousness, Thrombosis, X-ray
Clinical narrative: THROMBOSIS; Dizziness; Pass Out; Weakness in the all side of the body; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included sea food allergy, and other pre-existing medical conditions included the patient did not had any other illness at the time of vaccination and to one month prior and chronic or long standing health condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 11:25 for prophylactic vaccination. The batch number was not reported. As per procedure, no follow-up will be requested for this case. Concomitant medications included metformin for drug used for unknown indication.  On an unspecified date, the subject experienced thrombosis, dizziness, pass out, and weakness in the all side of the body, and was hospitalized (date unspecified). Laboratory data (dates unspecified) included: X-ray (NR: not provided) heart, head and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from thrombosis, dizziness, pass out, and weakness in the all side of the body. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: This is a report of a patient,  who was noted to have thrombosis on unspecified time after receiving the covid-19 vaccine ad26.cov.2.  Patient's height and weight were not reported. Patient medical history was not reported. Concomitant medications included metformin for unknown indication. Patient is allergic to seafoods.  On an unspecified date, the subject experienced dizziness and passed out. She also had weakness on the left side of the body. Patient was noted to have thrombosis. Patient was hospitalized, where laboratory and diagnostic tests were done. Results were not reported.  The information provided precludes a meaningful medical assessment. Additional information requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tofacitinib citrate. On MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of slight headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Headache, Musculoskeletal chest pain, Painful respiration
Clinical narrative: CHEST (RIBCAGE) PAIN; KIDNEY PAIN; HURTS TO BREATHE; ABDOMEN PAIN; SEVERE BACK PAIN; SEVERE HEADACHE; 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 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 APR-2021, the subject experienced chest (ribcage) pain. On APR-2021, the subject experienced kidney pain. On APR-2021, the subject experienced hurts to breathe. On APR-2021, the subject experienced abdomen pain. On APR-2021, the subject experienced severe back pain. On APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain, hurts to breathe, severe headache, abdomen pain, chest (ribcage) pain and kidney pain was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol ,comment is not required for non-serious cases
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: CHEST (RIBCAGE) PAIN; KIDNEY PAIN; HURTS TO BREATHE; ABDOMEN PAIN; SEVERE BACK PAIN; SEVERE HEADACHE; 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 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 APR-2021, the subject experienced chest (ribcage) pain. On APR-2021, the subject experienced kidney pain. On APR-2021, the subject experienced hurts to breathe. On APR-2021, the subject experienced abdomen pain. On APR-2021, the subject experienced severe back pain. On APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe back pain, hurts to breathe, severe headache, abdomen pain, chest (ribcage) pain and kidney pain was not reported. This report was non-serious.; Sender's Comments: V0: As per standard protocol ,comment is not required for non-serious cases
Sex: F
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Dry mouth, Positron emission tomogram, Urinary incontinence
Clinical narrative: DIARRHEA; DRY MOUTH; URINE LEAKAGE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included malignant neoplasm of endometrium.  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. Non-company suspect drugs included: lenvatinib mesilate (oral, batch number: 9848179 expiry: UNKNOWN, form of admin was not reported) 20 mg, 1 time every 1 day, from 17-DEC-2020 for malignant neoplasm of endometrium. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 2021, the subject experienced dry mouth. On 2021, the subject experienced urine leakage. Laboratory data (dates unspecified) included: Positron emission tomography (NR: not provided) 2 masses gone, size of 3 reduced, 1 mass by lymph node raised but firm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 2021, and the outcome of dry mouth and urine leakage was not reported. This report was non-serious. This report was associated with product quality complaint: 90000176991. The suspected product quality complaint has been confirmed to be voided (did not meet PQC criteria) based on the PQC evaluation/investigation performed.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Facial pain, Nausea, Pain, Pyrexia
Clinical narrative: PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 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, intramuscular, 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 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender's Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Hypertension
Clinical narrative: WEAKNESS; HYPERTENSION; HEADACHE; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS)  (VAER reference number 422221)  concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Company is unable to follow up for Batch/Lot number of the case. No concomitant medications were reported.  On an unspecified date, the subject experienced weakness, hypertension, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, hypertension and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Company i unable to follow up for batch/Lot number of the case. No concomitant medications were reported.  On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nausea was not reported. This report was non-serious. This case, from the same reporter is linked to 20210415566 and 20210441555. .
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypertension
Clinical narrative: HYPERTENSION; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and theophylline allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included fluoxetine. On an unspecified date, the subject experienced hypertension, and allergic reaction. Treatment medications (dates unspecified) included: amlodipine and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypertension and allergic reaction was not reported. This report was non-serious. This case linked to 20210415566 as reported by the same reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Dyspnoea, Heart rate increased, Hypertension
Clinical narrative: EXTREMELY HIGH BLOOD PRESSURE; INCREASED HEART RATE; SHORTNESS OF BREATH; INCREASED GAS AND INTESTINAL PROBLEM; CHEST PAIN; SHAKINESS; CAN'T DISTINGUISH HOT FROM COLD; UNCONTROLLED MUSCLE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease, thyroiditis, high blood pressure, non alcohol, non smoker, latex allergy, sulfa allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and  expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced extremely high blood pressure. On 15-APR-2021, the subject experienced increased heart rate. On 15-APR-2021, the subject experienced shortness of breath. On 15-APR-2021, the subject experienced increased gas and intestinal problem. On 15-APR-2021, the subject experienced chest pain. On 15-APR-2021, the subject experienced shakiness. On 15-APR-2021, the subject experienced can't distinguish hot from cold. On 15-APR-2021, the subject experienced uncontrolled muscle pain. Laboratory data included: Lab test (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely high blood pressure, increased heart rate, chest pain, and increased gas and intestinal problem, had not recovered from shakiness, and can't distinguish hot from cold, and the outcome of uncontrolled muscle pain and shortness of breath 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Myalgia, Sensory loss, Tremor
Clinical narrative: EXTREMELY HIGH BLOOD PRESSURE; INCREASED HEART RATE; SHORTNESS OF BREATH; INCREASED GAS AND INTESTINAL PROBLEM; CHEST PAIN; SHAKINESS; CAN'T DISTINGUISH HOT FROM COLD; UNCONTROLLED MUSCLE PAIN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included auto-immune disease, thyroiditis, high blood pressure, non alcohol, non smoker, latex allergy, sulfa allergy, and erythromycin allergy, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and  expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced extremely high blood pressure. On 15-APR-2021, the subject experienced increased heart rate. On 15-APR-2021, the subject experienced shortness of breath. On 15-APR-2021, the subject experienced increased gas and intestinal problem. On 15-APR-2021, the subject experienced chest pain. On 15-APR-2021, the subject experienced shakiness. On 15-APR-2021, the subject experienced can't distinguish hot from cold. On 15-APR-2021, the subject experienced uncontrolled muscle pain. Laboratory data included: Lab test (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely high blood pressure, increased heart rate, chest pain, and increased gas and intestinal problem, had not recovered from shakiness, and can't distinguish hot from cold, and the outcome of uncontrolled muscle pain and shortness of breath 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.
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Feeling of body temperature change, Full blood count, Headache
Clinical narrative: SLIGHT CALF CRAMPING; SEVERE HEADACHE; BRUISE AT THE INJECTION SITE; FEELING HOT AND COLD; BODY HURT/BODY ACHEY; ARM SORENESS AT INJECTION SITE; NAUSEA; DIZZINESS; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 25 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced couldn't sleep. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced body hurt/body achey. On 08-APR-2021, the subject experienced arm soreness at injection site. On 09-APR-2021, the subject experienced feeling hot and cold. On 10-APR-2021, the subject experienced bruise at the injection site. On 11-APR-2021, the subject experienced severe headache. On 20-APR-2021, the subject experienced slight calf cramping. On 21-APR-2021, Laboratory data included: CBC (NR: not provided) Normal, and CT scan (NR: not provided) CLEAR. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep, and arm soreness at injection site on 10-APR-2021, and body hurt/body achey on 09-APR-2021, was recovering from nausea, dizziness, feeling hot and cold, and bruise at the injection site, and had not recovered from severe headache, and slight calf cramping. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Insomnia, Muscle spasms, Nausea, Pain
Clinical narrative: SLIGHT CALF CRAMPING; SEVERE HEADACHE; BRUISE AT THE INJECTION SITE; FEELING HOT AND COLD; BODY HURT/BODY ACHEY; ARM SORENESS AT INJECTION SITE; NAUSEA; DIZZINESS; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 25 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced couldn't sleep. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced body hurt/body achey. On 08-APR-2021, the subject experienced arm soreness at injection site. On 09-APR-2021, the subject experienced feeling hot and cold. On 10-APR-2021, the subject experienced bruise at the injection site. On 11-APR-2021, the subject experienced severe headache. On 20-APR-2021, the subject experienced slight calf cramping. On 21-APR-2021, Laboratory data included: CBC (NR: not provided) Normal, and CT scan (NR: not provided) CLEAR. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep, and arm soreness at injection site on 10-APR-2021, and body hurt/body achey on 09-APR-2021, was recovering from nausea, dizziness, feeling hot and cold, and bruise at the injection site, and had not recovered from severe headache, and slight calf cramping. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SLIGHT CALF CRAMPING; SEVERE HEADACHE; BRUISE AT THE INJECTION SITE; FEELING HOT AND COLD; BODY HURT/BODY ACHEY; ARM SORENESS AT INJECTION SITE; NAUSEA; DIZZINESS; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 25 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: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 18:30 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness. On 07-APR-2021, the subject experienced couldn't sleep. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced body hurt/body achey. On 08-APR-2021, the subject experienced arm soreness at injection site. On 09-APR-2021, the subject experienced feeling hot and cold. On 10-APR-2021, the subject experienced bruise at the injection site. On 11-APR-2021, the subject experienced severe headache. On 20-APR-2021, the subject experienced slight calf cramping. On 21-APR-2021, Laboratory data included: CBC (NR: not provided) Normal, and CT scan (NR: not provided) CLEAR. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from couldn't sleep, and arm soreness at injection site on 10-APR-2021, and body hurt/body achey on 09-APR-2021, was recovering from nausea, dizziness, feeling hot and cold, and bruise at the injection site, and had not recovered from severe headache, and slight calf cramping. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Fatigue, Headache, Polymerase chain reaction
Clinical narrative: BURNING SENSATION ON LEG; SEVERE ABDOMINAL PAIN; HEADACHE; FATIGUE AND TIRED; This spontaneous report received from a parent concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included low platelet count, and concurrent conditions included leukemia, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 01-JAN-2021, Laboratory data included: PCR (NR: not provided) NEGATIVE. On 20-APR-2021, the subject experienced burning sensation on leg. On 20-APR-2021, the subject experienced severe abdominal pain. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced fatigue and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burning sensation on leg, severe abdominal pain, headache, and fatigue and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Malaise, Movement disorder
Clinical narrative: LIMITED USE OF LEFT ARM; SORE LEFT ARM; MALAISE; INJECTION SITE REDNESS; FATIGUE; HEADACHE; 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, intramuscular, batch number: Unknown) 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 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced arm tenderness. On 11-APR-2021, the subject experienced limited use of left arm. On 11-APR-2021, the subject experienced injection site redness. On 11-APR-2021, the subject experienced malaise. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fatigue, sore arm, arm tenderness, limited use of left arm, injection site redness, malaise and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LIMITED USE OF LEFT ARM; SORE LEFT ARM; MALAISE; INJECTION SITE REDNESS; FATIGUE; HEADACHE; 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, intramuscular, batch number: Unknown) 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 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced arm tenderness. On 11-APR-2021, the subject experienced limited use of left arm. On 11-APR-2021, the subject experienced injection site redness. On 11-APR-2021, the subject experienced malaise. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fatigue, sore arm, arm tenderness, limited use of left arm, injection site redness, malaise and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: SHORTNESS OF BREATH/FELT LIKE I  COULDN'T BREATHE; ACHEY; CHILLS; EXTREMELY FATIGUED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-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 achey. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extremely fatigued. On APR-2021, the subject experienced headache. Laboratory data included: Blood test (NR: not provided) normal. On 17-APR-2021, the subject experienced shortness of breath/felt like i couldn't breathe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achey, headache, chills, extremely fatigued and shortness of breath/felt like i couldn't breathe 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: Pain
Clinical narrative: SHORTNESS OF BREATH/FELT LIKE I  COULDN'T BREATHE; ACHEY; CHILLS; EXTREMELY FATIGUED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-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 achey. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced extremely fatigued. On APR-2021, the subject experienced headache. Laboratory data included: Blood test (NR: not provided) normal. On 17-APR-2021, the subject experienced shortness of breath/felt like i couldn't breathe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achey, headache, chills, extremely fatigued and shortness of breath/felt like i couldn't breathe 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; MILD FEVER (98F OR 99F); MUSCLE ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's past medical history included hepatitis b, and other pre-existing medical conditions included no known drug allergies and drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 16-MAR-2021 15:00 for prophylactic vaccination. The batch no was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced muscle ache. On 17-MAR-2021 23:00, the subject experienced headache. On 17-MAR-2021 23:00, the subject experienced mild fever (98f or 99f). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 98 or 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, mild fever (98f or 99f), and muscle ache on 19-MAR-2021. This report was non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: SHINGLES ON WRIST; This spontaneous report received from a patient via a company representative concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-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 28-MAR-2021, the subject experienced shingles on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on wrist. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: FLU-LIKE SYMPTOMS; WHOLE BODY ACHES; CHILLS; HEADACHE; FEVERISH; This spontaneous report received from a patient 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: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-APR-2021, the subject experienced flu-like symptoms. On 20-APR-2021, the subject experienced whole body aches. On 20-APR-2021, the subject experienced chills. On 20-APR-2021, the subject experienced headache. On 20-APR-2021, the subject experienced feverish. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu-like symptoms, whole body aches, headache, feverish, and chills. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Head discomfort, Pain, Pyrexia
Clinical narrative: ACHES; BALLOON HEAD; CHILLS; FEVER; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced aches, balloon head, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, aches and balloon head was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Malaise, Rash
Clinical narrative: FEELING DOWN; FEELING SICK; RASH; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 feeling down, feeling sick, and rash. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling down, feeling sick and rash was not reported. This report was non-serious.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered by device
Clinical narrative: PARTIAL DOSE ADMINISTRATION; This spontaneous report received from a pharmacist concerned a 20 year old of unspecified sex. 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, and batch number: 1808982 expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced partial dose administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administration was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Chest pain, Chills, Computerised tomogram, Discomfort
Clinical narrative: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Computerised tomogram abdomen, Computerised tomogram head, Headache
Clinical narrative: TINGLING; LIGHTHEADEDNESS; RANDOM SHARP PAINS AROUND CHEST ON BOTH SIDES PERSIST; NUMBNESS TO FACE; HEAVY FELLING; HEADACHE PERSISTS 2 WEEKS POST  VACCINE PULLING, ON LEFT AND  RIGHT SIDES; PAIN BEHIND LEFT THIGH; CHILLS ON HALF OF BODY; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no known medical history. the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-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 pain behind left thigh. On APR-2021, the subject experienced chills on half of body. On 11-APR-2021, the subject experienced tingling. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced random sharp pains around chest on both sides persist. On 11-APR-2021, the subject experienced numbness to face. On 11-APR-2021, the subject experienced heavy felling. On 11-APR-2021, the subject experienced headache persists 2 weeks post vaccine pulling, on left and right sides. Laboratory data included: Diagnostic ultrasound (NR: not provided) NEGATIVE. On 15-APR-2021, Laboratory data included: Blood pressure (NR: not provided) NOT REPORTED, and CT scan (NR: not provided) NEGATIVE. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache persists 2 weeks post vaccine pulling, on left and right sides, tingling, lightheadedness, random sharp pains around chest on both sides persist, numbness to face, and heavy felling, and the outcome of pain behind left thigh and chills on half of body was not reported. This report was non-serious.