chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH ON THE BACK, UNDERARM AND LEGS; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced rash on the back, underarm and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash on the back, underarm and legs was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dysarthria, Gait inability, Gastrooesophageal reflux disease
Clinical narrative: ACID REFLUX (STOMACH BLOATING, STOMACH ACHE, STOMACH FLUTTER, NAUSEA); ISSUE WITH ARTICULATION; BACK ACHE; UNABLE TO WALK; CHEST ACHING (CHEST HEAVY); RADIATING; LEG ACHES; FEELING SICK; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included gerd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced acid reflux (stomach bloating, stomach ache, stomach flutter, nausea). On 09-MAR-2021, the subject experienced issue with articulation. On 09-MAR-2021, the subject experienced back ache. On 09-MAR-2021, the subject experienced unable to walk. On 09-MAR-2021, the subject experienced chest aching (chest heavy). On 09-MAR-2021, the subject experienced radiating. On 09-MAR-2021, the subject experienced leg aches. On 09-MAR-2021, the subject experienced feeling sick. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from issue with articulation, back ache, unable to walk, chest aching (chest heavy), radiating, leg aches, feeling sick, and headache on 10-MAR-2021, and was recovering from acid reflux (stomach bloating, stomach ache, stomach flutter, nausea). 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: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pain in extremity
Clinical narrative: ACID REFLUX (STOMACH BLOATING, STOMACH ACHE, STOMACH FLUTTER, NAUSEA); ISSUE WITH ARTICULATION; BACK ACHE; UNABLE TO WALK; CHEST ACHING (CHEST HEAVY); RADIATING; LEG ACHES; FEELING SICK; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included gerd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced acid reflux (stomach bloating, stomach ache, stomach flutter, nausea). On 09-MAR-2021, the subject experienced issue with articulation. On 09-MAR-2021, the subject experienced back ache. On 09-MAR-2021, the subject experienced unable to walk. On 09-MAR-2021, the subject experienced chest aching (chest heavy). On 09-MAR-2021, the subject experienced radiating. On 09-MAR-2021, the subject experienced leg aches. On 09-MAR-2021, the subject experienced feeling sick. On 09-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from issue with articulation, back ache, unable to walk, chest aching (chest heavy), radiating, leg aches, feeling sick, and headache on 10-MAR-2021, and was recovering from acid reflux (stomach bloating, stomach ache, stomach flutter, nausea). 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: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: QUITE A FEW SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid 19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, administered on MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced quite a few side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of quite a few side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: BODY ACHES; WEAKNESS; CHILLS; HEADACHE; NAUSEA; FATIGUE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included mononucleosis, and thyroidectomy, 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 11-MAR-2021, and was recovering from headache, nausea, weakness, fatigue, and injection site pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: BODY ACHES; WEAKNESS; CHILLS; HEADACHE; NAUSEA; FATIGUE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included mononucleosis, and thyroidectomy, 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 11-MAR-2021, and was recovering from headache, nausea, weakness, fatigue, and injection site pain. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: RUNNY NOSE; CHILLS; MILD FEVER; TIRED; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 160 pounds, and height was 164.6 centimeters. The patient's concurrent conditions included shellfish allergy, mold allergy, iodine allergy, alcohol user, nonsmoker, vestibulitis and blood pressure, and other pre-existing medical conditions included no drug abuse. The patient was previously treated with for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25/05/2021) dose was not reported, administered on 10-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil for blood pressure, estradiol for vestibulitis, gabapentin for vestibulitis, ergocalciferol, and magnesium. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced mild fever. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, chills, mild fever, tired, and nausea on 12-MAR-2021. This report was non-serious.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: RUNNY NOSE; CHILLS; MILD FEVER; TIRED; NAUSEA; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 160 pounds, and height was 164.6 centimeters. The patient's concurrent conditions included shellfish allergy, mold allergy, iodine allergy, alcohol user, nonsmoker, vestibulitis and blood pressure, and other pre-existing medical conditions included no drug abuse. The patient was previously treated with for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25/05/2021) dose was not reported, administered on 10-MAR-2021 15:30 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil for blood pressure, estradiol for vestibulitis, gabapentin for vestibulitis, ergocalciferol, and magnesium. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced mild fever. On 11-MAR-2021, the subject experienced tired. On 11-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 102 degree F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, chills, mild fever, tired, and nausea on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Palpitations, Pyrexia
Clinical narrative: SHORTNESS OF BREATH; RACING HEART; BODY ACHES; FEVER; 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, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced body aches. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced racing heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and body aches, and had not recovered from racing heart, and shortness of breath. 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: Fatigue, Myalgia, Nausea, Presyncope, Vertigo
Clinical narrative: VERTIGO BUT NOT DIZZINESS; WHEN LEANS OVER ALMOST FAINT; INCREASED JOINT MUSCLE PAIN (HAS ARTHRITIS); TIREDNESS; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced vertigo but not dizziness. On 10-MAR-2021, the subject experienced when leans over almost faint. On 10-MAR-2021, the subject experienced increased joint muscle pain (has arthritis). On 10-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vertigo but not dizziness, when leans over almost faint, tiredness, slight nausea, and increased joint muscle pain (has arthritis). This report was non-serious.; Sender's Comments: MAC not required per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 01-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and had been requested. No concomitant medications were reported.  On 01-MAR-2021, 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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Chills, Heart rate
Clinical narrative: PULSE 104; BP 188/102; CHILLS; TEMP 100.4 F; 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 copd/asthma. 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 11-MAR-2021 for prophylactic vaccination on left arm at noon. No concomitant medications were reported. On 11-MAR-2021, the subject experienced pulse 104. On 11-MAR-2021, the subject experienced bp 188/102. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced temp 100.4 f. Laboratory data included: Blood pressure (NR: not provided) 188/102 mmHg, Body temperature (NR: not provided) 100.4 F, and Pulse rate (NR: not provided) 104 BPM The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulse 104, bp 188/102, temp 100.4 f, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypertension
Clinical narrative: PULSE 104; BP 188/102; CHILLS; TEMP 100.4 F; 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 copd/asthma. 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 11-MAR-2021 for prophylactic vaccination on left arm at noon. No concomitant medications were reported. On 11-MAR-2021, the subject experienced pulse 104. On 11-MAR-2021, the subject experienced bp 188/102. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced temp 100.4 f. Laboratory data included: Blood pressure (NR: not provided) 188/102 mmHg, Body temperature (NR: not provided) 100.4 F, and Pulse rate (NR: not provided) 104 BPM The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulse 104, bp 188/102, temp 100.4 f, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: VACCINE NOT ADMINISTERED IN DELTOID; 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 concurrent conditions included heart disease, defibrillator, lupus, fatty liver, prediabetic, and high blood pressure, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 08:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021 08:30, the subject experienced vaccine not administered in deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine not administered in deltoid was not reported. This report was non-serious.  Version created to amend previously reported information on 11/MAR/2021. Upon review, the following information was amended: Company causality updated for event.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Peripheral swelling
Clinical narrative: HEADACHE; LEG SWELLING; LOSS OF APPETITE; SHIVERS; WEAKNESS; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced leg swelling. On 12-MAR-2021, the subject experienced loss of appetite. On 12-MAR-2021, the subject experienced shivers. On 12-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, leg swelling, loss of appetite, shivers, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blister, Blood test, Feeling hot, Headache
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included covid, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced feeling hot. On 06-MAR-2021, the subject experienced blister on lip. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced fever. On 08-MAR-2021, the subject experienced stomach ache. On 08-MAR-2021, the subject experienced shingles. On 08-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne. Laboratory data included: Blood test (NR: not provided) Within normal limit (units unspecified), and Disorder thyroid (NR: not provided) Within normal limit (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 07-MAR-2021, stomach ache, and nausea on 09-MAR-2021, and feeling hot, and headache on 08-MAR-2021, was recovering from blister on lip, and had not recovered from blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne, and shingles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Lip blister, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included covid, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced feeling hot. On 06-MAR-2021, the subject experienced blister on lip. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced fever. On 08-MAR-2021, the subject experienced stomach ache. On 08-MAR-2021, the subject experienced shingles. On 08-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne. Laboratory data included: Blood test (NR: not provided) Within normal limit (units unspecified), and Disorder thyroid (NR: not provided) Within normal limit (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 07-MAR-2021, stomach ache, and nausea on 09-MAR-2021, and feeling hot, and headache on 08-MAR-2021, was recovering from blister on lip, and had not recovered from blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne, and shingles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 64 inches. The patient's past medical history included covid, and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies reported. no drug abuse or illicit drug usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced body aches. On 06-MAR-2021, the subject experienced feeling hot. On 06-MAR-2021, the subject experienced blister on lip. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021 22:00, the subject experienced fever. On 08-MAR-2021, the subject experienced stomach ache. On 08-MAR-2021, the subject experienced shingles. On 08-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne. Laboratory data included: Blood test (NR: not provided) Within normal limit (units unspecified), and Disorder thyroid (NR: not provided) Within normal limit (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 07-MAR-2021, stomach ache, and nausea on 09-MAR-2021, and feeling hot, and headache on 08-MAR-2021, was recovering from blister on lip, and had not recovered from blisters on forehead and on right and left side of eye / vesicle like chicken pox/acne, and shingles. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Flank pain, Hypokinesia, Spinal pain
Clinical narrative: PAIN BETWEEN FLANK AND SPINE (AREA OF LEFT KIDNEY); PAIN BETWEEN FLANK AND SPINE; UNABLE TO STAND; UNABLE TO BEND; 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 11-MAR-2021 09:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced pain between flank and spine (area of left kidney). On 12-MAR-2021, the subject experienced pain between flank and spine. On 12-MAR-2021, the subject experienced unable to stand. On 12-MAR-2021, the subject experienced unable to bend. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain between flank and spine (area of left kidney), pain between flank and spine, unable to stand and unable to bend was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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 and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-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. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Myalgia, Pyrexia
Clinical narrative: FELT COLD AT NIGHT TIME; LOW GRADE FEVER; MUSCLE ACHES; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 11-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt cold at night time. On 11-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, muscle aches, and felt cold at night time. This report was non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 26 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 expiry: UNKNOWN) dose was not reported, administered on 12-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 12-MAR-2021, the subject experienced fever. On 12-MAR-2021 11:45, Laboratory data included: Body temperature (NR: not provided) 103.7 degrees F. On 12-MAR-2021 22:00, Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER OF 101 DEGREES; 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 concurrent conditions included cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever of 101 degrees. Laboratory data included: Body temperature (NR: not provided) 101 deg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever of 101 degrees was not reported. This report was non-serious.; 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: Abdominal discomfort, Diarrhoea, Influenza like illness
Clinical narrative: GI FLU LIKE SYMPTOMS; LOOSE STOOLS; UPSET STOMACH; 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, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced GI flu like symptoms.  On 12-MAR-2021, the subject experienced loose stools. On 12-MAR-2021, the subject experienced upset stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gi flu like symptoms, loose stools, and upset stomach. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia
Clinical narrative: RIGHT ARM COULD NOT LIFT-UP; NUMB ON THE RIGHT ARM WHERE THE VACCINE WAS GIVEN; 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, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, once toatal administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced right arm could not lift-up. On 13-MAR-2021, the subject experienced numb on the right arm where the vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numb on the right arm where the vaccine was given and right arm could not lift-up was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: SKIN SENSITIVITY; BODY ACHES; FEVER OF 104; HEADACHE; TIREDNESS; This spontaneous report received from a health care professional 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: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced skin sensitivity. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced fever of 104. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, body aches, tiredness, headache and fever of 104 was not reported. This report was non-serious.  Version created to amend previously reported information on 12-MAR-2021. Upon review, following information was amended: The medically significant checkbox was unchecked.
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: SKIN SENSITIVITY; BODY ACHES; FEVER OF 104; HEADACHE; TIREDNESS; This spontaneous report received from a health care professional 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: 1805022, and batch number: 1805022 expiry: 25/MAY/2021) dose was not reported, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced skin sensitivity. On 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced fever of 104. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin sensitivity, body aches, tiredness, headache and fever of 104 was not reported. This report was non-serious.  Version created to amend previously reported information on 12-MAR-2021. Upon review, following information was amended: The medically significant checkbox was unchecked.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature decreased, Feeling cold, Injection site pain, Tremor
Clinical narrative: SHAKING; COLDNESS; TEMPERATURE OF 91.7; SORENESS AT THE INJECTION SITE; WEAKNESS ALL OVER; 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: Unk) dose was not reported, administered on 13-MAR-2021 11:20 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the subject experienced shaking. On 13-MAR-2021, the subject experienced coldness. On 13-MAR-2021, the subject experienced temperature of 91.7. On 13-MAR-2021, the subject experienced soreness at the injection site. On 13-MAR-2021, the subject experienced weakness all over. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking, coldness, temperature of 91.7, soreness at the injection site, and weakness all over. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: METAL TASTE IN MOUTH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 12-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 12-MAR-2021, the patient experienced metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from metal taste in mouth. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: CHILLS; MYALGIA; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 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: Unk) dose was not reported, administered on 11-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced myalgia. On 11-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgia, low grade fever, chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 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. No concomitant medications were reported. On an unspecified date, the subject experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: STUFFY NOSE; HEADACHE; SORE THROAT; RIGHT HIP ACHE; 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: 1805050, and batch number: 1805050 expiry: UNKNOWN) dose was not reported, administered on 28-FEB-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced stuffy nose. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced sore throat. On 08-MAR-2021, the subject experienced right hip ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right hip ache, and was recovering from stuffy nose, headache, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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 was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no.  On 12-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 12-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Pyrexia
Clinical narrative: FEVER OF 103; FEELING COLD; HEADACHE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On 12-MAR-2021 22:00, the subject experienced feeling cold. On 13-MAR-2021, the subject experienced fever of 103. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 103, headache and feeling cold was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Myalgia, Pyrexia, Vomiting
Clinical narrative: SICK; VOMITING; FEVER; CHILLS; MUSCLE ACHES; This spontaneous report received from a consumer via a company representative 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 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 2021, the subject experienced sick. On 2021, the subject experienced vomiting. On 2021, the subject experienced fever. On 2021, the subject experienced chills. On 2021, the subject experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, sick, vomiting and muscle aches was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Cold sweat, Ear swelling, Fatigue
Clinical narrative: GASTRIC DISORDER; SKIN COLD CLAMMY; STOMACH DISCOMFORT; THROBBING PAIN IN MY LOWER RIGHT LEG; FEELING TIRED IF PATIENT WERE COMING DOWN WITH A VIRAL INFECTION AND FELT LIKE PATIENT HIT A WALL; EAR SWELLING; EAR DISCHARGE; CHILLS; FEVER; ACHE; INJECTION SITE HURT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammatory rheumatic disease, psoriatic arthritis, and flares. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 22:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced injection site hurt. On 09-MAR-2021, the subject experienced feeling tired if subject were coming down with a viral infection and felt like subject hit a wall. On 09-MAR-2021, the subject experienced ear swelling. On 09-MAR-2021, the subject experienced ear discharge. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced ache. On 09-MAR-2021 04:00, the subject experienced throbbing pain in my lower right leg. On 11-MAR-2021, the subject experienced skin cold clammy. On 11-MAR-2021, the subject experienced stomach discomfort. On 12-MAR-2021, the subject experienced gastric disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-MAR-2021, was recovering from ache, skin cold clammy, and stomach discomfort, had not recovered from ear swelling, and the outcome of throbbing pain in my lower right leg, feeling tired if patient were coming down with a viral infection and felt like patient hit a wall, gastric disorder, ear discharge and injection site hurt was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder, Injection site pain, Otorrhoea, Pain, Pyrexia
Clinical narrative: GASTRIC DISORDER; SKIN COLD CLAMMY; STOMACH DISCOMFORT; THROBBING PAIN IN MY LOWER RIGHT LEG; FEELING TIRED IF PATIENT WERE COMING DOWN WITH A VIRAL INFECTION AND FELT LIKE PATIENT HIT A WALL; EAR SWELLING; EAR DISCHARGE; CHILLS; FEVER; ACHE; INJECTION SITE HURT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammatory rheumatic disease, psoriatic arthritis, and flares. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 22:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced injection site hurt. On 09-MAR-2021, the subject experienced feeling tired if subject were coming down with a viral infection and felt like subject hit a wall. On 09-MAR-2021, the subject experienced ear swelling. On 09-MAR-2021, the subject experienced ear discharge. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced ache. On 09-MAR-2021 04:00, the subject experienced throbbing pain in my lower right leg. On 11-MAR-2021, the subject experienced skin cold clammy. On 11-MAR-2021, the subject experienced stomach discomfort. On 12-MAR-2021, the subject experienced gastric disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-MAR-2021, was recovering from ache, skin cold clammy, and stomach discomfort, had not recovered from ear swelling, and the outcome of throbbing pain in my lower right leg, feeling tired if patient were coming down with a viral infection and felt like patient hit a wall, gastric disorder, ear discharge and injection site hurt was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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: Unk) dose was not reported, administered on 11-MAR-2021 13:00 in right deltoid for prophylactic vaccination. The batch Number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102-103 Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Feeling of body temperature change, Influenza like illness
Clinical narrative: flu-like symptoms; chills; HEAT (FELT EXTREMELY HOT); fever; ache; in and out feeling of hot and cold; 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: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, at 3 the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, at 6,the subject experienced heat (felt extremely hot). On 12-MAR-2021,at 6 the subject experienced fever. On 12-MAR-2021, at 6 the subject experienced ache. On 12-MAR-2021, the subject experienced in and out feeling of hot and cold. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, ache, and heat (felt extremely hot), and the outcome of flu-like symptoms and in and out feeling of hot and cold was not reported. This report was non-serious.