chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia, Tremor
Clinical narrative: TREMORS; FEVER; MUSCLE PAIN; 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 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced tremors. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced muscle pain. 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, muscle pain and tremors was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: BODY ACHES; MILD FEVER; This spontaneous report received from a parent concerned a 44 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, and mild fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, and mild fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SOME SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 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 MAR-2021, the subject experienced some side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some side effects was not reported. This report was non-serious. This case, from the same reporter.
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: PROFUSE SWEATING; This spontaneous report received from a consumer concerned an adult 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, expiry: UNKNOW) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced profuse sweating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of profuse sweating was not reported. This report was non-serious. This case, from the same reporter .
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: CHILLS; BURNING SENSATION AT INJECTION SITE; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, 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 chills, burning sensation at injection site, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning sensation at injection site, fever and chills was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Condition aggravated, Pain
Clinical narrative: FLARE UP; PAIN; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient was treated with golimumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with 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 and has been requested. No concomitant medications were reported. On 19-MAR-2021, the patient experienced flare up. On 19-MAR-2021, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with golimumab was not reported. The outcome of the flare up and pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cold sweat, Pain, Pyrexia
Clinical narrative: COLD SWEATS; BODY ACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number has not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced cold sweats, body ache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, cold sweats, and body ache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vertigo
Clinical narrative: VERTIGO; MUSCLE PAINS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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 MAR-2021, the subject experienced vertigo. On MAR-2021, the subject experienced muscle pains. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle pains, nausea and vertigo was not reported. This report was non-serious. This case, from the same reporter is linked to 20210355508.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight 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. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.   On an unspecified date, the subject experienced unspecified side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effect was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number is not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: POISON IVY (WORST CASE EVER HAD); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced poison ivy (worst case ever had). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from poison ivy (worst case ever had). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Myalgia, Unevaluable event
Clinical narrative: CANNOT KEEP EYES OPEN; FEEL VERY WEAK, NO STRENGTH AT ALL; LOT OF JOINT PAIN; LOT OF MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported.  The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced cannot keep eyes open. On 2021, the subject experienced feel very weak, no strength at all. On 2021, the subject experienced lot of joint pain. On 2021, the subject experienced lot of muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel very weak, no strength at all, lot of muscle pain, lot of joint pain and cannot keep eyes open was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia, Myalgia
Clinical narrative: KEPT HIM UP AT NIGHT WITH LACK OF SLEEP; VOMITING; JOINT PAIN MOSTLY IN KNEES AND ANKLES; CHILLS; PERSISTENT MYALGIA WITH 10/10 PAIN; HEADACHE; NAUSEA; This spontaneous report received from a physician 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, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced kept him up at night with lack of sleep. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced joint pain mostly in knees and ankles. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced persistent myalgia with 10/10 pain. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, and had not recovered from persistent myalgia with 10/10 pain, joint pain mostly in knees and ankles, vomiting, nausea, and kept him up at night with lack of sleep. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: KEPT HIM UP AT NIGHT WITH LACK OF SLEEP; VOMITING; JOINT PAIN MOSTLY IN KNEES AND ANKLES; CHILLS; PERSISTENT MYALGIA WITH 10/10 PAIN; HEADACHE; NAUSEA; This spontaneous report received from a physician 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, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 20-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced kept him up at night with lack of sleep. On 20-MAR-2021, the subject experienced vomiting. On 20-MAR-2021, the subject experienced joint pain mostly in knees and ankles. On 20-MAR-2021, the subject experienced chills. On 20-MAR-2021, the subject experienced persistent myalgia with 10/10 pain. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, and had not recovered from persistent myalgia with 10/10 pain, joint pain mostly in knees and ankles, vomiting, nausea, and kept him up at night with lack of sleep. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: STUFFINESS; 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stuffiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stuffiness was not reported. This report was non-serious.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: RASH; This spontaneous report received from a patient concerned an 88 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 25-MAR-2021 on left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on 27-MAR-2021. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling face
Clinical narrative: RED FACE; SWOLLEN FACE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 102 pounds, and height was 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, batch number: 1805018, expiry: 25/MAY/2021) dose was not reported, administered on 22-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced red face. On 22-MAR-2021, the subject experienced swollen face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, and swollen face on 22-MAR-2021. 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, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at 15:00 to left arm for prophylactic vaccination. Concomitant medications included methotrexate. On 28-MAR-2021 12:00, 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: Pharyngeal paraesthesia, Rash
Clinical narrative: TINGLING THROAT; RASH ON FACE; 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 03-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced rash on face, and tingling throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on face and tingling throat was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: HORRIBLE BODY PAIN; FEEL LIKE SHIT; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On APR-2021, the subject experienced horrible body pain. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced feel like shit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible body pain, fever and feel like shit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event, Off label use
Clinical narrative: WRONG ROUTE OF ADMINISTRATION; OFF LABEL USE; NO ADVERSE EVENT; 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 01-APR-2021 15:00 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-APR-2021 15:00, the subject experienced wrong route of administration. On 01-APR-2021 15:00, the subject experienced off label use. On 01-APR-2021 15:00, the subject experienced no adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong route of administration, off label use and no adverse event was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE HAND; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced sore hand. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore hand was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Illness, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: SICKER THAN A DOG; ARM SWELLED UP/3 INCH KNOT ON ARM; RED ARM; COULDN'T MOVE ARM; SORE ARM; FEVER; 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 pre-existing medical conditions included the patient previously received tetanus shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sicker than a dog. On 01-APR-2021, the subject experienced arm swelled up/3 inch knot on arm. On 01-APR-2021, the subject experienced red arm. On 01-APR-2021, the subject experienced couldn't move arm. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sicker than a dog, arm swelled up/3 inch knot on arm, red arm, sore arm, couldn't move arm, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SICKER THAN A DOG; ARM SWELLED UP/3 INCH KNOT ON ARM; RED ARM; COULDN'T MOVE ARM; SORE ARM; FEVER; 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 pre-existing medical conditions included the patient previously received tetanus shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sicker than a dog. On 01-APR-2021, the subject experienced arm swelled up/3 inch knot on arm. On 01-APR-2021, the subject experienced red arm. On 01-APR-2021, the subject experienced couldn't move arm. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sicker than a dog, arm swelled up/3 inch knot on arm, red arm, sore arm, couldn't move arm, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SWEATS; BODY ACHES/PAIN; SHOOTING ABDOMINAL PAIN BELOW THE RIBS; HEADACHE; NAUSEA; OVERALL FATIGUE; CHILLS; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sweats. On 05-APR-2021, the subject experienced body aches/pain. On 05-APR-2021, the subject experienced shooting abdominal pain below the ribs. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced overall fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, had not recovered from nausea, sweats, and shooting abdominal pain below the ribs, and the outcome of body aches/pain and overall fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: SWEATS; BODY ACHES/PAIN; SHOOTING ABDOMINAL PAIN BELOW THE RIBS; HEADACHE; NAUSEA; OVERALL FATIGUE; CHILLS; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sweats. On 05-APR-2021, the subject experienced body aches/pain. On 05-APR-2021, the subject experienced shooting abdominal pain below the ribs. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced overall fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, had not recovered from nausea, sweats, and shooting abdominal pain below the ribs, and the outcome of body aches/pain and overall fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Hyperhidrosis, Nausea, Pain
Clinical narrative: SWEATS; BODY ACHES/PAIN; SHOOTING ABDOMINAL PAIN BELOW THE RIBS; HEADACHE; NAUSEA; OVERALL FATIGUE; CHILLS; 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: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced sweats. On 05-APR-2021, the subject experienced body aches/pain. On 05-APR-2021, the subject experienced shooting abdominal pain below the ribs. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced nausea. On 05-APR-2021, the subject experienced overall fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 23-MAR-2021, was recovering from headache, had not recovered from nausea, sweats, and shooting abdominal pain below the ribs, and the outcome of body aches/pain and overall fatigue was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Syncope
Clinical narrative: FAINTED; WEAKNESS; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's past medical history included lightheadedness from injections. The patient had no history of any reaction to vaccines before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: GL12A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the patient was fainted after receiving the vaccine and treated with emergency medical services. On the same day, the patient felt dizzy and experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, and weakness on 05-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Fainted. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Pain
Clinical narrative: TASTE METALLIC; BODY ACHES; EXHAUSTION; 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, and batch number were not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced taste metallic. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the taste metallic, exhaustion and body aches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Nausea, Somnolence
Clinical narrative: SLEEPINESS; DIZZINESS; FEELING WEAK; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sleepiness, dizziness, feeling weak, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weak, nausea, sleepiness and dizziness was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthropathy, Joint swelling, Pain
Clinical narrative: BODY PAIN; JOINTS IN HANDS AND BACK STARTED FEELING SWOLLEN; JOINTS OF HAND AND BACK STARTED FEELING LOSSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included Hypermobile Ehlers Danlos Syndrome. 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 08-APR-2021 09:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 08-APR-2021, the subject experienced body pain. On 08-APR-2021, the subject experienced joints in hands and back started feeling swollen. On 08-APR-2021, the subject experienced joints in hands and back started feeling very loose. Treatment medications included: magnesium chloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and the outcome of joints in hands and back started feeling swollen and joints in hands and back started feeling very loose was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: LEFT ARM NUMBNESS; ARM SORENESS; LEFT SIDE OF THE BODY SORE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and other pre-existing medical conditions included the patient had history of no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced left side of the body sore. On 06-APR-2021, the subject experienced left arm numbness. On 06-APR-2021, the subject experienced arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm soreness, left arm numbness, and left side of the body sore. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: MILD RINGING SOUND IN LEFT EAR; 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, and batch number were not reported) dose was not reported, administered on 08-APR-2021 13:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced mild ringing sound in left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild ringing sound in left ear was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Headache
Clinical narrative: METALLIC TASTE; fatigue; headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20321A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced metallic taste. On 11-APR-2021, the subject experienced fatigue. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and metallic taste was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision. 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, Dizziness, Fatigue, Headache, Hypoaesthesia oral
Clinical narrative: LIGHTHEADEDNESS/ DIZZINESS; NUMB LIPS; LOWER LIP STARTED TREMBLING; TINGLING IN ARM AND LEGS; TRANSIENT CHILLS; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; HEADACHE; 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 high blood pressure, psoriatic arthritis, and autoimmune disorder. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced tingling in arm and legs. On APR-2021, the subject experienced transient chills. On 12-APR-2021, the subject experienced numb lips. On 12-APR-2021, the subject experienced lower lip started trembling. On an unspecified date, the subject experienced lightheadedness/ dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and muscle aches on 26-MAR-2021, had not recovered from fatigue, headache, and lightheadedness/ dizziness, and the outcome of tingling in arm and legs, transient chills, numb lips and lower lip started trembling was not reported. This report was non-serious. This case, from the same reporter is linked. Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia, Pyrexia, Tremor
Clinical narrative: LIGHTHEADEDNESS/ DIZZINESS; NUMB LIPS; LOWER LIP STARTED TREMBLING; TINGLING IN ARM AND LEGS; TRANSIENT CHILLS; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; HEADACHE; 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 high blood pressure, psoriatic arthritis, and autoimmune disorder. 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced tingling in arm and legs. On APR-2021, the subject experienced transient chills. On 12-APR-2021, the subject experienced numb lips. On 12-APR-2021, the subject experienced lower lip started trembling. On an unspecified date, the subject experienced lightheadedness/ dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and muscle aches on 26-MAR-2021, had not recovered from fatigue, headache, and lightheadedness/ dizziness, and the outcome of tingling in arm and legs, transient chills, numb lips and lower lip started trembling was not reported. This report was non-serious. This case, from the same reporter is linked. Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total administered on 07-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021. the patient got an antibody test which was negative. On 09-APR-2021, the patient experienced confirmed immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210422747-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total 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 number. No concomitant medications were reported. On an unspecified date, the patent experienced suspected clinical vaccine failure and suspected covid-19.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected clinical vaccine failure and suspected covid-19 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436442, 20210422101 and 20210423050.; Sender's Comments: 20210423002 Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Epistaxis, Feeling abnormal, Influenza like illness, Injection site warmth
Clinical narrative: RIGHT NOSTRIL BLEED; FLU LIKE SYMPTOMS; ON THE WAY TO FAINTING; SERUM FELT LIKE FIRE; DIZZINESS; HAVE NOT FELT LIKE MYSELF; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and other pre-existing medical conditions included take a thyroid pill daily. 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 06-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 have not felt like myself. On 06-APR-2021, the subject experienced on the way to fainting. On 06-APR-2021, the subject experienced serum felt like fire. On 06-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced right nostril bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on the way to fainting on 06-APR-2021, had not recovered from dizziness, and the outcome of right nostril bleed, serum felt like fire, flu like symptoms and have not felt like myself was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: RIGHT NOSTRIL BLEED; FLU LIKE SYMPTOMS; ON THE WAY TO FAINTING; SERUM FELT LIKE FIRE; DIZZINESS; HAVE NOT FELT LIKE MYSELF; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid disorder, and other pre-existing medical conditions included take a thyroid pill daily. 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 06-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 have not felt like myself. On 06-APR-2021, the subject experienced on the way to fainting. On 06-APR-2021, the subject experienced serum felt like fire. On 06-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced right nostril bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from on the way to fainting on 06-APR-2021, had not recovered from dizziness, and the outcome of right nostril bleed, serum felt like fire, flu like symptoms and have not felt like myself was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures, as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A SORE ARM WHEN PUSHED ON THE INJECTION SITE ABOUT 48 HOURS LATER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 a sore arm when pushed on the injection site about 48 hours later. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a sore arm when pushed on the injection site about 48 hours later was not reported. This report was non-serious.