chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Restlessness, Unevaluable event
Clinical narrative: 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021 22:00, the subject experienced body pains. On 15-MAR-2021 22:00, the subject experienced head felt like a giant balloon. On 15-MAR-2021 22:00, the subject experienced light headed and super woozy. On 15-MAR-2021 22:00, the subject experienced trouble walking. On 15-MAR-2021 22:00, the subject experienced arm has a big circle. On 15-MAR-2021 22:00, the subject experienced couldn't rest. On 15-MAR-2021 22:00, the subject experienced every joint was throbbing. On 15-MAR-2021 22:00, the subject experienced sore arm. On 15-MAR-2021 22:00, the subject experienced chills (superduper chills/vibrating). On 15-MAR-2021 22:00, the subject experienced hard knot at the injection site. On 15-MAR-2021 22:00, the subject experienced mild fever. On 15-MAR-2021 22:00, the subject experienced arm red. On 15-MAR-2021 22:00, the subject experienced serious headache. On 16-MAR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pains, head felt like a giant balloon, light headed and super woozy, trouble walking, couldn't rest, every joint was throbbing, chills (superduper chills/vibrating), mild fever, and serious headache on 16-MAR-2021, and had not recovered from arm has a big circle, arm red, sore arm, and hard knot at the injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Discomfort, Headache
Clinical narrative: CAN HEAR TIME SLOWING DOWN; SORE; WORST HEADACHE; This spontaneous report received from a consumer 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, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced can hear time slowing down, sore, and worst headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the worst headache, sore and can hear time slowing down was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea
Clinical narrative: CHILLS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Paraesthesia
Clinical narrative: TINGLING IN RIGHT ARM; BURNING DURING INJECTION; This spontaneous report received from a patient concerned a 77 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: 180531, and expiry: unknown) dose was not reported, administered on 15-MAR-2021 16:30 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced tingling in right arm. On 15-MAR-2021, the subject experienced burning during injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in right arm, and burning during injection on 15-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: MISSED THE DELTOID; 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced missed the deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of missed the deltoid was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: DIZZINESS; MALAISE; This spontaneous report received from a parent concerned an adult female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known history of drug abuse or illicit drug use. The patient had no known history of alcohol use. The patient had no known history of smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609) dose was not reported, once a total administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and malaise. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; SORE ARM; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 14-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 body aches. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fever, chills and body aches was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Nausea, Pain, Pyrexia
Clinical narrative: CHEST IRRITATION; ACHES; CHILLS; NAUSEA; FEVER; This spontaneous report received from a consumer concerned a 42 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chest irritation, aches, chills, nausea, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, fever, chills, aches and chest irritation was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: SHIVERING AND CHILLS; FEVER FOR 2 HOURS; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced shivering and chills. On MAR-2021, the subject experienced fever for 2 hours. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever for 2 hours, shivering and chills and headache was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: FLU LIKE SYMPTOMS; ARM PAIN; TIRED; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced tired. On 06-MAR-2021, the subject experienced flu like symptoms. On 06-MAR-2021, the subject experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 07-MAR-2021, and tired on 06-MAR-2021, and had not recovered from arm pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: A BIT TIRED; A LITTLE SORE AT INJECTION SITE; 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, once a total 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 a bit tired. On MAR-2021, the subject experienced a little sore at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a little sore at injection site and a bit tired was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Tremor
Clinical narrative: SHAKES; WEAKNESS; HEADACHE; 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: 1805029, and batch number: 1805029 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 shakes. On 10-MAR-2021, the subject experienced weakness. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shakes, headache, nausea, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: SORE ARM; FATIGUE; 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: Unk) 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 an unspecified date, the subject experienced sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: SORE NECK; SORE ARM; CHILLS; 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-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, treatment medications included: paracetamol. On 16-MAR-2021, the subject experienced sore neck. On 16-MAR-2021, the subject experienced sore arm. On 16-MAR-2021, the subject experienced chills. On 16-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sore arm, sore neck and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: HCP ADMINISTERED 0.1ML OF  JANSSEN COVID-19 VACCINE AND  THEN REALIZED THAT IT SHOULD  HAVE BEEN 0.5ML SO ADMINISTERED  THE REMAINING 0.4ML WITHIN 30S TO  1 MINUTE AFTER 0.1ML DOSE; This spontaneous report received from a patient concerned a patient 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) .5 ml, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced hcp administered 0.1ml of janssen covid-19 vaccine and then realized that it should have been 0.5ml so administered the remaining 0.4ml within 30s to 1 minute after 0.1ml dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hcp administered 0.1ml of janssen covid-19 vaccine and then realized that it should have been 0.5ml so administered the remaining 0.4ml within 30s to 1 minute after 0.1ml dose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain in extremity, Pyrexia
Clinical narrative: CHILLS NOT CONTINUOUS "EVERY 10 MINUTES"; FEVER; SLIGHT ARM PAIN NOT BAD; This spontaneous report received from a patient concerned a 23 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced slight arm pain not bad. On 17-MAR-2021, the subject experienced chills not continuous "every 10 minutes". On 17-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.12 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight arm pain not bad, and had not recovered from fever, and chills not continuous "every 10 minutes". This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dyspnoea, Eating disorder
Clinical narrative: 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, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:04 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced red. On 12-MAR-2021, the subject experienced pain in chest. On 12-MAR-2021, the subject experienced trouble in breathing. On 12-MAR-2021, the subject experienced body shacking. On 12-MAR-2021, the subject experienced body aching. On 12-MAR-2021, the subject experienced could not really eat. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps. Treatment medications included: paracetamol. On 13-MAR-2021, the subject experienced minor pain in joint. Additional treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in chest, trouble in breathing, body shacking, body aching, could not really eat, and chills on 14-MAR-2021, was recovering from hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps, and itching, and the outcome of minor pain in joint and red was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Rash, Tremor
Clinical narrative: 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, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:04 on left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced itching. On MAR-2021, the subject experienced red. On 12-MAR-2021, the subject experienced pain in chest. On 12-MAR-2021, the subject experienced trouble in breathing. On 12-MAR-2021, the subject experienced body shacking. On 12-MAR-2021, the subject experienced body aching. On 12-MAR-2021, the subject experienced could not really eat. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps. Treatment medications included: paracetamol. On 13-MAR-2021, the subject experienced minor pain in joint. Additional treatment medications (dates unspecified) included: hydrocortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in chest, trouble in breathing, body shacking, body aching, could not really eat, and chills on 14-MAR-2021, was recovering from hot spots, rash on lower back, hip, front thighs, side of ankles, belly and white bumps, and itching, and the outcome of minor pain in joint and red was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Dizziness, Hypersomnia, Nausea
Clinical narrative: LIGHT HEADED; SLEPT ALL DAY; NAUSEA; LOSS OF TASTE TO RIGHT SIDE OF MOUTH ONLY; 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 cardiac arrest, hypertension, chronic obstructive pulmonary disease, and heart condition, and concurrent conditions included penicillin allergy, codeine allergy, demerol allergy, and secor allergy. 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 13-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced light headed. On 16-MAR-2021, the subject experienced slept all day. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced loss of taste to right side of mouth only. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slept all day, and nausea on 17-MAR-2021, was recovering from light headed, and had not recovered from loss of taste to right side of mouth only. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Rash erythematous
Clinical narrative: REALLY RED SKIN; BUMP ON ARM (UNDERNEATH SKIN); SORE ARM (MUSCLE 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) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced bump on arm (underneath skin). On 15-MAR-2021, the subject experienced sore arm (muscle ache). On 17-MAR-2021, the subject experienced really red skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from really red skin, bump on arm (underneath skin), and sore arm (muscle ache). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient experienced allergy when treated with benzylpenicillin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 16:30 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced muscle aches. On 17-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101.5. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: FULL BODY CHILLS; 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, intramuscular, batch number: Unknown) dose was not reported, administered on 16-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 full body chills. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the full body chills and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear discomfort, Pain in extremity, Somnolence
Clinical narrative: DIZZINESS; EAR POPPING SENSATION WITH SWALLOWING; FEELING SLEEPY; VERTIGO; LEFT ARM PAIN; 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.     No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced left arm pain. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced ear popping sensation with swallowing. On 17-MAR-2021, the subject experienced feeling sleepy. On 17-MAR-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm pain, dizziness, ear popping sensation with swallowing, feeling sleepy, chills and vertigo was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: DIZZINESS; EAR POPPING SENSATION WITH SWALLOWING; FEELING SLEEPY; VERTIGO; LEFT ARM PAIN; 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: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.     No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced left arm pain. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced ear popping sensation with swallowing. On 17-MAR-2021, the subject experienced feeling sleepy. On 17-MAR-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm pain, dizziness, ear popping sensation with swallowing, feeling sleepy, chills and vertigo was not reported. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Body temperature, Body temperature increased, Fatigue
Clinical narrative: SWEATY; LOSS OF TASTE; WEAK; FEELING OF RASH UNDER SKIN; TIRED; INCREASED TEMPERATURE 98.1F; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned an 83 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: 1802072, and batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, on left arm, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced loss of taste. On 14-MAR-2021, the subject experienced weak. On 14-MAR-2021, the subject experienced feeling of rash under skin. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced increased temperature 98.1f. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle aches, and nausea on 14-MAR-2021, and had not recovered from sweaty, tired, weak, increased temperature 98.1f, feeling of rash under skin, and loss of taste. This report was non-serious.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Rash
Clinical narrative: SWEATY; LOSS OF TASTE; WEAK; FEELING OF RASH UNDER SKIN; TIRED; INCREASED TEMPERATURE 98.1F; HEADACHE; MUSCLE ACHES; NAUSEA; This spontaneous report received from a patient concerned an 83 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: 1802072, and batch number: 1802072 expiry: 25-MAY-2021) dose was not reported, on left arm, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced nausea. On 14-MAR-2021, the subject experienced sweaty. On 14-MAR-2021, the subject experienced loss of taste. On 14-MAR-2021, the subject experienced weak. On 14-MAR-2021, the subject experienced feeling of rash under skin. On 14-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced increased temperature 98.1f. Laboratory data included: Body temperature (NR: not provided) 98.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, muscle aches, and nausea on 14-MAR-2021, and had not recovered from sweaty, tired, weak, increased temperature 98.1f, feeling of rash under skin, and loss of taste. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: FATIGUE; MILD HEADACHE; 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: Unk) 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 fatigue. On MAR-2021, the subject experienced mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and mild headache was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: ACHE; 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 an unspecified date, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of ache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Pyrexia
Clinical narrative: COLD SWEAT; FATIGUE; FEVER; 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 15-MAR-2021, the subject experienced cold sweat. On 15-MAR-2021, the subject experienced fatigue. On 15-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, cold sweat, and fever. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Feeling hot, Headache, Pyrexia
Clinical narrative: VOMITING; FEELING HOT; RED ARMS; FEVER 102.6F; HEADACHE; SHAKING VIOLENTLY; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to latex. 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 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021;03:00 a.m, the subject experienced shaking violently. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 17-MAR-2021, the subject experienced feeling hot. On 17-MAR-2021, the subject experienced red arms. On 17-MAR-2021, the subject experienced fever 102.6f. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021 03:00 a.m, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arms on MAR-2021, and had not recovered from vomiting, shaking violently, fever 102.6f, headache, and feeling hot. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: VOMITING; FEELING HOT; RED ARMS; FEVER 102.6F; HEADACHE; SHAKING VIOLENTLY; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to latex. 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 16-MAR-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021;03:00 a.m, the subject experienced shaking violently. Laboratory data included: Body temperature (NR: not provided) 102.6 F. On 17-MAR-2021, the subject experienced feeling hot. On 17-MAR-2021, the subject experienced red arms. On 17-MAR-2021, the subject experienced fever 102.6f. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021 03:00 a.m, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red arms on MAR-2021, and had not recovered from vomiting, shaking violently, fever 102.6f, headache, and feeling hot. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: SORE ARM; SORE THROAT; This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and sulfa allergy. The patient experienced drug allergy when treated with codeine, and streptomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, once a total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced sore arm. On 14-MAR-2021, the subject experienced sore throat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache
Clinical narrative: STOMACH ACHE; HEADACHE; 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 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 numbers. On 2021, the subject experienced stomach ache. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach ache, and headache on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hypokinesia
Clinical narrative: TROUBLE LIFTING ARM; SHIVERS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced trouble lifting arm, and shivers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble lifting arm and shivers was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: SOMETIMES SHORT OF BREATH; DIARRHEA; DIZZY; HEADACHE; TIRED; 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 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 to left arm 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 dizzy. On 13-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced diarrhea. On an unspecified date, the subject experienced sometimes short of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, dizzy, headache, tired and sometimes short of breath was not reported. This report was non-serious.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Paraesthesia oral
Clinical narrative: ARM SORENESS; FEVER; FATIGUE; HEADACHE; LIP/MOUTH TINGLING; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 25/MAY/2021) dose was not reported, administered on 11-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced lip/mouth tingling. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced arm soreness. Laboratory data (12/mar/2021) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip/mouth tingling, and headache on 11-MAR-2021 19:00, arm soreness on 13-MAR-2021, fever on 12-MAR-2021, and fatigue on 14-MAR-2021. This report was non-serious.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: ARM SORENESS; FEVER; FATIGUE; HEADACHE; LIP/MOUTH TINGLING; This spontaneous report received from a patient concerned a 54 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: 25/MAY/2021) dose was not reported, administered on 11-MAR-2021 15:15 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced lip/mouth tingling. On 11-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced fatigue. On 13-MAR-2021, the subject experienced arm soreness. Laboratory data (12/mar/2021) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip/mouth tingling, and headache on 11-MAR-2021 19:00, arm soreness on 13-MAR-2021, fever on 12-MAR-2021, and fatigue on 14-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Hypoaesthesia
Clinical narrative: NUMBNESS IN BOTH ARMS; BURNING SENSATION IN THE LEGS; SEVERE HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced numbness in both arms. On 15-MAR-2021, the subject experienced burning sensation in the legs. On 15-MAR-2021, the subject experienced severe headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbness in both arms, and burning sensation in the legs, and had not recovered from severe headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Dyspnoea, Fatigue, Headache
Clinical narrative: FELT LIKE ASTHMA ATTACK; COUGH; HEADACHE; TIREDNESS; SHORTNESS OF BREATH; LOW O2 SAT ABOUT 92 % FOR A WEEK; 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 asthma, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and 1802072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced low o2 sat about 92 % for a week. On 09-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced felt like asthma attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, low o2 sat about 92 % for a week, headache, felt like asthma attack, and cough, and had not recovered from tiredness. 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: Oxygen saturation decreased
Clinical narrative: FELT LIKE ASTHMA ATTACK; COUGH; HEADACHE; TIREDNESS; SHORTNESS OF BREATH; LOW O2 SAT ABOUT 92 % FOR A WEEK; 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 asthma, and fibromyalgia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and 1802072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced shortness of breath. On 09-MAR-2021, the subject experienced low o2 sat about 92 % for a week. On 09-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On 15-MAR-2021, the subject experienced felt like asthma attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, low o2 sat about 92 % for a week, headache, felt like asthma attack, and cough, and had not recovered from tiredness. 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: Dizziness, Fatigue, Headache
Clinical narrative: DIZZINESS; HEADACHE; FATIGUE; 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, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 11:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced dizziness. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 16-MAR-2021, and had not recovered from headache, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Nausea, Pain
Clinical narrative: ACHEY; CHILLS; FEVER; NAUSEA; TIRED; WEAK; 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: 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 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced nausea. On 16-MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced weak. On 16-MAR-2021, the subject experienced achey. On 16-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and had not recovered from fever, nausea, tired, weak, and achey. This report was non-serious.