chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypophagia, Insomnia, Pain
Clinical narrative: PAIN ALL OVER BODY, FROM ANKLES UP TO HEAD (WORST BACK, CHEST NOT GOOD); SLEEPLESSNESS; FEELING LIKE DYING, NOT MAKING IT; SHORTNESS OF BREATH; NOT EATEN ANYTHING IN DAYS; 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 past medical history included horrible accident, right femur replaced, both ankles replaced, both knees replaced, and fuse lower back, and concurrent conditions included artificial hip, blurry vision, ptds (post traumatic demoralization syndrome), and panic attacks. 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-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced pain all over body, from ankles up to head (worst back, chest not good). On MAY-2021, the subject experienced sleeplessness. On MAY-2021, the subject experienced feeling like dying, not making it. On MAY-2021, the subject experienced shortness of breath. On MAY-2021, the subject experienced not eaten anything in days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain all over body, from ankles up to head (worst back, chest not good), and the outcome of sleeplessness, feeling like dying, not making it, shortness of breath and not eaten anything in days was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Migraine, Speech disorder, Toxicologic test
Clinical narrative: MIGRAINE; DIFFICULTY SPEAKING (STUTTER WITH A SLIGHT SLUR); This spontaneous report received from a parent concerned an 18 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use the patient did not have any no known allergies. 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced difficulty speaking (stutter with a slight slur). On 13-MAY-2021, Laboratory data included: CT scan (NR: not provided) Clear, EKG (NR: not provided) Negative, and Toxicologic test (NR: not provided) Negative. On an unspecified date, the subject experienced migraine. Treatment medications (dates unspecified) included: escitalopram oxalate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from difficulty speaking (stutter with a slight slur), and the outcome of migraine was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic, and smoker, and other pre-existing medical conditions included patient had no known drug allergies and no known drug abuse or illicit drug usage. 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 14-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 15-MAY-2021, the subject experienced headache.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: VEINS ARE APPEARING EVERYWHERE ON BODY MOSTLY ON THIGHS/SHOULDERS/GROIN; 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: 206A21A, and  expiry: UNKNOWN) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced veins are appearing everywhere on body mostly on thighs/shoulders/groin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of veins are appearing everywhere on body mostly on thighs/shoulders/groin was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: DOSE GIVEN BEYOND 2 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 14:40 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced dose given beyond 2 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given beyond 2 hours at room temperature was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF DRUG; POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine  was not applicable. The outcome of the incorrect storage of drug and poor quality drug administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210531096.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: TRANSIENT HEART PALPITATIONS; This spontaneous report received from a pharmacist concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included controlled hypertension, and smoking. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-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 27-APR-2021, the subject experienced transient heart palpitations. The action taken with covid-19 vaccine was not applicable. The patient recovered from transient heart palpitations on 30-APR-2021. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: POTENTIAL ADMINISTRATION OF AN EXPIRED JANSSEN COVID VACCINE; This spontaneous report received from a health care professional concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown if patient was pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 13-MAY-2021, the subject experienced potential administration of an expired janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of an expired janssen covid vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Computerised tomogram, Myalgia, Seizure
Clinical narrative: SEIZURE; SEVERE MUSCLE ACHES; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced seizure and transported to hospital. CT scan performed -no problems. Patient experienced sever muscle ache. Laboratory data (dates unspecified) included: CT scan (NR: not provided) No Problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure and severe muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210530480- covid-19 vaccine ad26.cov2.s-Seizure. This event is considered un assessable. 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.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Muscle contracture, Staring, Urinary incontinence
Clinical narrative: TIREDNESS; LOSS OF CONSCIOUSNESS; MUSCLE CONTRACTION; LOSS OF SPHINCTER CONTROL; BLANK EYES; This spontaneous report received from a patient concerned a 32 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the subject experienced loss of consciousness. On 11-MAY-2021, the subject experienced muscle contraction. On 11-MAY-2021, the subject experienced loss of sphincter control. On 11-MAY-2021, the subject experienced blank eyes. On 12-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, muscle contraction, loss of sphincter control, and blank eyes on 11-MAY-2021, and the outcome of tiredness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210530640- COVID-19 VACCINE AD26.COV2.S - Loss Of Consciousness. 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: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE STORED AT INAPPROPRIATE CONDITION BEFORE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 14-MAY-2021 10:19 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced vaccine stored at inappropriate condition before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine stored at inappropriate condition before administration was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea exertional, Fatigue
Clinical narrative: SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: SHORTNESS OF BREATH (WORSE UPON EXERTION); ELEVATED HEART RATE; DIZZINESS; CHEST PAIN; WEAKNESS; FEVER; MUSCLE ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, allergy to plavix, and compazine allergy. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with amlodipine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced shortness of breath (worse upon exertion). On 13-MAY-2021, the subject experienced elevated heart rate. On 13-MAY-2021, the subject experienced dizziness. On 13-MAY-2021, the subject experienced chest pain. On 13-MAY-2021, the subject experienced weakness. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced muscle aches. On 13-MAY-2021, the subject experienced headache. On 13-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, muscle aches, and headache, and had not recovered from shortness of breath (worse upon exertion), elevated heart rate, dizziness, weakness, fatigue, and chest pain. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: EXTREME TIREDNESS AND FATIGUE; This spontaneous report received from a parent concerned a 37 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced extreme tiredness and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme tiredness and fatigue was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: METALLIC TASTE; This spontaneous report received from a consumer concerned a 67 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: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced metallic taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from metallic taste. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN THE CALVES OF HER LEGS; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-MAY-2021, the subject experienced pain in the calves of her legs. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from pain in the calves of her legs. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms
Clinical narrative: LEG CRAMPS; TIREDNESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 140 pounds, and height was 153 centimeters. The patient's past medical history included left ankle injury, and leg cramps, and concurrent conditions included seasonal allergy, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. history of taking birth control medication 40 years ago but she stopped it since then due to severe leg cramps. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included naproxen sodium. On 15-MAY-2021, the subject experienced leg cramps. On 15-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine a was not applicable. The patient recovered from leg cramps on 15-MAY-2021, and had not recovered from tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: GENERAL PAIN HURTING; INJECTION SITE RED; PAINFUL INJECTION SITE; INJECTION SITE HOT; 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: 201AZ1A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced injection site hot. On MAY-2021, the subject experienced injection site red. On MAY-2021, the subject experienced painful injection site. On 16-MAY-2021, the subject experienced general pain hurting. 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 injection site red, painful injection site, injection site hot, and general pain hurting. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: PNEUMONIA; 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) dose, 1 total, 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 patient had pneumonia that almost killed him. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pneumonia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210531006- Covid-19 vaccine ad26.cov2.s-pneumonia. 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: Chills, Illness, Pyrexia
Clinical narrative: SICK AGAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced sick again. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sick again, fever and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Pain, Swelling
Clinical narrative: CONTINUOUSLY WORSENING PAIN ON ENTIRE LEFT SIDE OF BODY; MILD SWELLING; SOME SENSE OF NUMBNESS; MUSCLE ACHE; 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 13-MAY-2021 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 continuously worsening pain on entire left side of body, mild swelling, some sense of numbness, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the continuously worsening pain on entire left side of body, muscle ache, mild swelling and some sense of numbness was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: PERSISTENT MODERATE HEADACHE OVER EYES; MILD FEVER; This spontaneous report received from a patient concerned a 34 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage and no past medical history of medicines to prescriptions herbal supplements. The patient experienced drug allergy when treated with levofloxacin.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 09-MAY-2021 for prophylactic vaccination. Concomitant medications included lansoprazole. On 09-MAY-2021, the subject experienced persistent moderate headache over eyes. On 09-MAY-2021, the subject experienced mild fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient recovered from mild fever on 14-MAY-2021, and had not recovered from persistent moderate headache over eyes. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Illness, Pain, Pyrexia
Clinical narrative: SICK FOR 16  HOURS; LOOPY; ACHES; CHILLS; 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 was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sick for 16 hours, loopy, aches, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 16 hours, loopy, aches, chills, and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hangover, Nausea
Clinical narrative: DIZZY; FELT SORTA HUNGOVER; CHILLS; SUPER NAUSEATED; 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. No concomitant medications were reported. On an unspecified date, the subject experienced dizzy, sorta hungover, chills, and super nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the super nauseated, dizzy, chills and sorta hungover was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: A BIT OF CONGESTION IN THE CHEST; BODY ACHES AND SORE; MILD FEVER; NEAR CONSTANT HEADACHE; VERY TIRED; 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  (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. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced a bit of congestion in the chest, body aches and sore, mild fever, near constant headache, and very tired. The action taken with covid-19 vaccine  was not applicable. The outcome of the mild fever, body aches and sore, a bit of congestion in the chest, near constant headache and very tired was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; 101 FEVER FOR A DAY & HALF; 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  (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 chills, and 101 fever for a day & half. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine  was not applicable. The patient recovered from 101 fever for a day & half, and the outcome of chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HELL OF A FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hell of a fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hell of a fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: GENERAL MALAISE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 general malaise, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and general malaise was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: ARM FEELS LIKE IT'S GONNA FALL OFF; CRAZY BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm feels like it's gonna fall off, crazy body aches, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy body aches, and fever, and the outcome of arm feels like it's gonna fall off was not reported. This report was non-serious.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Contusion, Nausea, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM; 103 FEVER; NAUSEA; BRUISING ON RIGHT FOREARM; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced bruising on right forearm. On 04-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced 103 fever. On 04-MAY-2021, the subject experienced nausea.  Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine was not applicable. The patient recovered from sore arm, 103 fever, and nausea on 04-MAY-2021, and had not recovered from bruising on right forearm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: EXPOSURE TO JANSSEN COVID-19 VACCINE VIA BREAST MILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0242A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced exposure to janssen covid-19 vaccine via breast milk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exposure to janssen covid-19 vaccine via breast milk was not reported. This report was non-serious. This parent/child case is linked to 20210526707.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: INCREASED SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disorder, occasional social alcohol user, smoker, and shortness of breath, and other pre-existing medical conditions included the patient had no known allergies and no known drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, atorvastatin, budesonide/formoterol fumarate/glycopyrronium bromide, and hydrochlorothiazide/losartan potassium. On 14-MAY-2021, the subject experienced increased shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased shortness of breath. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin disorder
Clinical narrative: SPOTS THROUGHOUT THE BODY; BUMPS ALL OVER THE FACE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced spots throughout the body. On 12-APR-2021, the subject experienced bumps all over the face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bumps all over the face and spots throughout the body was not reported. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling of body temperature change, Influenza like illness, Muscular weakness, Myalgia
Clinical narrative: RIGHT ARM WEAKNESS; RIGHT ARM PAIN; MUSCLE ACHES; HOT AND COLD; FLU-LIKE SYMPTOMS; FREEZING; 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 high blood pressure, no alcohol consume, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced hot and cold. On 06-MAY-2021, the subject experienced flu-like symptoms. On 06-MAY-2021, the subject experienced freezing. On 06-MAY-2021, the subject experienced muscle aches. On 12-MAY-2021, the subject experienced right arm pain. On 14-MAY-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold, flu-like symptoms, freezing, and muscle aches on 07-MAY-2021, and was recovering from right arm pain, and right arm weakness. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT ARM WEAKNESS; RIGHT ARM PAIN; MUSCLE ACHES; HOT AND COLD; FLU-LIKE SYMPTOMS; FREEZING; 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 high blood pressure, no alcohol consume, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced hot and cold. On 06-MAY-2021, the subject experienced flu-like symptoms. On 06-MAY-2021, the subject experienced freezing. On 06-MAY-2021, the subject experienced muscle aches. On 12-MAY-2021, the subject experienced right arm pain. On 14-MAY-2021, the subject experienced right arm weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hot and cold, flu-like symptoms, freezing, and muscle aches on 07-MAY-2021, and was recovering from right arm pain, and right arm weakness. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Coronavirus test, Crying, Dysphonia, Irritability
Clinical narrative: LOST HER VOICE; CAN'T TALK SINCE GETTING THE VACCINE; VOICE HAS CHANGED; MADE HER STRESSED OUT; MAKES HER IRRITABLE; EVERY NIGHT SHE CRIES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. 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 and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Coronavirus test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced lost her voice. On MAR-2021, the subject experienced can't talk since getting the vaccine. On MAR-2021, the subject experienced voice has changed. On MAR-2021, the subject experienced made her stressed out. On MAR-2021, the subject experienced makes her irritable. On MAR-2021, the subject experienced every night she cries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can't talk since getting the vaccine, lost her voice, voice has changed, made her stressed out, makes her irritable, and every night she cries. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Language disorder, Stress
Clinical narrative: LOST HER VOICE; CAN'T TALK SINCE GETTING THE VACCINE; VOICE HAS CHANGED; MADE HER STRESSED OUT; MAKES HER IRRITABLE; EVERY NIGHT SHE CRIES; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker. 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 and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Coronavirus test (NR: not provided) NEGATIVE. On MAR-2021, the subject experienced lost her voice. On MAR-2021, the subject experienced can't talk since getting the vaccine. On MAR-2021, the subject experienced voice has changed. On MAR-2021, the subject experienced made her stressed out. On MAR-2021, the subject experienced makes her irritable. On MAR-2021, the subject experienced every night she cries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can't talk since getting the vaccine, lost her voice, voice has changed, made her stressed out, makes her irritable, and every night she cries. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered
Clinical narrative: OFF LABEL USE; JANSSEN COVID VACCINE DOSE GIVEN AFTER 6 HOUR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 23-JUL-2021) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced janssen covid vaccine dose given after 6 hour. On an unspecified date, the subject experienced off label use. The action taken with covid-19 vaccine  was not applicable. The outcome of the janssen covid vaccine dose given after 6 hour and off label use was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Contusion, Rash
Clinical narrative: BRUISE ON LEFT LEG JUST ABOVE KNEE CAP CREASE AND RIGHT THIGH A COUPLE INCHES BELOW THE BUTT AROUND 2-3 INCHES IN SIZE, DARK-PURPLISH, RIGHT LEG MORE BLUE AND THE LEFT LEG MORE PURPLE THAT HURT LIKE A NORMAL BRUISE AND NOT SWOLLEN; RED DOTS ON LEFT LEG FROM UPPER THIGH TO JUST BEFORE THE KNEE CAP; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 042821A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced red dots on left leg from upper thigh to just before the knee cap. Laboratory data included: Blood test (NR: not provided) Normal. On 16-MAY-2021, the subject experienced bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red dots on left leg from upper thigh to just before the knee cap on 14-MAY-2021, and had not recovered from bruise on left leg just above knee cap crease and right thigh a couple inches below the butt around 2-3 inches in size, dark-purplish, right leg more blue and the left leg more purple that hurt like a normal bruise and not swollen. This report was non-serious.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: J&J VACCINE MISTAKENLY ADMINISTERED TO 14 YEARS OLD; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 14 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 j&j vaccine mistakenly administered to 14 years old, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the j&j vaccine mistakenly administered to 14 years old and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin mass
Clinical narrative: KNOTS ON HEAD, EARS, NECK; RASH/ALL OVER FACE BUMPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the subject experienced knots on head, ears, neck, and rash/all over face bumps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash/all over face bumps and knots on head, ears, neck was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: NAUSEOUS FEELING; SEVERE BODY ACHES; 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 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced severe body aches. On 17-MAY-2021, the subject experienced nauseous feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe body aches, and the outcome of nauseous feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE WAS LEFT AT ROOM TEMPERATURE FOR APPROXIMATELY 4 HOURS AFTER FIRST PUNCTURE; This spontaneous report received from a pharmacist concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAY-2021, the subject experienced vaccine was left at room temperature for approximately 4 hours after first puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was left at room temperature for approximately 4 hours after first puncture was not reported. This report was non-serious.