chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: CHILLS; ACHY; EXTREMELY TRIED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and expiry: UNKNOWN) .5 ml, administered on 09-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 chills. On 10-MAR-2021, the subject experienced achy. On 10-MAR-2021, the subject experienced extremely tried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, chills, and extremely tried. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: SEVERE SIDE EFFECTS POST VACCINATION; 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, intramuscular, batch number: Unknown) 0.5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects post vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain
Clinical narrative: BODY ACHES; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced weakness. Treatment medications (dates unspecified) included: naproxen sodium, and ascorbic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body aches, headache, and weakness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: LEG SORENESS COULD BE DUE TO EXERCISING; MUSCLE SORENESS COULD BE DUE TO EXERCISING; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 03:00:00 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced leg soreness could be due to exercising, and muscle soreness could be due to exercising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle soreness could be due to exercising and leg soreness could be due to exercising was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: CRAPPY; 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, 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 crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crappy was not reported. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: ITCHINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced itchiness. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-MAR-2021, and nausea on 07-MAR-2021, and had not recovered from itchiness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Pyrexia
Clinical narrative: STOMACH PAINS; FEVER; HEADACHE; FATIGUE; 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, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced stomach pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, and fatigue, and had not recovered from stomach pains. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Application site pain, Arthralgia, Body temperature, Chills, Dyspnoea
Clinical narrative: RUNNY NOSE; MILD SHORTNESS OF BREATH; CHILLS; SHOULDER PAIN; HEADACHE; MILD FEVER; LOCAL ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced shoulder pain. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced mild fever. On 10-MAR-2021, the subject experienced local arm pain. Laboratory data included: Body temperature (NR: not provided) 99.0 UNITS UNSPECIFIED, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced mild shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, shoulder pain, headache, and local arm pain on 10-MAR-2021, was recovering from mild fever, and had not recovered from runny nose, and mild shortness of breath. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Oxygen saturation, Pyrexia, Rhinorrhoea
Clinical narrative: RUNNY NOSE; MILD SHORTNESS OF BREATH; CHILLS; SHOULDER PAIN; HEADACHE; MILD FEVER; LOCAL ARM PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known drug allergies. .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced shoulder pain. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced mild fever. On 10-MAR-2021, the subject experienced local arm pain. Laboratory data included: Body temperature (NR: not provided) 99.0 UNITS UNSPECIFIED, Oxygen saturation (NR: not provided) Normal, and Pulse rate (NR: not provided) Normal. On 11-MAR-2021, the subject experienced runny nose. On 11-MAR-2021, the subject experienced mild shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, shoulder pain, headache, and local arm pain on 10-MAR-2021, was recovering from mild fever, and had not recovered from runny nose, and mild shortness of breath. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: CRAPPY; 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, intramuscular, batch number: Unknown) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On 10-MAR-2021, the patient experienced crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of crappy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no drug or non-drug allergies. 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 11-MAR-2021, the subject experienced body aches. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced fever. On 11-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 fever, body aches, nausea, and chills. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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, intramuscular, batch number: 1805025,  expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anaemia, Diarrhoea, Fatigue, Muscle spasms, Myalgia
Clinical narrative: CALF CRAMPS; MUSCLE PAIN; NAUSEA; DIARRHOEA; FATIGUED; ARM HURT; ANEMIC; VACCINATION SITE BUMP; VACCINATION SITE RASH; 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, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced anemic. On MAR-2021, the subject experienced vaccination site bump. On MAR-2021, the subject experienced vaccination site rash. On 07-MAR-2021, the subject experienced arm hurt. On 08-MAR-2021, the subject experienced fatigued. On 09-MAR-2021, the subject experienced diarrhoea. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced calf cramps. On 10-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurt, fatigued, nausea, diarrhoea, and calf cramps, had not recovered from muscle pain, and the outcome of vaccination site bump, anemic and vaccination site rash was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vaccination site mass, Vaccination site rash
Clinical narrative: CALF CRAMPS; MUSCLE PAIN; NAUSEA; DIARRHOEA; FATIGUED; ARM HURT; ANEMIC; VACCINATION SITE BUMP; VACCINATION SITE RASH; 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, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced anemic. On MAR-2021, the subject experienced vaccination site bump. On MAR-2021, the subject experienced vaccination site rash. On 07-MAR-2021, the subject experienced arm hurt. On 08-MAR-2021, the subject experienced fatigued. On 09-MAR-2021, the subject experienced diarrhoea. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced calf cramps. On 10-MAR-2021, the subject experienced muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from arm hurt, fatigued, nausea, diarrhoea, and calf cramps, had not recovered from muscle pain, and the outcome of vaccination site bump, anemic and vaccination site rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: MILD HEADACHE; TIREDNESS; 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 seasonal allergies, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the patient experienced mild headache. On 11-MAR-2021, the patient experienced tiredness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from mild headache, and tiredness. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling drunk, Headache
Clinical narrative: DIZZINESS; DRUNK FEELING; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, arthritis, asthma, and sulfa allergy, and other pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with amlodipine besilate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced dizziness. On 11-MAR-2021, the subject experienced drunk feeling. On 11-MAR-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from slight headache, and had not recovered from dizziness, and drunk feeling. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: UNSPECIFIED SIDE EFFECTS OF VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, 1 total, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced unspecified side effects of vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified side effects of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: HIVES WHERE THE INJECTION WAS GIVEN; HIVES UNDER LEFT EAR; 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 allergy to strawberry/allergy to chocolate/allergy to shellfish, and tylenol with codeine allergy. The patient experienced drug allergy when treated with codeine, and paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced hives where the injection was given. On 11-MAR-2021, the subject experienced hives under left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives where the injection was given, and hives under left ear. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: SLIPPED OUT OF BED AND COULDN'T GET UP OFF FLOOR; This spontaneous report received from a consumer concerned a White, Not Hispanic/Latino 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: 1805022, and batch number: 1805022 expiry: UNKNOWN) 0.5 ml, administered on 09-MAR-2021 10:00 am to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021 20:00 pm , the patient experienced slipped out of bed and couldn't get up off floor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slipped out of bed and couldn't get up off floor on 09-MAR-2021. This report was non-serious
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Neck pain, Off label use
Clinical narrative: LOW GRADE FEVER; NECK SORENESS; DIZZINESS; FATIGUE; SHOULDER SORENESS; INDIVIDUAL 16 YEARS OF AGE  RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 09-MAR-2021, the subject experienced off label use. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced neck soreness. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced shoulder soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, neck soreness, dizziness, fatigue, shoulder soreness, off label use and individual 16 years of age received vaccine was not reported. This report was non-serious.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: LOW GRADE FEVER; NECK SORENESS; DIZZINESS; FATIGUE; SHOULDER SORENESS; INDIVIDUAL 16 YEARS OF AGE  RECEIVED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 16 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced individual 16 years of age received vaccine. On 09-MAR-2021, the subject experienced off label use. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced neck soreness. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced shoulder soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low grade fever, neck soreness, dizziness, fatigue, shoulder soreness, off label use and individual 16 years of age received vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: ADMINISTER EXTRA DOSE FROM THE VIAL; 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 ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) 1 ml, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced administer extra dose from the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administer extra dose from the vial was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: DRUG ADMINISTERED TOO HIGH UP IN ARM,BARELY TWO FINGERS DOWN; 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, intramuscular, batch number: Unknown) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the patient experienced drug administered too high up in arm, barely two fingers down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug administered too high up in arm,barely two fingers down was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasal congestion, Oropharyngeal pain
Clinical narrative: CONGESTION; SORE THROAT; TIREDNESS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included fatigued, and soreness in throat, and concurrent conditions included alcohol use, and weather changes causes allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: guaifenesin. On 09-MAR-2021, the subject experienced congestion. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, congestion, and sore throat. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Pain, Pain in extremity
Clinical narrative: SORE ARM; PAIN; REDNESS AT INJECTION SITE; This spontaneous report received from a patient via a company representative 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) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm, pain, and redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, pain and redness at injection site was not reported. This report was non-serious.; Reporter's Comments: This is a case of multiple patient.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE; 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 ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and expiry: UNKNOWN) .5 ml, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity
Clinical narrative: CHILLS; SEVERE PAIN IN UPPER RIGHT LEG; slight headache; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included upper right leg pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) .5 ml, administered on 09-MAR-2021 03:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chills, slight headache, and severe pain in upper right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, slight headache and severe pain in upper right leg was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Fatigue, Hyperhidrosis
Clinical narrative: LOSS OF TASTE; SWEATING; CHILLS; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and chills on 10-MAR-2021, and had not recovered from loss of taste, and tiredness. This report was non-serious.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Tenderness
Clinical narrative: INJECTION SITE PAIN; HEADACHE; TIREDNESS; SORE TO TOUCH; This spontaneous report received from a consumer concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included stroke, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022) .5 ml, administered on 05-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced injection site pain. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced tiredness. On 06-MAR-2021, the subject experienced sore to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, tiredness, and sore to touch. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Hyperhidrosis, Loss of consciousness, Rash macular
Clinical narrative: Systemic: After patient was directed to sit down for 15 min to be observed. A few min after patient sat down in chair he passed out and fell off his chair. Nurse gave epipen called 911. Had scrape on R front scalp and some blood on nostril.-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: Patient reported that he had a phobia of needles prior to vaccination. Vaccine was given at approximately 2:50pm. After he fell, the nurse noted he was face down. The nurse asked him to roll on his back and he responded after a few moments. His skin was red, blotchy, and sweaty. Patient said that he was ok and didn't want to get sent to ER. Epipen was administered at 3:02pm on 3/17/21 and ambulance arrived 3:07pm. The nurse noted some improvement but pt was complaining of hand and arm pain.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Blood folate normal, Blood thyroid stimulating hormone normal, Fatigue, Full blood count normal, Glycosylated haemoglobin
Clinical narrative: Severe ongoing fatigue and myalgia post second COVID vaccine injection
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Metabolic function test, Myalgia, Vitamin B12 normal, Vitamin D
Clinical narrative: Severe ongoing fatigue and myalgia post second COVID vaccine injection
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Vomiting for 3 days. Body aches.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: I was extremely fatigued with muscle soreness especially in my left arm pit. As of 4/18/2021 I noticed a large knot/lymph node in my arm pit and the soreness was constant.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Flushing, Hyperhidrosis, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Oligomenorrhoea
Clinical narrative: My menstral cycle started 7 days early which was 6 days after the 2nd dose. It was large clumps not a normal flow for a week then my regular period came. In total My menstral cycle lasted 10 days and is normally 4. Im still spotting and it has been 2weeks 3 days since shot.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Peripheral venous disease, Ultrasound Doppler, Ultrasound scan
Clinical narrative: This vaccine altered me, nor did I know, that I had a venous insufficiency condition. It attacked the affected areas.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dizziness exertional, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: patient complainted of rash, swelling, no pain, lack of energy and loss of appetide-Medium
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: patient complainted of rash, swelling, no pain, lack of energy and loss of appetide-Medium
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Chills, Fever, Nausea, Weakness in limbs, Very Sore Arm
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest X-ray, Chest discomfort, Chest pain, Dizziness
Clinical narrative: per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Full blood count, Hot flush, Metabolic function test, Pharyngeal swelling
Clinical narrative: per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Troponin
Clinical narrative: per patients mother: pt had complained of dizzyness right after leaving clininc. Mother was driving, she said that about 5 minutes later pt started getting hot flashes and had developed a rash across chest, decided to drive to hospital on the way there she progressively got worse she started to complaine of chest tightness/pain. once at ER she double over from severe stomach pain-said it felt like she had to go to the bathroom. Mom said that things quickly worsened. She started to have throat swelling. Epinepherine was administered and IV benedryl, pt stayed in ER and was observed for several hours. Mom reports they were sent home around 4pm and around 7320pm that night pt started feeling tightness in her chest and difficulty breathing mom gave epinephirine and called 911. EMT's transported her back to ER. She was stablized and sent home. pt continued to have these episodes of Chest tightening and difficulty breathing resulting in several more visits to the ER and one over night stay. Last visit to the Hopsital was on 4/15/21
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Head injury, Swelling face, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient felt dizzy/light-headed within 1-2 minutes of receiving his 2nd dose of Moderna vaccine on 4/18/21 at ~12:30pm. Patient stood up from the waiting area, walked approximately 20 feet to the pharmacy window to request assistance where he fainted and hit his head on the counter ledge. He has a raised bump (approximately 2 inches wide) on his right temple above his eyebrow. Patient remained conscious, received water/juice/granola bar & was monitored by the RPh for an additional 30-40 minutes.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Myalgia
Clinical narrative: NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination.  Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: NAUSEA; HEADACHE; INJECTION SITE PAIN; BODY ACHE; ARM HURT; CHILLS; JOINT PAIN; MYALGIA; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 125 pounds, and height was 174 centimeters. The patient's concurrent conditions included no alcohol user, and non smoker. The patient experienced drug allergy when treated with tetracycline.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: 25/MAY/2021) dose was not reported, administered on 10-MAR-2021 11:00 for prophylactic vaccination.  Concomitant medications included ascorbic acid/calcium/minerals nos/retinol/tocopheryl acetate/vitamin b nos/vitamins nos/zinc for drug used for unknown indication, calcium carbonate/colecalciferol for drug used for unknown indication, vitamin c for drug used for unknown indication, alendronate sodium for osteoporosis, nebivolol hydrochloride for slow heart down, aloe vera, and chondroitin sulfate/collagen/glucosamine. On 10-MAR-2021, the subject experienced body ache. On 10-MAR-2021, the subject experienced arm hurt. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced joint pain. On 10-MAR-2021, the subject experienced myalgia. On 10-MAR-2021 15:00, the subject experienced nausea. On 10-MAR-2021 12:30, the subject experienced headache. On 10-MAR-2021, the subject experienced injection site pain.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, arm hurt, chills, myalgia, nausea, joint pain, and injection site pain. and headache on 11-MAR-2021 This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Haematochezia, Hyperkalaemia
Clinical narrative: Patient admitted to hospital due to hyperkalemia; called to come to hospital based on labs from hemodialysis session a day prior- 3/21/21. Patient also complaining of bright red blood with bowel movement and weakness. Patient reports non compliance with medications and diet. Hyperkalemia treated and resolved. Evaluated by cardiology for halter monitor- will follow-up as an outpatient.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fever (102.3 at highest), chills, nauseous (threw up twice), sore arm, fatigue
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever (102.3 at highest), chills, nauseous (threw up twice), sore arm, fatigue
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Systemic: pain and warm to touch on the injection site-Medium, Additional Details: patient states she's getting better everyday and taking tylenol helps
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Muscle aches chills Fatigue Injection site pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Dizziness, Full blood count normal, Headache, Metabolic function test
Clinical narrative: This patient presented with my ER on 16APR21 with headache, lightheadedness, nausea, every day since vaccination which was  on the 9th of April.  This may be a duplicate, but I was advised to place the report regardless as the symptoms are persisting.  The patients symptoms nearly resolved after Tylenol and IV fluids.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urine analysis normal
Clinical narrative: This patient presented with my ER on 16APR21 with headache, lightheadedness, nausea, every day since vaccination which was  on the 9th of April.  This may be a duplicate, but I was advised to place the report regardless as the symptoms are persisting.  The patients symptoms nearly resolved after Tylenol and IV fluids.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: After vaccination around 4:30 pm, patient fainted briefly and became alert again after attending to him. Patients says he sometimes feels dizzy after giving blood or other vaccinations. He said he felt okay after we gave him water and candy, and elevated his legs when he lied down.  No epipen was given. Patient felt ok to go home without any assistance.
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: RAISED BUMP AT VACCINATION SITE; 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: 1802068, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced raised bump at vaccination site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raised bump at vaccination site was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Consciousness fluctuating
Clinical narrative: Pt. observed coming in and out of consciousness.  Pt. remains unstable and transported to Medical Center.  90/40, HR 32,  RR 22.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Product administered at inappropriate site
Clinical narrative: Redness and swelling at injection site
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Headache 10:30 a.m./chills 11:00 a.m./ temperature taken 11:10 a.m. 102.3/general fatigue  Fever broke 6:00 p.m. same day, chills went away.  Woke up on April 4, no symptoms
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Open reduction of fracture, Patella fracture, X-ray limb abnormal
Clinical narrative: Patient brought to Emergency Department due to knee pain after sustaining a fall 2 days prior to arrival- patient tripped over bump on sidewalk. No loss of conciseness. XR showed right patella fracture, received surgical intervention- ORIF.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Altered state of consciousness, Balance disorder, Disorientation, Dizziness, Face injury
Clinical narrative: Woke up at 4am went to pee and felt dizzy disoriented and almost as if hallucinating. Starting to lose balance and go in and out of consciousness for a few seconds, hitting walls in bathroom with face then exited  bathroom and fainted and was unconscious for 30ish seconds. Wife called 911 emt came blood pressure was low around 90/48. Went to PCP at 230pm later that day and blood pressure back to normal and no other issues found
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Woke up at 4am went to pee and felt dizzy disoriented and almost as if hallucinating. Starting to lose balance and go in and out of consciousness for a few seconds, hitting walls in bathroom with face then exited  bathroom and fainted and was unconscious for 30ish seconds. Wife called 911 emt came blood pressure was low around 90/48. Went to PCP at 230pm later that day and blood pressure back to normal and no other issues found