chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Injection site bruising, Injection site nodule, Injection site pain, Injection site rash
Clinical narrative: INJECTION SITE BRUISING; INJECTION SITE KNOTTING; INJECTION SITE SORENESS/PAIN; FEVER; COUGH; INJECTION SITE HEAT; INJECTION SITE RASH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site heat. On APR-2021, the subject experienced injection site rash. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site bruising. On 03-APR-2021, the subject experienced injection site knotting. On 03-APR-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 05-APR-2021, was recovering from injection site bruising, injection site soreness/pain, injection site knotting, and cough, and the outcome of injection site rash and injection site heat was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544451.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Pyrexia
Clinical narrative: INJECTION SITE BRUISING; INJECTION SITE KNOTTING; INJECTION SITE SORENESS/PAIN; FEVER; COUGH; INJECTION SITE HEAT; INJECTION SITE RASH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site heat. On APR-2021, the subject experienced injection site rash. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site bruising. On 03-APR-2021, the subject experienced injection site knotting. On 03-APR-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 05-APR-2021, was recovering from injection site bruising, injection site soreness/pain, injection site knotting, and cough, and the outcome of injection site rash and injection site heat was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544451.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Impaired work ability, Influenza
Clinical narrative: BAD CASE OF THE FLU; GOT REALLY SICK; HAD TO TAKE OFF WORK; This spontaneous report received from a patient via a company representative concerned a 34 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced got really sick. On 20-MAY-2021, the subject experienced had to take off work. On an unspecified date, the subject experienced bad case of the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad case of the flu, got really sick and had to take off work was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544577.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included suppressed immune system. 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 headache, and nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE ALMOST KILLED ME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine almost killed me. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine almost killed me was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Herpes zoster, Nausea
Clinical narrative: DIZZINESS; SHINGLES; EXTREME NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, shingles, and extreme nausea. The action taken with covid-19 vaccine  was not applicable. The outcome of the extreme nausea, dizziness and shingles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: ADMINISTERED 2.5ML OF VACCINE; 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  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced administered 2.5ml of vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administered 2.5ml of vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Injection site pain, Pain
Clinical narrative: EXTREMELY SICK; BODY ACHES; HEADACHE; FATIGUE; SEVERE INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 subject experienced extremely sick, body aches, headache, fatigue, severe injection site pain, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely sick, headache, fatigue, severe injection site pain, fever and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: EXTREMELY SICK; BODY ACHES; HEADACHE; FATIGUE; SEVERE INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (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 subject experienced extremely sick, body aches, headache, fatigue, severe injection site pain, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely sick, headache, fatigue, severe injection site pain, fever and body aches was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: HARSH PAIN IN THE SHOULDER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch no was not reported ,The Company is unable to performed follow up to request batch /Lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced harsh pain in the shoulder, and fatigue. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from harsh pain in the shoulder, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: INTENSE BODY ACHES; CHILLS; VERY SORE ARM; TERRIBLE HEADACHE; 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. No past medical history or concurrent conditions were 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 intense body aches, chills, very sore arm, terrible headache, and fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from intense body aches, chills, terrible headache, and fever, and the outcome of very sore arm was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Somnolence
Clinical narrative: SLEEPINESS; VERY SLIGHT ACHES IN THE HIPS; SLIGHT FEVER OF 99; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced sleepiness. On MAY-2021, the subject experienced very slight aches in the hips. On MAY-2021, the subject experienced slight fever of 99. Laboratory data included: Body temperature (NR: not provided) 99. The action taken with covid-19 vaccine  was not applicable. The outcome of the slight fever of 99, very slight aches in the hips and sleepiness was not reported. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT  ADMINISTERED; This spontaneous report received from a health care professional concerned an 18 year old male. The patient's weight was 269 pounds, and height was 70 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient health status was healthy. the patient had no known allergies. the patient have no history of 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: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and allergy to grass. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, administered on 24-MAY-2021 13:15 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced product administered to subject of inappropriate age. On 24-MAY-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product administered to patient of inappropriate age was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nonspecific reaction, Urticaria
Clinical narrative: BAD REACTION; DIFFICULTY BREATHING; HIVES; This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced bad reaction, difficulty breathing, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, difficulty breathing and hives was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAY-2021 for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Toothache
Clinical narrative: EXACTLY, 12 HOURS AFTER STARTED WITH BODY ACHES; TEETH EVEN HURT; HEAD ACHE THAT WAS SO BAD COULD NOT TAKE HEAD OFF THE PILLOW; HAD INTERMITTENT FEVERS FOR ABOUT A WEEK; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced exactly, 12 hours after started with body aches, teeth even hurt, head ache that was so bad could not take head off the pillow, and had intermittent fevers for about a week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exactly, 12 hours after started with body aches, teeth even hurt, head ache that was so bad could not take head off the pillow, and had intermittent fevers for about a week. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: LIGHT HEADEDNESS; BAD HEADACHE; This spontaneous report received from a health care professional concerned a male 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 allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 13-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced light headedness. On 24-MAY-2021, the subject experienced bad headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from light headedness, and bad headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: ADMINISTRATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administration error, and incorrect storage of vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of the administration error and incorrect storage of vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Hepatic enzyme, Hepatic enzyme increased
Clinical narrative: ELEVATED LIVER ENZYMES; This spontaneous report received from a health care professional concerned a 21 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included social alcohol drinker, and non smoker, and other pre-existing medical conditions included the patient had no history of any drug abuse or illicit drug use and no pre-existing conditions.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced elevated liver enzymes. Laboratory data included: Hepatic enzyme (NR: not provided) Elevated liver enzymes. The action taken with covid-19 vaccine  was not applicable. The outcome of elevated liver enzymes was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Nasopharyngitis, Pain
Clinical narrative: BODY ACHES; SHORTNESS OF BREATH; SNEEZING; MUSCLE ACHE; FELT GENERAL TIREDNESS/EXTREME FATIGUE; COLD; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included right sided breast cancer, and torn meniscus surgery, and concurrent conditions included physical therapy. The patient experienced drug allergy when treated with clarithromycin, and cefuroxime axetil. 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold. On 17-MAY-2021, the subject experienced felt general tiredness/extreme fatigue. On 18-MAY-2021, the subject experienced body aches. On 18-MAY-2021, the subject experienced shortness of breath. On 18-MAY-2021, the subject experienced sneezing. On 18-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on MAY-2018, had not recovered from muscle ache, and body aches, and the outcome of shortness of breath, cold and felt general tiredness/extreme fatigue was not reported. This report was non-serious.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: BODY ACHES; SHORTNESS OF BREATH; SNEEZING; MUSCLE ACHE; FELT GENERAL TIREDNESS/EXTREME FATIGUE; COLD; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's past medical history included right sided breast cancer, and torn meniscus surgery, and concurrent conditions included physical therapy. The patient experienced drug allergy when treated with clarithromycin, and cefuroxime axetil. 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 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold. On 17-MAY-2021, the subject experienced felt general tiredness/extreme fatigue. On 18-MAY-2021, the subject experienced body aches. On 18-MAY-2021, the subject experienced shortness of breath. On 18-MAY-2021, the subject experienced sneezing. On 18-MAY-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sneezing on MAY-2018, had not recovered from muscle ache, and body aches, and the outcome of shortness of breath, cold and felt general tiredness/extreme fatigue was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Nausea
Clinical narrative: TIGHTNESS OF CHEST; SHORTNESS OF BREATH; VOMITING; COUGH; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and penicillin allergy. 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 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced tightness of chest. On 16-MAY-2021, the subject experienced shortness of breath. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced cough. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness of chest, shortness of breath, cough, nausea, fatigue, and vomiting. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: TIGHTNESS OF CHEST; SHORTNESS OF BREATH; VOMITING; COUGH; NAUSEA; FATIGUE; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, and penicillin allergy. 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 14-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced tightness of chest. On 16-MAY-2021, the subject experienced shortness of breath. On 16-MAY-2021, the subject experienced vomiting. On 16-MAY-2021, the subject experienced cough. On 16-MAY-2021, the subject experienced nausea. On 16-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tightness of chest, shortness of breath, cough, nausea, fatigue, and vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: ACHES; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 not requested. No concomitant medications were reported. On an unspecified date, the subject experienced aches, fever, and fatigue. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, aches and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included valve replacement surgery, and back surgery, and concurrent conditions included diabetes. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced fever. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient recovered from fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED THAT WAS AT ROOM TEMPERATURE FOR MORE THEN 6 HOURS; VACCINE WAS STORED AT  ROOM TEMPERATURE FOR MORE THAN 6 HOURS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered that was at room temperature for more then 6 hours, and vaccine was stored at room temperature for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered that was at room temperature for more then 6 hours and vaccine was stored at room temperature for more than 6 hours was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dysarthria, Headache
Clinical narrative: SLURRED/STUTTERED SPEECH (ON-AND-OFF); COLD SWEATS; WEAKNESS; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, iodine contrast dye allergy, alcohol non-user, and smoking, and other pre-existing medical conditions included the patient had known drug allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced slurred/stuttered speech (on-and-off). On 24-MAY-2021, the subject experienced cold sweats. On 24-MAY-2021, the subject experienced weakness. On 24-MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slurred/stuttered speech (on-and-off), severe headache, weakness, and cold sweats. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 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 2021, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from side effects on 2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: BODY IS IN PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be  requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body is in pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body is in pain was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Urticaria
Clinical narrative: TROUBLE BREATHING; HIVES; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced trouble breathing. On 09-APR-2021, the subject experienced hives. Treatment medications included: cortisone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine  was not applicable. The patient recovered from trouble breathing, and hives on 10-APR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Limb discomfort, Pain in extremity, Sensory disturbance
Clinical narrative: UNCONTROLLED ITCHING; PAINFUL LEGS; HEAVY LEGS; PAIN INJECTION SITE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: CU516151, and  expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced pain injection site. On 01-MAY-2021, the subject experienced painful legs. On 01-MAY-2021, the subject experienced heavy legs. On 04-MAY-2021, the subject experienced uncontrolled itching. The action taken with covid-19 vaccine was not applicable. The patient recovered from painful legs, and heavy legs on MAY-2021, and pain injection site on 02-MAY-2021, and had not recovered from uncontrolled itching. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Eye irritation, Influenza like illness, Lymphadenopathy
Clinical narrative: SWOLLEN LYMPH NODE; FLU LIKE SYMPTOMS; BURNING EYES; VACCINE KNOCKED ME DOWN; BACK PAIN; HIP PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product intolerance
Clinical narrative: SWOLLEN LYMPH NODE; FLU LIKE SYMPTOMS; BURNING EYES; VACCINE KNOCKED ME DOWN; BACK PAIN; HIP PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from swollen lymph node, flu like symptoms, burning eyes, vaccine knocked me down, back pain, and hip pain. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Purpura
Clinical narrative: LITTLE PAIN IN ARM; RED DOTS ON LEGS LIKE PURPURA; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and non alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, and clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced red dots on legs like purpura. On an unspecified date, the subject experienced little pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in arm, and had not recovered from red dots on legs like purpura. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (Cellulitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Diabetes mellitus, Mental handicap NOS and Reaction to previous exposure to any vaccine (Had a bad reaction to tetanus shot.).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) had resolved.            No relevant concomitant medications were reported. Patient had symptoms of injection site warmth, redness, lump and pain. As per the reporter, the reaction was caused by a scratch not the vaccine, as it hadn't exactly taken place at the injection site.  Treatment information included Ibuprofen, hydrocortisone cream, cold compress and antibiotics. Action taken with mRNA-1273 in response to the events were not applicable.  Company Comment: Based on the reporter's causality (reaction was caused by a scratch not the vaccine) the event is assessed as not related to mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: The diagnosis of the reported events and new treatment were reported.; Sender's Comments: Based on the reporter's causality (reaction was caused by a scratch not the vaccine) the event is assessed as not related to mRNA-1273.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. Event outcome was not reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: This follow-up was received on 20-MAY-2021 with updated route of administration and contact details.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Emotional distress, Feeling abnormal, Illness, Insomnia
Clinical narrative: Eyesight fading in left eye /; This has caused him great distress; Felt sick; Can't sleep; tinnitus; taking his concentration away/ life has been turned upside down; life has been turned upside down / Felt awful / Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Eyesight fading in left eye /) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patients medical history was not provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down) and FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible). In May 2021, the patient experienced VISION BLURRED (Eyesight fading in left eye /) (seriousness criterion medically significant), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep). At the time of the report, VISION BLURRED (Eyesight fading in left eye /), TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down), FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep) outcome was unknown.            Patient received both doses of Moderna Covid-19 vaccine and he reported that he has felt terrible, awful and sick for 4 weeks. He cannot sleep and his eyesight is fading in his left eye. This caused him such great distress. He did not give consent for safety to follow up.   No treatmnent or concomitant medication were reported by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Significant follow up appended to AER; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Eyesight fading in left eye /; This has caused him great distress; Felt sick; Can't sleep; tinnitus; taking his concentration away/ life has been turned upside down; life has been turned upside down / Felt awful / Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Eyesight fading in left eye /) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a and 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patients medical history was not provided.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down) and FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible). In May 2021, the patient experienced VISION BLURRED (Eyesight fading in left eye /) (seriousness criterion medically significant), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep). At the time of the report, VISION BLURRED (Eyesight fading in left eye /), TINNITUS (tinnitus), DISTURBANCE IN ATTENTION (taking his concentration away/ life has been turned upside down), FEELING ABNORMAL (life has been turned upside down / Felt awful / Felt terrible), EMOTIONAL DISTRESS (This has caused him great distress), ILLNESS (Felt sick) and INSOMNIA (Can't sleep) outcome was unknown.            Patient received both doses of Moderna Covid-19 vaccine and he reported that he has felt terrible, awful and sick for 4 weeks. He cannot sleep and his eyesight is fading in his left eye. This caused him such great distress. He did not give consent for safety to follow up.   No treatmnent or concomitant medication were reported by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Significant follow up appended to AER; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start  date of the events, a causal relationship cannot be excluded