chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Confusional state, Dizziness
Clinical narrative: CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever.  On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever.  On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever.  On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 05/26/2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 29-MAY-2021, the subject experienced administered expired vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Pain
Clinical narrative: BODY ACHES; HEADACHES; BOTTOM LIP TWITCHING ON AND OFF; This spontaneous report received from a patient concerned a 28 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, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced bottom lip twitching on and off. On 29-MAY-2021, the subject experienced body aches. On 29-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headaches on MAY-2021, and had not recovered from bottom lip twitching on and off. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous report received from a patient 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 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 MAY-2021, the subject experienced brownish and scaly rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brownish and scaly rash was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity
Clinical narrative: LUMP IN LEFT ARM; SORENESS IN LEFT ARM; This spontaneous report received from a patient 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced lump in left arm. On 12-MAY-2021, the subject experienced soreness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump in left arm, and soreness in left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash
Clinical narrative: BRUISING ON ANKLES; RED SPOTS ON LEGS; This spontaneous report received from a patient concerned a 45 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced bruising on ankles. On 29-MAY-2021, the subject experienced red spots on legs.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spots on legs, and bruising on ankles. This report was non-serious.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Somnolence
Clinical narrative: SLEEPY; TIRED; This spontaneous report received from a patient concerned a 94 year old female. The patient's weight was 137 pounds, and height was not reported. The patient's concurrent conditions included atrial fibrillation, oral cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergies but can not remember which allergies patient had. patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem for atrial fibrillation, acetylsalicylic acid, biotin, calcium carbonate/magnesium hydroxide/zinc, colecalciferol, glucosamine hydrochloride, glucosamine sulfate, magnesium, and nutrients nos. On 29-MAY-2021, the subject experienced sleepy. On 29-MAY-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy, and tired. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: STOMACH PAIN; VOMITING; DIARRHEA; NAUSEA; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced muscle aches. Treatment medications included: paracetamol. On 27-MAY-2021, the subject experienced stomach pain. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches on 26-MAY-2021, had not recovered from stomach pain, vomiting, and diarrhea, and the outcome of nausea was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: STOMACH PAIN; VOMITING; DIARRHEA; NAUSEA; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid.  On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced muscle aches. Treatment medications included: paracetamol. On 27-MAY-2021, the subject experienced stomach pain. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches on 26-MAY-2021, had not recovered from stomach pain, vomiting, and diarrhea, and the outcome of nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: THE SYRINGE WAS DEFECTIVE; 0.1 ML OF VACCINE WAS GIVEN DUE TO DEFECTIVE SYRINGE; 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) .1 ml, administered on 29-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAY-2021, the subject experienced 0.1 ml of vaccine was given due to defective syringe. On an unspecified date, the subject experienced the syringe was defective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 0.1 ml of vaccine was given due to defective syringe and the syringe was defective was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 04219-21A,  expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood test, Body temperature, Lymphoedema, Pyrexia
Clinical narrative: HORRIBLE BACK PAIN (WITH A PAIN SCALE OF 7.5 OUT OF 10); SWOLLEN POUCH ON LEFT LOWER BACK APPROXIMATELY FOUR INCHES DIAMETER AND THREE INCHES HEIGHT DIAGNOSED AS LYMPHATIC ISSUE DUE TO VACCINE; FEVER OF MORE OR LESS 100 F; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight was 150 pounds, and height was 190 centimeters. The patient's pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced horrible back pain (with a pain scale of 7.5 out of 10). On 24-MAY-2021, the subject experienced swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine. On 24-MAY-2021, the subject experienced fever of more or less 100 f. Laboratory data included: Body temperature (NR: not provided) more or less 100 F. Treatment medications included: paracetamol. On 25-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine on MAY-2021, and was recovering from horrible back pain (with a pain scale of 7.5 out of 10), and fever of more or less 100 f. This report was non-serious. This case, from the same reporter is linked to 20210557778.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's 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: not reported) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious
Sex: M
Vaccine: COVID19
Symptoms: Chills, Limb mass, Pain
Clinical narrative: LUMP IN THE CREASE OF ARM; BODY SORENESS; CHILLS; This spontaneous report received from a consumer concerned a 40 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: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body soreness. On 28-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced lump in the crease of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAY-2021, and had not recovered from lump in the crease of arm, and body soreness. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: SWELLING OF LEGS; 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 used to getting high, and concurrent conditions included citrus acid allergy. 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 swelling of legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling of legs was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Heart rate increased, Hyperhidrosis
Clinical narrative: RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccinations. the patient had no history of allergy to vaccine, drug or food. the patient had no pre-existing acute illness 30 days prior to vaccination. patient had no history of hospitalization in last 30 days, the patient had no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at time of vaccination. the patient was not breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210549259.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Discomfort, Ear pain, Lymph node pain, Lymphadenopathy
Clinical narrative: GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 11:15 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 discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia, Productive cough
Clinical narrative: GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 11:15 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 discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Vaginal haemorrhage
Clinical narrative: HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasal congestion, Nasopharyngitis, Pain
Clinical narrative: LIGHT COUGH; RUNNY NOSE; COLD; NASAL CONGESTION; CHILLS; BODY PAIN; This spontaneous report received from a patient concerned a 45 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, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body pain. On 16-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced light cough. On 28-MAY-2021, the subject experienced runny nose. On 28-MAY-2021, the subject experienced cold. On 28-MAY-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and chills on 16-MAY-2021, and was recovering from light cough, runny nose, cold, and nasal congestion. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: LIGHT COUGH; RUNNY NOSE; COLD; NASAL CONGESTION; CHILLS; BODY PAIN; This spontaneous report received from a patient concerned a 45 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, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body pain. On 16-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced light cough. On 28-MAY-2021, the subject experienced runny nose. On 28-MAY-2021, the subject experienced cold. On 28-MAY-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and chills on 16-MAY-2021, and was recovering from light cough, runny nose, cold, and nasal congestion. This report was non-serious.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Asthenia, COVID-19, Chest pain, Depression
Clinical narrative: suicidal thoughts; Depression; Chest pain; Fingers go numb/my arm feels numb; lack of sleep and sleeping issues; Nightmares; Stressed out; Weakness; Runny Nose; very angry; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2019.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant), DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose), ANGER (very angry) and HEADACHE (Headache). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) and ANGER (very angry) outcome was unknown and DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, COVID-19: positve Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Initial Additional information received On 04-May-2021: Initial Additional information received. On 10-May-2021: Initial Additional information received. On 17-May-2021: Initial Additional information received. On 20-May-2021: Initial Additional information received.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Nightmare, Rhinorrhoea, Sleep disorder
Clinical narrative: suicidal thoughts; Depression; Chest pain; Fingers go numb/my arm feels numb; lack of sleep and sleeping issues; Nightmares; Stressed out; Weakness; Runny Nose; very angry; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2019.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant), DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose), ANGER (very angry) and HEADACHE (Headache). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) and ANGER (very angry) outcome was unknown and DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, COVID-19: positve Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Initial Additional information received On 04-May-2021: Initial Additional information received. On 10-May-2021: Initial Additional information received. On 17-May-2021: Initial Additional information received. On 20-May-2021: Initial Additional information received.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Stress, Suicidal ideation
Clinical narrative: suicidal thoughts; Depression; Chest pain; Fingers go numb/my arm feels numb; lack of sleep and sleeping issues; Nightmares; Stressed out; Weakness; Runny Nose; very angry; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2019.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant), DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose), ANGER (very angry) and HEADACHE (Headache). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) and ANGER (very angry) outcome was unknown and DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, COVID-19: positve Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Initial Additional information received On 04-May-2021: Initial Additional information received. On 10-May-2021: Initial Additional information received. On 17-May-2021: Initial Additional information received. On 20-May-2021: Initial Additional information received.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immune thrombocytopenia, Rash, Thrombocytopenia
Clinical narrative: thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) and IMMUNE THROMBOCYTOPENIA (ITP) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anxiety and Stomachache. Concomitant products included LAMOTRIGINE (LAMICTAL) for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (Petechia rash) and FATIGUE (Tiredness). On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization and medically significant) and IMMUNE THROMBOCYTOPENIA (ITP) (seriousness criteria hospitalization and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), IMMUNE THROMBOCYTOPENIA (ITP), RASH (Petechia rash) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory details was given.  Reportedly, the patient had to go to the hospital for a week and was still being monitored.  Treatment information was given as steroids   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20 May 2021 contain significant information includes updation of 2 more medically significant events and patient was hospitalized for the events too.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Aplastic anaemia, Chills, Feeling cold, Haemoglobin, Peripheral swelling
Clinical narrative: Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor.  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 19-May-2021: Additional information received captured patient demographics.; 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.