chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: flu-like symptoms; chills; HEAT (FELT EXTREMELY HOT); fever; ache; in and out feeling of hot and cold; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 15:00 to left arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, at 3 the subject experienced flu-like symptoms. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, at 6,the subject experienced heat (felt extremely hot). On 12-MAR-2021,at 6 the subject experienced fever. On 12-MAR-2021, at 6 the subject experienced ache. On 12-MAR-2021, the subject experienced in and out feeling of hot and cold. Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, ache, and heat (felt extremely hot), and the outcome of flu-like symptoms and in and out feeling of hot and cold was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Convalescent plasma transfusion, Headache, Nausea, Pain
Clinical narrative: BODY ACHES; VOMITING; CHILLS; FEVER; NAUSEA; HEADACHE; 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 covid-19, and concurrent conditions included heart disease. 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 10-MAR-2021 08:45 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On DEC-2020, Laboratory data included: Convalescent plasma transfusion (NR: not provided) still have antibodies present. On 10-MAR-2021 16:30, the subject experienced body aches. On 10-MAR-2021 16:30, the subject experienced vomiting. On 10-MAR-2021 16:30, the subject experienced chills. On 10-MAR-2021 16:30, the subject experienced fever. On 10-MAR-2021 16:30, the subject experienced nausea. On 10-MAR-2021 16:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-MAR-2021, and was recovering from body aches, chills, nausea, vomiting, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: BODY ACHES; VOMITING; CHILLS; FEVER; NAUSEA; HEADACHE; 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 covid-19, and concurrent conditions included heart disease. 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 10-MAR-2021 08:45 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On DEC-2020, Laboratory data included: Convalescent plasma transfusion (NR: not provided) still have antibodies present. On 10-MAR-2021 16:30, the subject experienced body aches. On 10-MAR-2021 16:30, the subject experienced vomiting. On 10-MAR-2021 16:30, the subject experienced chills. On 10-MAR-2021 16:30, the subject experienced fever. On 10-MAR-2021 16:30, the subject experienced nausea. On 10-MAR-2021 16:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 12-MAR-2021, and was recovering from body aches, chills, nausea, vomiting, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Diarrhoea, Pain
Clinical narrative: BODY ACHES; DIARRHEA; CHILLS; TEMP 99.2; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to codeine ivp dye.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, expiry: UNKNOWN) .5 ml, administered on 12-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced diarrhea. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced temp 99.2. On 12-MAR-2021, the subject experienced body aches. Laboratory data included: Body temperature (NR: not provided) 99.2 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the diarrhea, chills, temp 99.2 and body aches was not reported. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Injection site pain, Pain
Clinical narrative: ACHY; SLIGHT HEADACHE; SHOULDER PAIN AT INJECTION SITE; WEAK; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced achy. On 11-MAR-2021, the subject experienced slight headache. On 11-MAR-2021, the subject experienced shoulder pain at injection site. On 11-MAR-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy, slight headache, shoulder pain at injection site, and weak. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: ACHES/BODY ACHE; HEADACHE; FEVER; BURNING SENSATION ON INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 08-MAR-2021, the subject experienced burning sensation on injection site. On 09-MAR-2021, the subject experienced aches/body ache. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/body ache, headache, and fever on 13-MAR-2021, and burning sensation on injection site on 08-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: FEVER; BODY ACHES; HEADACHE; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced body aches. On 12-MAR-2021, the subject experienced headache. On 13-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, and body aches. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Fatigue, Headache, Heart rate irregular
Clinical narrative: HEART RACING; HEART IRREGULAR; CHILLS; HEADACHE; FATIGUE; SORE ARM; VOMITING; SORE FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:45 in right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced sore face. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart racing (NR: not provided) 100 beats per minute. On 12-MAR-2021 17:00, the subject experienced heart racing. On 12-MAR-2021 17:00, the subject experienced heart irregular. On 12-MAR-2021 17:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart racing, vomiting, sore arm, sore face, fatigue, and heart irregular, and the outcome of headache and chills was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as Nonserious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Vomiting
Clinical narrative: HEART RACING; HEART IRREGULAR; CHILLS; HEADACHE; FATIGUE; SORE ARM; VOMITING; SORE FACE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 13:45 in right arm for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced sore face. On 12-MAR-2021, the subject experienced sore arm. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced fatigue. Laboratory data included: Heart racing (NR: not provided) 100 beats per minute. On 12-MAR-2021 17:00, the subject experienced heart racing. On 12-MAR-2021 17:00, the subject experienced heart irregular. On 12-MAR-2021 17:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from heart racing, vomiting, sore arm, sore face, fatigue, and heart irregular, and the outcome of headache and chills was not reported. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as Nonserious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: HEADACHE; HIGH BODY TEMPERATURE; CHILLS; This spontaneous report received from a consumer concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included undergoing cancer treatment, controlled hypertension, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 12-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced high body temperature. On 12-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 103 (unit unspecified), around 101.8 (unit unspecified). On 13-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 13-MAR-2021, and had not recovered from high body temperature, and headache. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Nausea, Pain in extremity, Pyrexia
Clinical narrative: FLU HIT ME; LOW GRADE FEVER; NAUSEA; SORE ARM; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included diabetes, copd, emhysema, cardiovascular issue, peipheral artery disease, b/l lower extremities, rheumatoid artheritis, fibromylgia, chronic pain, asthma, smoker, shell fish allergy, sulfa allergy, iodine allergy, codein allergy, and pcn allergy. The patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced low grade fever. On 10-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced flu hit me. On 10-MAR-2021, the subject experienced sore arm. Laboratory data included: Body temperature (NR: not provided) 98.9 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, nausea, and flu hit me on 10-MAR-2021, and the outcome of sore arm was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SITE SORENESS; This spontaneous report received from a patient concerned an 81 year old male. The patient's height, and weight were not reported. The patient's past medical history included injured trapezius.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for drug used for unknown indication, and clopidogrel bisulfate for drug used for unknown indication. On 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM AND LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced arm and leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm and leg pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: STILL ACHY EVERYTHING HURTS  INSIDE AND OUT; DIZZINESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-MAR-2021, the subject experienced still achy everything hurts inside and out. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from still achy everything hurts inside and out, and fever, and the outcome of headache and dizziness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; ARM SORENESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced arm soreness. On 14-MAR-2021, the subject experienced headache. On 14-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches, chills, headache, fever and arm soreness was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: CHEST PAIN IN THE MIDDLE OF CHEST; FELT TERRIBLE; ACHES ALL OVER; EXTREMELY TIRED; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was not reported and height was 63 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced felt terrible. On 11-MAR-2021, the subject experienced aches all over. On 11-MAR-2021, the subject experienced extremely tired. On 11-MAR-2021, the subject experienced terrible headache. On 12-MAR-2021, the subject experienced chest pain in the middle of chest. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible headache on 12-MAR-2021, was recovering from extremely tired, and felt terrible, had not recovered from chest pain in the middle of chest, and the outcome of aches all over was not reported. This report was non-serious.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling, Rash
Clinical narrative: HANDS SWOLLEN; RASH ON ARMS, THIGHS, BOTH FEET AND HANDS; JOINTS HURT; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with doxycycline. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced rash on arms, thighs, both feet and hands. On 13-MAR-2021, the subject experienced joints hurt. On 14-MAR-2021, the subject experienced hands swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on arms, thighs, both feet and hands, hands swollen, and joints hurt. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: TENDERNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced tenderness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tenderness at injection site was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: SWOLLEN UNDERAM; PAINFUL/SORE UNDERARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-MAR-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced swollen underam. On 12-MAR-2021, the subject experienced painful/sore underarm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen underam, and painful/sore underarm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included not menstruated. 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 08-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number.  No concomitant medications were reported. On 12-MAR-2021, the subject experienced menstrual bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from menstrual bleeding. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Pain, Pain in extremity
Clinical narrative: SORENESS OF LEFT ARM; BODY ACHES; HEADACHE; BURNING SENSATION ON INJECTION SITE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported has been requested On 08-MAR-2021, the subject experienced burning sensation on injection site. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced headache. Treatment medications included: ibuprofen. On 11-MAR-2021, the subject experienced soreness of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 10-MAR-2021, and burning sensation on injection site, and headache on 11-MAR-2021, and was recovering from soreness of left arm. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Peripheral coldness
Clinical narrative: CHILLS; COLD HANDS; FATIGUE; LOSS OF APPETITE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.T The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-MAR-2021, the subject experienced chills. On 14-MAR-2021, the subject experienced cold hands. On 14-MAR-2021, the subject experienced fatigue. On 14-MAR-2021, the subject experienced loss of appetite. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, cold hands, fatigue and loss of appetite was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Insomnia, Piloerection, Rash
Clinical narrative: RASH; HEADACHE; BACK ACHE; GOOSE BUMPS; INSOMNIA; This spontaneous report received from a patient concerned a 42 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced insomnia. On 10-MAR-2021, the subject experienced goose bumps. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced backache. On 12-MAR-2021, the subject experienced rash. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from headache, backache, and insomnia on 11-MAR-2021, and goose bumps on 10-MAR-2021, and had not recovered from rash. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Heart rate, Heart rate increased
Clinical narrative: HEART RATE INCREASED; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1502072, and batch number: 1502072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:05, the subject experienced heart rate increased. On 11-MAR-2021 21:05, the subject experienced chills. On 11-MAR-2021 21:05, the subject experienced fever. On 11-MAR-2021 21:05, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 106.7 (units unspecified), and Heart rate (NR: not provided) 120 (units unspecified), 65 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEART RATE INCREASED; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non-drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1502072, and batch number: 1502072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:05, the subject experienced heart rate increased. On 11-MAR-2021 21:05, the subject experienced chills. On 11-MAR-2021 21:05, the subject experienced fever. On 11-MAR-2021 21:05, the subject experienced headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 106.7 (units unspecified), and Heart rate (NR: not provided) 120 (units unspecified), 65 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate increased, and chills on 12-MAR-2021, was recovering from fever, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Headache; Fatigue; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 11-MAR-2021 16:30 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced dizziness. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, headache and fatigue was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: DIARRHEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805za, and batch number: 1805ZA expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAR-2021, the subject experienced diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 12-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm
Clinical narrative: SUNBURN-LOOKING SPOT (UNDERNEATH LEFT ARM & LEFT BREAST); WARM TO TOUCH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and non smoker. The patient experienced drug allergy when treated with diphenhydramine hydrochloride, and dextropropoxyphene hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 00:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 13-MAR-2021, the subject experienced sunburn-looking spot (underneath left arm & left breast). On 13-MAR-2021, the subject experienced warm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sunburn-looking spot (underneath left arm & left breast), and warm to touch. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: DENTURES MADE GAG AFTER RECEIVING VACCINE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included spinal issues 7 surgeries,, and concurrent conditions included ex-smoker, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no known 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: 1805020, and batch number: 1805020 expiry: 01/MAY/2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced dentures made gag after receiving vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dentures made gag after receiving vaccine. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808020,  expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021 21:00, the subject experienced body aches. On 11-MAR-2021 21:00, the subject experienced chills. On 11-MAR-2021 21:00, the subject experienced headache. On 11-MAR-2021 21:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 12-MAR-2021, and fever on 11-MAR-2021, and had not recovered from body aches. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 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 leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Pyrexia, Tinnitus
Clinical narrative: LOSS OF APETITE; TINNITUS RINGING IN EARS; HEADACHE; LEG PAIN; HEAVINESS; LOSS OF ENERGY; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 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 leg pain. On 06-MAR-2021, the subject experienced heaviness. On 06-MAR-2021, the subject experienced loss of energy. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. On 06-MAR-2021, the subject experienced tired. On 07-MAR-2021, the subject experienced tinnitus ringing in ears. On 07-MAR-2021, the subject experienced loss of apetite. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg pain, heaviness, and chills on 07-MAR-2021, and fever, and headache on 09-MAR-2021, was recovering from tinnitus ringing in ears, and had not recovered from tired, loss of apetite, and loss of energy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: DELAYED TYPE HYPERSENSITIVITY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced delayed type hypersensitivity. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from delayed type hypersensitivity. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: FEVER; MUSCLE ACHES; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced muscle aches. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, muscle aches, headache, and nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Retching, Tremor
Clinical narrative: VOMITING; NAUSEA; FEVER; CHILLS; DRY HEAVING; SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced dry heaving. On MAR-2021, the subject experienced shaking. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, and had not recovered from chills, dry heaving, nausea, shaking, and vomiting. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; NAUSEA; FEVER; CHILLS; DRY HEAVING; SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced dry heaving. On MAR-2021, the subject experienced shaking. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced vomiting. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on MAR-2021, and had not recovered from chills, dry heaving, nausea, shaking, and vomiting. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: HARD-QUARTER SIZED LUMP UNDER SKIN AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On an unspecified date, the subject experienced hard-quarter sized lump under skin at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard-quarter sized lump under skin at injection site. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: HEADACHE; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced did not feel well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and did not feel well was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased
Clinical narrative: ELEVATED C-REACTIVE PROTEIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced elevated c-reactive protein. Laboratory data included: C-reactive protein (NR: not provided) 12 mg/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated c-reactive protein was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 05:15 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021 11:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.   .
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Headache, Injection site swelling, Insomnia
Clinical narrative: CHILLS; INFLAMED LEFT ARM FROM SITE OF  INJECTION; NAUSEA; HEADACHE; PAIN RADIATING FROM PREVIOUS COLLAR BONE INJURY; MIGRAINE; LEFT-SIDE OF BODY ACHING; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included exposure to covid-19, and collar bone injury, and concurrent conditions included diabetic, and other pre-existing medical conditions included patient had no known drug allergies .she was taking pain medication for back and fee (using for 13 years).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced pain radiating from previous collar bone injury. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced left-side of body aching. On 09-MAR-2021, the subject experienced couldn't sleep. On 09-MAR-2021, the subject experienced inflamed left arm from site of injection. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021 02:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left-side of body aching, couldn't sleep, chills, inflamed left arm from site of injection, and nausea on 09-MAR-2021, and had not recovered from headache, pain radiating from previous collar bone injury, and migraine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pain
Clinical narrative: CHILLS; INFLAMED LEFT ARM FROM SITE OF  INJECTION; NAUSEA; HEADACHE; PAIN RADIATING FROM PREVIOUS COLLAR BONE INJURY; MIGRAINE; LEFT-SIDE OF BODY ACHING; COULDN'T SLEEP; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included exposure to covid-19, and collar bone injury, and concurrent conditions included diabetic, and other pre-existing medical conditions included patient had no known drug allergies .she was taking pain medication for back and fee (using for 13 years).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced pain radiating from previous collar bone injury. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced left-side of body aching. On 09-MAR-2021, the subject experienced couldn't sleep. On 09-MAR-2021, the subject experienced inflamed left arm from site of injection. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021 02:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left-side of body aching, couldn't sleep, chills, inflamed left arm from site of injection, and nausea on 09-MAR-2021, and had not recovered from headache, pain radiating from previous collar bone injury, and migraine. This report was non-serious.