chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash erythematous, Restless legs syndrome
Clinical narrative: RASH RESEMBLING A SUN BURN; DIARRHEA; BODY ACHE; CHILLS; FEVER; ASTHMA; RESTLESS LEG SYNDROME; MIGRANE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient experienced drug allergy when treated with cortisone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced asthma. On 08-MAR-2021, the subject experienced restless leg syndrome. On 08-MAR-2021, the subject experienced migrane. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced rash resembling a sun burn. On 09-MAR-2021, the subject experienced diarrhea. On 09-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma, and migrane on 08-MAR-2021, and restless leg syndrome, body ache, and fever on 09-MAR-2021, had not recovered from rash resembling a sun burn, and diarrhea, and the outcome of chills was not reported. 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.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received tylenol (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 11-MAR-2021 for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 805031, and batch number: 805031) dose was not reported, once a total administered on 11-MAR-2021 08:55 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 (units unspecified). Treatment medications included: paracetamol. On 11-MAR-2021 16:30, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s, and tylenol was not applicable. The patient recovered with sequelae from fever on 11-MAR-2021, and had not recovered from chills. This report was non-serious. This case, involving the same patient is linked to 20210322068.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Eye swelling
Clinical narrative: REDNESS AROUND BOTH EYES; SWELLING AROUND BOTH EYES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included some seasonal allergies, and dust allergies, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced redness around both eyes. On 09-MAR-2021, the subject experienced swelling around both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the redness around both eyes and swelling around both eyes was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: COLD; ACHY JOINTS; LOW FEVER; MILD HEADACHE; TIRED; 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: 1805025, and batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 09-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021 18:00, the subject experienced cold. On 09-MAR-2021 18:00, the subject experienced achy joints. On 09-MAR-2021 18:00, the subject experienced low fever. On 09-MAR-2021 18:00, the subject experienced mild headache. On 09-MAR-2021 18:00, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from achy joints, low fever, mild headache, tired, and cold. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling hot, Pyrexia, Tremor
Clinical narrative: TEMP OF 104; SHAKING; WEAKNESS; BODY FELT ON FIRE; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 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 08-MAR-2021, the patient experienced temp of 104. On 08-MAR-2021, the patient experienced shaking. On 08-MAR-2021, the patient experienced weakness. On 08-MAR-2021, the patient experienced body felt on fire. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temp of 104, shaking, weakness and body felt on fire was not reported. 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: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraines.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 08-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 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: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Flushing, Headache
Clinical narrative: FACIAL FLUSHING; SLIGHTLY ELEVATED BLOOD PRESSURE; NIGHT SWEATS; CHILLS; MALAISE; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included patient indicated that when she received allergy shots in the past she would experience some facial flushing &felt similar to how she felt post-janssen vaccine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced facial flushing. On 08-MAR-2021, the subject experienced slightly elevated blood pressure. On 08-MAR-2021, the subject experienced night sweats. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced malaise. On 08-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly elevated blood pressure on 08-MAR-2021, and night sweats on 09-MAR-2021, and was recovering from facial flushing, chills, headache, nausea, and malaise. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Night sweats
Clinical narrative: FACIAL FLUSHING; SLIGHTLY ELEVATED BLOOD PRESSURE; NIGHT SWEATS; CHILLS; MALAISE; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy, and other pre-existing medical conditions included patient indicated that when she received allergy shots in the past she would experience some facial flushing &felt similar to how she felt post-janssen vaccine.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced facial flushing. On 08-MAR-2021, the subject experienced slightly elevated blood pressure. On 08-MAR-2021, the subject experienced night sweats. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced malaise. On 08-MAR-2021, the subject experienced nausea. Treatment medications included: diphenhydramine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from slightly elevated blood pressure on 08-MAR-2021, and night sweats on 09-MAR-2021, and was recovering from facial flushing, chills, headache, nausea, and malaise. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: SHORTNESS OF BREATH WITH EXERCISE; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced shortness of breath with exercise. On 10-MAR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath with exercise, and lightheadedness on 10-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dyspnoea, Fatigue, Migraine
Clinical narrative: MILD SHORTNESS OF BREATH; BODY ACHES; CHILLS; SORE THROAT; RIGHT ARM SORENESS; NAUSEA; FATIGUE; FEVER; MIGRAINE; 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 infection, and concurrent conditions included acid reflux, and migraine.  The patient was previously treated with omeprazole for acid reflux. 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: 31-MAY-2021) dose was not reported, administered on 09-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced right arm soreness. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F. On an unspecified date, the subject experienced mild shortness of breath. Treatment medications (dates unspecified) included: botulinum toxin type a, sumatriptan, and topiramate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, right arm soreness, body aches, chills, fever, sore throat, nausea, and fatigue, and the outcome of mild shortness of breath was not reported. 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: Nausea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: MILD SHORTNESS OF BREATH; BODY ACHES; CHILLS; SORE THROAT; RIGHT ARM SORENESS; NAUSEA; FATIGUE; FEVER; MIGRAINE; 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 infection, and concurrent conditions included acid reflux, and migraine.  The patient was previously treated with omeprazole for acid reflux. 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: 31-MAY-2021) dose was not reported, administered on 09-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced right arm soreness. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F. On an unspecified date, the subject experienced mild shortness of breath. Treatment medications (dates unspecified) included: botulinum toxin type a, sumatriptan, and topiramate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, right arm soreness, body aches, chills, fever, sore throat, nausea, and fatigue, and the outcome of mild shortness of breath was not reported. 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: SARS-CoV-2 test
Clinical narrative: MILD SHORTNESS OF BREATH; BODY ACHES; CHILLS; SORE THROAT; RIGHT ARM SORENESS; NAUSEA; FATIGUE; FEVER; MIGRAINE; 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 infection, and concurrent conditions included acid reflux, and migraine.  The patient was previously treated with omeprazole for acid reflux. 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: 31-MAY-2021) dose was not reported, administered on 09-MAR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 09-MAR-2021, the subject experienced migraine. On 09-MAR-2021, the subject experienced body aches. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced sore throat. On 09-MAR-2021, the subject experienced right arm soreness. On 09-MAR-2021, the subject experienced nausea. On 09-MAR-2021, the subject experienced fatigue. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 10-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F. On an unspecified date, the subject experienced mild shortness of breath. Treatment medications (dates unspecified) included: botulinum toxin type a, sumatriptan, and topiramate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, right arm soreness, body aches, chills, fever, sore throat, nausea, and fatigue, and the outcome of mild shortness of breath was not reported. 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, Chills
Clinical narrative: CHILLS; 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.1 F.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lip swelling, Nausea, Pain, Pyrexia
Clinical narrative: LIP SWELLING; VOMITING; LOW GRADE FEVER; CHILLS; NAUSEA; BODY ACHES TO UPPER THIGHS; This spontaneous report received from a patient via a company representative concerned a 74 year old female. The patient's weight was 116 pounds, and height was 155.44 centimeters. The patient's past medical history included hives, and concurrent conditions included anxiety, waldenstrom, alcohol use, non smoker, sulfa allergy, dog allergy, and cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use, no illness at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included ibrutinib. On 09-MAR-2021, the subject experienced body aches to upper thighs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced lip swelling. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip swelling, and vomiting on 10-MAR-2021, and had not recovered from chills, nausea, low grade fever, and body aches to upper thighs. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: LIP SWELLING; VOMITING; LOW GRADE FEVER; CHILLS; NAUSEA; BODY ACHES TO UPPER THIGHS; This spontaneous report received from a patient via a company representative concerned a 74 year old female. The patient's weight was 116 pounds, and height was 155.44 centimeters. The patient's past medical history included hives, and concurrent conditions included anxiety, waldenstrom, alcohol use, non smoker, sulfa allergy, dog allergy, and cat allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use, no illness at the time of vaccination.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 09:00 for prophylactic vaccination. Concomitant medications included ibrutinib. On 09-MAR-2021, the subject experienced body aches to upper thighs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced nausea. On 10-MAR-2021, the subject experienced lip swelling. On 10-MAR-2021, the subject experienced vomiting. On 10-MAR-2021, the subject experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lip swelling, and vomiting on 10-MAR-2021, and had not recovered from chills, nausea, low grade fever, and body aches to upper thighs. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: RASH THAT LOOKS LIKE WELTS; PAIN AT INJECTION SITE; INJECTION SITE SWOLLEN; INJECTION SITE HARD; 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 hypertension, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 25/MAY/2021) dose was not reported, administered on 06-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced injection site hard. On 07-MAR-2021, the subject experienced pain at injection site. On 07-MAR-2021, the subject experienced injection site swollen. On 10-MAR-2021, the subject experienced rash that looks like welts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain at injection site, and injection site swollen, had not recovered from rash that looks like welts, and the outcome of injection site hard was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE; This spontaneous report received from a vaccine facility 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: 1805022, and batch number: 1805022 expiry: 08-APR-2022) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING CRAPPY; This spontaneous report received from a consumer 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 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 feeling crappy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling crappy was not reported. This report was non-serious.  Additional information was received from physician on 23-MAR-2021 following information was updated and incorporated into case narrative: Vaccine facility details were updated.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: BODY ACHES; SWOLLEN THROAT; CHILLS; FEVER OF 103.8; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin, and allergic to sulfa, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient has no previous history of headaches. she has no food allergies.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 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced swollen throat. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever of 103.8. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103.8. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, was recovering from chills, fever of 103.8, body aches, and nausea, and had not recovered from swollen throat. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: BODY ACHES; SWOLLEN THROAT; CHILLS; FEVER OF 103.8; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin, and allergic to sulfa, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient has no previous history of headaches. she has no food allergies.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 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced swollen throat. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever of 103.8. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103.8. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, was recovering from chills, fever of 103.8, body aches, and nausea, and had not recovered from swollen throat. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Pain, Pyrexia
Clinical narrative: ACHINESS; DISCOMFORT; CHILLS; TIREDNESS; FEVER; This spontaneous report received from a vaccine facility via a company representative concerned an 18 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 allergies. 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 15:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject started having symptoms around 8 pm achiness. On 10-MAR-2021, the subject experienced discomfort. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced tiredness. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient recovered from achiness, discomfort, and chills on 11-MAR-2021, was recovering from tiredness, and had not recovered from fever. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; 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: Unknown) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-MAR-2021, the 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: Dyskinesia, Fatigue, Headache, Hypoaesthesia, Paraesthesia
Clinical narrative: HAND JERKING IN RIGHT HAND; BLURRED VISION; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; EXHAUSTION AND FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021 18:30, the subject experienced hand jerking in right hand. On 06-MAR-2021 18:30, the subject experienced blurred vision. On 06-MAR-2021 18:30, the subject experienced numbness in right arm. On 06-MAR-2021 18:30, the subject experienced tingling in right arm. On 06-MAR-2021 18:30, the subject experienced exhaustion and fatigue. On 06-MAR-2021 18:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion and fatigue, and headache on 08-MAR-2021, was recovering from hand jerking in right hand, and had not recovered from blurred vision, numbness in right arm, and tingling in right arm. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: HAND JERKING IN RIGHT HAND; BLURRED VISION; NUMBNESS IN RIGHT ARM; TINGLING IN RIGHT ARM; EXHAUSTION AND FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021 18:30, the subject experienced hand jerking in right hand. On 06-MAR-2021 18:30, the subject experienced blurred vision. On 06-MAR-2021 18:30, the subject experienced numbness in right arm. On 06-MAR-2021 18:30, the subject experienced tingling in right arm. On 06-MAR-2021 18:30, the subject experienced exhaustion and fatigue. On 06-MAR-2021 18:30, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from exhaustion and fatigue, and headache on 08-MAR-2021, was recovering from hand jerking in right hand, and had not recovered from blurred vision, numbness in right arm, and tingling in right arm. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling hot, Headache, Myalgia
Clinical narrative: CHILLS; MUSCLE ACHE; BODY ACHE; HEADACHE; DIARRHEA; NAUSEA; HOT; RUNNY NOSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced muscle ache. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced hot. On 11-MAR-2021, the subject experienced runny nose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, muscle ache, body ache, diarrhea, nausea, hot, and runny nose, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: CHILLS; MUSCLE ACHE; BODY ACHE; HEADACHE; DIARRHEA; NAUSEA; HOT; RUNNY NOSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced muscle ache. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced hot. On 11-MAR-2021, the subject experienced runny nose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, muscle ache, body ache, diarrhea, nausea, hot, and runny nose, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Fatigue, Headache
Clinical narrative: STOMACH PAIN; FELT VERY LETHARGIC; JOINT PAIN; FELT VERY FATIGUED; HEADACHE; DIFFICULTY SLEEPING; LIGHT HEADED; BODY ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced light headed. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced difficulty sleeping. On 12-MAR-2021, the subject experienced stomach pain. On 12-MAR-2021, the subject experienced felt very lethargic. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced felt very fatigued. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, body ache, headache, joint pain, stomach pain, felt very fatigued, difficulty sleeping, and felt very lethargic. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Pain
Clinical narrative: STOMACH PAIN; FELT VERY LETHARGIC; JOINT PAIN; FELT VERY FATIGUED; HEADACHE; DIFFICULTY SLEEPING; LIGHT HEADED; BODY ACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced light headed. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced difficulty sleeping. On 12-MAR-2021, the subject experienced stomach pain. On 12-MAR-2021, the subject experienced felt very lethargic. On 12-MAR-2021, the subject experienced joint pain. On 12-MAR-2021, the subject experienced felt very fatigued. On 12-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from light headed, body ache, headache, joint pain, stomach pain, felt very fatigued, difficulty sleeping, and felt very lethargic. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Pruritus, Rash, Urticaria
Clinical narrative: HIVES; HEADACHE; ITCHING; RASH; BURNING; 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, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hives, headache, itching, rash, and burning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives, headache, itching, rash and burning was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myalgia, Pain in extremity
Clinical narrative: MODERATE CHEST PAIN; MODERATE UPPER ARM PAIN; FELT LIKE PULLED MUSCLE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, once a total administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced moderate upper arm pain. On 09-MAR-2021, the subject experienced moderate chest pain. On 09-MAR-2021, the subject experienced felt like pulled muscle. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from moderate upper arm pain, moderate chest pain, and felt like pulled muscle. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: MODERATE CHEST PAIN; MODERATE UPPER ARM PAIN; FELT LIKE PULLED MUSCLE; This spontaneous report received from a patient concerned a 66 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, once a total administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced moderate upper arm pain. On 09-MAR-2021, the subject experienced moderate chest pain. On 09-MAR-2021, the subject experienced felt like pulled muscle. Treatment medications (dates unspecified) included: menthol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from moderate upper arm pain, moderate chest pain, and felt like pulled muscle. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Fatigue, Heart rate increased
Clinical narrative: HIGH BLOOD PRESSURE; INCREASED HEART RATE; HEART PALPITATIONS; SHORTNESS OF BREATH; CHEST TIGHTNESS; TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressures, and increased heart rate, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies.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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced heart palpitations. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced chest tightness. On 10-MAR-2021, the subject experienced high blood pressure. On 10-MAR-2021, the subject experienced increased heart rate. Laboratory data included: EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, heart palpitations, shortness of breath, chest tightness, high blood pressure, and increased heart rate. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Palpitations
Clinical narrative: HIGH BLOOD PRESSURE; INCREASED HEART RATE; HEART PALPITATIONS; SHORTNESS OF BREATH; CHEST TIGHTNESS; TIRED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressures, and increased heart rate, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies.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 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced tired. On 08-MAR-2021, the subject experienced heart palpitations. On 08-MAR-2021, the subject experienced shortness of breath. On 08-MAR-2021, the subject experienced chest tightness. On 10-MAR-2021, the subject experienced high blood pressure. On 10-MAR-2021, the subject experienced increased heart rate. Laboratory data included: EKG (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, heart palpitations, shortness of breath, chest tightness, high blood pressure, and increased heart rate. 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: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness; CHILLS; FATIGUE; MUSCLE ACHES; HEADACHE; 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: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 15:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported. On 11-MAR-2021 06:00, the subject experienced dizziness. On 11-MAR-2021 06:00, the subject experienced chills. On 11-MAR-2021 06:00, the subject experienced fatigue. On 11-MAR-2021 06:00, the subject experienced muscle aches. On 11-MAR-2021 06:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, muscle aches, chills, headache, and dizziness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: This spontaneous report received from a parent concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced was not feeling well. Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and was not feeling well was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: LIQUID LEAKING FROM THE INJECTION SITE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18020270, and batch number: 18020270 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced liquid leaking from the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from liquid leaking from the injection site. This report was non-serious.