chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Swelling
Clinical narrative: SWELLING; REDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced swelling. On 2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling and redness was not reported. This report was non-serious.  Additional information received from company representative on 08-MAR-2021. The following information was updated and incorporated into the case narrative: reporter and AER at units.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: SORENESS AT INJECTION SITE; HEADACHE; MUSCLE ACHES; JOINT PAIN; FATIGUE; FEVER; 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 batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced soreness at injection site. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from soreness at injection site, headache, muscle aches, fatigue, and fever on 08-MAR-2021, and was recovering from joint pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: SORENESS AT INJECTION SITE; HEADACHE; MUSCLE ACHES; JOINT PAIN; FATIGUE; FEVER; 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 batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced soreness at injection site. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced muscle aches. On 06-MAR-2021, the subject experienced joint pain. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from soreness at injection site, headache, muscle aches, fatigue, and fever on 08-MAR-2021, and was recovering from joint pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Nausea, Pyrexia
Clinical narrative: POSSIBLE NAUSEA; MALAISE; LOW GRADE TEMPERATURE (99.2 F); This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cold, and other pre-existing medical conditions included she stated she runs cold and that her regular temperature was usually 97.8 f. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced malaise. On 09-MAR-2021, the subject experienced low grade temperature (99.2 f). Laboratory data included: Body temperature (NR: not provided) 99.2 F. On an unspecified date, the subject experienced possible nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from malaise, and low grade temperature (99.2 f), and the outcome of possible nausea was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Dysgeusia, Headache
Clinical narrative: METALLIC TASTE IN MOUTH; HIGH BLOOD GLUCOSE LEVEL; SLIGHT 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, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 11:45 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 metallic taste in mouth. On 09-MAR-2021, the subject experienced high blood glucose level. On 09-MAR-2021, the subject experienced slight headache. On 09-MAR-2021 12:50, Laboratory data included: Blood glucose (NR: not provided) 243 mg/dL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the metallic taste in mouth, slight headache and high blood glucose level was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: IT OPENED THE LUNGS; 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 asthma. 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 05-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 it opened the lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of it opened the lungs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: HEADACHE; SEVERE BODY ACHE; FEVER; CHILL; VOMITING; 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 immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 12:30 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 headache. On 08-MAR-2021, the subject experienced severe body ache. On 08-MAR-2021, the subject experienced fever. On 08-MAR-2021, the subject experienced chill. On 08-MAR-2021, the subject experienced vomiting. Treatment medications (dates unspecified) included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chill, and vomiting, and had not recovered from headache, and severe body ache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Migraine, Pain
Clinical narrative: CHILLS; BODY ACHES; HEADACHES; MIGRAINES; This spontaneous report received from a patient concerned a 60 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: 1802070, and batch number: 1802070 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headaches. On 06-MAR-2021, the subject experienced migraines. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and body aches on 07-MAR-2021, and had not recovered from headaches, and migraines. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: HEADACHE; MUSCLE ACHES; CHILLS; PAIN IN THE ARM; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight was 145 pounds, and height was not reported. The patient's past medical history included eczema, and cancer breast, and concurrent conditions included enzyme deficiency, sulfate allergy, non-smoker, and non-alcohol user. The patient experienced drug allergy when treated with amoxicillin, and tramadol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On 08-MAR-2021, the subject experienced muscle aches. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced pain in the arm. On 08-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from muscle aches, chills, pain in the arm, and tiredness, and had not recovered from headache. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Heart rate increased, Insomnia, Nasopharyngitis
Clinical narrative: RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; 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 concurrent conditions included hypothyroidism. 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 07-MAR-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rapid heartbeat. On MAR-2021, the subject experienced feeling anxious. On MAR-2021, the subject experienced loss of sleep. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced skin felt hot. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced achyness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, feeling anxious, loss of sleep, nausea, skin felt hot, cold, and achyness on MAR-2021. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; 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 concurrent conditions included hypothyroidism. 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 07-MAR-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced rapid heartbeat. On MAR-2021, the subject experienced feeling anxious. On MAR-2021, the subject experienced loss of sleep. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced skin felt hot. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced achyness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, feeling anxious, loss of sleep, nausea, skin felt hot, cold, and achyness on MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: HEADACHE; CHILLS; FEVER; MUSCLE ACHES; TIRED; 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: 18005022, and batch number: 18005022 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced fever. On 07-MAR-2021, the subject experienced muscle aches. On 07-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, chills, fever, muscle aches, and tired. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling jittery, Hypoaesthesia, Paraesthesia
Clinical narrative: HANDS NUMBNESS ESPECIALLY FINGERS TIPS; FEELING OFF; BODY TINGLING; JITTERY; 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: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 11:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced body tingling. On 09-MAR-2021, the subject experienced jittery. On 09-MAR-2021 17:30, the subject experienced feeling off. On 09-MAR-2021 18:00, the subject experienced hands numbness especially fingers tips. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hands numbness especially fingers tips, and jittery, and had not recovered from feeling off, and body tingling. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Swelling face, Swelling of eyelid
Clinical narrative: SWELLING OF BOTH EYELIDS- UPPER AND CORNER; SWELLING OF LEFT SIDE OF FACE; HEADACHE BEHIND EYES; DIZZINESS; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. The patient's past medical history included hysterectomy, and concurrent conditions included dust allergy, allergy to cats, antibiotic allergy (hives), diverticulitis, alcohol intolerance, and drug intolerance. The patient was previously treated with calcium for hives. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802025, and batch number: 1802025 expiry: 25-MAY-2021) .5 ml, administered on 08-MAR-2021 09:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced swelling of both eyelids- upper and corner. On 09-MAR-2021, the subject experienced swelling of left side of face. On 09-MAR-2021, the subject experienced headache behind eyes. On 09-MAR-2021, the subject experienced dizziness. Treatment medications included: achillea millefolium/aconitum napellus/arnica montana root/atropa belladonna/baptisia tinctoria/bellis perennis/calendula officinalis/echinacea spp./hamamelis virginiana/hypericum perforatum/matricaria recutita/ruta graveolens/symphytum officinale. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 09-MAR-2021, was recovering from swelling of both eyelids- upper and corner, and headache behind eyes, and had not recovered from swelling of left side of face. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: MUSCLE ACHES; FATIGUE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the patient experienced muscle aches. On 07-MAR-2021, the patient experienced fatigue. On 07-MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle aches, and fatigue on 08-MAR-2021, and had not recovered from fever. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site pain, Somnolence, Therapeutic response unexpected
Clinical narrative: SLEEPINESS 30 MINUTES AFTER VACCINATION; INJECTION SITE TENDERNESS; SLIGHT HEADACHE; STONED FEELING; DECREASED RINGING IN RIGHT EAR (UNEXPECTED THERAPEUTIC BENEFIT); This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ringing in right ear only from approximately 15 years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced sleepiness 30 minutes after vaccination. On 09-MAR-2021, the subject experienced injection site tenderness. On 09-MAR-2021, the subject experienced slight headache. On 09-MAR-2021, the subject experienced stoned feeling. On 09-MAR-2021, the subject experienced decreased ringing in right ear (unexpected therapeutic benefit). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sleepiness 30 minutes after vaccination, stoned feeling, and slight headache, had not recovered from injection site tenderness, and the outcome of decreased ringing in right ear (unexpected therapeutic benefit) was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: ACHY; CHILLS; SLIGHT FEVER; 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 expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up request to batch/lot numbers. No concomitant medications were reported. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced slight fever. On 06-MAR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, chills and achy was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: PAIN AT INJECTION SITE; SEVERE MUSCLE ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; 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: Unknown) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, chills, headache, and fatigue on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210320105 and 20210320117.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN AT INJECTION SITE; SEVERE MUSCLE ACHES; CHILLS; HEADACHE; FATIGUE; FEVER; 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: Unknown) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced pain at injection site. On 06-MAR-2021, the subject experienced severe muscle aches. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fatigue. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe muscle aches, chills, headache, and fatigue on 07-MAR-2021, was recovering from pain at injection site, and the outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210320105 and 20210320117.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Myalgia, Nausea
Clinical narrative: DIZZINESS WITH MOVEMENT; MUSCLE ACHES ALL OVER; SLIGHT NAUSEA; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, overweight, and dental numbing, and other pre-existing medical conditions included the patient had no known allergies. The patient experienced drug allergy when treated with epinephrine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 09:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021 16:00, the subject experienced dizziness with movement. On 08-MAR-2021 16:00, the subject experienced muscle aches all over. On 08-MAR-2021 16:00, the subject experienced slight nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches all over, dizziness with movement, and slight nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; FEVER; CHILLS; ARM 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, intramuscular, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 12:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the  patient experienced body aches. On 08-MAR-2021, the  patient experienced fever. On 08-MAR-2021, the  patient experienced chills. On 08-MAR-2021, the  patient experienced arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm pain, was recovering from chills, and had not recovered from body aches, and fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Influenza like illness, Insomnia
Clinical narrative: SORE ARM; MILD NAUSEA; DIZZINESS; LOW ENERGY; FELT LIKE FLU SYMPTOMS; FELT MISERABLE; DID NOT SLEEP THAT NIGHT; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 09:15 am for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021 17:00, the subject experienced sore arm. On 05-MAR-2021 17:00, the subject experienced mild nausea. On 05-MAR-2021 17:00, the subject experienced dizziness. On 05-MAR-2021 17:00, the subject experienced low energy. On 05-MAR-2021 17:00, the subject experienced felt like flu symptoms. On 05-MAR-2021 17:00, the subject experienced felt miserable. On 05-MAR-2021 17:00, the subject experienced did not sleep that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, mild nausea, dizziness, felt like flu symptoms, and felt miserable on 07-MAR-2021, low energy on 08-MAR-2021, and did not sleep that night on 06-MAR-2021. 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: Nausea, Pain in extremity
Clinical narrative: SORE ARM; MILD NAUSEA; DIZZINESS; LOW ENERGY; FELT LIKE FLU SYMPTOMS; FELT MISERABLE; DID NOT SLEEP THAT NIGHT; 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: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 09:15 am for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021 17:00, the subject experienced sore arm. On 05-MAR-2021 17:00, the subject experienced mild nausea. On 05-MAR-2021 17:00, the subject experienced dizziness. On 05-MAR-2021 17:00, the subject experienced low energy. On 05-MAR-2021 17:00, the subject experienced felt like flu symptoms. On 05-MAR-2021 17:00, the subject experienced felt miserable. On 05-MAR-2021 17:00, the subject experienced did not sleep that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, mild nausea, dizziness, felt like flu symptoms, and felt miserable on 07-MAR-2021, low energy on 08-MAR-2021, and did not sleep that night on 06-MAR-2021. 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: Asthenia, Fatigue, Headache, Vision blurred
Clinical narrative: FATIGUE; WEAK; HEADACHE; UNABLE TO FOCUS; 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 asthma, high blood pressure, gout, and seasonal type 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, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: 25-MAY-2021) .5 ml, administered on 07-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced fatigue. On 07-MAR-2021, the subject experienced weak. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced unable to focus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, weak, headache, and unable to focus on 09-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: RADIATING PAIN DOWN ARM/PAINFUL THUMB; PAIN IN WRIST; This spontaneous report received from a patient concerned a 68 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, expiry: not reported) dose was not reported, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the patient experienced radiating pain down arm/painful thumb and pain in wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from radiating pain down arm/painful thumb, and pain in wrist. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: INCREASE HEART RATE; HEADACHE; NAUSEA; TIREDNESS; FEVER; 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 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced increase heart rate. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, nausea, tiredness, and fever on 06-MAR-2021, and had not recovered from increase 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: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: INCREASE HEART RATE; HEADACHE; NAUSEA; TIREDNESS; FEVER; 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 05-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced nausea. On 05-MAR-2021, the subject experienced tiredness. On 05-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced increase heart rate. Laboratory data included: Heart rate (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, nausea, tiredness, and fever on 06-MAR-2021, and had not recovered from increase 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, Pain, Pyrexia
Clinical narrative: CHILLS; FEVER; BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 04-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 chills. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and body aches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia
Clinical narrative: SORE JOINTS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sore joints, and low fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) UNKNOWN. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore joints and low fever was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache
Clinical narrative: HEADACHE; COLD FLUSH  THROUGH BODY IMMEDIATELY FOLLOWING INJECTION; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes - non insulin, and azithromycin allergy, and other 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, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 08:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced cold flush through body immediately following injection. On 09-MAR-2021 14:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold flush through body immediately following injection on 09-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: BODY ACHES; CHILLS; LACK OF ENERGY; HEADACHE; FELT TIRED ALL THE DAY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-MAR-2021, the subject experienced felt tired all the day. On 07-MAR-2021, the subject experienced body aches. On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced lack of energy. On 07-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt tired all the day, body aches, chills, lack of energy and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: CHILLS; HEADACHE; JOINT ACHE; 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, expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Deltoid 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 headache. On 08-MAR-2021, the subject experienced joint ache. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint ache, and chills on 09-MAR-2021, and had not recovered from headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: MIGRAINE; This spontaneous report received from a 55 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included penicillin allergy, environmental allergy, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 12:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021 18:00, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILL; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 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 an unspecified date, the patient experienced chill, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chill and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; 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: Unknown, and 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 10-MAR-2021, the subject experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.  Version created to amend previously reported information on 10-MAR-2021. Upon review the following information was amended: The event suspected covid-19 infection was downgraded from serious to non-serious and dose and route updated to unknown.; Sender's Comments: V1:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Eye movement disorder, Fall, Head injury, Loss of consciousness
Clinical narrative: WAS UNCONSCIOUS FOR A COUPLE MINUTES; SLUMPED IN HIS CHAIR/FELL ON THE FLOOR; HIT HIS HEAD; EYES ROLLED TO THE BACK OF HIS HEAD; This spontaneous report received from a parent concerned a 27 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, and batch number were not reported) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, in afternoon and within 3 minutes after vaccination the patient experienced slumped in his chair/fell on the floor, eyes rolled to the back of his head, hit his head, and was unconscious for a couple minutes. The clinicians observed the patient for about 15 additional minutes and sent the patient on his way. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the hit his head, eyes rolled to the back of his head, was unconscious for a couple minutes and slumped in his chair/fell on the floor was not reported. The reporter causality between COVID-19 VACCINE AD26.COV2.S and slumped in his chair/fell on the floor, eyes rolled to the back of his head, hit his head and was unconscious for a couple minutes was possible. The company causality between COVID-19 VACCINE AD26.COV2.S and slumped in his chair/fell on the floor, eyes rolled to the back of his head, hit his head and was unconscious for a couple minutes was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210327022-unconscious for couple minutes. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Computerised tomogram, Generalised tonic-clonic seizure, Hypotension
Clinical narrative: TONIC- CLONIC SEIZURES; LOW BLOOD PRESSURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced tonic- clonic seizures for 3 minutes and the patient's blood pressure was low 94/72 and then the Emergency medical services (EMS) was called and the patient was transported for evaluation the same day. The patient visited emergency room or department/urgent care facility for treatment of the events. On APR-2021, Laboratory data included: Blood glucose (NR: not provided) 97, CT scan (NR: not provided) Negative (units unspecified) and Blood pressure (NR: not provided) 94/72. On 08-APR-2021, patient was discharged from emergency room/urgent care facility and followed up with neurology. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tonic- clonic seizures and low blood pressure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210417256, 20210417209, 20210417456 and 20210417122.; Sender's Comments: V0:20210417620-Covid-19 vaccine ad26.cov2.s-Tonic-clonic seizures. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: BLOOD CLOT; RIGHT LEG PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 at 02:19 for prophylactic vaccination. No concomitant medications were reported.  The patient reported that she had a blood clot/pain in right leg 2-3 days after she received the vaccine. She reported that she used compression socks for a week. The patient also reported that she experienced headaches (date unspecified), which still come and go every other day. The patient stated that she had the same blood clot pain in the same leg as when she had COVID-19 infection in MAR-2020.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of blood clot and right leg pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: A patient of unspecified age and sex reported a "blood clot/pain" in right leg 2-3 days after vaccine. The patient had a history of "blood clot pain" in the same leg when she had COVID infection one year ago. History of thrombosis would provide a plausible alternative explanation for the event, although there are insufficient details to make a meaningful medical assessment. The patient was contacted and could not be immediately reached. Additional information has been requested for further assessment.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Pneumonia, Thrombosis, X-ray
Clinical narrative: PNEUMONIA; BLOOD CLOTS; This spontaneous report received from a consumer concerned an 89 year old male. Initial information was received on 13-APR-2021 and processed with additional information received on 15-APR-2021.  The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure (ejection fraction 20%), large lower left groin hernia, atrial fibrillation, and dementia. No known drug allergies was reported. There was no history of blood clots.  The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. Batch number was not reported, will be requested. Concomitant medications included apixaban twice a day for atrial fibrillation.  On 11-MAR-2021, the patient was taken to Emergency Room (ER) and diagnosed with pneumonia. Patient was awake over 48 hours 'felt due to dementia and illness'.   On 14-MAR-2021, the patient was taken back to hospital and X-ray and CAT scan showed saddle pulmonary embolism.  On 15-MAR-2021, the patient was discharged to a home with hospice.  On 23-MAR-2021, the patient deceased. It was unknown if autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender's Comments: V0: An 89-year old man experienced fatal saddle pulmonary embolism 10 days after vaccine. Relevant medical history included congestive heart failure with ejection fraction 20%, atrial fibrillation (A Fib), and dementia. Relevant concomitant medication (others not reported) included Eliquis for A fib. The patient was diagnosed with pneumonia in the Emergency Department 7 days after vaccine, and 3 days later was brought back to the hospital and diagnosed with saddle pulmonary embolus. He was discharged home on hospice the next day and died 19 days after vaccine. There was no reported thrombocytopenia. The patient's age, concurrent pneumonia, and complicated past medical history are confounders. There is insufficient information to make a meaningful medical assessment. Additional information has been requested, including attempts to contact the patient's treating physicians.; Reported Cause(s) of Death: PNEUMONIA; BLOOD CLOTS