chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: HAND PAIN (RHEUMATOID ARTHRITIS); LETHARGIC; BODY ACHES; EYE PAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, frequency once total, administered on 26-MAR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that the patient did not feel any symptoms until 01-APR-2021.  On 01-APR-2021, the patient experienced hand pain described as rheumatoid arthritis, lethargy, body aches, eye pain/ocular pressure, chills and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lethargic, body aches, fever, chills, eye pain, and rheumatoid arthritis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210409942-Covid-19 vaccine ad26.cov2.s-Hand pain (Rheumatoid arthritis). This event(s) is considered unassessable. The event(s) 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(s).
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.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 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced injection site was hot/warm. On 03-APR-2021, the subject experienced whole arm was sore. On 03-APR-2021, the subject experienced pain at the injection site. On 03-APR-2021, the subject experienced injection site was swollen. On 03-APR-2021, the subject experienced redness that was around the size of a quarter that had expanded out about 3 inches in diameter. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, redness that was around the size of a quarter that had expanded out about 3 inches in diameter, injection site was hot/warm, whole arm was sore, and injection site was swollen. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: FEELING SLEEPY; FEELING  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: 1805020,expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced feeling sleepy. On 29-MAR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling sleepy, and feeling tired on 31-MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: MINOR LEG PAINS; SLIGHT FEVER; SORE ARM AT INJECTION SPOT; 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: not reported) dose was not reported, 1 total administered on 03-APR-2021 for prophylactic vaccination.The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 03-APR-2021, the subject experienced sore arm at injection spot. On 04-APR-2021, the subject experienced minor leg pains. On 04-APR-2021, the subject experienced slight fever. Laboratory data included: Body temperature (NR: not provided) 99.2. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor leg pains, slight fever, and sore arm at injection spot on 05-APR-2021. This report was non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Diarrhoea, Headache, Pyrexia
Clinical narrative: DIARRHEA; CHILLS; LOW FEVER; A MASSIVE HEADACHE; EVERY BONE EVER BROKEN WAS THROBBING HORRIBLY; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 90 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number were not reported) dose was not reported, administered on 06-APR-2021 at 12:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced every bone ever broken was throbbing horribly. On 06-APR-2021 18:52, the subject experienced diarrhea. On 06-APR-2021 18:52, the subject experienced chills. On 06-APR-2021 18:52, the subject experienced low fever. On 06-APR-2021 18:52, the subject experienced a massive headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low fever, chills, diarrhea, a massive headache and every bone ever broken was throbbing horribly was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: RASH; HIVES; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced hives, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hives and rash was not reported. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: A MINOR ITCHINESS; RASH ON BOTH ARMS FROM ELBOW DOWN; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, overweight, alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced a minor itchiness. On 06-APR-2021, the subject experienced rash on both arms from elbow down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on both arms from elbow down, and a minor itchiness. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pruritus
Clinical narrative: SYSTEMIC ITCHINESS (LEGS, FACE AND ARM); STUFFY NOSE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included uterine cancer, and concurrent conditions included seasonal allergy, non smoker, and abstains from alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042821A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 10:30 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced systemic itchiness (legs, face and arm). On 06-APR-2021, the subject experienced stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stuffy nose, and systemic itchiness (legs, face and arm). This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not was required as per standard procedure as the case assessed as non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Periorbital swelling
Clinical narrative: SWOLLEN ALMOND SHAPE SPOT UNDER RIGHT EYE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to contrast dye. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced swollen almond shape spot under right eye. On 06-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site pain, and had not recovered from swollen almond shape spot under right eye. This report was non-serious.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: TREMORS GOT BETTER; This spontaneous report received from a patient concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, chronic lymphocytic leukemia, essential tremors, asthma, and lung problem.  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 24-MAR-2021 to right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included ibrutinib for chronic lymphocytic leukemia.  On an unspecified date, the subject experienced tremors got better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tremors got better was not reported. This report was non-serious. This report was associated with product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Pain, Pyrexia
Clinical narrative: BODY ACHE; LIGHT HEADED; CHILLS; 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'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 01-APR-2021 approximately at 11:00 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced body ache. On 01-APR-2021, the subject experienced light headed. On 01-APR-2021, the subject experienced chills. On 01-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, and fever on 02-APR-2021, and light headed on 01-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: FEELING BAD; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced feeling bad, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling bad, fever, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Pruritus, Rash
Clinical narrative: ITCHING ON CHEST, ARMS AND LEGS; A HARD TIME SLEEPING; RASH; 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 sulfa drugs allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 around 14:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced a hard time sleeping. On APR-2021, the subject experienced rash. On 01-APR-2021, around 19:00 the subject experienced itching on chest, arms and legs. On 02-APR-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching on chest, arms and legs, and rash, and the outcome of a hard time sleeping was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Visual impairment
Clinical narrative: AFFECTED VISION; FELT SICK FOR 5 DAYS; 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 administration not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced affected vision and felt sick for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt sick for 5 days and affected vision was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for  this case. No concomitant medications were reported. On an unspecified date, the subject experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING SICK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE EVENTS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410630.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: SORENESS IN ARM; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced soreness in arm. On 24-MAR-2021, the subject experienced injection site redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site redness on 26-MAR-2021, and had not recovered from soreness in arm. This report was non-serious.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Nausea
Clinical narrative: NAUSEA; MIGRAINE/HEADACHE; CHILLS; This spontaneous report received from a patient concerned a 22 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: 0431A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 14:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced migraine/headache. On 05-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 05-APR-2021, and had not recovered from nausea, and migraine/headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle tightness
Clinical narrative: TIGHTNESS IN LEGS; NUMBNESS IN LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to follow-up to request batch/lot numbers. No concomitant medications were reported.  On 06-APR-2021, the subject experienced tightness in legs. On 06-APR-2021, the subject experienced numbness in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tightness in legs, and numbness in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vomiting
Clinical narrative: VOMITING; 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced vomiting. On APR-2021, the subject experienced fever.  Laboratory data included: Body temperature (NR: not provided) 104. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and vomiting was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: SWOLLEN ARMPIT; DISCOMFORT; GENERAL BODY PAIN; HEADACHES; INJECTION SITE PAIN; 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 (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen armpit, discomfort, general body pain, headaches, injection site pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, injection site pain, general body pain, swollen armpit, discomfort and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: SWOLLEN ARMPIT; DISCOMFORT; GENERAL BODY PAIN; HEADACHES; INJECTION SITE PAIN; 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 (form of admin and route of admin were not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced swollen armpit, discomfort, general body pain, headaches, injection site pain, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches, injection site pain, general body pain, swollen armpit, discomfort and fever was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: 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 04-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced irritating itchy rash on middle of foot and keens. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irritating itchy rash on middle of foot and keens. This report was non-serious.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 11:00 in left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 14:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Laboratory test normal, Nausea
Clinical narrative: NAUSEA; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned an 81 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune, prediabetic, cholesterol, tricuspid valve leek, and severe osteoporosis, and other pre-existing medical conditions included patient is allergic to simvastatin and aspirin. 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 15-MAR-2021 for prophylactic vaccination on right arm. Concomitant medications included pravastatin for cholesterol, and furosemide for tricuspid valve leak.  On 15-MAR-2021, the subject experienced flu like symptoms. On an unspecified date, the subject experienced nausea, and headache. Laboratory data (dates unspecified) included: Laboratory test normal (NR: not provided) NEGATIVE (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, headache, and flu like symptoms. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Hypersensitivity
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; CONGESTION; PAIN IN HANDS; LIGHT HEADEDNESS; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non smoker, and other pre-existing medical conditions included the patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 13:35 for prophylactic vaccination on left arm.. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 06-APR-2021, the subject experienced light headedness. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced pain in hands. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced congestion. Laboratory data included: Body temperature (NR: not provided) 102 F, 100 F. On 06-APR-2021 02:00, the subject experienced chills. On 06-APR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, was recovering from fever, headache, nausea, body aches, congestion, and pain in hands, and had not recovered from light headedness. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: CHILLS; FEVER; HEADACHE; NAUSEA; CONGESTION; PAIN IN HANDS; LIGHT HEADEDNESS; BODY ACHES; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non smoker, and other pre-existing medical conditions included the patient did not have known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 13:35 for prophylactic vaccination on left arm.. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 06-APR-2021, the subject experienced light headedness. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced pain in hands. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced congestion. Laboratory data included: Body temperature (NR: not provided) 102 F, 100 F. On 06-APR-2021 02:00, the subject experienced chills. On 06-APR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 06-APR-2021, was recovering from fever, headache, nausea, body aches, congestion, and pain in hands, and had not recovered from light headedness. This report was non-serious.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: TERRIBLE MIGRAINE HEADACHE; This spontaneous report received from a consumer concerned an 18 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: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the subject experienced terrible migraine headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from terrible migraine headache. This report was non-serious.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: FEVER 101 F; FATIGUE; HEADACHE; This spontaneous report received from a parent concerned a 20-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: 1805025, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced fever 101 Fahrenheit. On 06-APR-2021, the patient experienced fatigue. On 06-APR-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from fever 101 Fahrenheit, and fatigue. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Pain in extremity
Clinical narrative: PAIN IN LUMBAR AREA / SACRAL AREA; KNEE PAIN / PAIN TO HIPS; CHILLS; PAIN AT BOTTOM OF FEET; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on Left deltoid  for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced pain in lumbar area / sacral area. On 06-APR-2021, the subject experienced knee pain / pain to hips. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pain at bottom of feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in lumbar area / sacral area, knee pain / pain to hips, chills, pain at bottom of feet, headache and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PAIN IN LUMBAR AREA / SACRAL AREA; KNEE PAIN / PAIN TO HIPS; CHILLS; PAIN AT BOTTOM OF FEET; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on Left deltoid  for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. On 06-APR-2021, the subject experienced pain in lumbar area / sacral area. On 06-APR-2021, the subject experienced knee pain / pain to hips. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced pain at bottom of feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in lumbar area / sacral area, knee pain / pain to hips, chills, pain at bottom of feet, headache and fever was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Nausea, Pain
Clinical narrative: ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA  OF THE VACCINATION); NUMBNESS IN LEFT FINGER; CHILLS; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 40 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, intramuscular, batch number: 042A2A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021; 13:16 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced aching body (including the chest and around the area of the vaccination). On 06-APR-2021, the patient experienced numbness in left finger. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, chills, and aching body (including the chest and around the area of the vaccination), and had not recovered from headache, and numbness in left finger. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Product quality issue
Clinical narrative: 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 6th dose able to be pulled and administered out of 5 dose vial, and product quality issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 6th dose able to be pulled and administered out of 5 dose vial was not reported. This report was non-serious. The report was associated with product quality complaint :90000175485
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Headache, Hypoaesthesia, Pain
Clinical narrative: ACHE; LUMP IN ARMPIT CLOSE TO BREAST; TINGLING IN FINGERTIPS; NUMBNESS IN FINGERTIPS; PAIN IN ARM WHEN MOVING; FATIGUE; HEADACHE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced lump in armpit close to breast. On APR-2021, the subject experienced tingling in fingertips. On APR-2021, the subject experienced numbness in fingertips. On APR-2021, the subject experienced pain in arm when moving. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, fatigue, headache, fever, lump in armpit close to breast, tingling in fingertips, numbness in fingertips and pain in arm when moving was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: ACHE; LUMP IN ARMPIT CLOSE TO BREAST; TINGLING IN FINGERTIPS; NUMBNESS IN FINGERTIPS; PAIN IN ARM WHEN MOVING; FATIGUE; HEADACHE; 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: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced ache. On APR-2021, the subject experienced lump in armpit close to breast. On APR-2021, the subject experienced tingling in fingertips. On APR-2021, the subject experienced numbness in fingertips. On APR-2021, the subject experienced pain in arm when moving. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, fatigue, headache, fever, lump in armpit close to breast, tingling in fingertips, numbness in fingertips and pain in arm when moving was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, muscle ache, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pollakiuria
Clinical narrative: URINATING VERY FREQUENTLY; VOMITING; CHILLS; NAUSEA; MUSCLE ACHE; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced urinating very frequently, vomiting, chills, nausea, muscle ache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, muscle ache, fatigue, urinating very frequently and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210409934.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: URINATING VERY FREQUENTLY; VOMITING; CHILLS; NAUSEA; MUSCLE ACHE; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced urinating very frequently, vomiting, chills, nausea, muscle ache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, vomiting, muscle ache, fatigue, urinating very frequently and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20210409934.
Sex: F
Vaccine: COVID19
Symptoms: Chemotherapy, Diarrhoea, Lacrimation increased, Radiotherapy, Surgery
Clinical narrative: DIARRHEA 3 DAYS POST IMMUNIZATION; RUNNY EYES; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's past medical history included breast cancer, and tonsillectomy, and concurrent conditions included erythromycin allergy, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021at left arm for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: Chemotherapy (NR: not provided) unknown. On FEB-2021, Laboratory data included: Surgery (NR: not provided) unknown. On APR-2021, Laboratory data included: Radiation therapy (NR: not provided) unknown. On 05-APR-2021, the subject experienced diarrhea 3 days post immunization. On 05-APR-2021, the subject experienced runny eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea 3 days post immunization, and the outcome of runny eyes was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lacrimation increased, Pain
Clinical narrative: BODY ACHES; WATERY EYES; CHILLS; HEADACHES; 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, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, body aches, watery eyes, and headaches. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: BODY ACHES; WATERY EYES; CHILLS; HEADACHES; 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, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced watery eyes. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, body aches, watery eyes, and headaches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Underdose
Clinical narrative: LIQUID CAME OUT AND WENT ON ARM; POSSIBLE UNDERDOSE; 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, route of admin not reported, batch number: not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-APR-2021, the subject experienced liquid came out and went on arm. On 06-APR-2021, the subject experienced possible underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liquid came out and went on arm and possible underdose was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Pyrexia, Sleep disorder, Tachycardia
Clinical narrative: HEART RATE HIT 80, NORMALLY 60; MOVING A LOT AND VERY LITTLE DEEP SLEEP BETWEEN 2AM TO 4AM; TEMPERATURE HIGHER BY 2 FAHRENHEIT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-APR-2021 on an unspecified site 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 APR-2021, the patient experienced heart rate hit 80, normally 60. On APR-2021, the patient experienced moving a lot and very little deep sleep between 2am to 4am. On APR-2021, the patient experienced temperature higher by 2 Fahrenheit. Laboratory data included: Body temperature (NR: not provided) higher by 2 F, and Heart rate (NR: not provided) increased to 80 (units not specified) from 60 (units not specified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature higher by 2 Fahrenheit, heart rate hit 80, normally 60 and moving a lot and very little deep sleep between 2am to 4am was not reported. This report was non-serious.