chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hip fracture, Injection site pain, Pain in extremity, Thrombosis
Clinical narrative: BROKEN HIP; HAIRLINE FRACTURE IN ARM; FELL; PAIN IN BACK OF CALF; BLOOD CLOT; MILDLY SORE ARM AROUND INJECTION SITE; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shoulder pain. The patient did not have a history of blood clots, and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: Unknown) dose was not reported, 1 total, administered on 09-MAY-2021, about 17:00 pm, to left arm for prophylactic vaccination. Concomitant medications included ibuprofen for shoulder pain.  On an unspecified date in MAY-2021, the patient had mildly sore arm around injection site which had resolved (Unspecified date). On 11-MAY-2021, two days after receiving the vaccine, about 8:00 am in the morning, the patient fell and broke her hip and arm. The hip needed a rod and the patient had surgery to repair the hip by 17:00-18:00pm, the arm was a hair-line fracture and the patient was hospitalized.  About a week and a half after the surgery, the patient experienced pain in back of calf, had an ultrasound, and found blood clot. She was put on blood thinners (unknown name). The blood clot was resolving, breaking up and going away. The reporter did not think that blood clot had anything to do with suspect company. On 02-JUN-2021, the patient was discharged from the rehab within the hospital, where she had her surgery and other care. The patient was hospitalized for 23 days. Its marked 3 weeks since she fell, she had very health exercises and does boot camps. The patient could now take 2 steps with walker, could stand up and pivot, go to bathroom by herself, physical therapy would be given at the patient's house, and it is expected that she will make full recovery.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sore arm around injection site, was recovering from blood clot, and the outcome of fell, broken hip, pain in back of calf and hairline fracture in arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210605202-Covid-19 vaccine ad26.cov2.-Blood clot ,Broken hip, Hairline fracture in arm, Fell. 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).  20210605202-Covid-19 vaccine ad26.cov2.-Pain in back of calf. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Upper limb fracture
Clinical narrative: BROKEN HIP; HAIRLINE FRACTURE IN ARM; FELL; PAIN IN BACK OF CALF; BLOOD CLOT; MILDLY SORE ARM AROUND INJECTION SITE; This spontaneous report received from a consumer concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shoulder pain. The patient did not have a history of blood clots, and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022 expiry: Unknown) dose was not reported, 1 total, administered on 09-MAY-2021, about 17:00 pm, to left arm for prophylactic vaccination. Concomitant medications included ibuprofen for shoulder pain.  On an unspecified date in MAY-2021, the patient had mildly sore arm around injection site which had resolved (Unspecified date). On 11-MAY-2021, two days after receiving the vaccine, about 8:00 am in the morning, the patient fell and broke her hip and arm. The hip needed a rod and the patient had surgery to repair the hip by 17:00-18:00pm, the arm was a hair-line fracture and the patient was hospitalized.  About a week and a half after the surgery, the patient experienced pain in back of calf, had an ultrasound, and found blood clot. She was put on blood thinners (unknown name). The blood clot was resolving, breaking up and going away. The reporter did not think that blood clot had anything to do with suspect company. On 02-JUN-2021, the patient was discharged from the rehab within the hospital, where she had her surgery and other care. The patient was hospitalized for 23 days. Its marked 3 weeks since she fell, she had very health exercises and does boot camps. The patient could now take 2 steps with walker, could stand up and pivot, go to bathroom by herself, physical therapy would be given at the patient's house, and it is expected that she will make full recovery.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mildly sore arm around injection site, was recovering from blood clot, and the outcome of fell, broken hip, pain in back of calf and hairline fracture in arm was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210605202-Covid-19 vaccine ad26.cov2.-Blood clot ,Broken hip, Hairline fracture in arm, Fell. 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).  20210605202-Covid-19 vaccine ad26.cov2.-Pain in back of calf. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hypersomnia, Malaise
Clinical narrative: CHILLS; GENERAL MALAISE; FEVER; TIRED; ACHY ALL OVER/YUKINESS; SLEEPING A LOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive. 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 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sleeping a lot. Laboratory data included: Body temperature (NR: not provided) 99.6. On 28-MAY-2021, the subject experienced achy all over/yukiness. On 28-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced general malaise. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, fever, chills, achy all over/yukiness, tired and sleeping a lot was not reported. This report was non-serious.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: CHILLS; GENERAL MALAISE; FEVER; TIRED; ACHY ALL OVER/YUKINESS; SLEEPING A LOT; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hiv positive. 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 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced sleeping a lot. Laboratory data included: Body temperature (NR: not provided) 99.6. On 28-MAY-2021, the subject experienced achy all over/yukiness. On 28-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced general malaise. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the general malaise, fever, chills, achy all over/yukiness, tired and sleeping a lot was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 antibody test, T-lymphocyte count, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 55-year-old white and non-Hispanic or Latino male. Initial information received from patient on 02-JUN-2021 was processed with additional information received on 03-JUN-2021. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfa. Patient was non-alcohol user, and non-smoker. Patient had no any history of drug abuse or illicit drug use.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported,1 total, administered on 13-MAR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On14-MAY-2021, the patient went to doctor for a regular antibody test and also completed a spike protein test. The antibody test was negative (confirmed immunological vaccine failure). The result of spike protein test was negative. On 26-MAY-2021, the patient had T-cell test and antibody test. Both tests were negative. Laboratory data included: Antibody test (NR: not provided) as Negative, and SARS-CoV-2 IgG antibody test (NR: not provided) as negative. On 26-MAY-2021, Laboratory data included: Antibody test (NR: not provided) as Negative, and T-lymphocyte count (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000181572.; Sender's Comments: V0:20210606012-COVID-19 VACCCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dyspnoea, Insomnia
Clinical narrative: SHORTNESS OF BREATH; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09/JUN/2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced trouble sleeping. Laboratory data (dates unspecified) included: CT scan (NR: not provided) Signs of Pneumonia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, and trouble sleeping. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pruritus, Psoriasis, Skin discolouration, Skin exfoliation
Clinical narrative: PEELING AND FLAKING ON SCALP, LEFT SIDE AND LOWER BACK; BUNCH OF LITTLE SPOTS; PSORIASIS FLARE; ITCHING ALL OVER BODY; FELT MORE WEAK; This spontaneous report received from a patient concerned a 56 year old female. The patient's weight was 170 pounds, and height was 64 inches. The patient's past medical history included psoriasis, weak bronchial artery in lung, pre-chronic obstructive pulmonary disease, and asthma, and other pre-existing medical conditions included no known allergies and on antacids medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAY-2021, the subject experienced felt more weak. On 26-MAY-2021, the subject experienced itching all over body. On 29-MAY-2021, the subject experienced psoriasis flare. On an unspecified date, the subject experienced peeling and flaking on scalp, left side and lower back, and bunch of little spots. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient was recovering from itching all over body, had not recovered from psoriasis flare, peeling and flaking on scalp, left side and lower back, and bunch of little spots, and the outcome of felt more weak was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as the per standard operating procedure as the case is assessed as Non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORENESS IN ARM; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 30-MAY-2021, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness in arm. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: SWEATING; CHILLS; KILLER HEADACHE; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 sweating, chills, and killer headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, killer headache and sweating was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; JOINT PAIN; CHILLS; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced sore throat. On 02-JUN-2021, the subject experienced joint pain. On 02-JUN-2021, the subject experienced chills. On 02-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore throat, fever, joint pain and chills was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Panic disorder, Pyrexia
Clinical narrative: PANIC; ANXIETY; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 panic, anxiety, chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the panic, anxiety, chills, fever and headache was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pyrexia
Clinical narrative: LOSS OF SMELL; LOSS OF TASTE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced fever. On 03-JUN-2021, the subject experienced loss of smell. On 03-JUN-2021, the subject experienced loss of taste. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, loss of smell and loss of taste was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Headache, Pain in jaw, Paraesthesia oral
Clinical narrative: PAIN IN EAR; PAIN IN JAW; STRANGE FEELING IN BACK OF THROAT AS IF SOMETHING WAS STUCK BOTTOM OF THROAT; ITCHING; TINGLING IN LIPS; BLOTCHING FLANK (UPPER BACK, NECK AND FACE); DISCOLORATION; RASH ALL OVER ARM (ARM OF VACCINE); TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included asthma, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use and also had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On 01-JUN-2021, the subject experienced strange feeling in back of throat as if something was stuck bottom of throat. On 01-JUN-2021, the subject experienced itching. On 01-JUN-2021, the subject experienced tingling in lips. On 01-JUN-2021, the subject experienced blotching flank (upper back, neck and face). On 01-JUN-2021, the subject experienced discoloration. On 01-JUN-2021, the subject experienced rash all over arm (arm of vaccine). On 01-JUN-2021, the subject experienced tiredness. On 01-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced pain in ear. On 02-JUN-2021, the subject experienced pain in jaw. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange feeling in back of throat as if something was stuck bottom of throat on 02-JUN-2021, and itching, and blotching flank (upper back, neck and face) on 01-JUN-2021, was recovering from rash all over arm (arm of vaccine), tiredness, and headache, had not recovered from pain in ear, and pain in jaw, and the outcome of tingling in lips and discoloration was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Skin discolouration, Throat irritation
Clinical narrative: PAIN IN EAR; PAIN IN JAW; STRANGE FEELING IN BACK OF THROAT AS IF SOMETHING WAS STUCK BOTTOM OF THROAT; ITCHING; TINGLING IN LIPS; BLOTCHING FLANK (UPPER BACK, NECK AND FACE); DISCOLORATION; RASH ALL OVER ARM (ARM OF VACCINE); TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid, and concurrent conditions included asthma, non-alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use and also had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On 01-JUN-2021, the subject experienced strange feeling in back of throat as if something was stuck bottom of throat. On 01-JUN-2021, the subject experienced itching. On 01-JUN-2021, the subject experienced tingling in lips. On 01-JUN-2021, the subject experienced blotching flank (upper back, neck and face). On 01-JUN-2021, the subject experienced discoloration. On 01-JUN-2021, the subject experienced rash all over arm (arm of vaccine). On 01-JUN-2021, the subject experienced tiredness. On 01-JUN-2021, the subject experienced headache. On 02-JUN-2021, the subject experienced pain in ear. On 02-JUN-2021, the subject experienced pain in jaw. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strange feeling in back of throat as if something was stuck bottom of throat on 02-JUN-2021, and itching, and blotching flank (upper back, neck and face) on 01-JUN-2021, was recovering from rash all over arm (arm of vaccine), tiredness, and headache, had not recovered from pain in ear, and pain in jaw, and the outcome of tingling in lips and discoloration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210557803.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Influenza like illness, Migraine
Clinical narrative: MIGRAINE LIKE HEADACHES; HIGH BLOOD PRESSURE; FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced flu like symptoms. On 03-JUN-2021, the subject experienced migraine like headaches. On 03-JUN-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 2021, and the outcome of migraine like headaches and high blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Rash, Ultrasound scan
Clinical narrative: DEEP VEIN THROMBOSIS; RED SPOTS ON RIGHT LEG; This spontaneous report received from a consumer concerned a 66-year-old white and Non-Hispanic or Latino male. The patient's height and weight were not reported. The patient's concurrent conditions included hard of hearing, and other pre-existing medical conditions included, patient had no comorbidities condition, was not overweight and was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 22-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, about 5 days later after vaccination, patient started getting red spots on both legs, but the spots on the right leg went away later it became worse next day. On an unspecified date, patient experienced the pain which became bad and when reporter looked at it she thought it was cellulitis because it was hot, red and swollen. The Patient had swelling from the knee down and experienced lot of pain in his knee. The patient was sent to outpatient clinic where the ultrasound was done on 02-JUN-2021 and DVT (Deep vein thrombosis) was diagnosed. The blood clot was behind the knee of patient. The patient visited the emergency room but since he had no comorbidities condition he was not admitted and was sent home with medication. The patient was given Eliquis as a treatment drug for the event. The reporter mentioned that the medication was expensive, and the patient was on Medicare and there were programs to help with it. The reporter mentioned that medication can put the patient at risk of kidney failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red spots on right leg on 2021 and had not recovered from Deep vein thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210607591- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Deep Vein thrombosis- 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: Application site discolouration, Injection site pain, Rash
Clinical narrative: FLESHY KIND OF COLORED TURNS WHITE WHEN PUSHED ON IT; RASH FROM ELBOW TO WRIST INSIDE OF FOREARMS A LITTLE BIT OF THE CHEST NEAR V NECK SHAPED, MIDDLE OF NECK TO TOP OF BREAST AREA/RASH ON BOTH ARMS; PAIN DURING INJECTION OF SHOT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fleshy kind of colored turns white when pushed on it, rash from elbow to wrist inside of forearms a little bit of the chest near v neck shaped, middle of neck to top of breast area/rash on both arms, and pain during injection of shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash from elbow to wrist inside of forearms a little bit of the chest near v neck shaped, middle of neck to top of breast area/rash on both arms, pain during injection of shot and fleshy kind of colored turns white when pushed on it was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hot flush, Vision blurred, Visual impairment
Clinical narrative: HOT FLASH LIKE SYMPTOM; BLURRED VISION; IMPAIRED VISION; WEIRD FEELING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included carpal tunnel surgery, deviated septum surgery, and rectal seal surgery, and concurrent conditions included sleeping trouble, penicillin allergy, alcohol user, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced hot flash like symptom. On 26-MAY-2021, the subject experienced blurred vision. On 26-MAY-2021, the subject experienced impaired vision. On 26-MAY-2021, the subject experienced weird feeling. The action taken with covid-19 vaccine was not applicable. The patient was recovering from blurred vision, had not recovered from impaired vision, and the outcome of hot flash like symptom and weird feeling was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: VERTIGO; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021 18:00, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vertigo was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: DIZZINESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included no known allergies or medical conditions. the patient was currently taking anti-depressants. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced not feeling well. On MAY-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and not feeling well. This report was non-serious.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a pharmacist concerned a 67 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced incorrect product storage. On 03-JUN-2021, the subject experienced vaccine administered past the 6 hours frame inside the fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered past the 6 hours frame inside the fridge and incorrect product storage was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned multiple patients.  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) 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 sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from a 62-year-old American Indian or Alaskan native, not Hispanic/Latino male patient. The patient's height, and weight were not reported. The patient drinks a glass of wine occasionally, and does not smoke. He had no known drug allergies and no drug abuse or illicit drug use. The patient had no health conditions and exercises regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total, administered on left arm on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUN-2021, the patient got an antibody test done which showed no antibodies (suspected immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210608194-Covid 19 vaccine-Suspected immunological vaccine failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: RASH AND HIVES IN CHEST ABDOMEN BACK AND NECK; INJECTION SITE SORENESS; LOW GRADE FEVER; FATIGUE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. Concomitant medications included liothyronine for energy booster, ascorbic acid/biotin/calcium carbonate/calcium pantothenate/chromium nicotinate/colecalciferol/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium hydroxide/manganese gluconate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/selenomethionine/sodium molybdate/thiamine hydrochloride/tocopheryl acetate/zinc gluconate, levothyroxine, and spironolactone. On 24-MAY-2021, the subject experienced body aches. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced injection site soreness. On 24-MAY-2021, the subject experienced low grade fever. On 24-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced rash and hives in chest abdomen back and neck. On 01-JUN-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 26-MAY-2021, and injection site soreness, low grade fever, and fatigue on 25-MAY-2021, and had not recovered from rash and hives in chest abdomen back and neck. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: RASH AND HIVES IN CHEST ABDOMEN BACK AND NECK; INJECTION SITE SORENESS; LOW GRADE FEVER; FATIGUE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/illicit drug use. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 23-MAY-2021 for prophylactic vaccination. Concomitant medications included liothyronine for energy booster, ascorbic acid/biotin/calcium carbonate/calcium pantothenate/chromium nicotinate/colecalciferol/cupric oxide/cyanocobalamin/ferrous fumarate/folic acid/magnesium hydroxide/manganese gluconate/nicotinamide/phytomenadione/potassium iodide/pyridoxine hydrochloride/retinol/riboflavin/selenomethionine/sodium molybdate/thiamine hydrochloride/tocopheryl acetate/zinc gluconate, levothyroxine, and spironolactone. On 24-MAY-2021, the subject experienced body aches. On 24-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced injection site soreness. On 24-MAY-2021, the subject experienced low grade fever. On 24-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced rash and hives in chest abdomen back and neck. On 01-JUN-2021, treatment medications included: prednisone. Additional treatment medications (dates unspecified) included: diphenhydramine, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 26-MAY-2021, and injection site soreness, low grade fever, and fatigue on 25-MAY-2021, and had not recovered from rash and hives in chest abdomen back and neck. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: BLOOD SUGAR INCREASED 40-50 POINTS; This spontaneous report received from a patient concerned a 58 year old female. The patient's weight was 269 pounds, and height was 55 inches. The patient's past medical history included anxiety, and depression, and concurrent conditions included diabetes type ii (non-insulin), fish allergy, high blood pressure, asthma, arthritis, alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient was not pregnant at the time of vaccination. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. Concomitant medications included glipizide for diabetes type ii (non-insulin), and metformin hydrochloride for diabetes type ii (non-insulin). On APR-2021, the subject experienced blood sugar increased 40-50 points. Laboratory data included: Blood glucose (NR: not provided) Sugar increased 40-50 points. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood sugar increased 40-50 points was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTRATION OF EXPIRED JNJ VACCINE; This spontaneous report received from a pharmacist concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21a, expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced administration of expired JNJ vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired JNJ vaccine was not reported. This report was non-serious. This report was associated with product quality complaint : 90000181676
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: SICK REALLY BAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced sick really bad. The action taken with covid-19 vaccine was not applicable. The patient recovered from sick really bad on 31-MAY-2021. This report was non-serious. This report was associated with product quality complaint: 90000181659.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Lethargy, Pyrexia
Clinical narrative: FEELING KIND OF LETHARGIC; FEELING VERY ANXIOUS; FEVER; This spontaneous report received from a patient concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included azithromycin allergy, high blood pressure, broke back, and broke neck, and other pre-existing medical conditions included patient got disabled from physical injuries. patient was not able to keep up the metabolic energy with exercise. patient was steadily getting better from the injuries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced feeling kind of lethargic. On 03-JUN-2021, the subject experienced feeling very anxious. On 03-JUN-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-JUN-2021, had not recovered from feeling kind of lethargic, and the outcome of feeling very anxious was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: CONSUMER GIVEN EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25-MAY-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced consumer given expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of consumer given expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING ILL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 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 ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling ill was not reported.                        This report was non-serious. This case, involving the same patient is linked to 20210610903.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: VOMITING; This spontaneous report received from a pharmacist concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 03-JUN-2021. This report was non-serious.