chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tachypnoea
Clinical narrative: HEART RACING; DIFFICULTY BREATHING; TACHYPNEA; FEELING HOT; MUSCLE PAIN IN LEFT LEG; TIRED; 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 drug allergies. 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 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced feeling hot. On 05-APR-2021, the subject experienced muscle pain in left leg. On 05-APR-2021, the subject experienced tired. On 05-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced tachypnea. On 08-APR-2021, the subject experienced difficulty breathing. On 08-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing, heart racing, and tired on 09-APR-2021, tachypnea, and headache on 08-APR-2021, and feeling hot, and muscle pain in left leg on 06-APR-2021. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Injection site erythema, Nasopharyngitis
Clinical narrative: COLD; RUNNY NOSE; CHILLS; FEVER; HEADACHE; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 65 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site redness. On 29-MAR-2021, the subject experienced cold. On 29-MAR-2021, the subject experienced runny nose. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. 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 cold, runny nose, chills, fever, and headache on 30-MAR-2021, and injection site redness on 10-MAR-2021. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: COLD; RUNNY NOSE; CHILLS; FEVER; HEADACHE; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 65 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site redness. On 29-MAR-2021, the subject experienced cold. On 29-MAR-2021, the subject experienced runny nose. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. 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 cold, runny nose, chills, fever, and headache on 30-MAR-2021, and injection site redness on 10-MAR-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Pain, Sensitive skin
Clinical narrative: BODY ACHES; SKIN SENSITIVITY; CHILLS; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. It was not reported whether the patient had been pregnant before. 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 body aches, skin sensitivity, chills, and vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, skin sensitivity, and chills, and the outcome of vaccine exposure during pregnancy was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; 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 1 total administered for prophylactic vaccination. Vaccination site was not reported. 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, patient experienced suspected covid 19 infection and suspected clinical vaccination failure after receiving Janssen COVID-19 vaccine. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) as Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid 19 infection and suspected clinical vaccination failure was not reported. The product quality complaint number was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210422101, 20210423002 and 2021042305; Sender's Comments: 20210436442-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination 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: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus, Vascular occlusion
Clinical narrative: ATTACK OF HYPER OCCLUSIVES; RECRUITMENT TINNITUS; This spontaneous report received from a patient concerned a 66 year old of unspecified 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 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the subject experienced attack of hyper occlusives. On 02-APR-2021, the subject experienced recruitment tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from attack of hyper occlusives, and recruitment tinnitus. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Rash, Urine analysis
Clinical narrative: This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 185 pounds, and height was 67 inches. The patient's concurrent conditions included hiv, non alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with acetylsalicylic acid. 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, Laboratory data included: Urine analysis (NR: not provided) WNL. On 20-MAR-2021, the subject experienced skin rash. On 20-MAR-2021, the subject experienced extreme fatigue. Laboratory data (dates unspecified) included: Blood test (NR: not provided) WNL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, and skin rash. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: 41 INCIDENCES WHERE  THE TEMPERATURES DROPPED BELOW 36F; 15 DOSES ADMINISTERED OUT OF RECOMMENDED TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients. 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: 202A21A expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced 41 incidences where the temperatures dropped below 36f, and 15 doses administered out of recommended temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 41 incidences where the temperatures dropped below 36f and 15 doses administered out of recommended temperature was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pulse abnormal, Pyrexia
Clinical narrative: VIBRATING PULSE IN GROIN FOR 3 DAYS; SORE ARM; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 vibrating pulse in groin for 3 days, sore arm, chills, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vibrating pulse in groin for 3 days, sore arm, fever, fatigue and chills was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: TENDERNESS AT INJECTION SITE; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 tenderness at injection site, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness at injection site and slight headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436174.
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage urinary tract, Myalgia, Pain
Clinical narrative: BLOOD IN URINE WITH CLOTS; BODY ACHES/WHOLE BODY HURT; MUSCLE ACHES; This spontaneous report received from a patient concerned a 73 year old male. 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: 1808980, expiry: UNKNOWN) dose was not reported, frequency 1 total,  administered on 07-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included medication for high blood pressure. On 08-APR-2021, the patient's "whole body hurt" with muscle aches and body aches. On 16-APR-2021, the patient experienced "blood in urine with clots", sometimes the clots were dry and other times they were wet. Patient experienced blood in urine each time he urinated having started on 16-APR-2021 and he had never experienced this prior to receiving the vaccine. Patient stated that he did not experience any other side effects such as fever, abdominal pain or leg pain. Patient had not yet sought medical attention and had not taken any  medications to treat his adverse effects. Patient stated that he had planned to reach out to a healthcare professional on 19-APR-2021 (tomorrow). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches, body aches/whole body hurt and blood in urine with clots was not reported. This report was serious (other medically important condition).; Sender's Comments: V0:20210436909-Covid-19 vaccine .Ad26.Cov2.S-Blood in urine with clots. 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).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Sensory disturbance, Vertigo
Clinical narrative: DIZZINESS; VERTIGO; SPINNING AND FALLING SENSATION; FELT OFF; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had not known allergies. 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 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced dizziness. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced spinning and falling sensation. On 19-MAR-2021, the subject experienced felt off. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vertigo, spinning and falling sensation, and felt off. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: LEG PAIN; FEVER; EXTREMELY TIRED; HEADACHE; FELT AWFUL; CHILLS; 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced felt awful. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced extremely tired. On 08-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced leg pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative, and Platelet count (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, extremely tired, headache, felt awful and leg pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Platelet count, Pyrexia
Clinical narrative: LEG PAIN; FEVER; EXTREMELY TIRED; HEADACHE; FELT AWFUL; CHILLS; 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) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced felt awful. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced extremely tired. On 08-APR-2021, the subject experienced headache. On an unspecified date, the subject experienced leg pain. Laboratory data (dates unspecified) included: Blood test (NR: not provided) negative, and Platelet count (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, extremely tired, headache, felt awful and leg pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Antiphospholipid antibodies positive, Blood urine present, Headache, Protein urine present
Clinical narrative: PROTEIN IN URINE; BLOOD IN URINE; VOMITING; HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, rheumatoid arthritis, systemic lupus erythematosus, obesity, stage 2 chronic kidney disease, and psoriatic arthritis. 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 08-APR-2021 for prophylactic vaccination.  Concomitant medications included nitrofurantoin for blood in urine, and protein in urine. On 11-APR-2021 04:00, the subject experienced abdominal pain. On 11-APR-2021 09:00, the subject experienced vomiting. On 11-APR-2021 09:00, the subject experienced headache. On 14-APR-2021, the subject experienced protein in urine. On 14-APR-2021, the subject experienced blood in urine. Laboratory data included: Urinalysis (NR: not provided) positive for blood, positive for protein. Laboratory data (dates unspecified) included: Lupus anticoagulant positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 12-APR-2021, was recovering from headache, and vomiting, and the outcome of protein in urine and blood in urine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vomiting
Clinical narrative: PROTEIN IN URINE; BLOOD IN URINE; VOMITING; HEADACHE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, rheumatoid arthritis, systemic lupus erythematosus, obesity, stage 2 chronic kidney disease, and psoriatic arthritis. 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 08-APR-2021 for prophylactic vaccination.  Concomitant medications included nitrofurantoin for blood in urine, and protein in urine. On 11-APR-2021 04:00, the subject experienced abdominal pain. On 11-APR-2021 09:00, the subject experienced vomiting. On 11-APR-2021 09:00, the subject experienced headache. On 14-APR-2021, the subject experienced protein in urine. On 14-APR-2021, the subject experienced blood in urine. Laboratory data included: Urinalysis (NR: not provided) positive for blood, positive for protein. Laboratory data (dates unspecified) included: Lupus anticoagulant positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abdominal pain on 12-APR-2021, was recovering from headache, and vomiting, and the outcome of protein in urine and blood in urine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Fatigue, Head discomfort
Clinical narrative: LEG CRAMPS; SHORTNESS OF BREATH; FEELING SLEEPY; DIZZINESS; HEAVY HEAD; VISION NOT NORMAL; NAUSEA; FEELING VERY TIRED; FEVER; MUSCLE PAINS; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced muscle pains. On 09-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced heavy head. On 16-APR-2021, the subject experienced vision not normal. On 16-APR-2021, the subject experienced shortness of breath. On 16-APR-2021, the subject experienced feeling sleepy. On 16-APR-2021, the subject experienced nausea. On 16-APR-2021, the subject experienced feeling very tired. On 18-APR-2021, the subject experienced leg cramps. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Information (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle pains, and fever on 11-APR-2021, and leg cramps on 18-APR-2021, and had not recovered from nausea, dizziness, feeling very tired, heavy head, vision not normal, shortness of breath, and feeling sleepy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: LEG CRAMPS; SHORTNESS OF BREATH; FEELING SLEEPY; DIZZINESS; HEAVY HEAD; VISION NOT NORMAL; NAUSEA; FEELING VERY TIRED; FEVER; MUSCLE PAINS; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced muscle pains. On 09-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced heavy head. On 16-APR-2021, the subject experienced vision not normal. On 16-APR-2021, the subject experienced shortness of breath. On 16-APR-2021, the subject experienced feeling sleepy. On 16-APR-2021, the subject experienced nausea. On 16-APR-2021, the subject experienced feeling very tired. On 18-APR-2021, the subject experienced leg cramps. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Information (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle pains, and fever on 11-APR-2021, and leg cramps on 18-APR-2021, and had not recovered from nausea, dizziness, feeling very tired, heavy head, vision not normal, shortness of breath, and feeling sleepy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Visual impairment
Clinical narrative: LEG CRAMPS; SHORTNESS OF BREATH; FEELING SLEEPY; DIZZINESS; HEAVY HEAD; VISION NOT NORMAL; NAUSEA; FEELING VERY TIRED; FEVER; MUSCLE PAINS; BODY ACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced muscle pains. On 09-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced heavy head. On 16-APR-2021, the subject experienced vision not normal. On 16-APR-2021, the subject experienced shortness of breath. On 16-APR-2021, the subject experienced feeling sleepy. On 16-APR-2021, the subject experienced nausea. On 16-APR-2021, the subject experienced feeling very tired. On 18-APR-2021, the subject experienced leg cramps. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No Information (units unspecified). Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, muscle pains, and fever on 11-APR-2021, and leg cramps on 18-APR-2021, and had not recovered from nausea, dizziness, feeling very tired, heavy head, vision not normal, shortness of breath, and feeling sleepy. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 chest pain. Treatment medications (dates unspecified) included: glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased, Headache, Malaise
Clinical narrative: BLOOD PRESSURE DROPPED; NOT FEELING WELL; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure dropped, not feeling well, and headache. Laboratory data (dates unspecified) included: Blood pressure dropped (NR: not provided) Blood pressure dropped The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, blood pressure dropped and not feeling well was not reported. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Polymerase chain reaction, Suspected COVID-19
Clinical narrative: COVID SYMPTOMS; CHILLS; NAUSEA; TASTE SENSATION; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 56 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: PCR (NR: not provided) Negative (unit unspecified).  On 11-APR-2021, the subject experienced taste sensation. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced covid symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from taste sensation, and chills, was recovering from lightheadedness, and covid symptoms, and had not recovered from nausea. This report was non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: COVID SYMPTOMS; CHILLS; NAUSEA; TASTE SENSATION; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 56 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: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: PCR (NR: not provided) Negative (unit unspecified).  On 11-APR-2021, the subject experienced taste sensation. On 11-APR-2021, the subject experienced lightheadedness. On 11-APR-2021, the subject experienced chills. On 11-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced covid symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from taste sensation, and chills, was recovering from lightheadedness, and covid symptoms, and had not recovered from nausea. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: SPONTANEOUS HEADACHE; This spontaneous report received from a health care professional concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's past medical history included abdominal aortic aneurysm, ascending aortic aneurysm, atrial fibrillation, degenerative disc, heart issue, stroke, drug allergy, blood clot behind eye, smoker, and overweight, and other pre-existing medical conditions included patient had medical history of naturally throwing clots and short term memory. The patient was previously treated with promethazine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802029, and batch expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation, hydrocodone, levothyroxine, and lisinopril.  On an unspecified date, the subject experienced spontaneous headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spontaneous headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: CONFIRMED COVID19; 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 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported. On 15-APR-2021, the subject experienced confirmed covid19. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive for Covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed covid19 was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Diarrhoea, Fatigue, Hypersomnia
Clinical narrative: SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARRHEA; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid irradiated, and concurrent conditions included aneurysm, and hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sleeping alot, racing heart, abdominal pain, still not getting her energy back/feeling better, diarrhea, fatigue, and fever. Laboratory data (dates unspecified) included: Investigation (NR: not provided) NOTHING WAS FOUND, and X-ray (NR: not provided) NOTHING WAS FOUND. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleeping alot, and still not getting her energy back/feeling better, and the outcome of fever, diarrhea, abdominal pain, racing heart and fatigue was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Palpitations, Pyrexia, X-ray
Clinical narrative: SLEEPING ALOT; RACING HEART; ABDOMINAL PAIN; STILL NOT GETTING HER ENERGY BACK/FEELING BETTER; DIARRHEA; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid irradiated, and concurrent conditions included aneurysm, and hyperthyroidism. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sleeping alot, racing heart, abdominal pain, still not getting her energy back/feeling better, diarrhea, fatigue, and fever. Laboratory data (dates unspecified) included: Investigation (NR: not provided) NOTHING WAS FOUND, and X-ray (NR: not provided) NOTHING WAS FOUND. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleeping alot, and still not getting her energy back/feeling better, and the outcome of fever, diarrhea, abdominal pain, racing heart and fatigue was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: SEVER SHAKING; COLD; DIZZINESS; FEVER; NAUSEA; 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 past medical history included covid-19. The patient was previously treated with amoxicillin/clavulanic acid for covid-19.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sever shaking. On APR-2021, the subject experienced cold. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F, 102 F, 101 F, 99.8 F. Treatment medications (dates unspecified) included: ibuprofen, dimenhydrinate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever shaking, dizziness, fever, and nausea on APR-2021, and the outcome of cold was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: SEVER SHAKING; COLD; DIZZINESS; FEVER; NAUSEA; 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 past medical history included covid-19. The patient was previously treated with amoxicillin/clavulanic acid for covid-19.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sever shaking. On APR-2021, the subject experienced cold. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103 F, 102 F, 101 F, 99.8 F. Treatment medications (dates unspecified) included: ibuprofen, dimenhydrinate, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sever shaking, dizziness, fever, and nausea on APR-2021, and the outcome of cold was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN ARM AND PAIN IN LEFT LEG; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: unknown) dose was not reported, administered on 10-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 10-APR-2021, the subject experienced pain in arm and pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm and pain in left leg was not reported. This report was non-serious.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Headache, Limb discomfort, Thrombosis
Clinical narrative: CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported.  On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in extremity, Sensory disturbance, Thrombosis
Clinical narrative: CLOTS ON RIGHT LEG; HEADACHE; PRESSURE ON BOTH LEGS; PRESSURE ON HANDS; This spontaneous report received from a patient via a company representative concerned a 64 year old Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure and diabetes.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total administered on 17-MAR-2021 at left arm for prophylactic vaccination.  No concomitant medications were reported.  On 17-MAR-2021, the patient had experienced headache after vaccination. On 27-MAR-2021, the patient began to experience intermittent pain on right leg. On 30-MAR-2021, she experienced headache again and was still having leg pain; she visited the Emergency Room (ER) and was admitted on 30-MAR-2021. On 02-APR-2021, the patient experienced clots on right leg. On APR-2021, a catheter was placed in catheterization procedure and her right leg vein was unclogged of a clot. A second clot did not require removal because the vein had already unclogged itself after medication. The patient was administered unspecified anticoagulants. She was discharged on 5-APR-2021 and was prescribed ticagrelor which was then changed to clopidogrel. On 18-APR-2021, the patient experienced a headache again and feeling of pressure on legs and hands. Patient was advised to visit ER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from clots on right leg and intermittent pain on right leg on 02-APR-2021, recovered with sequelae from headache on 19-MAR-2021, and had not recovered from pressure on both legs and pressure on hands. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: This 64 year-old Hispanic or Latino female with history of high blood pressure and diabetes was hospitalized for clots in her right leg 13 days after receiving the Janssen Covid-19 vaccine. Concomitant medications were not reported. On the day of her vaccination, she experienced a headache. Ten days later, she began to experience intermittent leg pain. Three days later (ie, 13 days post vaccination), she went to the emergency room (ER) and was admitted to the hospital. During the hospitalization, a clot was removed via catheterization and she was administered unspecified anticoagulants. A second clot resolved on its own without surgical intervention. After 6 days in the hospital, she was discharged with ticagrelor which was later changed to clopidogrel. She recovered from the clots. Thirteen days after discharge, she began to experience headache and "pressure" in both legs and hands. She was advised to go to the ER; no further information was provided. Based on the limited information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. Additional information is being sought.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, from the same reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysgeusia, Dyspnoea, Fatigue, Insomnia
Clinical narrative: RIGHT MIDDLE FINGER TURNED PURPLE; FINGERS SWELLING; INSOMNIA; RINGING IN THE EARS; CHEST PAIN; SHORTNESS OF BREATH; FATIGUE; BODY ACHE; METALLIC TASTE IN MOUTH; FINGERS TURNED COLD AND TINGLY; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, "over Christmas" and had since recovered. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-DEC-2020, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. On 23-MAR-2021, the subject experienced metallic taste in mouth. On 23-MAR-2021, the subject experienced fingers turned cold and tingly. On 24-MAR-2021, the subject experienced body ache. On 24-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced insomnia. On 25-MAR-2021, the subject experienced ringing in the ears. On 25-MAR-2021, the subject experienced chest pain. On 25-MAR-2021, the subject experienced shortness of breath. On 08-APR-2021, the subject experienced right middle finger turned purple. On 08-APR-2021, the subject experienced fingers swelling. Treatment medications (dates unspecified) included: doxycycline, and azithromycin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from right middle finger turned purple, chest pain, metallic taste in mouth, and fingers swelling, had not recovered from insomnia, ringing in the ears, and shortness of breath, and the outcome of fingers turned cold and tingly, body ache and fatigue was not reported. This report was non-serious.