chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Movement disorder, Pain in extremity, Scan
Clinical narrative: FEELING NUMBNESS IN THE PALM  OF HER RIGHT HAND AND IN RIGHT LEG AND FOOT; DIFFICULT TO MOVE FOR ABOUT 4 DAYS; FELT SEVERE PAIN IN BOTH THE HANDS, LEGS, AND ARMS; ABNORMAL HEART BEAT; HIGH BLOOD PRESSURE; FELT WEAK; SLIGHT HEADACHE; PAIN ON INJECTION SITE; LOSS OF APPETITE; SLIGHT CHILLS; This spontaneous report received from a patient concerned a 26 year old ,  female. The patient's height, and weight were not reported. The patient's concurrent conditions included nonsmoker, non alcohol use, and blood pressure, and other 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, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the patient experienced loss of appetite, slight chills, weakness, slight headache and pain on injection site. After 2-3 weeks after receiving vaccine, on 01-MAY-2021, the patient experienced sever pain in hands, legs and arms and it was very difficult to move for about 4 days. Patient went to the clinic in May to seek help for her pain and new heart side effects. Patient noticed that her heart was beating abnormally, It would beat hard 10 minutes and then stop. On MAY-2021, Laboratory data included: Scan (NR: not provided) No abnormalities with heart. In clinic they also checked blood pressure and Laboratory data included: Blood pressure (NR: not provided) Abnormally high, Heart rate (NR: not provided) normal, Patient did an Magnetic resonance imaging (MRI) 3 days after the clinic appointment and had No abnormalities, results came normal. On 11-JUL-2021, the patient experienced feeling numbness in the palm of right hand and in right leg and foot and Patient said it's not serious but had been dealing with the symptoms continuously. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficult to move for about 4 days, and loss of appetite, slight chills, weakness, slight headache, and pain on injection site on 11-APR-2021, had not recovered from felt severe pain in both the hands, legs, and arms, abnormal heart beat, and feeling numbness in the palm of right hand and in right leg and foot, and the outcome of high blood pressure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210730598-covid-19 vaccine ad26.cov2.s -Abnormal heart beat. 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Mobility decreased
Clinical narrative: COULD NOT MOVE LEGS, ARMS AND UPPER BODY; LOSS OF APPETITE; CHILLS; This spontaneous report received from a consumer concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included aneurysm in 2012 (rupture killed the nerve with one leg), the aneurysm changed the way he was walking and problems walking and concurrent conditions included ex-alcohol user (Stopped drinking 2 years ago), non-smoker, rheumatoid arthritis, and blood thinner. The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 03-MAR-2021 in left deltoid for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. The last dose of infliximab was in FEB-2021. The patient did not discuss getting the vaccine with rheumatoid arthritis doctor.  On 05-MAY-2021, the patient had more limited movement until could not move legs and was not walking good. It went up from legs to arms, upper body (coded as could not move legs, arms and upper body). The patient went to emergency room at hospital and stayed in hospital for 1 week. The patient went to rehabilitation one week after for physical therapy. The patient was about ninety percentage back to where he was before the vaccine. The patient also experienced chills and loss of appetite. The symptoms lasted 3 weeks and went away.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and chills, and was recovering from could not move legs, arms and upper body. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210730947-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Could not move legs, arms and upper body. 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: U
Vaccine: COVID19
Symptoms: General physical condition abnormal, Surgery
Clinical narrative: EMERGENCY SURGERY; HEALTH/ AUTOIMMUNE ISSUES; This spontaneous report received from a patient concerned a patient of an unspecified age, sex, race, and ethnic origin. 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, and expiry: unknown) dose, start therapy date were not reported, frequency time was 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced health/ autoimmune issues ever since received vaccine and had emergency surgery. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the emergency surgery and health/ autoimmune issues was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210731463-Covid-19 vaccine ad26.cov2.s -Emergency Surgery. 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: COVID-19 pneumonia, Death, Dependence on respirator
Clinical narrative: PATIENT PLACED ON VENTILATOR; DEATH; COVID PNEUMONIA; This spontaneous report received from a consumer via a company representative via social media concerned a 49 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient had no health problems. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry unknown) dose was not reported, administered in late APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. In late APR-2021, on the night of vaccination, the patient experienced flu like symptoms. She was hospitalized and was in intensive care unit (ICU) (date unspecified), she never got better from flu like symptoms. It was claimed that the patient had Covid pneumonia. On an unspecified date, patient experienced sever lung damage and lung complications, and the patient was placed on ventilator.  On 02-MAY-2021, the patient died from unknown cause of death It was unknown if the autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 02-MAY-2021, and the outcome of covid pneumonia and patient placed on ventilator was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0 -20210731688-Covid-19 vaccine ad26.cov2.s-Death, Covid Pneumonia, Patient placed on ventilator. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; This spontaneous report received from a consumer concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-JUL-2021. 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, expiry: UNKNOWN) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date the patient (reporter's sister-in-law's husband ) got COVID-19 after getting vaccinated (suspected clinical vaccination failure).  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the COVID-19 and suspected vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000186312.; Sender's Comments: V0: 20210732319-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
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. Initial information was processed with the additional information received on 16-JUL-2021. The patient's height, and weight were not reported. The patient's past medical history included organ transplant.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient did not show antibodies (suspected immunological vaccine failure). Laboratory data (dates unspecified) included: Antibody test (NR: not provided) No antibody found. 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). This report was associated with product quality complaint: 90000186131.; Sender's Comments: V0: 20210733429-covid-19 vaccine ad26.cov2.s -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
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Laboratory test, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-JUL-2021. 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 expiry: Unknown), 1 total, dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient experienced slight fever. Laboratory data included: body temperature (NR: not provided) 98.9 to 100.1. On 08-JUL-2021, the patient went to doctor office for slight fever over 3 days and wanted to be sure that he was not affected with COVID-19. Assistant of physician conducted three tests. Laboratory data included: COVID-19 antibody test and SARS-CoV-2 rapid diagnostic test which showed negative and unspecified test to evaluate immunity to COVID-19 however, unspecified immunity test showed negative results (captured as confirmed immunological vaccine failure) and the patient had no signs of antibody in his system. It was reported that, patients physician did not have any recommendation due to the limited data and information on this matter, and he will contacting them to have a recommendation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and slight fever was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA:90000186307.; Sender's Comments: V0:20210733506-Covid-19 vaccine 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
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SLIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. Initial information was processed along with the additional information received on 16-JUL-2021. 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 expiry: Unknown), 1 total, dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient experienced slight fever. Laboratory data included: body temperature (NR: not provided) 98.9 to 100.1. On 08-JUL-2021, the patient went to doctor office for slight fever over 3 days and wanted to be sure that he was not affected with COVID-19. Assistant of physician conducted three tests. Laboratory data included: COVID-19 antibody test and SARS-CoV-2 rapid diagnostic test which showed negative and unspecified test to evaluate immunity to COVID-19 however, unspecified immunity test showed negative results (captured as confirmed immunological vaccine failure) and the patient had no signs of antibody in his system. It was reported that, patients physician did not have any recommendation due to the limited data and information on this matter, and he will contacting them to have a recommendation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed immunological vaccine failure and slight fever was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA:90000186307.; Sender's Comments: V0:20210733506-Covid-19 vaccine 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
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Impaired driving ability, Impaired work ability, Loss of personal independence in daily activities, Medication error
Clinical narrative: MEDICATION ERROR; LOWER BACK PAIN; CRAMPING IN ARM; BLURRED VISION; CAN NOT DRIVE; CAN NOT WORK; NEED HELP FROM OTHERS TO CARE FOR CHILDREN; BOTH LEG PAIN; This spontaneous report received from a parent concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shrimp allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. no medical conditions as per patient and no medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1809887 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced cramping in arm. On APR-2021, the subject experienced blurred vision. On APR-2021, the subject experienced can not drive. On APR-2021, the subject experienced can not work. On APR-2021, the subject experienced need help from others to care for children. On APR-2021, the subject experienced both leg pain. On 10-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, cramping in arm, both leg pain, and blurred vision, and the outcome of medication error, can not drive, can not work and need help from others to care for children was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity, Vision blurred
Clinical narrative: MEDICATION ERROR; LOWER BACK PAIN; CRAMPING IN ARM; BLURRED VISION; CAN NOT DRIVE; CAN NOT WORK; NEED HELP FROM OTHERS TO CARE FOR CHILDREN; BOTH LEG PAIN; This spontaneous report received from a parent concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included shrimp allergy, non-smoker, and non alcohol user, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. no medical conditions as per patient and no medications.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1809887 expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On APR-2021, the subject experienced lower back pain. On APR-2021, the subject experienced cramping in arm. On APR-2021, the subject experienced blurred vision. On APR-2021, the subject experienced can not drive. On APR-2021, the subject experienced can not work. On APR-2021, the subject experienced need help from others to care for children. On APR-2021, the subject experienced both leg pain. On 10-APR-2021, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, cramping in arm, both leg pain, and blurred vision, and the outcome of medication error, can not drive, can not work and need help from others to care for children was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Increased appetite, Stress
Clinical narrative: INCREASED APPETITE; FATIGUE; SLEPT FOR 14 TO 16 HOURS; STRESS; 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, and batch number were not reported) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUN-2021, the subject experienced sleepiness (slept for 14 to 16 hours). On 30-JUN-2021, the subject experienced stress. On an unspecified date, the subject experienced increased appetite, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, increased appetite, sleepiness (slept for 14 to 16 hours) and stress was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 5 decade old male of unknown race and ethnicity. 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, and batch number were not reported, UNKNOWN expiry) dose, 1 total, 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 patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). It was unknown whether the Autopsy was performed.; Sender's Comments: V0: 20210733844-covid-19 vaccine ad26.cov2.s-Death. 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); Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLAIN-BARRE SYNDROME; This spontaneous report received from a health care professional via social media via company representative concerned a male patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the subject experienced Guillain-Barre syndrome. The reporter had a patient last week who now had this syndrome four weeks after taking the vaccine and can barely walk or 'hold in anything" This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received via social media post concerns a male patient of unspecified age and ethnicity who had Guillain-Barre syndrome 4 weeks after receiving the Janssen Covid-19 vaccine.  The patient was reported as "can barely walk" or hold in anything".  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, and the occurrence of GBS could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Injection site pain
Clinical narrative: UPSET STOMACH/SLIGHT BUTTERFLY PAIN; AREA OF PAIN AROUND THE INJECTION SITE; 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, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the subject experienced upset stomach/slight butterfly pain. On 14-JUL-2021, the subject experienced area of pain around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach/slight butterfly pain, and area of pain around the injection site on 14-JUL-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: PATIENT HAD NO MORE INDIGESTION AFTER TAKING VACCINE (UNEXPECTED THERAPEUTIC EFFECT); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included indigestion. The patient was previously treated with famotidine for indigestion.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. . The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced subject had no more indigestion after taking vaccine (unexpected therapeutic effect). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of patient had no more indigestion after taking vaccine (unexpected therapeutic effect) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Constipation, Eye pain, Malaise, Urinary retention
Clinical narrative: CAN'T PEE; CAN'T CRAP; IN BED ALL THE TIME; EYES ACHE/HURT IN EYES; FEELING REALLY SICK; 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 and expiry: Unknown) dose was not reported, 1 total, administered on 15-MAY-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 an unspecified date, the patient experienced can't pee, can't crap, in bed all the time, eyes ache/hurt in eyes, and was feeling really sick. The patient's doctor would be coming on 16-JUL-2021.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the can't pee, can't crap, in bed all the time, eyes ache/hurt in eyes and feeling really sick was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210734547-Covid-19 vaccine ad26.cov2.s - CAN'T PEE. 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: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: SO  SO SO ACHEY; SHIVERS; MASSIVE FEVER; 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 was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUL-2021, the subject experienced so so so achey. On JUL-2021, the subject experienced shivers. On JUL-2021, the subject experienced massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive fever, shivers and so so so achey was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza, Insomnia, Pain, Vomiting
Clinical narrative: TERRIBLE BODY PAINS; VOMITING; SOME FLU; DIDN'T SLEEP WELL; TERRIBLE 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced terrible body pains, vomiting, some flu, didn't sleep well, and terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible body pains, terrible headache, vomiting, some flu and didn't sleep well was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pain
Clinical narrative: VERY LETHARGIC; ACHES; 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: Unknown) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-APR-2021, the subject experienced very lethargic. On 03-APR-2021, the subject experienced aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very lethargic on 06-APR-2021, and the outcome of aches was not reported. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Injection site reaction, Injection site swelling, Myalgia
Clinical narrative: PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Soft tissue injury
Clinical narrative: PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Bedridden, Chills, Fatigue
Clinical narrative: SEVERE SIDE EFFECTS AT NIGHT; SHAKING/MOVING; COULD NOT GET OUT OF BED; CHILLS; HIGH FEVER; FATIGUED/TIRED; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 60 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects at night, shaking/moving, could not get out of bed, chills, high fever, fatigued/tired, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued/tired, and weakness, and the outcome of severe side effects at night, chills, shaking/moving, could not get out of bed and high fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: SEVERE SIDE EFFECTS AT NIGHT; SHAKING/MOVING; COULD NOT GET OUT OF BED; CHILLS; HIGH FEVER; FATIGUED/TIRED; WEAKNESS; This spontaneous report received from a patient via a company representative concerned a 60 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects at night, shaking/moving, could not get out of bed, chills, high fever, fatigued/tired, and weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigued/tired, and weakness, and the outcome of severe side effects at night, chills, shaking/moving, could not get out of bed and high fever was not reported. This report was non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old female of unknown race and ethnic origin. 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: 1805025 and expiry date: 09-Jul-2021) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUL-2021, the patient started getting slight coughs, chills, slight fever, runny nose and extremely tired. On 14-JUL-2021 the patient tested for PCR COVID test which resulted positive on 15-JUL-2021 with confirmed covid-19 test and confirmed clinical vaccination failure. The patient is worried about how she got COVID as she was using a mask everywhere she went, didn't go out much, and social distanced. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection as of 16-JUL-2021, she still had all the same symptoms but was feeing less tired and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210738448-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Injection site pain, Migraine, X-ray
Clinical narrative: MIGRAINE; CHEST PAIN; PAIN AT THE INJECTION SITE; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: OU3A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain at the injection site. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced chest pain. On 20-APR-2021, Laboratory data included: EKG (NR: not provided) Normal, and X-ray (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 23-APR-2021, chest pain on 22-APR-2021, and pain at the injection site. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: ADMINISTERED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; STORED PRE-FILLED SYRINGE THAT WAS 10 MINUTES PAST ITS 6 HOUR MAXIMUM IN THE REFRIGERATOR; This spontaneous report received from a physician concerned a 57 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: 1808982, expiry: 07-AUG-2021) dose was not reported, administered on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. On 17-JUL-2021, the subject experienced stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator and stored pre-filled syringe that was 10 minutes past its 6 hour maximum in the refrigerator was not reported. This report was non-serious.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: ACHY; INJECTION SITE PAIN; This spontaneous report received from a consumer concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1821281 expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUL-2021, the subject experienced achy. On 02-JUL-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achy, and injection site pain on 03-JUL-2021. This report was non-serious. This case, from the same reporter is linked to 20210738857.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: DOSE GIVEN POST EXPIRY TIME; This spontaneous report received from a health care professional 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 16-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-JUL-2021, the subject experienced dose given post expiry time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given post expiry time was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Pyrexia, Tremor
Clinical narrative: SHAKING; COULD HARDLY GET OUT OF BED; CHILLS; HIGH FEVER; REALLY FATIGUED/SO TIRED; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stress.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 shaking, could hardly get out of bed, chills, high fever, and really fatigued/so tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, shaking, high fever, could hardly get out of bed and really fatigued/so tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MUSCLE SORENESS WHICH WAS WORSE IN HIS SIDES AND BACK; FATIGUE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included back pain. 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 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the subject experienced muscle soreness which was worse in his sides and back. On 15-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from muscle soreness which was worse in his sides and back. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia, Sinus congestion
Clinical narrative: TROUBLE BREATHING; CONGESTION; FEVER; 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: Unknown) dose was not reported, administered on 20-APR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced fever. On 04-MAY-2021, the subject experienced trouble breathing. On 04-MAY-2021, the subject experienced congestion. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, and congestion on 07-MAY-2021, and fever on 21-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210432473 and 20210428876.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: ACHY; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included brain tumor, and allergy to tree nuts. 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 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-JUL-2021, the subject experienced achy. On 14-JUL-2021, the subject experienced fever.  Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and achy. This report was non-serious. This case, from the same reporter is linked to 20210738675.