chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Skin disorder, Swelling face, Urticaria
Clinical narrative: SUN REACTIVE; HIVES ON FACE, NECK  AND CHEST; SWELLING OF THE FACE; SKIN ISSUES DOWN ARMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 260 pounds, and height was 62 inches. The patient's concurrent conditions included heavy plegic migraine, rheumatoid arthritis, and non smoker.  The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, moxifloxacin hydrochloride, and oseltamivir phosphate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included adalimumab for rheumatoid arthritis.  On 15-APR-2021, the subject experienced swelling of the face. On 15-APR-2021, the subject experienced skin issues down arms. On 15-APR-2021, the subject experienced hives on face, neck and chest. On an unspecified date, the subject experienced sun reactive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face, hives on face, neck and chest, and skin issues down arms, and the outcome of sun reactive was not reported. This report was non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain assessment, Pain of skin
Clinical narrative: TIREDNESS; SKIN PAIN; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart attack, and smoker, and concurrent conditions included type 2 diabetes mellitus, allergy to vodka, and immune to pain relievers.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821288 expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, Laboratory data included: Pain scale (NR: not provided) 3 on a 1-10 scale, 7 out of 10. On 10-JUN-2021, the subject experienced skin pain. On 12-JUN-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiredness, and skin pain. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 52 year old male. The patient's weight was 145 pounds, and height was 58 centimeters. The patient was non alcohol user, non-smoker, and had no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, 1 total administered on 19-MAR-2021 on Left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the patient had confirmed covid-19 infection and had positive laboratory result. The patient also experienced suspected clinical vaccination failure. The symptoms included coughing and congestion. The patient had not recovered from confirmed covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183455.; Sender's Comments: V0. 20210642919-covid-19 vaccine ad26.cov2.s-Suspected 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
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product administration error, Product storage error
Clinical narrative: POSSIBLE ADMINISTRATION ERROR; INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a physician 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) 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 19-JUN-2021, the subject experienced possible administration error. On 19-JUN-2021, the subject experienced incorrect product storage. On 19-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible administration error, incorrect product storage and out of specification product use was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: MIGRAINES; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 migraines, and muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraines and muscle aches was not reported. This report was non-serious. This case, from the same reporter is linked to 20210644749.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy artery, Computerised tomogram, Feeling drunk, Giant cell arteritis, Ultrasound scan
Clinical narrative: MEDICATION CAUSED FEELING OF SEVERELY DRUNK; TEMPORAL ARTERITIS; WEAK VOMITTING; This spontaneous report received from a patient via a company representative concerned a 50 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 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 temporal arteritis. On 07-APR-2021, the subject experienced weak vomiting. On MAY-2021, Laboratory data included: CT scan (NR: not provided) temporal arteritis, and Ultrasound scan (NR: not provided) temporal arteritis. On 28-MAY-2021, Laboratory data included: Biopsy artery (NR: not provided) Negative to giant cell. On an unspecified date, the subject experienced medication caused feeling of severely drunk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weak vomiting on 10-APR-2021, was recovering from temporal arteritis, and had not recovered from medication caused feeling of severely drunk. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: MEDICATION CAUSED FEELING OF SEVERELY DRUNK; TEMPORAL ARTERITIS; WEAK VOMITTING; This spontaneous report received from a patient via a company representative concerned a 50 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 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 temporal arteritis. On 07-APR-2021, the subject experienced weak vomiting. On MAY-2021, Laboratory data included: CT scan (NR: not provided) temporal arteritis, and Ultrasound scan (NR: not provided) temporal arteritis. On 28-MAY-2021, Laboratory data included: Biopsy artery (NR: not provided) Negative to giant cell. On an unspecified date, the subject experienced medication caused feeling of severely drunk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weak vomiting on 10-APR-2021, was recovering from temporal arteritis, and had not recovered from medication caused feeling of severely drunk. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION/MILD SYMPTOMS/COLD/LOSS OF SMELL; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, 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: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid 19 infection/mild symptoms/cold/loss of smell and suspected clinical vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid 19 infection/mild symptoms/cold/loss of smell and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183529 The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210645515-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; GENERAL MALAISE; This spontaneous report received from a patient concerned a 64-year-old female. Initial information was processed along with the additional information received on 22-JUN-2021. The patient's weight was 115 pounds, and height was 66 inches. The patient's concurrent conditions included nonsmoker, and alcohol user (infrequently). Patient had no known allergies and had no drug abuse or illicit drug usage. No medications were used by the patient.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805205, and expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 to left arm at approximately 15:15 for prophylactic vaccination. Concomitant medications included aciclovir (occasionally). The patient had not taken it within the first few days of receiving the vaccine and she did not remember the exact dates of when she took it after.  On 16-MAR-2021, the patient experienced general malaise. She did blood work on 09-JUN-2021 and 11-JUN-2021, which showed no response to the spike protein antibody (confirmed immunological vaccine failure). On 09-JUN-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) as 3.24 AU/ml, Non-Reactive, Negative. On 11-JUN-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) as Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general malaise on 17-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with RA: 90000183695.; Sender's Comments: V0: 20210645526-COVID-19 VACCINE AD26.COV2.S- Confirmed immunological vaccine 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
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, sex, ethnicity and race. 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, 1 total, administered on 12-MAR-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 have had reported the event antibody low after vaccination (suspected immunological vaccine failure).  Laboratory data (dates unspecified) included: Antibody test revealed antibodies becomes very low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210645530-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
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer concerned a 16 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. 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 inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Joint noise
Clinical narrative: TICKING SOUND IN THE BACK OF NECKTICKING SOUND IN SKULL; ANNOYANCE; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, non-smoker, coronary artery disease, high blood pressure, anxiety, and depression, and other pre-existing medical conditions included the patient have no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced ticking sound in the back of neck. On 12-MAY-2021, the subject experienced ticking sound in skull. On 12-MAY-2021, the subject experienced annoyance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ticking sound in the back of neck, ticking sound in skull, and annoyance. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Eye pain, Headache, Pain in extremity, Pyrexia
Clinical narrative: BACK PAIN; FEVER; LITTLE HEADACHE; EYES HURTING; SINUS PAIN FOREHEAD AND EYES; LITTLE PAIN IN HER RIGHT LEG; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced sinus pain forehead and eyes. On JUN-2021, the subject experienced little pain in her right leg. Treatment medications included: ibuprofen, and paracetamol. On 17-JUN-2021, the subject experienced eyes hurting. On 17-JUN-2021, the subject experienced fever. On 17-JUN-2021, the subject experienced little headache. On 18-JUN-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pain forehead and eyes, and little pain in her right leg, and the outcome of fever, eyes hurting, little headache and back pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Sinus pain
Clinical narrative: BACK PAIN; FEVER; LITTLE HEADACHE; EYES HURTING; SINUS PAIN FOREHEAD AND EYES; LITTLE PAIN IN HER RIGHT LEG; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced sinus pain forehead and eyes. On JUN-2021, the subject experienced little pain in her right leg. Treatment medications included: ibuprofen, and paracetamol. On 17-JUN-2021, the subject experienced eyes hurting. On 17-JUN-2021, the subject experienced fever. On 17-JUN-2021, the subject experienced little headache. On 18-JUN-2021, the subject experienced back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sinus pain forehead and eyes, and little pain in her right leg, and the outcome of fever, eyes hurting, little headache and back pain was not reported. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site hypoaesthesia, Injection site pain, Nausea, Pain in extremity
Clinical narrative: VOMITING; SENSITIVITY TO HEAT; NAUSEA; LOW GRADE FEVER; NUMBNESS AT THE INJECTION SITE; ARM HURT REALLY BAD/SORE TO THE TOUCH; LEFT ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's past medical history included adhd, and hypertension, and other pre-existing medical conditions included the patient have no known allergies. The patient experienced drug allergy when treated with esomeprazole magnesium for drug used for unknown indication, and drug allergy when treated with diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced numbness at the injection site. On 17-JUN-2021, the subject experienced arm hurt really bad/sore to the touch. On 17-JUN-2021, the subject experienced left arm pain at injection site. On 17-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) never got over 100F. On 18-JUN-2021, the subject experienced nausea. On 20-JUN-2021, the subject experienced vomiting. On 20-JUN-2021, the subject experienced sensitivity to heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, numbness at the injection site, and arm hurt really bad/sore to the touch on 20-JUN-2021, sensitivity to heat, left arm pain at injection site, and nausea on 21-JUN-2021, and low grade fever on 18-JUN-2021. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Temperature intolerance, Vomiting
Clinical narrative: VOMITING; SENSITIVITY TO HEAT; NAUSEA; LOW GRADE FEVER; NUMBNESS AT THE INJECTION SITE; ARM HURT REALLY BAD/SORE TO THE TOUCH; LEFT ARM PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's past medical history included adhd, and hypertension, and other pre-existing medical conditions included the patient have no known allergies. The patient experienced drug allergy when treated with esomeprazole magnesium for drug used for unknown indication, and drug allergy when treated with diazepam. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced numbness at the injection site. On 17-JUN-2021, the subject experienced arm hurt really bad/sore to the touch. On 17-JUN-2021, the subject experienced left arm pain at injection site. On 17-JUN-2021, the subject experienced low grade fever. Laboratory data included: Body temperature (NR: not provided) never got over 100F. On 18-JUN-2021, the subject experienced nausea. On 20-JUN-2021, the subject experienced vomiting. On 20-JUN-2021, the subject experienced sensitivity to heat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, numbness at the injection site, and arm hurt really bad/sore to the touch on 20-JUN-2021, sensitivity to heat, left arm pain at injection site, and nausea on 21-JUN-2021, and low grade fever on 18-JUN-2021. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Headache, Limb discomfort
Clinical narrative: HEAVY FEELING IN BOTH LEGS, HEAVINESS HARDER IN RIGHT LEG; TIREDNESS; FEVER; HEADACHE; NAUSEA; CHILLS; BACK PAIN; PAIN IN BODY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding ulcer, and concurrent conditions included non-alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUN-2021, the subject experienced back pain. On 20-JUN-2021, the subject experienced pain in body. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced fever. On 20-JUN-2021, the subject experienced headache. On 20-JUN-2021, the subject experienced nausea. Treatment medications included: paracetamol. On 21-JUN-2021, the subject experienced tiredness. On 22-JUN-2021, the subject experienced heavy feeling in both legs, heaviness harder in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on 21-JUN-2021, and headache on 22-JUN-2021, had not recovered from heavy feeling in both legs, heaviness harder in right leg, and the outcome of pain in body, tiredness and back pain was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: HEAVY FEELING IN BOTH LEGS, HEAVINESS HARDER IN RIGHT LEG; TIREDNESS; FEVER; HEADACHE; NAUSEA; CHILLS; BACK PAIN; PAIN IN BODY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included bleeding ulcer, and concurrent conditions included non-alcohol user, non-smoker, and penicillin allergy, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 07-AUG-2021) dose was not reported, administered on 20-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUN-2021, the subject experienced back pain. On 20-JUN-2021, the subject experienced pain in body. On 20-JUN-2021, the subject experienced chills. On 20-JUN-2021, the subject experienced fever. On 20-JUN-2021, the subject experienced headache. On 20-JUN-2021, the subject experienced nausea. Treatment medications included: paracetamol. On 21-JUN-2021, the subject experienced tiredness. On 22-JUN-2021, the subject experienced heavy feeling in both legs, heaviness harder in right leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and nausea on 21-JUN-2021, and headache on 22-JUN-2021, had not recovered from heavy feeling in both legs, heaviness harder in right leg, and the outcome of pain in body, tiredness and back pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: MISCARRIED WITHIN A WEEK OF HER J&J VACCINE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative via social media concerned a 30 year old female. The patient's height, and weight were not reported. The patient was pregnant at the time of vaccination (gravida 1). The date of the patient's last menstrual period and expected delivery date was not reported. The patient's obstetrician (OB) told her that it was safe to get vaccinated. 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 (vaccine exposure during pregnancy). 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, within a week after vaccination, the patient had miscarriage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of miscarried within a week of vaccination was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210648705.; Sender's Comments: V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Miscarriage within a week of her J&J vaccine. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  V0: 20210648176 -Covid-19 vaccine ad26.cov2.s-Vaccine exposure during pregnancy. This event(s) is considered not related. The event(s) has an unknown/unclear 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: 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 patient via a company representative concerned a male of unspecified age and ethnicity. 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 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 21-JUN-2021, the patient experienced suspected covid-19 infection, and had experienced low symptoms. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient had suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210648299-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: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypokinesia, Injection site bruising, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: DOES NOT MOVE ARM/CANNOT LIFT RIGHT ARM ABOVE SHOULDER; DAILY ACTIVITIES ARE AFFECTED DUE TO THE PAIN; SORENESS OF ARM FOR ABOUT A WEEK; SWELLING AT INJECTION SITE; POSSIBLE NERVE DAMAGE; BRUISE AT INJECTION SITE; BURNING SENSATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nerve damage in left-leg due to knee replacement, diabetes, stent in right coronary artery, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced hive like rashes when treated with levofloxacin, and ketorolac tromethamine.  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 08-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate. On 08-APR-2021, the subject experienced possible nerve damage. On 08-APR-2021, the subject experienced bruise at injection site. On 08-APR-2021, the subject experienced burning sensation. On 08-APR-2021, the subject experienced soreness of arm for about a week. On 08-APR-2021, the subject experienced swelling at injection site. On an unspecified date, the subject experienced does not move arm/cannot lift right arm above shoulder, and daily activities are affected due to the pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on 08-APR-2021, and swelling at injection site on 15-APR-2021, was recovering from bruise at injection site, had not recovered from soreness of arm for about a week, and possible nerve damage, and the outcome of does not move arm/cannot lift right arm above shoulder and daily activities are affected due to the pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury, Pain in extremity
Clinical narrative: DOES NOT MOVE ARM/CANNOT LIFT RIGHT ARM ABOVE SHOULDER; DAILY ACTIVITIES ARE AFFECTED DUE TO THE PAIN; SORENESS OF ARM FOR ABOUT A WEEK; SWELLING AT INJECTION SITE; POSSIBLE NERVE DAMAGE; BRUISE AT INJECTION SITE; BURNING SENSATION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included nerve damage in left-leg due to knee replacement, diabetes, stent in right coronary artery, smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced hive like rashes when treated with levofloxacin, and ketorolac tromethamine.  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 08-APR-2021 for prophylactic vaccination. Concomitant medications included clopidogrel bisulfate. On 08-APR-2021, the subject experienced possible nerve damage. On 08-APR-2021, the subject experienced bruise at injection site. On 08-APR-2021, the subject experienced burning sensation. On 08-APR-2021, the subject experienced soreness of arm for about a week. On 08-APR-2021, the subject experienced swelling at injection site. On an unspecified date, the subject experienced does not move arm/cannot lift right arm above shoulder, and daily activities are affected due to the pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on 08-APR-2021, and swelling at injection site on 15-APR-2021, was recovering from bruise at injection site, had not recovered from soreness of arm for about a week, and possible nerve damage, and the outcome of does not move arm/cannot lift right arm above shoulder and daily activities are affected due to the pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Eye movement disorder, Feeling cold, Headache, Vision blurred
Clinical narrative: slight blurriness in the center of vision; NEED TO BLINK MORE OFTEN; TEETH CLATTERING; CHILLS; HEADACHE/LOW GRADE HEADACHE IN FOREHEAD, TOP OF HEAD AND EACH TEMPLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 04-JUN-2021 15:39 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced slight blurriness in the center of vision. On JUN-2021, the subject experienced need to blink more often. On JUN-2021, the subject experienced teeth clattering. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced headache/low grade headache in forehead, top of head and each temple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from teeth clattering, and chills on JUN-2021, and had not recovered from headache/low grade headache in forehead, top of head and each temple, slight blurriness in the center of vision, and need to blink more often. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: PEOPLE HAD DIED; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified ages with unknown ethnicity and race. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not reported, 1 total, 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, reporter stated that people had died from vaccine and they were healthy before the vaccination. Patients were died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the event patient had died was fatal.  This report was serious (Death). This case, from the same reporter is linked to 20210648176; Sender's Comments: V0: 20210648705- covid-19 vaccine ad26.cov2.s-People had died . 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
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Chills, Headache, Pain in extremity, Paraesthesia
Clinical narrative: WEIRD REACTION TO THE JANSSEN COVID-19 VACCINE; TINGLING NUMBNESS IN RIGHT ARM NON-VACCINATED ARM; SORENESS IN THE LEFT ARM; CHILLS; HEADACHES; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 expiry: 30-SEP-2021) dose was not reported, administered on 22-JUN-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced weird reaction to the janssen covid-19 vaccine. On 22-JUN-2021, the subject experienced tingling numbness in right arm non-vaccinated arm. On 22-JUN-2021, the subject experienced soreness in the left arm. On 22-JUN-2021, the subject experienced chills. On 22-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weird reaction to the janssen covid-19 vaccine, tingling numbness in right arm non-vaccinated arm, soreness in the left arm, chills, and headaches. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE GIVEN FROM THE VIAL WHICH WAS PUNCTURED AND KEPT IN REFRIGERATOR ONE DAY BEFORE; PUNCTURED VIAL OF VACCINE KEPT IN REFRIGERATOR FOR A DAY; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced vaccine given from the vial which was punctured and kept in refrigerator one day before. On 23-JUN-2021, the subject experienced punctured vial of vaccine kept in refrigerator for a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given from the vial which was punctured and kept in refrigerator one day before and punctured vial of vaccine kept in refrigerator for a day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210652114.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Condition aggravated, Feeling abnormal
Clinical narrative: BODY ACHES; BODY TEMPERATURE 95.5 F; LETHARGY; NOT FEELING LIKE HIMSELF; CHILLS; HEADACHE; FEELING WORSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling worse. On 15-JUN-2021, the subject experienced body aches. On 15-JUN-2021, the subject experienced body temperature 95.5 f. On 15-JUN-2021, the subject experienced lethargy. On 15-JUN-2021, the subject experienced not feeling like himself. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 95.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature 95.5 f on 17-JUN-2021, and had not recovered from headache, body aches, chills, lethargy, not feeling like himself, and feeling worse. This report was non-serious. This case, from the same reporter is linked to 20210651363.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain
Clinical narrative: BODY ACHES; BODY TEMPERATURE 95.5 F; LETHARGY; NOT FEELING LIKE HIMSELF; CHILLS; HEADACHE; FEELING WORSE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced feeling worse. On 15-JUN-2021, the subject experienced body aches. On 15-JUN-2021, the subject experienced body temperature 95.5 f. On 15-JUN-2021, the subject experienced lethargy. On 15-JUN-2021, the subject experienced not feeling like himself. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 95.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body temperature 95.5 f on 17-JUN-2021, and had not recovered from headache, body aches, chills, lethargy, not feeling like himself, and feeling worse. This report was non-serious. This case, from the same reporter is linked to 20210651363.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Illness, Oropharyngeal pain
Clinical narrative: COUGHING; VERY SICK; SORE THROAT; NO ENERGY; FEVER OF 103.5; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had only been sick only 6 times in his life. 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 MAR-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 21-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Awaiting results. On 22-JUN-2021, the subject experienced coughing. On 22-JUN-2021, the subject experienced very sick. On 22-JUN-2021, the subject experienced sore throat. On 22-JUN-2021, the subject experienced no energy. On 22-JUN-2021, the subject experienced fever of 103.5. Laboratory data included: Body temperature (NR: not provided) 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 103.5, coughing, sore throat, no energy, and very sick. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COUGHING; VERY SICK; SORE THROAT; NO ENERGY; FEVER OF 103.5; This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had only been sick only 6 times in his life. 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 MAR-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 21-JUN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Awaiting results. On 22-JUN-2021, the subject experienced coughing. On 22-JUN-2021, the subject experienced very sick. On 22-JUN-2021, the subject experienced sore throat. On 22-JUN-2021, the subject experienced no energy. On 22-JUN-2021, the subject experienced fever of 103.5. Laboratory data included: Body temperature (NR: not provided) 103.5 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever of 103.5, coughing, sore throat, no energy, and very sick. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: 2 PATIENTS WERE GIVEN THE JANSSEN AFTER 6 HOURS OF BEING PUNCTURED.; This spontaneous report received from a pharmacist concerned a 49 year old female. The patient's weight was 315 pounds, and height was 167.64 centimeters. The patient's pre-existing medical conditions included patient had no known allergy, no history of hospitalization in last 30 days, no pre-existing acute illness 30 days prior to vaccination, no illness at the time of vaccination, no past history of similar events, no adverse events after any previous vaccination. she was not currently breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820095 expiry: 04-JUL-2021) 0.5 ml, administered on 03-JUN-2021 11:40 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced 2 subjects were given the janssen after 6 hours of being punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 patients were given the janssen after 6 hours of being punctured was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612064.