chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Rash, Rash erythematous, Rash pruritic
Clinical narrative: SHORTNESS OF BREATH; CHEST PINCHING; FAST HEART BEAT; RASHES HAD REDNESS; RASHES AS ITCHY; RASHES ON CHEST AND BACK AS PAINFUL; EASILY GOT TIRED; FELT HEART WAS CONGESTED; COUGH; LITTLE BIT OF HEADACHE; This spontaneous report received from a patient concerned a 48 year old male. The patient's weight was 150 pounds, and height was 170 centimeters. The patient's past medical history included low platelet, and bypass surgery, and concurrent conditions included rashes allergy, non drinker, and non-smoker, 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, intramuscular, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for low platelet. On 31-MAR-2021, the subject experienced little bit of headache. On APR-2021, the subject experienced felt heart was congested. On APR-2021, the subject experienced cough. On 12-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced chest pinching. On 12-APR-2021, the subject experienced fast heart beat. On 12-APR-2021, the subject experienced rashes had redness. On 12-APR-2021, the subject experienced rashes as itchy. On 12-APR-2021, the subject experienced rashes on chest and back as painful. On 12-APR-2021, the subject experienced easily got tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit of headache on 01-APR-2021, had not recovered from shortness of breath, chest pinching, fast heart beat, rashes on chest and back as painful, easily got tired, rashes as itchy, and rashes had redness, and the outcome of felt heart was congested and cough was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: FACE, HAND AND ARM NUMBNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's weight was 56.8 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported) frequency one total, 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. Concomitant medications included tadalafil, and treprostinil sodium.  The patient reported that on an unspecified date she experienced possible adverse event from vaccine which caused face, hand and arm numbness. The patient was hospitalized on 13-APR-2021. No further details were provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from face, hand and arm numbness. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient is linked.; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-FACE, HAND AND ARM NUMBNESS. This event is considered unassessable. The event 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.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dysstasia, Hyperhidrosis
Clinical narrative: CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Presyncope, Pyrexia, Visual impairment
Clinical narrative: CHILLS; FEVER; LOST MY VISION; CLOSE TO FAINT; PALENESS; DIZZINESS; UNABLE TO STAND; SWEATING; LOSS OF ENERGY IN LEGS/BODY WEAKNESS; This spontaneous report received from a patient concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced lost my vision. On 09-APR-2021, the subject experienced close to faint. On 09-APR-2021, the subject experienced paleness. On 09-APR-2021, the subject experienced dizziness. On 09-APR-2021, the subject experienced unable to stand. On 09-APR-2021, the subject experienced sweating. On 09-APR-2021, the subject experienced loss of energy in legs/body weakness. On 10-APR-2021 14:00, the subject experienced chills. On 10-APR-2021 14:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost my vision, close to faint, paleness, dizziness, unable to stand, sweating, and loss of energy in legs/body weakness on 09-APR-2021, and fever on 14-APR-2021, and was recovering from chills. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Contusion, Muscle spasms
Clinical narrative: ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender's Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Limb discomfort, Migraine
Clinical narrative: BREATHING EFFECTED; LOW MIGRAINE; ARM EXTREMELY SORE; 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. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced breathing effected, low migraine, and arm extremely sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing effected, and low migraine, and had not recovered from arm extremely sore. This report was non-serious.; Sender's Comments: V0:As per protocol, MAC comment is not required for non-serious case
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAR-2021 patient did an antibody test for covid-19 antibodies, no antibodies were found. On 16-APR-2021, patient did the examination again, however no antibodies were found second time. The patient experienced confirmed immunological vaccine failure. On 25-MAR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies found (units unspecified). On 16-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) No antibodies found (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210436395. This report was associated with product quality complaint: 90000176773.; Sender's Comments: V0-20210435716-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological 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: Hypoaesthesia, Injection site haemorrhage, Loss of consciousness, Muscular weakness, Vomiting
Clinical narrative: PASSED OUT; BOTH ARMS WENT COMPLETELY NUMB; LEGS CRUMBLED/COULDN'T STAND UP; VOMITED; THE DAY GOT THE VACCINE IT BLED AND A BLOOD CLOT CAME ON MY ARM; This spontaneous self-report concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 28-MAR-2021, the day the patient got the vaccine it bled and a 'blood clot' came on my arm (coded to injection site bleeding). On 01-APR-2021, the patient passed out in a store, both arms went completely numb, legs crumbled/couldn't stand up, and vomited. The patient believed this was a side effect of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events (passed out, both arms went completely numb, legs crumbled/couldn't stand up, vomited, and the day got the vaccine it bled/blood clot came on my arm) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This patient of unknown age and gender passed out 3 days after receiving the Janssen Covid-19 vaccine. The patient was in a store when when both arms became numb, legs "crumbled" and could not stand; the patient also vomited. No other information regarding the serious loss of consciousness  was provided. Additionally, on the day of vaccination, the patient experienced bleeding at the injection site and a clot formed. Considering the missing information (e.g., age, sex, medical history, concomitant medications, clinical details leading up the event, corrective treatment, event outcome), the serious loss of consciousness is considered unclassifiable. The nonserious injection site reaction is consistent with a causal association with vaccination.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; 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 past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird 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
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Pain, Somnolence
Clinical narrative: BODY ACHING; COULD NOT MOVE; TROUBLE BREATHING; SWEATING; SLEEPY/SLEEP MOST OF THE DAY AND NIGHT; NO ENERGY; FELT TIRD; HEADACHE IN THE BACK OF HEAD; 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 past medical history included knee replacement, and concurrent conditions included non-smoker, and non-alcoholic, and other pre-existing medical conditions included the patient had no known drug allergies and no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced sleepy/sleep most of the day and night. On MAR-2021, the subject experienced no energy. On MAR-2021, the subject experienced felt tird. On MAR-2021, the subject experienced headache in the back of head. On 09-MAR-2021, the subject experienced trouble breathing. On 09-MAR-2021, the subject experienced sweating. On 09-MAR-2021, the subject experienced body aching. On 09-MAR-2021, the subject experienced could not move. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, body aching, and could not move, had not recovered from trouble breathing, and headache in the back of head, and the outcome of no energy, sleepy/sleep most of the day and night and felt tird 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: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; This spontaneous report received from a patient via a company representative concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, 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, 7 days after the vaccine, the patient  experienced Transient Ischaemic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transient ischaemic attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-transient ischaemic attack .This event is considered unassessable. The event 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.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Fatigue, Hypertension, Nasopharyngitis
Clinical narrative: MILD COLD SYMPTOMS; SORE ARM; WEAKNESS; FATIGUE; THIRD STAGE HBP; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry-unknown) dose was not reported, 1 total administered on 06-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After the vaccine administration he felt "kind of weak and tired" and had mild cold symptoms and his arm was little sore With weakness on 06-MAR-2021, patient visited to the dentist to get a cleaning, they took his vital signs in the office, and were not able to do a cleaning because the blood pressure was very high (196/150). They waited 10 minutes and took the Blood Pressure again, still 196/150. he always had low BP. then bought a blood pressure monitor and it was continuously very high and even higher than at the dentist.due to this patient scheduled a doctor appointment on 3/25 physician took Blood pressure and prescribed some lab test. He had another appointment on 4/1,that time blood work was good everything functioning well, physician not understand   why the BP was so high. patient told he received vaccine recently. On 25-MAR-2021 He was diagnosed with stage 3 High Blood Pressure, then physician put him on blood pressure medication. he also report works out every day ,very healthy and never had medical condition before, never took any medication ,No family history of HBP or heart condition Laboratory data included: Blood pressure (NR: not provided) 196/150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from third stage high blood pressure, and the outcome of sore arm, mild cold symptoms, weakness and fatigue was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441025.; Sender's Comments: V0-20210436063-covid-19 vaccine ad26.cov2.s-Third stage high blood pressure. 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: MILD COLD SYMPTOMS; SORE ARM; WEAKNESS; FATIGUE; THIRD STAGE HBP; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry-unknown) dose was not reported, 1 total administered on 06-MAR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After the vaccine administration he felt "kind of weak and tired" and had mild cold symptoms and his arm was little sore With weakness on 06-MAR-2021, patient visited to the dentist to get a cleaning, they took his vital signs in the office, and were not able to do a cleaning because the blood pressure was very high (196/150). They waited 10 minutes and took the Blood Pressure again, still 196/150. he always had low BP. then bought a blood pressure monitor and it was continuously very high and even higher than at the dentist.due to this patient scheduled a doctor appointment on 3/25 physician took Blood pressure and prescribed some lab test. He had another appointment on 4/1,that time blood work was good everything functioning well, physician not understand   why the BP was so high. patient told he received vaccine recently. On 25-MAR-2021 He was diagnosed with stage 3 High Blood Pressure, then physician put him on blood pressure medication. he also report works out every day ,very healthy and never had medical condition before, never took any medication ,No family history of HBP or heart condition Laboratory data included: Blood pressure (NR: not provided) 196/150. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from third stage high blood pressure, and the outcome of sore arm, mild cold symptoms, weakness and fatigue was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210441025.; Sender's Comments: V0-20210436063-covid-19 vaccine ad26.cov2.s-Third stage high blood pressure. 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: Limb mass, Thrombosis
Clinical narrative: LARGE BLOOD CLOT; SWOLLEN BALL ON SIDE OF KNEE; This spontaneous report received from a female patient of unspecified age reporting on self. 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 was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced large blood clot and swollen ball on side of knee. The swollen ball on side of knee was going on for a couple days now. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from large blood clot, and swollen ball on side of knee. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, unknown ethnicity, who experienced a large blood clot and swelling on the side of the knee (laterality not reported) on an unspecified number of days after receiving the cobid-19 vaccine ad26.cov.2. The information provided precludes a meaningful medical assessment. Additional information requested.
Sex: M
Vaccine: COVID19
Symptoms: Extravasation
Clinical narrative: BLOOD OOZING OUT OF INSULIN PUMP; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes. 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 was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced blood oozing out of insulin pump. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood oozing out of insulin pump was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT IN FOOT; This spontaneous report was received from a patient via a company representative and 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 not reported) 1 total 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, two days after vaccination, the patient experienced a blood clot in his foot. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The outcome of blood clot in foot was not reported. This report was serious (other medically important condition).; Sender's Comments: V0:  This male of unspecified age and ethnicity reported to have experience blood clot in foot 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No other information was reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per WHO causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information is requested
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLACTIC REACTION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included banana allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-APR-2021, the patient felt a little lightheaded 15 minutes after vaccination. The patient was then left for 25 minutes to 30 minutes. It was reported that the patient's body got hot all over, ears started itching, face started tingling and was feeling tight. The patient's chest and neck also started feeling tight. The patient visited emergency room for treatment of the events. It was reported that the patient was having an anaphylactic reaction and was given Benadryl and prednisone. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and prednisone non-company. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210436119-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram
Clinical narrative: BELL'S PALSY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient had no known drug allergies. The patient was not involved in any accident nor had any prior history of Bell's palsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total, administered on 08-MAR-2021 on left deltoid for prophylactic vaccination.  On 22-MAR-2021, the patient developed slurred speech. On 08-APR-2021, the patient had drooping eyelids, was unable to close mouth and had puff cheeks. On 12-APR-2021, the patient visited her doctor's office and diagnosed with Bell's palsy which was further confirmed with computerized tomography (CAT) scan. On an unspecified date in APR-2021, Laboratory data included: computerized tomography CAT) scan (NR: not provided) Bell's Palsy. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from bell's palsy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210436167-covid-19 vaccine ad26.cov2.s-Bell's palsy. 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: Asthenia, Blood pressure measurement, Chest pain, Decreased appetite, Dizziness
Clinical narrative: CHEST PAIN; HIGH BLOOD PRESSURE; HEART BURN; YELLOW SKIN; DIZZINESS; LOSS OF APPETITE; TIREDNESS; FEELING WEAK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808979, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included losartan potassium for hypertension. On APR-2021, the subject experienced yellow skin. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced feeling weak. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced high blood pressure. On 18-APR-2021, the subject experienced heart burn. Laboratory data included: Blood pressure (NR: not provided) 180 not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart burn, high blood pressure, yellow skin, dizziness, loss of appetite, tiredness, feeling weak and chest pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Hypertension, Yellow skin
Clinical narrative: CHEST PAIN; HIGH BLOOD PRESSURE; HEART BURN; YELLOW SKIN; DIZZINESS; LOSS OF APPETITE; TIREDNESS; FEELING WEAK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808979, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. Concomitant medications included losartan potassium for hypertension. On APR-2021, the subject experienced yellow skin. On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced loss of appetite. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced feeling weak. On 18-APR-2021, the subject experienced chest pain. On 18-APR-2021, the subject experienced high blood pressure. On 18-APR-2021, the subject experienced heart burn. Laboratory data included: Blood pressure (NR: not provided) 180 not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart burn, high blood pressure, yellow skin, dizziness, loss of appetite, tiredness, feeling weak and chest pain was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: FEELING BAD; This spontaneous report received from a health care professional via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included idiopathic thrombocytopenic purpura. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced feeling bad. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling bad was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 number. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was reported that, the patient death occurred after receiving the vaccine. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked.; Sender's Comments: V0: -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
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: BODY ACHE; FEELING TIRED; This spontaneous report received from a consumer concerned a 40 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced body ache. On 08-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, and feeling tired. This report was non-serious. This case, from the same reporter is linked to 20210435771.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arteriovenous fistula, Cerebral haemorrhage, Cerebrovascular accident, Headache, Vomiting
Clinical narrative: STROKE; BRAIN BLEED; BRAIN FISTULA; VOMITING; HEADACHE; This spontaneous report received from a patient concerned a 53-year-old female. The patient's height, and weight were not reported. The patient's past medical history included hormone replacement therapy: bioidenticals, and surgery. 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 administered for prophylactic vaccination. Vaccination site was unknown. 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, after two week of vaccination, the patient had a brain fistula which was considered as a stroke because it was a bleeding not a clot. She had really bad headache and was throwing up all night (vomiting). She called her primary health care physician they told her to visit hospital. First she went to the community hospital in her local city from where she was transferred to another hospital for surgery. The surgery occurred in first week of April. She was currently hospitalized. Number of days in hospital were unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, vomiting, brain fistula, brain bleed and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments:-covid-19 vaccine ad26.cov2.s-Haemorrhagic stroke . 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: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: This spontaneous report received from patient via the VAERS (Vaccine Adverse Event Reporting System) concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin for drug used for unknown indication.  On 16-MAR-2021, the patient experienced platelet count decreased. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of platelet count decreased was not reported. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE TO BACK OF HEAD, BEHIND THE RIGHT EAR; This spontaneous report received from a patient via a company representative concerned a 49 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-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 APR-2021, the subject experienced headache to back of head, behind the right ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache to back of head, behind the right ear. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache
Clinical narrative: COULD NOT BREATH; FELT REALLY TIRED; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included previous stroke, and aneurysm, and concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0402A214, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced could not breath. On 07-APR-2021, the subject experienced felt really tired. On 07-APR-2021, the subject experienced headache. 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 felt really tired, headache, and could not breath. This report was non-serious.; Sender's Comments: V0: As per standard protocol, MAC comment is not required for non-serious case
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Headache, Nonspecific reaction
Clinical narrative: TROUBLE BREATHING; PINCHING IN THE CHEST; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced pinching in the chest. On APR-2021, the subject experienced trouble getting out of bed. On APR-2021, the subject experienced severe headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, pinching in the chest, trouble breathing, and trouble getting out of bed. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Scan
Clinical narrative: TROUBLE BREATHING; PINCHING IN THE CHEST; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on12-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced pinching in the chest. On APR-2021, the subject experienced trouble getting out of bed. On APR-2021, the subject experienced severe headache. On 15-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown, and Scan (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, pinching in the chest, trouble breathing, and trouble getting out of bed. This report was non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Neck pain, Rash macular
Clinical narrative: POSSIBLE THROMBOCYTOPENIA; RASH FROM KNEE TO FEET /SPOTTY RED DOTS ON LEG; SLEEPINESS; NECK ACHE; TIREDNESS; MUSCLE ACHE; HEADACHE; This spontaneous self-report concerned a 53 year old male patient. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the patient received the vaccine, waited at facility for 15 minutes, and everything was okay.  On 17-APR-2021, the patient experienced neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness, which he treated with Aleve (naproxen sodium). He also noticed his feet had a rash from his knee to feet, and according to his sister (who is a healthcare professional) it looked like small micro-embolisms (thrombocytopenia). The patient went to his physician who said the spotty red dots could be petechiae caused by thrombocytopenia.  As recommended by his primary care physician, the patient has an appointment for lab work, including platelet counts, on 20-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tiredness, neck ache, rash from knee to feet (red dots), muscle ache, and possible thrombocytopenia, and the outcome of sleepiness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  This 53-year-old male patient was found to have petechiae-like rash on his knees to feet, that according to attending physician could be caused by thrombocytopenia, 2 days after receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection. The patient underwent laboratory procedure including platelet count (results not reported).  The patient complained of neck ache, muscle ache and felt a sense of tiredness, headache, sleepiness that he treated with Aleve (naproxen sodium) on the day the petechiae-like rash appeared.  No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information as requested.