chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Thrombosis, Ultrasound scan
Clinical narrative: LEG PAIN DIAGNOSED AS BLOOD CLOT; HEADACHE; MILD FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: unknown) dose was not reported, 1 in total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, in APR-2021, the patient experienced mild fever (99 degrees fahrenheit), headache and leg pain diagnosed as blood clot (leg pain) on 21-APR-2021. On an unspecified date in APR-2021, laboratory data included: Body temperature (NR: not provided) 99 F, and Diagnostic ultrasound (NR: not provided) unknown.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pain diagnosed as blood clot, headache and mild fever was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:2021045225-covid-19 vaccine ad26.cov2.s-Leg pain diagnosed as blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Headache, Peripheral swelling, Thrombosis
Clinical narrative: TRANSIENT ISCHEMIC ATTACK MORE FREQUENT; POSSIBLE BLOOD CLOT; SHORTNESS OF BREATH; CHEST PAIN; SWELLING IN ONE LEG; PULSATING HEADACHE; This spontaneous report received from a patient via social media 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, 1 in 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, after took vaccine the patient had major health problems which was described as transient ischemic attack which was more frequent and lasted longer, headaches were a pulsating headache, shortness of breath(more than usual),chest pains, swelling in one leg and seems to be blood clots. The patient was enquire about the involvement of people in vaccine study with conditions like hepatitis C, strokes, chronic obstructive pulmonary disease, chronic headaches, liver problems, transient ischemic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the transient ischemic attack more frequent, pulsating headache, shortness of breath, chest pain, swelling in one leg and possible blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210452291JANSSEN COVID-19 VACCINE Ad26.COV2.S  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.
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT ISCHEMIC ATTACK MORE FREQUENT; POSSIBLE BLOOD CLOT; SHORTNESS OF BREATH; CHEST PAIN; SWELLING IN ONE LEG; PULSATING HEADACHE; This spontaneous report received from a patient via social media 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, 1 in 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, after took vaccine the patient had major health problems which was described as transient ischemic attack which was more frequent and lasted longer, headaches were a pulsating headache, shortness of breath(more than usual),chest pains, swelling in one leg and seems to be blood clots. The patient was enquire about the involvement of people in vaccine study with conditions like hepatitis C, strokes, chronic obstructive pulmonary disease, chronic headaches, liver problems, transient ischemic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the transient ischemic attack more frequent, pulsating headache, shortness of breath, chest pain, swelling in one leg and possible blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210452291JANSSEN COVID-19 VACCINE Ad26.COV2.S  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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report (social media) received from a patient via a company representative concerned a 60 year old male. The patients 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: not reported batch number: Unknown) dose was not reported, 1 total administered, 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 patient took vaccine and at night patient experienced heart attack and died due to heart attack. 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 to; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s -Heart attack. 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).; Reported Cause(s) of Death: HEART ATTACK
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Tachycardia
Clinical narrative: TACHYCARDIA; CHEST DISCOMFORT WHEN LYING DOWN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-APR-2021, the subject experienced tachycardia. On 26-APR-2021, the subject experienced chest discomfort when lying down. Laboratory data included: Heart rate (NR: not provided) 95-130 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, and chest discomfort when lying down. 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: 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 concerned two patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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.  The reporter stated that the patients tested positive for covid-19 infection, few weeks after the vaccination.  Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. 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: 20210452384-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
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Death
Clinical narrative: DEATH; UNSPECIFIED COMPLICATIONS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, once total, 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.  The six patients died on unspecified date due to unknown cause. It was also stated that these patients had some unspecified complications. It was unknown, whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of complications was not reported. This report was serious (Death).; Sender's Comments: V0: 20210452419-covid-19 vaccine ad26.cov2.s-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Nausea, Pain, Pain in extremity, Urinary tract infection
Clinical narrative: BRONCHITIS; VOMITING; NAUSEA; SORE LEFT ARM; BODY ACHES; POSSIBLE UTI; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hidradenitis suppurativa, penicillin allergy, latex allergy, and overweight. 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 was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the patient experienced body aches, chest pain, intermittent dyspnea, and sore left arm, which resulted in hospitalization. Patient was hospitalized on 13-APR-2021. The patient was discharged on an unspecified date. Patient went to another hospital as patient's symptoms did not subside. On APR-2021, the patient was diagnosed with bronchitis. Patient was not able to provide admission and discharge date. On 25-APR-2021, the patient experienced vomiting and nausea. Patient was additionally in contact with her health care professional regarding a possible urinary tract infection and/or yeast infection. Patient was not having any problem before the vaccine, even though patient can't say the Janssen Covid-19 vaccine caused her issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore left arm on APR-2021, and vomiting, and nausea on 26-APR-2021, had not recovered from intermittent dyspnea, and the outcome of bronchitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210413562- covid-19 vaccine ad26.cov2.s-Bronchitis,bodyaches. 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: BRONCHITIS; VOMITING; NAUSEA; SORE LEFT ARM; BODY ACHES; POSSIBLE UTI; This spontaneous report received from a patient concerned a 31 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included hidradenitis suppurativa, penicillin allergy, latex allergy, and overweight. 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 was administered on 12-APR-2021 to left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 13-APR-2021, the patient experienced body aches, chest pain, intermittent dyspnea, and sore left arm, which resulted in hospitalization. Patient was hospitalized on 13-APR-2021. The patient was discharged on an unspecified date. Patient went to another hospital as patient's symptoms did not subside. On APR-2021, the patient was diagnosed with bronchitis. Patient was not able to provide admission and discharge date. On 25-APR-2021, the patient experienced vomiting and nausea. Patient was additionally in contact with her health care professional regarding a possible urinary tract infection and/or yeast infection. Patient was not having any problem before the vaccine, even though patient can't say the Janssen Covid-19 vaccine caused her issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and sore left arm on APR-2021, and vomiting, and nausea on 26-APR-2021, had not recovered from intermittent dyspnea, and the outcome of bronchitis was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210413562- covid-19 vaccine ad26.cov2.s-Bronchitis,bodyaches. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Somnolence
Clinical narrative: BIT SLEEPY; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 02-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 subject experienced bit sleepy, and soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 02-APR-2021, and the outcome of bit sleepy was not reported. This report was non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, thyroid, alcohol use (occasional wine), and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041AZ1A or 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 09-APR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that on unspecified date, the patient experienced suspected immunological vaccine failure and reported that antibody test called Sars-cov2-spikeAK was given to the patient by her primary care physician which came back negative for antibodies. The consumer also reported that the patient did not had any other side effects. Laboratory data included: Sars-cov-2 antibody test (NR: not provided) Negative antibody test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210452504-Covid-19 vaccine ad26.cov2.s-Suspected 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: Fatigue
Clinical narrative: FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. o 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 MAR-2021, the subject experienced  fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from some fatigue the following day on MAR-2021. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Malaise
Clinical narrative: DEATH; FELT SICK; This spontaneous report received from a consumer (social media) via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry date: Unknown) frequency 1 total, dose and 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, after getting the vaccine, the patient felt sick. On the next dat, the patient was deceased. The cause of death was not reported. It was unknown whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: -covid-19 vaccine ad26.cov2.s -Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersomnia, Pyrexia
Clinical narrative: SLEPT FOR 18 HOURS STRAIGHT; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, 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 fever, slept for 18 hours straight, and fatigue.  Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, slept for 18 hours straight, and fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Thrombosis
Clinical narrative: CLOT IN LEGS; ESCALATING PAIN IN LOWER BACK; ESCALATING PAIN IN LEG; This spontaneous report received from a patient via news story concerned a 4 decade (early 40s) 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, and batch number were not reported) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. In APR-2021, the patient experienced clot in legs and was hospitalized. The patient was improving and scheduled to leave the hospital in few days. On 16-APR-2021, the Patient experienced escalating pain in lower back and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from clot in legs, and the outcome of escalating pain in lower back and escalating pain in leg was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: - Clot in legs (PT-Thrombosis). This event is considered unassessable. The event 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Oedema peripheral, Pain in extremity, Ultrasound scan
Clinical narrative: SWOLLEN ANKLE WITH RED STREAKS; PAIN IN LEG; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 160 pounds and height was 67.2 inches. The patient's concurrent conditions included psoriatic arthritis, fibromyalgia, insomnia, restless leg syndrome, anxiety, nightmares and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included Prazosin for nightmares, Methotrexate for psoriatic arthritis, Norco (hydrocodone bitartrate/paracetamol) for psoriatic arthritis pain, Pramipexole for restless leg syndrome, Bupropion for smoking cessation, sleeping pills, anxiety medication as needed and headache medication. On APR-2021, the patient experienced swollen ankle with red streaks (her leg was huge and going over her shoe) and pain in leg. She went to hospital and did several tests like an ultrasound which ruled out blood clots and was also prescribed a 7 day course of antibiotics. On 22-APR-2021, she was admitted to hospital due to events and was prescribed IV antibiotics. On an unspecified date in APR-2021, Blood pressure result was good, Diagnostic ultrasound ruled out infection and blood clot and X-ray ruled out infection and blood clot. On 26-APR-2021, she was discharged and another 7 day course of antibiotics was given. Treatment medications included: fentanyl and IV pain medication. She had purchased compression hose for the swelling and had been wearing these.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankle with red streaks and pain in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210452933-Covid vaccine-swollen ankle. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0- 20210452933-Covid vaccine-pain in leg. This event(s) is labeled by standard procedures. The event(s) is considered not related.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: SWOLLEN ANKLE WITH RED STREAKS; PAIN IN LEG; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 160 pounds and height was 67.2 inches. The patient's concurrent conditions included psoriatic arthritis, fibromyalgia, insomnia, restless leg syndrome, anxiety, nightmares and headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 and expiry: unknown) dose was not reported, administered at left arm on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included Prazosin for nightmares, Methotrexate for psoriatic arthritis, Norco (hydrocodone bitartrate/paracetamol) for psoriatic arthritis pain, Pramipexole for restless leg syndrome, Bupropion for smoking cessation, sleeping pills, anxiety medication as needed and headache medication. On APR-2021, the patient experienced swollen ankle with red streaks (her leg was huge and going over her shoe) and pain in leg. She went to hospital and did several tests like an ultrasound which ruled out blood clots and was also prescribed a 7 day course of antibiotics. On 22-APR-2021, she was admitted to hospital due to events and was prescribed IV antibiotics. On an unspecified date in APR-2021, Blood pressure result was good, Diagnostic ultrasound ruled out infection and blood clot and X-ray ruled out infection and blood clot. On 26-APR-2021, she was discharged and another 7 day course of antibiotics was given. Treatment medications included: fentanyl and IV pain medication. She had purchased compression hose for the swelling and had been wearing these.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen ankle with red streaks and pain in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210452933-Covid vaccine-swollen ankle. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY V0- 20210452933-Covid vaccine-pain in leg. This event(s) is labeled by standard procedures. The event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Renal pain
Clinical narrative: FELT LIKE SOMEONE WAS PUSHING DOWN BACK OR SPINE COMPRESSION OR TINGE; BACKPAIN; SORE KIDNEYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-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 APR-2021, the subject experienced felt like someone was pushing down back or spine compression or tinge. On APR-2021, the subject experienced backpain. On APR-2021, the subject experienced sore kidneys. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the backpain, sore kidneys and felt like someone was pushing down back or spine compression or tinge was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acquired dysfibrinogenaemia, Haemorrhage, Thrombosis
Clinical narrative: PROFOUND BLEEDING; CLOTTING; SUSPECT DYSFIBRINOGENEMIA; This spontaneous report received from a health care professional via a Regulatory Authority and concerned a 48 year old, female. The patient's height, weight and medical history were not reported. The patient was not pregnant at the time of reporting. The patient had no other illness at the time of vaccination, no chronic or long-standing health conditions, the patient was healthy without history of dysfibrinogenemia.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced profound bleeding, and clotting and was suspected to have dysfibrinogenemia. The patient was currently hospitalized for the events (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from profound bleeding, clotting, and suspected dysfibrinogenemia. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: VO:-covid-19 vaccine ad26.cov2.s -profound bleeding, clotting, suspect dysfibrinogenemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Platelet count, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: PULMONARY EMBOLISM/RIGHT SIDED MID BACK PAIN; This spontaneous report received from a health care professional concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease. The patient was previously treated with infliximab for Crohn's disease. The patient experienced drug allergy when treated with infliximab (Remicade). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total administered on 31-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included vitamins nos, azathioprine, dicycloverine, and mesalazine for drug used for unknown indication.  On 22-APR-2021 by evening, the patient experienced right-sided mid-back pain and shortness of breath and was presented to ED (emergency department) on 23-APR-2021. The patient's pain was sharp and worsened with coughing and deep inspiration; she felt that she was taking shallow breaths. Upon ED (emergency department) presentation, there was no shortness of breath, chest pain, dizziness, fevers, dysuria, or abdominal pain. The patient had reproducible pain on her right mid-back area. There was some mild diffuse tenderness in her abdomen, but it was reported that she always had a tender abdomen due to Crohn's disease. The patient had no peritoneal signs and had no recent travel history. On 23-APR-2021, the CTA (Computed tomography angiography) of chest was done with and without contrast and found out central and peripheral pulmonary emboli in the right lower lobe. The patient had no CT (computerized tomography) evidence of right heart strain. The patient's ground glass opacities within the right lower lobe was somewhat band like in appearance and concerned for early pulmonary infarcts. It was reported that this might also relate to sub segmental atelectasis or less likely an inflammatory/infectious process. The patient had also small right pleural effusion; no acute inflammatory process in the abdomen or pelvis. On 23-APR-2021, the patient's platelet count was 252 k/mcL and was tested negative for covid test. The patient was diagnosed with pulmonary embolism; she consulted hematology/oncology specialist and recommended with initiation of argatroban for treatment of pulmonary embolism. The patient was admitted to inpatient on 23-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pulmonary embolism/right sided mid back pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0;-covid-19 vaccine ad26.cov2.s-Pulmonary Embolism. 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Blood pressure measurement, Computerised tomogram, Electrocardiogram, Feeling abnormal
Clinical narrative: TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received from a patient concerned a 57-year-old Asian and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included blood pressure, and numbness. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 042142114, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to left arm for prophylactic vaccination.  On 15-APR-2021 the patient called paramedics due to right side felt numb. Paramedics diagnosed her wrong as having a panic attack. On 17-apr-2021, the patient started feeling numb and disoriented and close to midnight she felt like going to pass out. She also felt right side was not working and she called paramedics again and was taken to emergency room. Her blood pressure was at 172/111 and she was shaking a little. She underwent the laboratory test magnetic resonance imaging (MRI), computed tomography scan, magnetic resonance angiogram and blood work was performed. On 18-Apr-2021, At 17:00, the patient  was informed that she was moved to another hospital since she was diagnosed with and she was diagnosed with transient ischemic attack (TIA)/Stroke. The patient described that her side was still numb so they performed magnetic resonance angiogram (MRA). No Damage was found hence she was discharged from the hospital on 20-Apr-2021. The patient was hospitalized for 4 days. The patient was prescribed with amlodipine for blood pressure and clopidogrel bisulfate for a blood thinner. Patient reports continuing to "feel a little numb" intermittently. She describes the initial symptoms as "feeling like I was going to die". She stresses that she "has never been to an emergency room in her life". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from transient ischemic attack (tia)/stroke, and the outcome of felt like going to die was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210453183-COVID-19 VACCINE AD26.COV2.S-transient ischemic attack (tia)/stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: TRANSIENT ISCHEMIC ATTACK (TIA)/STROKE; FELT LIKE GOING TO DIE; This spontaneous report received from a patient concerned a 57-year-old Asian and not Hispanic or Latino female. The patient's height, and weight were not reported.  The patient's concurrent conditions included blood pressure, and numbness. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: 042142114, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to left arm for prophylactic vaccination.  On 15-APR-2021 the patient called paramedics due to right side felt numb. Paramedics diagnosed her wrong as having a panic attack. On 17-apr-2021, the patient started feeling numb and disoriented and close to midnight she felt like going to pass out. She also felt right side was not working and she called paramedics again and was taken to emergency room. Her blood pressure was at 172/111 and she was shaking a little. She underwent the laboratory test magnetic resonance imaging (MRI), computed tomography scan, magnetic resonance angiogram and blood work was performed. On 18-Apr-2021, At 17:00, the patient  was informed that she was moved to another hospital since she was diagnosed with and she was diagnosed with transient ischemic attack (TIA)/Stroke. The patient described that her side was still numb so they performed magnetic resonance angiogram (MRA). No Damage was found hence she was discharged from the hospital on 20-Apr-2021. The patient was hospitalized for 4 days. The patient was prescribed with amlodipine for blood pressure and clopidogrel bisulfate for a blood thinner. Patient reports continuing to "feel a little numb" intermittently. She describes the initial symptoms as "feeling like I was going to die". She stresses that she "has never been to an emergency room in her life". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient had not recovered from transient ischemic attack (tia)/stroke, and the outcome of felt like going to die was not reported. This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20210453183-COVID-19 VACCINE AD26.COV2.S-transient ischemic attack (tia)/stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Death
Clinical narrative: DEATH; COMPLICATIONS FROM THE VACCINE; This spontaneous report received from a consumer concerned an adult 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) dose, start therapy date were not reported, once total for prophylactic vaccination. The batch number was not reported. In this scenario follow-up is not required to obtain batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two months after vaccination, the patient died of unknown cause. The patient death occurred in hospital. It was also stated that patient had some unspecified complications. iT was also reported that, patient was healthy man in his early sixties. It was unknown, whether autopsy was performed or not. On an unspecified date, the subject experienced death, and complications from the vaccine.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of complications from the vaccine was not reported. This report was serious (Death).; 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling of body temperature change, Pruritus
Clinical narrative: INTERNAL ITCHINESS; MILD CHILLS; FATIGUE; This spontaneous report received from a consumer concerned a 41 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced fatigue. On 23-APR-2021, the subject experienced internal itchiness. On 23-APR-2021, the subject experienced mild chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 11-APR-2021, and was recovering from internal itchiness, and mild chills. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Contusion, Dizziness, Fatigue
Clinical narrative: MELENA; BLOOD IN STOOL; BRUISING ON THE LOWER HALF OF HER BODY; HEAVY VAGINAL BLEEDING; HEMATURIA; ABDOMINAL PAIN; DIZZINESS; HYPERTENSION; ARM SWELLING; EARLY MENSES; HEAVY MENSTRUAL FLOW; MUSCLE ACHES; FATIGUE; 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 administration not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient got the vaccine and had arm swelling, fatigue, muscle aches, and abdominal pain. The following Monday on 12-APR-2021, the patient experienced heavy vaginal bleeding which was not related to menses. Tuesday on 13-APR-2021, the patient had  bruising on the lower half of her body. On Wednesday 14-APR-2021, the patient noticed a large bruise on her thigh and experienced hematuria which was not consistent every time she uses the restroom. On the following Friday 16-APR-2021, the patient experienced blood in the stool. Additionally, following Saturday and Sunday, the patient noticed she had more bruises. On 27-APR-2021, she went to urgent care and then followed by the emergency room (ER), and got her bloodwork taken and her platelets were 345. The patient was experiencing menses early and going through 1 ultra tampon every hour. She was also having headache, dizziness, melena, and hypertension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, and muscle aches on APR-2021, had not recovered from abdominal pain, heavy vaginal bleeding, hematuria, bruising on the lower half of her body, hypertension, and melena, and the outcome of fatigue, early menses, heavy menstrual flow, headache, dizziness and blood in stool was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210453653-covid-19 vaccine ad26.cov2.s-malena, blood in stool. 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: Haematochezia, Haematuria, Headache, Heavy menstrual bleeding, Hypertension
Clinical narrative: MELENA; BLOOD IN STOOL; BRUISING ON THE LOWER HALF OF HER BODY; HEAVY VAGINAL BLEEDING; HEMATURIA; ABDOMINAL PAIN; DIZZINESS; HYPERTENSION; ARM SWELLING; EARLY MENSES; HEAVY MENSTRUAL FLOW; MUSCLE ACHES; FATIGUE; 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 administration not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, one total, administered to the left arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient got the vaccine and had arm swelling, fatigue, muscle aches, and abdominal pain. The following Monday on 12-APR-2021, the patient experienced heavy vaginal bleeding which was not related to menses. Tuesday on 13-APR-2021, the patient had  bruising on the lower half of her body. On Wednesday 14-APR-2021, the patient noticed a large bruise on her thigh and experienced hematuria which was not consistent every time she uses the restroom. On the following Friday 16-APR-2021, the patient experienced blood in the stool. Additionally, following Saturday and Sunday, the patient noticed she had more bruises. On 27-APR-2021, she went to urgent care and then followed by the emergency room (ER), and got her bloodwork taken and her platelets were 345. The patient was experiencing menses early and going through 1 ultra tampon every hour. She was also having headache, dizziness, melena, and hypertension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm swelling, and muscle aches on APR-2021, had not recovered from abdominal pain, heavy vaginal bleeding, hematuria, bruising on the lower half of her body, hypertension, and melena, and the outcome of fatigue, early menses, heavy menstrual flow, headache, dizziness and blood in stool was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210453653-covid-19 vaccine ad26.cov2.s-malena, blood in stool. 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).