chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE REACTION; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 experienced unspecified adverse reaction. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse reaction was not reported. This report was non-serious. This case, from the same reporter is linked to 20220243783.
Sex: F
Vaccine: COVID19
Symptoms: Apallic syndrome
Clinical narrative: VEGETABLE STATE; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: cold, and fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vegetable state, wheelchair, and lost health. It was reported as " Wife now a vegetable state after talking the Covid vaccines .Cain and wheelchair, Lost her job ! And her health". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vegetable state. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220244559-covid-19 vaccine ad26.cov2.s-vegetable state. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: MEDICAL PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never ever had any of those medical problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered 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, three weeks after the vaccination, the patient experienced medical problems, and was hospitalized (date and duration unspecified). The reporter stated "My daughter ended up in the hospital after taking their shot. It was about 3 weeks afterward and so I am just not completely sure the shot was the cause of it but I do know that she never ever had any of those medical problems before she got the shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medical problems was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20220244707-Covid-19-vaccine ad26.CoV-2.s-Medical problems. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: STAGE 3 LYMPHOMA; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, 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 patient experienced stage 3 lymphoma. It was reported that, "my friend now has stage 3 Lymphoma".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 lymphoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220245831-covid-19 vaccine ad26.cov2.s-stage 3 lymphoma. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Thrombosis
Clinical narrative: BLOOD CLOTS ON ARMS; BIG RED SPOTS ON ARMS; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots on arms, and big red spots on arms. The reporter stated that "Friend of mine just told me she is getting a big red spots and blood clots on her arms. She got the vaccines." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the big red spots on arms and blood clots on arms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220245834-COVID-19 VACCINE AD26.COV2.S-Blood clots on arms. 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. Therefore, this event is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Leukaemia
Clinical narrative: LEUKEMIA; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry was not reported) 1 total, 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.  It was reported that "my buddy got leukemia from the shot, unbelievable/one friend got leukemia". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leukemia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220245881.; Sender's Comments: V0: 20220245849-COVID-19 VACCINE AD26.COV2.S-Leukemia. 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. Therefore, this event is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: UNCONTROLLABLE BLOOD PRESSURE (190/110); This spontaneous report received from a consumer via social media  through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced uncontrollable blood pressure (190/110). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 190/110 unit unspecified. The reporter posted that "another got uncontrollable blood pressure190/110, and this is supposed to be safe, not." The action taken with covid-19 vaccine  was not applicable. The outcome of uncontrollable blood pressure (190/110) was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220245849.; Sender's Comments: V0:20220245881- covid-19 vaccine - uncontrollable blood pressure (190/110). 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via social media a company representative concerned a female of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: lung surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, 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.  The patient reported that "I had a stroke 2 days after my 1st shot. I had to wait so long because I had lung surgery. I was so happy to start and already made the 2nd appointment and ended up being taken by the ambulance to the hospital. After 2 days went to a rehab because I couldn't stand. I'm fine now. Good thing I wasn't paralyzed".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220245951-covid-19 vaccine ad26.cov2.s-Stroke. 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). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID-19; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose not reported, 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 experienced got covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000218330.     .
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Capillary fragility, Dyspnoea, Fatigue, Lung disorder
Clinical narrative: BRADYCARDIA; BROKEN CAPILLARIES; VARICOSE VEINS; SHORTNESS OF BREATH; LUNG ISSUES / PROBLEM WITH THE LUNGS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative via social media concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: 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 patient experienced health problems that she never had before and the doctors could not diagnose anything. A couple of weeks after she had the Johnson and Johnson vaccine, she developed broken capillaries and varicose veins. It was quick to come on and extreme. Then she had extreme fatigue and shortness of breath. One Doctor said it was bradycardia the other one said it was a problem with the lungs (lung issues) but lung doctor said her lungs were fine. Doctors did not know what it was. She want her healthy life back. Doctors were afraid to get involved was what she thought. They act uncomfortable and politely go to another discussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the broken capillaries, varicose veins, extreme fatigue, shortness of breath, bradycardia and lung issues / problem with the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220246253-covid-19 vaccine ad26.cov2.s-bradycardia. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Varicose vein
Clinical narrative: BRADYCARDIA; BROKEN CAPILLARIES; VARICOSE VEINS; SHORTNESS OF BREATH; LUNG ISSUES / PROBLEM WITH THE LUNGS; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative via social media concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: 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 patient experienced health problems that she never had before and the doctors could not diagnose anything. A couple of weeks after she had the Johnson and Johnson vaccine, she developed broken capillaries and varicose veins. It was quick to come on and extreme. Then she had extreme fatigue and shortness of breath. One Doctor said it was bradycardia the other one said it was a problem with the lungs (lung issues) but lung doctor said her lungs were fine. Doctors did not know what it was. She want her healthy life back. Doctors were afraid to get involved was what she thought. They act uncomfortable and politely go to another discussion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the broken capillaries, varicose veins, extreme fatigue, shortness of breath, bradycardia and lung issues / problem with the lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220246253-covid-19 vaccine ad26.cov2.s-bradycardia. 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). Therefore, this event(s) is considered unassessable.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Psoriasis
Clinical narrative: PLAQUE PSORIASIS; BACK PAIN; ARTHRITIC PAINS; PAIN IN FINGERS; This spontaneous report received from a patient concerned a 4 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis, back pain, arthritic pains, and pain in fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from plaque psoriasis, had not recovered from arthritic pains, and the outcome of back pain and pain in fingers was not reported. This report was non-serious. This case, involving the same patient is linked to 20220251315.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium test, Culture stool, Diarrhoea, Laboratory test
Clinical narrative: Started with mild diarrhea which kept getting worse.  Eventually called doctor and he ordered stool culture and c difficile cultures to be done.  I took Cipro and eventually diarrhea stopped
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: STROKE; BRAIN BLEED; This spontaneous report received from a consumer via a company representative 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, expiry: unknown) dose, start therapy date were not reported, 01 total administered 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.  It was reported that on an unspecified date, "mother (patient) had a stroke and a brain bleed." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and brain bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220246736-covid-19 vaccine ad26.cov2.s-Stroke, Brain bleed. 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). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vaccination site pain
Clinical narrative: OCCASIONAL PAIN/SORENESS AFTER WORKING OUT; FATIGUE; GOT COVID VACCINE AND SORENESS IN ARM; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. 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. The company was unable to perform follow up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced occasional pain/soreness after working out, fatigue, and got covid vaccine and soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient had not recovered from occasional pain/soreness after working out, fatigue, and got covid vaccine and soreness in arm. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: PAIN IN ANKLE; VACCINATION SITE PAIN; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included torn meniscus, lupus, and psoriatic arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced pain in ankle, and vaccination site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab was not reported. The outcome of the pain in ankle and vaccination site pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20220249334.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: MORE RINGING IN EARS THAN NORMAL (MORE IN LEFT EAR); HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included: migraine, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient was otherwise healthy and not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-SEP-2021, the patient experienced headache. On an unspecified date, the patient experienced more ringing in ears than normal (more in left ear). Treatment medications (dates unspecified) included: acetylsalicylic acid/caffeine/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 20-SEP-2021, and the outcome of more ringing in ears than normal (more in left ear) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Intracardiac thrombus, Lung disorder, Suspected COVID-19, Vaccination failure
Clinical narrative: STROKES IN THE BRAIN; CLOTS IN THE HEART; SUSPECTED COVID-19 INFECTION; LUNGS WERE BAD; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total (first dose) administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced strokes in the brain, clots in the heart, suspected covid-19 infection, lungs were bad, suspected clinical vaccination failure and on unspecified date, the patient was hospitalized for unspecified number of days. The reporter stated that; "my brother is in the hospital with strokes in the brain, clots in the heart, sick with C-19, his lungs are bad, they give very bad health news and his shot was from this company". The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from strokes in the brain, clots in the heart, suspected covid-19 infection, and lungs were bad, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000218419.; Sender's Comments: V0: 20220247928-COVID-19 VACCIN-strokes in the brain, clots in the heart, suspected covid-19 infection, and lungs were bad. 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). Therefore, this event(s) is considered unassessable. 20220247928-COVID-19 VACCINE -suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: INJECTION SIGHT WAS SORE; This spontaneous report received from a patient via a company representative of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced injection sight was sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection sight was sore. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Influenza like illness, Palpitations, Paraesthesia
Clinical narrative: EXPIRED VACCINE USED; MILD FLU LIKE SYMPTOMS; HEART PALPITATIONS; NUMBNESS AND TINGLING IN LEGS; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 28-SEP-2021, the patient experienced expired vaccine used, mild flu like symptoms, heart palpitations, and numbness and tingling in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild flu like symptoms on 01-OCT-2021, had not recovered from heart palpitations, and numbness and tingling in legs, and the outcome of expired vaccine used was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Infection
Clinical narrative: COUGHING; ALWAYS GOT INFECTIONS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number was not reported) 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 patient experienced coughing, and always got infections. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the coughing and always got infections was not reported. This report was non-serious. This parent/child case is linked to 20220251231.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: SEVERE VERTIGO; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included vertigo. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-DEC-2021, the patient experienced severe vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe vertigo. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Illness, Influenza like illness, Malaise, SARS-CoV-2 test
Clinical narrative: VERY SICK; VERY DIZZY; REALLY BAD FLU LIKE SYMPTOMS; EXTREMELY ILL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 23-JAN-2022 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 very sick, very dizzy, really bad flu like symptoms, and extremely ill. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sick, very dizzy, really bad flu like symptoms, and extremely ill. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis, torn meniscus, and lupus. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. On an unspecified date, the patient experienced pain in ankle and vaccination site pain (dose number in series 1). The outcome of pain in ankle and vaccination site pain was not reported (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown) dose was not reported, 1 total, on an unspecified date in 2021 for prophylactic vaccination which was an off label use as inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 29-OCT-2021, the patient received additional covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, and batch number was not reported) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration of vaccine (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220246857 (dose number in series 1).
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: NOT WELL FROM THE SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 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 experienced not well from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not well from the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220250680.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 VIRUS AFTER VACCINATION; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 virus after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 virus after vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: FEELING DIZZY; SWEATS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: 23-AUG-2021) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced feeling dizzy, and sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling dizzy and sweats was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOT IN LEG; BLOOD CLOT IN LUNGS; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in leg, and blood clot in lungs. As per reporter, "Just want to thank you guys personally for giving me a blood clot not only in my leg but now my lungs. Should never of gotten the vaccine with you guys." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in leg and blood clot in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220250709-covid-19 vaccine ad26.cov2.s- Blood clot in leg, blood clot in lungs. 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). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Thrombosis, Vaccination failure
Clinical narrative: BLOOD CLOTS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no problems and was extremely healthy at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s booster (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, and batch number and expiry were not reported) dose, start therapy date were not reported 01 total was administered 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 got sick and tested positive for Coronavirus disease (COVID-19), hence suspected COVID-19 infection and suspected clinical vaccination failure. Patient also had blood clots (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots, suspected clinical vaccination failure and suspected COVID-19 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with product quality complaint (PQC): 90000218636 This case, from the same reporter is linked to 20220251156, 20220251028 and 20220250507.; Sender's Comments: V0: 20220250720-COVID-19 VACCINE AD26.COV2.S- blood clots. 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). Therefore, this event(s) is considered unassessable. 20220250720-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Electromyogram, Increased appetite, Magnetic resonance imaging, Musculoskeletal stiffness
Clinical narrative: BODY GOT LOCKED UP; NERVE PAIN IN LEGS; TINGLING IN HANDS/FEETS/ IT WOULD GO  UP TO MY HIP IN MY ARMS IT WAS ONLY IN FINGERS/HANDS/ IT TRAVELS  UP LEG/TINGLING GETS WORSE; WENT TO SLEEP AND WOKE UP EARLY AND LIKE ON SPEED/COCAINE (MORE  THAN COFFEE); ARM SORENESS; CRAZY HUNGRY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis, and artificial disc in neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 5905029 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient experienced crazy hungry. On 30-MAR-2021, the patient experienced arm soreness. On 31-MAR-2021, the patient experienced went to sleep and woke up early and like on speed/cocaine (more than coffee). On 13-APR-2021, the patient experienced nerve pain in legs. On 13-APR-2021, the patient experienced tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse. On JUN-2021, the patient experienced body got locked up. On SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, EMG (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy hungry, and went to sleep and woke up early and like on speed/cocaine (more than coffee) on 31-MAR-2021, and arm soreness, had not recovered from tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse, and nerve pain in legs, and the outcome of body got locked up 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Paraesthesia, Psychomotor hyperactivity
Clinical narrative: BODY GOT LOCKED UP; NERVE PAIN IN LEGS; TINGLING IN HANDS/FEETS/ IT WOULD GO  UP TO MY HIP IN MY ARMS IT WAS ONLY IN FINGERS/HANDS/ IT TRAVELS  UP LEG/TINGLING GETS WORSE; WENT TO SLEEP AND WOKE UP EARLY AND LIKE ON SPEED/COCAINE (MORE  THAN COFFEE); ARM SORENESS; CRAZY HUNGRY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: spinal stenosis, and artificial disc in neck. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 5905029 and expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient experienced crazy hungry. On 30-MAR-2021, the patient experienced arm soreness. On 31-MAR-2021, the patient experienced went to sleep and woke up early and like on speed/cocaine (more than coffee). On 13-APR-2021, the patient experienced nerve pain in legs. On 13-APR-2021, the patient experienced tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse. On JUN-2021, the patient experienced body got locked up. On SEP-2021, Laboratory data included: Blood test (NR: not provided) Normal, EMG (NR: not provided) Normal, and MRI (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crazy hungry, and went to sleep and woke up early and like on speed/cocaine (more than coffee) on 31-MAR-2021, and arm soreness, had not recovered from tingling in hands/feets/feet it would go up to my hip in my arms it was only in fingers/hands/ it travels up leg/tingling gets worse, and nerve pain in legs, and the outcome of body got locked up 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: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) 1 total, 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.  The reporter stated that, "my brother took their vaccine and was dead a few days later". On an unspecified date, the patient died. The cause of death was unknown. 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).; Sender's Comments: V0: 20220250755-COVID-19 VACCINE AD26.COV2.S-Dead. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 61 year old of unknown race female. The patient's height, and weight were not reported. The patient's concurrent conditions included: immunocompromised. The patient was previously treated with covid-19 vaccine  (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, 1 total administered at right arm on 11-MAR-2021 for prophylactic vaccination. It was unknown if patient experienced any adverse events following vaccination with covid-19 vaccine (dose number in series 1). It was reported that be on an unspecified date between her dose number in series 1 and dose number in series 2, the patient's doctor drew her blood and it was normal. The patient received covid-19 vaccine (dose number in series 2)(suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at right arm on 29-NOV-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate (Xeljanz 5mg twice).  On 16-JAN-2022, the patient reported that after receiving booster dose she developed covid which was confirmed by rapid and PCR (polymerase chain reaction) test. On 16-JAN-2022, the patient tested positive by rapid test at home (confirmed covid-19 infection). On 19-JAN-2022, the patient tested positive by PCR test (confirmed clinical vaccination failure) (all events with dose number in series 2). On 22-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 26-JAN-2022, Laboratory data included: COVID-19 virus test (NR: not provided) Negative.  The action taken with covid-19 vaccine  was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.; Sender's Comments: V0:20220250779-COVID-19 VACCINE -confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.