chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Pain, Rash
Clinical narrative: ACHE ALL OVER THE BODY; GENERAL FEELING OF BLAH; JOINT PAIN; RASH ON INNER THIGHS AND INNER ARMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212AZIA, expiry: UNKNOWN) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced rash on inner thighs and inner arms. On an unspecified date, the patient experienced ache all over the body, general feeling of blah, and joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash on inner thighs and inner arms, joint pain, ache all over the body and general feeling of blah was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 64 year old white and not hispanic or latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included: lupus, dust allergy, animal dander allergy, bees allergy, reaction to some anesthesia (malignant hyperthermia), penicillin allergy, and adhesive allergy, and other pre-existing medical conditions included: Patient had allergies to Sulfa, Beta-blockers and nylon handles on recyclable plastic bags.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included hydroxychloroquine for lupus.  On 05-AUG-2021, the patient reported lack of antibodies (confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) negative. On 07-Oct-2021 the patient was placed in a covid-19 unit at the doctor's office during a lupus follow up, The patient was unknowingly scheduled an appointment with the primary care physician on a day that was reserved for covid-19 patients. She never had covid-19 or covid-19 symptoms and was very careful, so the patient was upset. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000196985.; Sender's Comments: V0: 20211020555-Covid-19 vaccine ad26.cov2.s -Confirmed immunological vaccine failure .This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Thrombosis
Clinical narrative: BLOOD CLOT; SWOLLEN LEGS; This spontaneous report received from a patient concerned a female of unspecified age, and unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient believed that she had blood clots due to having swollen legs and all the other symptoms of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and swollen legs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211020575-covid-19 vaccine ad26.cov2.s -Blood clot. 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).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 75 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported.  The patient's concurrent conditions included: severe rheumatoid arthritis, hypercholesterolaemia, hypertension, immunocompromised, sulfa allergy, non-alcohol user, and non-smoker. The patient was not a drug abuser or illicit drug user. The patient was previously treated with methotrexate and was instructed not to take sulfa drugs while on methotrexate. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-APR-2021 to left arm for prophylactic vaccination.  Concomitant medications included atorvastatin calcium for hypercholesterolaemia, losartan for hypertension, rituximab for rheumatoid arthritis given on an unspecified date in JUL-2021, acetylsalicylic acid, ascorbic acid/sodium ascorbate, denosumab, ergocalciferol, fish oil, levothyroxine, loratadine, losartan potassium, omeprazole, potassium citrate and prednisone.  The consumer (patient's wife) reported that on 08-OCT-2021, the patient received lab result of SARS Covid-19 spike antibody as not detected (Confirmed immunological vaccine failure). Laboratory data included: COVID-19 antibody test (NR: not provided) Not detected. The consumer was very much concerned about the possibility of lack of immunity because the patient had underlying immunocompromised health status. The reporter wanted to know if medicine rituximab would interact with the efficacy of the vaccine as rituximab was administered on an unspecified date in JUL-2021. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20211020586-covid-19 vaccine-Confirmed immunological failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER THE NIGHT; SOME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 fever the night, and some fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever the night, and some fatigue. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 66 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-MAY-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-AUG-2021, Patient did a standard COVID-19 virus test which came back negative. On 31-AUG-2021, He did COVID-19 rapid POC test that tested positive. He experienced suspected covid-19 infection and was sick for one day. Laboratory data included: Pyrexia (NR: not provided) 102 F. In SEP-2021, he experienced suspected clinical vaccination failure. He took Tylenol and slept through it and fever broke next morning. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 01-SEP-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0: 20211021024-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: PAIN IN RIGHT ARM AT INJECTION SITE TO SHOULDER BLADE, HAND DOWN TO FINGERS, AND PAINFUL TO BONE; NUMB ARM; This spontaneous report received from a patient concerned a 39 year old of unspecified 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: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the patient experienced pain in right arm at injection site to shoulder blade, hand down to fingers, and painful to bone. On 22-MAY-2021, the patient experienced numb arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in right arm at injection site to shoulder blade, hand down to fingers, and painful to bone, and the outcome of numb arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected immunological vaccine failure. On an unspecified date, the patient did an Antibody test and the result came out to be Negative (suspected immunological vaccine failure) and as such she felt that she had no protection and was not leaving her house. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20211006267.; Sender's Comments: V0: 20211021245-covid-19 vaccine ad26.cov2.s- Suspected immunological vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 Total, administered 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: Skyrizi (risankizumab) (form of admin unknown, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date in SEP-2021, the patient experienced covid-19 (captured as suspected covid-19 infection and suspected clinical vaccination failure). On an unknown date in 2021, the event COVID-19 resolved. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021421-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: BAD COUGH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient never had a fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced bad cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad cough was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018110 and 20211018825.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old male of White race and unspecified ethnicity. The patient's weight was 340 pounds, and height was 71 inches. The patient's past medical history included: alcohol user (on weekends in his twenties), and concurrent conditions included: non alcohol user, non smoker, and allergic to penicillin causing hives. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 for prophylactic vaccination. Age at the time of vaccination was 49 years. The patient had no concomitant medications. On 11-OCT-2021, the patient experienced feeling achy, congested, fever and worn down. The patient described it as "a feeling like he had after a weekend in his twenties when he drank alcohol". The patient had a COVID-19 virus rapid test in the morning (11-OCT-2021) and the result came positive (coded as suspected covid-19 infection, and suspected clinical vaccination failure). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197128.; Sender's Comments: V0 20211021482-COVID-19 VACCINE - suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Pain in extremity, Rash erythematous
Clinical narrative: TINY FLAT RED DOTS ON RIGHT ARM (AREA HAS SPREAD A LITTLE BIT); LEG PAIN UNDER KNEE AREA IN BOTH LEGS (AFFECTING RIGHT LEG MORE); HEADACHE/HEAD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. 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 06-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-OCT-2021, the patient experienced headache. On 09-OCT-2021, the patient experienced headache/head pressure. On 11-OCT-2021, the patient experienced tiny flat red dots on right arm (area has spread a little bit). On 11-OCT-2021, the patient experienced leg pain under knee area in both legs (affecting right leg more). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-OCT-2021, and had not recovered from leg pain under knee area in both legs (affecting right leg more), tiny flat red dots on right arm (area has spread a little bit), and headache/head pressure. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cerebrovascular accident, Myocardial infarction
Clinical narrative: TWO HEART ATTACKS; CONGESTIVE HEART FAILURE; STROKE; This spontaneous report received from a patient via a company representative concerned a 63 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient has a past medical history of 2 heart attacks and heart issues of congestive heart failure, concurrent conditions included moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) with frequency time 1 total, dose and start therapy date were not reported for Covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) for moderate to severe ulcerative colitis.  On APR-2021, the patient experienced stroke. On an unspecified date, the patient experienced two heart attacks and congestive heart failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke, and the outcome of heart attack and congestive heart failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211021607-COVID-19 VACCINE AD26.COV2.S-stroke, two heart attacks,  congestive heart failure. 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, UNK
Symptoms: Hidradenitis, Vaccination complication
Clinical narrative: HIDRADENITIS SUPPURATIVA FLARE UPS; SICK AFTER COVID-19 VACCINE; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Moderate to severe hidradenitis suppurativa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe hidradenitis suppurativa. No concomitant medications were reported. On an unspecified date, the patient experienced hidradenitis suppurativa flare ups, and sick after covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient recovered from sick after covid-19 vaccine, and had not recovered from hidradenitis suppurativa flare ups. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. 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, 1 total, start therapy date was not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced peripheral neuropathy symptoms. Consumer stated that there are 'several hundreds if not thousands of people' who are having peripheral neuropathy symptoms, after receiving all three available covid-19 vaccines (non-company vaccines included) and definitely some of them (exact number is unknown) received the Janssen Covid-19 vaccine. The consumer read this on social media boards. It was stated that 'Young healthy people' are reporting this. No more information was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of peripheral neuropathy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211020241.; Sender's Comments: V0: 20211021687 -covid-19 vaccine ad26.cov2.s- peripheral neuropathy. 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).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: FLARE UP OF DIARRHEA (DIARRHEA  AGGRAVATED); FATIGUE; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included adalimumab for moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. On 2021, the patient experienced fatigue. On an unspecified date, the patient experienced flare up of diarrhea (diarrhea aggravated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flare up of diarrhea (diarrhea aggravated), and the outcome of fatigue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOOKS TERRIBLE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age 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 not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced not feeling well, looks terrible and reported positive to PCR (polymerase chain reaction) tests (suspected clinical vaccination failure, suspected covid-19 infection). The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and looks terrible was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211018993. This report was associated with Product quality complaint.; Sender's Comments: V0: 20211021857-Covid-19 vaccine - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Fatigue
Clinical narrative: SPONDYLITIS ANKYLOSING AGGRAVATED; FATIGUE; This spontaneous report received from a patient concerned a 5 decade old female unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: Ankylosing spondylitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 02-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: Humira (adalimumab) (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported. On an unspecified date, the patient experienced spondylitis ankylosing aggravated, and fatigue. As per the report, the reporter's stated that there was a reasonable possibility with ankylosing spondylitis flare up and adalimumab, and there was was no reasonable possibility with event fatigue and adalimumab . The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from spondylitis ankylosing aggravated, and the outcome of fatigue was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211021873-covid-19 vaccine ad26.cov2.s-spondylitis ankylosing aggravated. 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: MEDICAL HISTORY
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. Patient's concurrent conditions included acquired immunodeficiency syndrome (AIDS), was diagnosed with AIDS in March 1999. Patient T cells were 100. He was taking his treatment for AIDS regularly and the virus had became undetected with T Cells of 1500. Four years ago in 2017, patient was admitted to the hospital due to methicillin-resistant staphylococcus aureus infection (MRSA infection) in the torso and legs and he was injected with 4 bags of vancomycin. He was going septic. The Patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, patient's antibodies test came back negative and patient experienced confirmed immunological vaccine failure. With all the past experience in mind, patient was concerned of having undetectable antibodies. He wanted to wait for the Janssen vaccine booster. His doctor recommended to take Moderna or Pfizer vaccine in order to develop antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000197220.; Sender's Comments: V0: 20211022439-Covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: PARTIAL DOSE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-OCT-2021, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination into left arm. The product was stored in appropriate temperature conditions and was properly stored from receipt to administration. It was unknown for how many times, and for how long (cumulative), the vaccine was removed from storage. No concomitant medications were reported.  On 20-SEP-2021, the patient got Covid and was really sick with Covid. It was reported that, the patient had Real-time reverse transcriptase-polymerase chain reaction (RTPCR) test done on vacation while she was there. She contacted her doctor. Laboratory data included: COVID-19 PCR test (NR: not provided), the swab was taken and she was contacted back on 21-SEP-2021 with a positive test result (confirmed covid-19 infection and confirmed clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211022587-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pyrexia
Clinical narrative: HEART RATE SO HIGH; FEVER SO HIGH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart rate so high, and fever so high. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart rate so high and fever so high was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: LOSS OF TASTE; LOSS OF SMELL; This spontaneous report received from a consumer concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included: cold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced loss of taste, and loss of smell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of taste and loss of smell was not reported. This report was non-serious.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: SWELLING IN ARM; TONGUE STARTED TO FEEL TINGLY AND HOT; LEFT ARM NUMBNESS AND TINGLING (FELT LIKE PINS AND NEEDLES); HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's past medical history included: chronic miscarriages, and concurrent conditions included: irritable bowel syndrome, brca (breast cancer gene), seasonal allergy, penicillin allergy, social drinker, and non-smoker, and other pre-existing medical conditions included: Patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with azithromycin, influenza vaccine, and macrogol 3350.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, and expiry: UNKNOWN) dose was not reported, administered on 12-OCT-2021 12:30 for prophylactic vaccination. No concomitant medications were reported.  On 12-OCT-2021, the patient experienced swelling in arm. On 12-OCT-2021, the patient experienced tongue started to feel tingly and hot. On 12-OCT-2021, the patient experienced left arm numbness and tingling (felt like pins and needles). On 12-OCT-2021, the patient experienced headache. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tongue started to feel tingly and hot, left arm numbness and tingling (felt like pins and needles), headache, and swelling in arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: PROBLEMS; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problems was not reported. This report was non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Skin discolouration
Clinical narrative: SPOTS ON SKIN THAT STARTED PINK THEN TURNED BROWN, DIME TO PENNY SIZE MARKS AND BIGGEST WAS ABOUT 2 INCHES AND SOME PINPRICK SIZE DOTS OR DOTS  WITH A CIRCLE OVER IT; FELT WOOZY, KIND OF DIZZY; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.The batch number was not reported. The company is unable to perform follow-up to request batch/lot number.  No concomitant medications were reported.  On 10-APR-2021, the patient experienced spots on skin that started pink then turned brown, dime to penny size marks and biggest was about 2 inches and some pinprick size dots or dots with a circle over it. On 10-APR-2021, the patient experienced felt woozy, kind of dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt woozy, kind of dizzy on 10-APR-2021, and had not recovered from spots on skin that started pink then turned brown, dime to penny size marks and biggest was about 2 inches and some pinprick size dots or dots with a circle over it. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE THAT HAD REACHED TWO HOUR LIMIT; This spontaneous report received from a health care professional 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced administered expired vaccine that had reached two hour limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine that had reached two hour limit was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Unevaluable event, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; BREAKTHROUGH COVID 19 INFECTION; BAD REACTION; This spontaneous report received from a health care professional concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 13-Oct-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered at the end of APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced bad reaction, and was hospitalized. The patient experienced a breakthrough Covid-19 vaccine and thought it was a delta variant (suspected clinical vaccination failure). The duration of hospitalization was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad reaction, breakthrough covid 19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000197407; Sender's Comments: V0:20211022886-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure . This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20211022886-covid-19 vaccine ad26.cov2.s-breakthrough covid 19 infection, bad reaction. 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: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Lung disorder, Malaise
Clinical narrative: DID NOT FEEL WELL; PERSISTENT LIGHT HEADACHE; BURNING LUNGS SENSATION (LUNGS FEELING LIKE THEY ARE ON A FIRE); This spontaneous report received from a patient concerned a 37 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a pretty healthy. Patient lift weights and also run a mile or two on a regular basis (usually a mile in less than 7:30 so at a very fast pace). 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 18-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced burning lungs sensation (lungs feeling like they are on a fire). On 18-AUG-2021, the patient experienced did not feel well. On 18-AUG-2021, the patient experienced persistent light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning lungs sensation (lungs feeling like they are on a fire), had not recovered from persistent light headache, and the outcome of did not feel well was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Vaccination failure
Clinical narrative: COVID PNEUMONIA; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a consumer via a company representative via media article concerned a 58-year-old male. The patient's height, and weight were not reported. Patient had no existing condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, it was reported that a fully vaccinated patient who died of COVID pneumonia. The patient was vaccinated in March. The patient had started a cough and ended when patient was ventilated. After more than a month of fighting COVID-19, a physician told that patient was no longer able to get oxygen. The physician cannot give him any more oxygen. Patient was 100 percent and had failed (suspected clinical vaccine failure).  On an unspecified date, the patient died from Covid pneumonia. It was unspecified if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccine failure was not reported and of Covid pneumonia was fatal. This report was serious (Death, and Life Threatening). This report was associated with a product quality complaint: 90000197223.; Sender's Comments: V0: 20211022931-Covid-19 vaccine ad26.cov2.s- Covid pneumonia. 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). 20211022931-Covid-19 vaccine ad26.cov2.s- suspected clinical vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: COVID PNEUMONIA
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: WEIRD FEELING FROM NECK TO ARM; This spontaneous report received from a patient via a company representative concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ortho surgery, and surgery, and concurrent conditions included: vascular issues, allergy to shell fish, and x-ray dye allergy, and other pre-existing medical conditions included: Patient was healthy and took vitamins daily. 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 APR-2020 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included clopidogrel bisulfate.  On APR-2020, the patient experienced weird feeling from neck to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from weird feeling from neck to arm on APR-2020. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: HIVES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAY-2021, the patient experienced hives. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives. This report was non-serious.