chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Back pain, Blood potassium decreased, Dehydration, Diarrhoea
Clinical narrative: massive stomach sickness, puking, diarreaha, dehyrdration, massive pain in arm  neck and back.  massive pain and dehydration, dry heves for hours,.  Fever above 102 degrees for 3 days. loss of muscle mass, messed up my thyroid, loss of potassium, no focus, and mental ability very impaired, naseaua.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Muscle mass, Nausea, Neck pain, Pain in extremity
Clinical narrative: massive stomach sickness, puking, diarreaha, dehyrdration, massive pain in arm  neck and back.  massive pain and dehydration, dry heves for hours,.  Fever above 102 degrees for 3 days. loss of muscle mass, messed up my thyroid, loss of potassium, no focus, and mental ability very impaired, naseaua.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Retching, Thyroid disorder, Vomiting
Clinical narrative: massive stomach sickness, puking, diarreaha, dehyrdration, massive pain in arm  neck and back.  massive pain and dehydration, dry heves for hours,.  Fever above 102 degrees for 3 days. loss of muscle mass, messed up my thyroid, loss of potassium, no focus, and mental ability very impaired, naseaua.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Pyrexia
Clinical narrative: Chills Fever Chest Pain Shortness of breath
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on hands
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10/15/21 Bright red bump at injection site- hot and tender to the touch. Headaches and diarrhea.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: 10/15/21 Bright red bump at injection site- hot and tender to the touch. Headaches and diarrhea.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Myalgia, Pain in extremity, Pain of skin
Clinical narrative: 4 weeks of extreme fatigue, joint swelling and pain in hands, feet, muscles. skin around joints hurts to touch at night.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Cold sweat, Discomfort, Headache
Clinical narrative: Severe headache starting the day after and lasting 7 days,  Woke up in cold sweat 3 nights after vaccination, fever for 5 days as well.  Deep internal chest pain, stemming from injection site stretching into heart and lung region across chest, deepest pain centralized in the left upper torsoe, with bouts of pain reaching to the lower lungs, and into the neck.   The pain could be described as a sense of movement or pulsing, resulting in extreme discomfort.  I've been perfectly healthy and without sickness for 5 years, and now after the shot I've felt pain every day.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neck pain, Pulmonary pain, Pyrexia
Clinical narrative: Severe headache starting the day after and lasting 7 days,  Woke up in cold sweat 3 nights after vaccination, fever for 5 days as well.  Deep internal chest pain, stemming from injection site stretching into heart and lung region across chest, deepest pain centralized in the left upper torsoe, with bouts of pain reaching to the lower lungs, and into the neck.   The pain could be described as a sense of movement or pulsing, resulting in extreme discomfort.  I've been perfectly healthy and without sickness for 5 years, and now after the shot I've felt pain every day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Haemoglobin, Metabolic function test, Parosmia, Thirst
Clinical narrative: Patient began smelling smoke Felt that she was 'not completely hydrated' but yet was drinking a lot of water and did not feel dehydrated
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Small hives occurred on the left forearm and the forearm started to itch, approximately 6 hours after the shot was administered at 3:10 PM.  The itching progressed on the left forearm and started on the right arm over the next 20 to 30 minutes.  If you put it on a 1-10 scale, 10 being the worst itch.  The left arm was an 8 and the right was a 2.  The right arm did not appear to have any noticeable hives. No swelling occurred in the face or throat.  When the forearm itching progressed to the point it became unbearable an 8.  A topical Cortisone-10 ointment was applied on both forearms and one Clemastine Fumarate 1.34mg tablet was administered.  This helped with the forearm itching, it went down to a 1.5.  Experienced random itches on the head, neck, back, and legs; 7 to 12 hours after the shot was administered.  No hives where present in any other body locations.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional 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 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: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Feeling abnormal
Clinical narrative: EXACERBATION OF CHRONIC FATIGUE SYNDROME/ACTIVITY INTOLERANCE/BRAIN FOG/GENERALIZED WEAKNESS/MALAISE; FEELING VERY POOR; 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: on and off anaemia, chronic fatigue syndrome, pollen allergy, iodine allergy, and latex allergy, and other pre-existing medical conditions included: The patient was on blood thinner. The patient had lot of health problems. The patient denied ever having active COVID infection/diagnosis. The patient experienced drug allergy when treated with lisinopril for drug used for unknown indication.  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 03-MAY-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 11-MAY-2021, the patient experienced exacerbation of chronic fatigue syndrome/activity intolerance/brain fog/generalized weakness/malaise. On 11-MAY-2021, the patient experienced feeling very poor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from exacerbation of chronic fatigue syndrome/activity intolerance/brain fog/generalized weakness/malaise, and feeling very poor. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: MAGNETIC CHARACTERISTICS/MADE MAGNETIC; This spontaneous report received from a patient via a company representative concerned an adult 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 were not reported) 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 08-OCT-2021, the patient experienced magnetic characteristics/made magnetic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of magnetic characteristics/made magnetic was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned an adult 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 (suspension for injection, route of administration not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-OCT-2021, antibody test was performed with negative result (confirmed immunological vaccine failure). 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 regulatory authority.; Sender's Comments: V0: 20211017456-COVID-19 VACCINE -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: Breast cancer
Clinical narrative: BREAST CANCER; This spontaneous report received from a consumer 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 and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021(date unspecified), the patient was diagnosed with breast cancer and had surgery for the breast cancer in SEP-2021 (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of breast cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211017470-COVID-19 VACCINE AD26.COV2.S-Breast Cancer. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSE REACTIONS; This spontaneous report received from a consumer (company representative) via social media concerned two female patients of an unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) frequency time 1 total, dose, therapy start date and therapy end 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, "two women died from adverse reactions after receiving Johnson and Johnson vaccine shot". It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine was not applicable. The patient died from adverse reactions. This report was serious (Death).; Sender's Comments: V0 20211017484-COVID-19 VACCINE-Adverse reactions. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ADVERSE REACTIONS
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; 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 action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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 not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to and 20211017025.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 22 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: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017536, 20211017111 and 20211017116.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This is a spontaneous, non-serious report received from a patient via a company representative. A patient of unspecified age, sex, height and weight received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: unknown/not reported), dose and start therapy date: not reported, for immunization. No past medical history, concomitant medications or concurrent conditions reported. On an unspecified date, patient had effects a couple of weeks later after vaccination. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of having effects a couple of weeks later after vaccination: not reported. The company is unable to perform follow-up to request batch/lot numbers.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 52 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: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Inflammation, Malaise, Pyrexia
Clinical narrative: INFLAMMATION FOR DAYS; ANXIETY OF WONDERING IF THE SHOT WOULD KILL; NOT A GOOD FEELING; FEVER; 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: Unknown, Expiry: 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 inflammation for days, anxiety of wondering if the shot would kill, fever, and not a good feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, inflammation for days, anxiety of wondering if the shot would kill and not a good feeling was not reported. This report was non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 43 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, and batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 01-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced sore arm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm at injection site. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous, non-serious report received from a patient. A patient of unspecified age, sex, height and weight received the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch/lot# unknown/not reported) dose and start therapy date: not reported, for immunization. Medical history, concomitant medications and concurrent conditions not reported. On an unspecified date, patient experienced sore arm/sharp pain in leg, bit of nausea and headache. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from sore arm/sharp pain in leg, bit of nausea and headache. The company was unable to perform follow-up to request batch/lot number.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: BACK ACHE; INCREASED HEART RATE; FEVER; FATIGUE/VERY TIRED; This spontaneous report received from a patient via a company representative concerned a 67 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: 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 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced back ache. On 08-OCT-2021, the patient experienced increased heart rate. On 08-OCT-2021, the patient experienced fever. On 08-OCT-2021, the patient experienced fatigue/very tired. Laboratory data included: Heart rate (NR: not provided) Increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back ache, increased heart rate, fever, and fatigue/very tired on 09-OCT-2021. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Arthralgia, Blood test, Chest X-ray, Insomnia
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Muscle spasms, Oedema peripheral, Rash, Weight decreased
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Borrelia test, Chlamydia test negative, Full blood count normal
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Glucose tolerance impaired, Laboratory test, Muscle spasms, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Testicular swelling, Urine analysis normal
Clinical narrative: NOT ABLE TO WORK FOR PAST 3 WEEKS; RASH ON BOTH LEGS ABOVE THE KNEES WITH SOME SMALL SPOTS ON THE TRUNK; SEVERE JOINT PAIN SPECIALLY IN HANDS, KNEES AND FEET; SWELLING/EDEMA IN BOTH KNEES; WEIGHT LOSS; INSOMNIA DUE TO THE CHRONIC PAIN; LEG CRAMPING; 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced swelling/edema in both knees. On APR-2021, the patient experienced weight loss. On APR-2021, the patient experienced insomnia due to the chronic pain. On APR-2021, the patient experienced leg cramping. On APR-2021, the patient experienced severe joint pain specially in hands, knees and feet. On 18-JUL-2021, the patient experienced rash on both legs above the knees with some small spots on the trunk. On 04-AUG-2021, Laboratory data included: Blood test (NR: not provided) Negative. On 12-AUG-2021, Laboratory data included: Antibody test (NR: not provided) Negative. On SEP-2021, the patient experienced not able to work for past 3 weeks. Laboratory data (dates unspecified) included: X-ray (NR: not provided) Not reported, Not reported, and X-ray NOS chest (NR: not provided) Not reported. Treatment medications (dates unspecified) included: diclofenac. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on both legs above the knees with some small spots on the trunk on JUL-2021, and had not recovered from swelling/edema in both knees, severe joint pain specially in hands, knees and feet, weight loss, insomnia due to the chronic pain, leg cramping, and not able to work for past 3 weeks. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: HIGH ANXIETY ISSUES; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 high anxiety issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of high anxiety issues was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Fatigue, Feeling abnormal, Headache, Illness
Clinical narrative: RUNNY NOSE; LIKE GOING THROUGH NIGHTMARE; FEELING VERY BAD; ANSWERING QUESTIONS/RESPONDING WITH A LONG DELAY; TIRED JOINTS; SICK; SLIGHT HEADACHE; FEELING TIRED; RECEIVED JANSSEN VACCINE AS A BOOSTER SHOT AFTER TWO DOSES OF PFIZER; 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: EW0179, expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 07-OCT-2021, the patient experienced sick, tired joints, slight headache, feeling tired, and received janssen vaccine as a booster shot after two doses of pfizer. On 08-OCT-2021, the patient experienced answering questions/responding with a long delay, like going through nightmare, and feeling very bad. On 10-OCT-2021, the patient experienced runny nose. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, feeling tired, slight headache, tired joints, and runny nose, and the outcome of answering questions/responding with a long delay, like going through nightmare, received janssen vaccine as a booster shot after two doses of pfizer and feeling very bad was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Nightmare, Rhinorrhoea, Speech disorder
Clinical narrative: RUNNY NOSE; LIKE GOING THROUGH NIGHTMARE; FEELING VERY BAD; ANSWERING QUESTIONS/RESPONDING WITH A LONG DELAY; TIRED JOINTS; SICK; SLIGHT HEADACHE; FEELING TIRED; RECEIVED JANSSEN VACCINE AS A BOOSTER SHOT AFTER TWO DOSES OF PFIZER; 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: EW0179, expiry: UNKNOWN) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 07-OCT-2021, the patient experienced sick, tired joints, slight headache, feeling tired, and received janssen vaccine as a booster shot after two doses of pfizer. On 08-OCT-2021, the patient experienced answering questions/responding with a long delay, like going through nightmare, and feeling very bad. On 10-OCT-2021, the patient experienced runny nose. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, feeling tired, slight headache, tired joints, and runny nose, and the outcome of answering questions/responding with a long delay, like going through nightmare, received janssen vaccine as a booster shot after two doses of pfizer and feeling very bad was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer 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 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 sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018220.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINES; This spontaneous report received from a health care professional concerned multiple (two) patients. 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 administration of expired vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccines was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, Headache, Mucosal disorder, Oropharyngeal pain, Pyrexia
Clinical narrative: SORE THROAT; MUCUS BUILDING UP; TERRIBLE AFTER EFFECTS; FEVER; HEADACHE; 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 number. No concomitant medications were reported.  On an unspecified date, the patient experienced sore throat, mucus building up, terrible after effects, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, headache, sore throat, mucus building up and terrible after effects was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Off label use
Clinical narrative: VACCINE GIVEN SUBCUTANEOUS AND NOT INTRAMUSCULAR; OFF LABEL USE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: amputee. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, subcutaneous, batch number: Unknown) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-OCT-2021, the patient experienced vaccine given subcutaneous and not intramuscular. On 08-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given subcutaneous and not intramuscular and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211018542.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous report received from a consumer concerned a White female of an unspecified age and ethnicity. Initial information was processed along with the additional information received on 11-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 not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on an unspecified date in SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had laboratory tests done which resulted as positive for Covid-19 PCR test (confirmed covid-19 infection) and experienced the loss of taste, congestion and cough (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000196853.; Sender's Comments: V0: 20211018360-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: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Body temperature, Chills, Pyrexia
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; CHILLS; GRADUALLY INCREASING FEVER; This spontaneous report received from a patient concerned a 46 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seasonal allergies, high blood pressure (controlled), high cholesterol (controlled), non alcohol user, and non smoker. The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1820095 expiry: 02-OCT-2021) dose was not reported, 1 total administered to left arm on 11-AUG-2021 09:00AM for prophylactic vaccination. No concomitant medications were reported.  On 11-AUG-2021, 12 hours after vaccination at 09:00pm, the patient experienced a gradually increasing fever and at 10:00pm it was at 102.5 degrees Fahrenheit. The patient took Tylenol which did not work till 2:00 am but after that the temperature went down. The patient also experienced chills but had no headache or aches. On 01-OCT-2021. the patient had an antibody test (serology test) through his allergist and it was a SARS-CoV2 IgG (severe acute respiratory syndrome coronavirus 2 immunoglobulin G) Nucleocap and IgM (Immunoglobulin M) Spike QL. The results were ready in 24 hours and showed antibody IgG negative and antibody IgM negative (confirmed immunological vaccine failure). The patient was concerned that he may not be protected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and gradually increasing fever on 12-AUG-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a Product Quality Complaint.; Sender's Comments: V0: 20211018382-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