chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Facial paralysis
Clinical narrative: LEFT SIDE FACIAL PARALYSIS INCLUDING EYE; This spontaneous report received from a consumer concerned a 55 year old white and not Hispanic or Latino male. The patient's height, and weight were not reported. The patient had no medical problems before the vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown), dose was not reported, 1 total, administered on 28-MAY-2021 to left arm as prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included unspecified blood pressure medication, an unspecified diuretic, aluminium hydroxide/magnesium hydroxide (Maalox) for stomach issue, and vitamin b nos.  On 29-MAY-2021, Saturday around midnight the patient experienced left side facial drooping. On 30-MAY-2021, the patient was hospitalized. The patient did not have a stroke, but was on medication now with facial paralysis, taking multiple medications including unspecified steroids. The patient was getting blood work every 10 days now and was seeing a neurologist for the paralysis. It was also reported that the patient could not see out of left eye due to drooping but seemed to be looking better after a week with steroids. On an unspecified date in 2021, Laboratory data included: Blood test (NR: not provided) Not reported.  The patient was hospitalized for 1 day and was discharged on 31-May-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left side facial paralysis including eye. This report was serious (Hospitalization Caused/Prolonged).; Sender's Comments: V0:20210608311 -COVID-19 VACCINE AD26.COV2.S-Left side facial paralysis including eye. 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, UNK
Symptoms: Chills, Eye irritation, Fatigue, Headache, Hypersensitivity
Clinical narrative: SNEEZING; BURNING EYES; SKIN PLAQUE; LIMBS STIFFNESS; SORE THROAT; SWELLING OF FEET; GENERALIZED ACHING; DRUG EFFECT INCOMPLETE; CHILLS; FATIGUE; ALLERGY; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, and concurrent conditions included psoriatic arthritis. 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 is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 26-AUG-2020 for psoriatic arthritis; and methotrexate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported.  On an unspecified date, the subject experienced sneezing, burning eyes, skin plaque, limbs stiffness, sore throat, swelling of feet, generalized aching, drug effect incomplete, chills, fatigue, allergy, nausea, and headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and montelukast sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, and chills, was recovering from skin plaque, had not recovered from fatigue, sneezing, burning eyes, nausea, allergy, headache, sore throat, and drug effect incomplete, and the outcome of limbs stiffness and swelling of feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Musculoskeletal stiffness, Nausea, Oropharyngeal pain, Pain, Peripheral swelling
Clinical narrative: SNEEZING; BURNING EYES; SKIN PLAQUE; LIMBS STIFFNESS; SORE THROAT; SWELLING OF FEET; GENERALIZED ACHING; DRUG EFFECT INCOMPLETE; CHILLS; FATIGUE; ALLERGY; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, and concurrent conditions included psoriatic arthritis. 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 is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 26-AUG-2020 for psoriatic arthritis; and methotrexate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported.  On an unspecified date, the subject experienced sneezing, burning eyes, skin plaque, limbs stiffness, sore throat, swelling of feet, generalized aching, drug effect incomplete, chills, fatigue, allergy, nausea, and headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and montelukast sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, and chills, was recovering from skin plaque, had not recovered from fatigue, sneezing, burning eyes, nausea, allergy, headache, sore throat, and drug effect incomplete, and the outcome of limbs stiffness and swelling of feet was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Skin plaque, Sneezing, Therapeutic product effect incomplete
Clinical narrative: SNEEZING; BURNING EYES; SKIN PLAQUE; LIMBS STIFFNESS; SORE THROAT; SWELLING OF FEET; GENERALIZED ACHING; DRUG EFFECT INCOMPLETE; CHILLS; FATIGUE; ALLERGY; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included diarrhea, and concurrent conditions included psoriatic arthritis. 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 is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for infusion in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, from 26-AUG-2020 for psoriatic arthritis; and methotrexate ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. No concomitant medications were reported.  On an unspecified date, the subject experienced sneezing, burning eyes, skin plaque, limbs stiffness, sore throat, swelling of feet, generalized aching, drug effect incomplete, chills, fatigue, allergy, nausea, and headache. Treatment medications (dates unspecified) included: cetirizine hydrochloride, and montelukast sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from generalized aching, and chills, was recovering from skin plaque, had not recovered from fatigue, sneezing, burning eyes, nausea, allergy, headache, sore throat, and drug effect incomplete, and the outcome of limbs stiffness and swelling of feet was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: OVERNIGHT 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: 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 subject experienced overnight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of overnight fever was not reported. This report was non-serious.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Neuralgia
Clinical narrative: HYPOAESTHESIA; NEURALGIA; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority [VAERS FDA Inbound Unit] concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and illness at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 265AZ1A expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced hypoaesthesia. On 30-APR-2021, the subject experienced neuralgia. On 30-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, hypoaesthesia, and neuralgia. This report was non-serious.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: STOMACH BLOATING; LEG SWELLING; LEGS HURT; MUSCLE ACHES; FATIGUED; DIARRHEA; VOMITTING; SWEATING; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline diabetic, congestive heart failure, lung failure, and smoker, and other pre-existing medical conditions included ipratropium bromide inhaler,breo inhaler,albuterol inhaler. 2 clamps on liver. sulfate drugs, zithromax, ambien allergy. The patient experienced drug allergy when treated with zolpidem tartrate, sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine, and azithromycin. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Concomitant medications included furosemide for congestive heart failure, potassium for congestive heart failure, spironolactone for congestive heart failure, fluticasone furoate/vilanterol trifenatate for lung failure, ipratropium bromide for lung failure, and salbutamol for lung failure. On 02-JUN-2021, the subject experienced diarrhea. On 02-JUN-2021, the subject experienced vomitting. On 02-JUN-2021, the subject experienced sweating. On 02-JUN-2021, the subject experienced muscle aches. On 02-JUN-2021, the subject experienced fatigued. On 05-JUN-2021, the subject experienced stomach bloating. On 05-JUN-2021, the subject experienced leg swelling. On 05-JUN-2021, the subject experienced legs hurt. The action taken with covid-19 vaccine was not applicable. The patient recovered from diarrhea, vomitting, and sweating, was recovering from muscle aches, and fatigued, and had not recovered from leg swelling, stomach bloating, and legs hurt. This report was non-serious.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: STOMACH BLOATING; LEG SWELLING; LEGS HURT; MUSCLE ACHES; FATIGUED; DIARRHEA; VOMITTING; SWEATING; This spontaneous report received from a patient concerned a 51 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included borderline diabetic, congestive heart failure, lung failure, and smoker, and other pre-existing medical conditions included ipratropium bromide inhaler,breo inhaler,albuterol inhaler. 2 clamps on liver. sulfate drugs, zithromax, ambien allergy. The patient experienced drug allergy when treated with zolpidem tartrate, sulfacetamide sodium/sulfadiazine/sulfadimidine/sulfamerazine, and azithromycin. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Concomitant medications included furosemide for congestive heart failure, potassium for congestive heart failure, spironolactone for congestive heart failure, fluticasone furoate/vilanterol trifenatate for lung failure, ipratropium bromide for lung failure, and salbutamol for lung failure. On 02-JUN-2021, the subject experienced diarrhea. On 02-JUN-2021, the subject experienced vomitting. On 02-JUN-2021, the subject experienced sweating. On 02-JUN-2021, the subject experienced muscle aches. On 02-JUN-2021, the subject experienced fatigued. On 05-JUN-2021, the subject experienced stomach bloating. On 05-JUN-2021, the subject experienced leg swelling. On 05-JUN-2021, the subject experienced legs hurt. The action taken with covid-19 vaccine was not applicable. The patient recovered from diarrhea, vomitting, and sweating, was recovering from muscle aches, and fatigued, and had not recovered from leg swelling, stomach bloating, and legs hurt. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: JOINT PAIN; SORE ARM; MUSCLE ACHES; HEADACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included hit by a drunk driver when was 20, and concurrent conditions included osteoarthritis, and body aches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced joint pain. On 03-JUN-2021, the subject experienced sore arm. On 03-JUN-2021, the subject experienced muscle aches. On 03-JUN-2021, the subject experienced headaches. On 03-JUN-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, headaches, joint pain, and sore arm, and the outcome of injection site pain was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: REFROZEN AND THAWED VACCINE WAS ADMINISTERED; VACCINE WAS PLACED IN THE FREEZER, THEN THAWED OUT OVERNIGHT; This spontaneous report received from a consumer 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 was not reported, administered on 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 MAY-2021, the subject experienced refrozen and thawed vaccine was administered. On MAY-2021, the subject experienced vaccine was placed in the freezer, then thawed out overnight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the refrozen and thawed vaccine was administered and vaccine was placed in the freezer, then thawed out overnight was not reported. This report was non-serious.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; BODYACHES; CHILLS; TIREDNESS; LOW GRADE FEVER 99-100 DEGREE F; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021,six hours after vaccination, patient experienced chills, body aches, low grade fever (99-100 degrees F) and tiredness. The patient took paracetamol (Tylenol) to manage her symptoms and went to sleep. On 10-APR-2021, the patient woke up at 05:30 and all symptoms was resolved, except for the tiredness.  On 04-MAY-2021, the patient took her first antibody tests (blood) and the result was negative. On 27-MAY-2021, the patient took her second antibody tests (blood) and the result came as negative(confirmed immunological vaccine failure). The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, chills, and low grade fever 99-100 degree f on 10-APR-2021, had not recovered from tiredness, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612856-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
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; BODYACHES; CHILLS; TIREDNESS; LOW GRADE FEVER 99-100 DEGREE F; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker. The patient had no known allergies and no drug abuse/illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 to right arm as prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021,six hours after vaccination, patient experienced chills, body aches, low grade fever (99-100 degrees F) and tiredness. The patient took paracetamol (Tylenol) to manage her symptoms and went to sleep. On 10-APR-2021, the patient woke up at 05:30 and all symptoms was resolved, except for the tiredness.  On 04-MAY-2021, the patient took her first antibody tests (blood) and the result was negative. On 27-MAY-2021, the patient took her second antibody tests (blood) and the result came as negative(confirmed immunological vaccine failure). The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, chills, and low grade fever 99-100 degree f on 10-APR-2021, had not recovered from tiredness, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210612856-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: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations
Clinical narrative: HEART PALPITATIONS; ARM PAIN; 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced heart palpitations, and arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain and heart palpitations was not reported. This report was non-serious.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fall, Headache, Insomnia, Mobility decreased
Clinical narrative: FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid 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 fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. 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). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Speech disorder
Clinical narrative: FALLEN SEVERAL TIMES; BARELY MOBILE; DIFFICULTY SPEAKING; SHORTNESS OF BREATH; BARELY ABLE TO SLEEP; HEADACHES; FEVER; This spontaneous report received from a patient concerned a 64 year old male other race and unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total administered to right deltoid 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 fever, headaches and shortness of breath. He stated that he was barely mobile (severe discomfort, feels like a handicapped, needs assistance to do anything) after receiving vaccination about 2 months ago. He felt like a handicapped person who needs assistance to do anything. He was barely able to sleep and found it difficult to speak. He stated he had fallen several times after receiving the vaccine. On an unspecified date, he had been hospitalized at 2 different hospitals and both instances did not help with his symptoms. He stated his HCP was aware and he could not help. He sounded to be in severe discomfort and as stated several times to fix it. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from barely mobile, fever, difficulty speaking, shortness of breath, headaches, fallen several times, and barely able to sleep. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: - fallen several times, barely mobile, difficulty speaking, shortness of breath, barely able to sleep. 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). - headaches, fever. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chronic lymphocytic leukaemia, Computerised tomogram, Haematocrit, Haemoglobin
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Monocyte count, Neutrophil count, Plasminogen activator inhibitor, Prophylaxis, Red cell distribution width
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: CHRONIC LYMPHOCYTIC LEUKEMIA; This spontaneous report received from a patient via a company representative concerned a 62 year old white and not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 and patient was in bed for 18 days and concurrent conditions included fatigue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: 25-MAY-2021) dose was not reported, 1 total, administered on 15-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAR-2021, The patient developed pain in joints or bones. On 17-MAR-2021, two days later, the patient felt very tired and extreme fatigue. On 24-MAY-2021, the patient had additional bloodwork and CT Scan and has been diagnosed with Chronic Lymphocytic Leukemia (CLL) On 24-MAY-2021, laboratory data included: Blood neutrophils (NR: 42.2 - 75.2) 25.3 %, Blood neutrophils (NR: 1.4 - 6.5) 3.5 10*3/uL, Blood test (NR: not provided) Elevated WBC, CT scan (NR: not provided) Enlarged lymph nodes., Haemoglobin (NR: 11.0 - 18.0) 12.5 g/dL, Hematocrit (NR: 35.0 - 60.0) 40.3 %, Lymphocytes (NR: 20.5 - 51.1) 70.7 %, Lymphocytes (NR: 1.2 - 3.4) 9.7 10*3/uL, MCH (NR: 37.0 - 31.0) 28.0 pg, MCHC (NR: 33.0 - 37.0) 30.9 g/dL, MCV (NR: 80.0 - 99.9) 90.4 fL, Mean platelet volume (NR: 708 - 11.0) 7.0 fL, Monocytes (NR: 1.7 - 9.3) 4.0 %, Monocytes (NR: 0.1 - 0.6) 0.5 10*3/uL, Plasminogen activator inhibitor (NR: 150.0 - 450.) 261 10*3/uL, Prophylaxis (NR: 4.00 - 6.00) 4.46 10*6/uL, Red cell distribution width (NR: 16.6 - 13.7) 13.8 %, and WBC (NR: 4.5 - 10.5) 13.7 10*3/uL. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue/ very tired, and the outcome of joint pain, chronic lymphocytic leukemia and bone pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210614079-covid-19 vaccine ad26.cov2.s-Chronic Lymphocytic Leukemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE ADMINISTERED AFTER THE 6 HOUR MARK AFTER FIRST PUNCTURE IN REFRIGERATED CONDITIONS; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a 20 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  (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the subject experienced vaccine administered after the 6 hour mark after first puncture in refrigerated conditions. On 04-JUN-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine administered after the 6 hour mark after first puncture in refrigerated conditions and incorrect storage of drug was not reported. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Migraine, Nasal pruritus, Sinonasal obstruction
Clinical narrative: DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing, Taste disorder
Clinical narrative: DIFFICULTY/TROUBLE BREATHING; MIGRAINES; SINUS FLUID BUILDUP FEELING; TASTES SOME KIND OF WATER-LIKE LIQUID IN MOUTH; SNEEZING ON AND OFF; ITCHY NOSE ON AND OFF; STRONG HEADACHES; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no history of allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAY-2021, the subject experienced difficulty/trouble breathing. On 23-MAY-2021, the subject experienced migraines. On 23-MAY-2021, the subject experienced sinus fluid buildup feeling. On 23-MAY-2021, the subject experienced tastes some kind of water-like liquid in mouth. On 23-MAY-2021, the subject experienced sneezing on and off. On 23-MAY-2021, the subject experienced itchy nose on and off. On 23-MAY-2021, the subject experienced strong headaches. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from strong headaches, migraines, sinus fluid buildup feeling, tastes some kind of water-like liquid in mouth, difficulty/trouble breathing, sneezing on and off, and itchy nose on and off. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenopia, Headache, Unevaluable event, Vertigo
Clinical narrative: EYE STRAIN; WREAKED HAVOC ON  KNEES, SHOULDERS, AND JAW; WHIRLIES; BRUTAL 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 (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 subject experienced eye strain, wreaked havoc on knees, shoulders, and jaw, whirlies, and brutal headache. The action taken with covid-19 vaccine was not applicable. The outcome of the wreaked havoc on knees, shoulders, and jaw, brutal headache, eye strain and whirlies was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF-LABEL USE; This spontaneous report received from a physician concerned a 15 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: 201A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 02-JUN-2021, the subject experienced off-label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off-label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Oedema peripheral, Pain, Pyrexia, Somnolence
Clinical narrative: DIZZINESS; SLEEPY; BODY ACHES; SWELLING IN THE LEFT  ARM AND LEFT FOOT; VOMITING; FEVER; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978,expiry: unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced swelling in the left arm and left foot. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced sleepy. On 06-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced dizziness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from vomiting, and fever on 06-JUN-2021, was recovering from body aches, and had not recovered from sleepy, swelling in the left arm and left foot, and dizziness. This report was non-serious.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: DIZZINESS; SLEEPY; BODY ACHES; SWELLING IN THE LEFT  ARM AND LEFT FOOT; VOMITING; FEVER; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808978,expiry: unknown) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, the subject experienced swelling in the left arm and left foot. On 05-JUN-2021, the subject experienced vomiting. On 05-JUN-2021, the subject experienced fever. On 06-JUN-2021, the subject experienced sleepy. On 06-JUN-2021, the subject experienced body aches. On 07-JUN-2021, the subject experienced dizziness. The action taken with covid-19 vaccine  was not applicable. The patient recovered from vomiting, and fever on 06-JUN-2021, was recovering from body aches, and had not recovered from sleepy, swelling in the left arm and left foot, and dizziness. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Pyrexia
Clinical narrative: DIZZINESS (WHEN WALKING); FEVER; SORE ARM; SEVERE HEADACHES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced sore arm. On 07-JUN-2021, the subject experienced severe headaches. On 08-JUN-2021, the subject experienced dizziness (when walking). On 08-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from sore arm, and had not recovered from severe headaches, dizziness (when walking), and fever. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE ADMINISTERED TO PATIENT 45 MINS PAST 6 HOUR EXPIRATION DEADLINE; This spontaneous report received from a pharmacist 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 (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced vaccine administered to subject 45 mins past 6 hour expiration deadline. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered to patient 45 mins past 6 hour expiration deadline was not reported. This report was non-serious.