chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECT CLINICAL VACCINATION FAILURE; SUSPECT COVID-19 INFECTION; This spontaneous report received from a patient concerned a 73 year old male.  Initial information was processed along with additional information on 06-MAY-2021.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 0.5 ml, 1 total, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-APR-2021, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. The patient was so sick for 7 days and no fever. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection and was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178616.; Sender's Comments: V0: 20210509524-covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: SWOLLEN CHIN GLANDS; NAUSEA; HEADACHE FELT LIKE MIGRAINE; COULD NOT SLEEP; FEVER; LEFT ARM FELT WEIRD AND PARALYSING KIND OF SENSATION; FELT LIKE LOOSING ARM AND COULD NOT FEEL FINGERS AFTER VACCINATION; RAPID HEARTBEAT; FELT LIKE MOLTEN LAVA FLOWING AND HOT SENSATION IN LEFT ARM; DIZZINESS; LOWER GASTROINTESTINAL DISCOMFORT; BODY ACHES; NUMBNESS OR LOSS SENSATION OF FACIAL AREA ESPECIALLY CHIN AREA; SWEATING FROM BACK TO NECK AREA; CHEST TIGHTNESS; SENSITIVITY TO LIGHT AND SOUND; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included crohn's disease, vertigo, and heart murmur. The patient experienced drug allergy when treated with macrogol 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: 043A21a, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced left arm felt weird and paralysing kind of sensation. On 06-MAY-2021, the subject experienced felt like loosing arm and could not feel fingers after vaccination. On 06-MAY-2021, the subject experienced rapid heartbeat. On 06-MAY-2021, the subject experienced felt like molten lava flowing and hot sensation in left arm. On 06-MAY-2021, the subject experienced dizziness. On 06-MAY-2021, the subject experienced lower gastrointestinal discomfort. On 06-MAY-2021, the subject experienced body aches. On 06-MAY-2021, the subject experienced numbness or loss sensation of facial area especially chin area. On 06-MAY-2021, the subject experienced sweating from back to neck area. On 06-MAY-2021, the subject experienced chest tightness. On 06-MAY-2021, the subject experienced sensitivity to light and sound. On 06-MAY-2021, the subject experienced could not sleep. On 06-MAY-2021, the subject experienced fever. On 06-MAY-2021, the subject experienced headache felt like migraine. Laboratory data included: Body temperature (NR: not provided) 99.6, 97.6. On 06-MAY-2021 18:00, the subject experienced nausea. On 07-MAY-2021, the subject experienced swollen chin glands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm felt weird and paralysing kind of sensation, felt like loosing arm and could not feel fingers after vaccination, rapid heartbeat, felt like molten lava flowing and hot sensation in left arm, dizziness, headache felt like migraine, lower gastrointestinal discomfort, fever, body aches, numbness or loss sensation of facial area especially chin area, sweating from back to neck area, chest tightness, sensitivity to light and sound, swollen chin glands, and could not sleep, and the outcome of nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Neuropathy peripheral, Taste disorder
Clinical narrative: NEUROPATHY LEFT HAND AND FINGERTIPS BUT NO DISCOLORATION OR LOSS OF TEMPERATURE OR PULSE; HORRIBLE TASTE IN MOUTH; MOUTH CONSTANTLY FEELS LIKE FUZZ IN IT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency one total dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Around 25-MAR-2021 patient received Vaccine, after vaccination she experience horrible taste in mouth, also neuropathy left hand fingertips with no discoloration or loss of temperature or pulse. Her mouth constantly feels like fuzz in it. Her sense of smell was perfect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible taste in the mouth, neuropathy left hand and fingertips but no discoloration or loss of temperature or pulse and mouth constantly feels like fuzz in it was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516652-covid-19 vaccine ad26.cov2.s-neuropathy left hand and fingertips but no discoloration or loss of temperature or pulse. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Diabetes mellitus inadequate control
Clinical narrative: UNREGULATED BLOOD SUGAR LEVELS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  Patient stated that patient had a perfect control over her blood sugar levels. Patient followed a really strict routine to control blood sugar levels and it was almost always around 100. On 28-MAR-2021, the next morning after vaccination, the patient's blood sugar levels were totally unregulated and went to 298. The blood sugar levels kept going up and down. Patient stated that insulin or eating sugar did not work as it used to work earlier. Patient had to call 911 four times because the sugar levels were going down significantly and eating honey or sugary substances did not help to bring it up. Emergency medical services administered glucose and patient did not need to go to hospital. Patient was scared to go out and exercise because she was not sure what brought down or increased her blood sugar levels. After 41 days, the sugar levels were still not regulated. Patient had a transmitter device Dexcone that checked and reported the blood sugar levels every 5 minutes. Patient had been using the device for long time and only one time the sugar was over 260. After the vaccine shot, her device shot down and stopped working. Patient talked to doctor about blood sugar levels and doctor stated that it was unusual and reassured her that it would not cause a permanent damage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unregulated blood sugar levels. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516750-COVID-19 VACCINE AD26.COV2.S-Unregulated blood sugar levels. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chest pain, Hypotension, Influenza like illness
Clinical narrative: ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, 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 glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Pain in extremity, Trismus
Clinical narrative: ROLLING ACHE IN CHEST; FEELS LIKE FLU; STIFFNESS OF NECK; JAW GETTING READY LOCK AND FEELS OUT OF ALIGNMENT; LOW BLOOD PRESSURE/LOWER THAN NORMAL BLOOD PRESSURE; ACHINESS IN FINGERS FOR LONG TIME; ACHINESS IN SHOULDER ANKLE AND KNEE FOR LONG TIME; NECK PAIN; GLANDS SWOLLEN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included temporomandibular disorder, and irritable bowel syndrome, and concurrent conditions included sulfonamide allergy, non alcoholic, non smoker, and controlled high blood pressure. The patient was previously treated with for drug used for unknown indication; and experienced drug allergy when treated with chlorpromazine for drug used for unknown indication. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, 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 glands swollen. On 30-APR-2021, the subject experienced neck pain. On 01-MAY-2021, the subject experienced achiness in fingers for long time. On 01-MAY-2021, the subject experienced achiness in shoulder ankle and knee for long time. On 02-MAY-2021, the subject experienced low blood pressure/lower than normal blood pressure. Laboratory data included: Blood pressure (NR: not provided) 112/65, 126/71, 124/84, 120/82, 138/72. On 06-MAY-2021, the subject experienced jaw getting ready lock and feels out of alignment. On an unspecified date, the subject experienced rolling ache in chest, feels like flu, and stiffness of neck. The action taken with covid-19 vaccine was not applicable. The patient was recovering from glands swollen, and neck pain, had not recovered from jaw getting ready lock and feels out of alignment, achiness in fingers for long time, and achiness in shoulder ankle and knee for long time, and the outcome of low blood pressure/lower than normal blood pressure, feels like flu, stiffness of neck and rolling ache in chest was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Hypertension, Pain, Palpitations
Clinical narrative: HIGH BLOOD PRESSURE; NO APPETITE; SWOLLEN ARM; PALPITATION; PAIN; HEADACHE; This spontaneous report received from a physician concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included tendon surgery on the right limb, and concurrent conditions included COPD (chronic obstructive pulmonary disorder), non alcohol user, non smoker, thyroid, diabetic, no drug abuse or illicit drug usage, and hysterectomy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 05-MAY-2021, the patient experienced high blood pressure, no appetite, swollen arm, pain, palpitation and headache, and was hospitalized for same. On 06-May-2021, the patient was discharged. Laboratory data included: Blood pressure high (NR: not provided) 140/126, 159/156, 172/111.  Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, headache, no appetite, and swollen arm, and the outcome of palpitation and pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210516972-JANSSEN COVID-19 VACCINE-High blood pressure ,no appetite, swollen arm, palpitations, pain - 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) 20210516972-JANSSEN COVID-19 VACCINE- Headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: HIGH BLOOD PRESSURE; NO APPETITE; SWOLLEN ARM; PALPITATION; PAIN; HEADACHE; This spontaneous report received from a physician concerned a 49 year old female. The patient's height, and weight were not reported. The patient's past medical history included tendon surgery on the right limb, and concurrent conditions included COPD (chronic obstructive pulmonary disorder), non alcohol user, non smoker, thyroid, diabetic, no drug abuse or illicit drug usage, and hysterectomy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 to left arm for prophylactic vaccination.  No concomitant medications were reported.  On 05-MAY-2021, the patient experienced high blood pressure, no appetite, swollen arm, pain, palpitation and headache, and was hospitalized for same. On 06-May-2021, the patient was discharged. Laboratory data included: Blood pressure high (NR: not provided) 140/126, 159/156, 172/111.  Treatment medications (dates unspecified) included: tramadol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, headache, no appetite, and swollen arm, and the outcome of palpitation and pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210516972-JANSSEN COVID-19 VACCINE-High blood pressure ,no appetite, swollen arm, palpitations, pain - 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) 20210516972-JANSSEN COVID-19 VACCINE- Headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Computerised tomogram, Hypophagia, Pallor, Pneumonia
Clinical narrative: HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. 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, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: HARDLY EATING; SKIN IS PALE; PNEUMONIA; BACK HURTING REAL BAD; LOST 30 LBS; This spontaneous report received from a consumer concerned a 66 year old white, Not Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included patient might have a touch of emphysema, alcohol use (used to drink beer, about 12 pack once weekly), and non smoker, and other pre-existing medical conditions included patient had no known allergy, the patient had no history of drug abuse/illicit drug use. 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, 1 total to right arm on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with pneumonia and had lungs hurting on deep breath on 14-MAR-2021. Lung specialist which patient consulted did not know whether patient had covid-19 or not. The patients's pneumonia had got worse which resulted in weight loss of 30 lbs (pound). The patient had underwent CT (computerized tomography) scan by regular physician to determine pneumonia. The patient was put on prednisone and Doxycycline. The patient had subsequently went to lung specialist and was prescribed with Trelegy and 30 days of generic Augmentin. on 14-MAR-2021 patient had his back hurting very bad, was put on Flexeril for back pain, Flonase, Montelukast 10 mg and Tessalon. Subsequently patient was put on dexamethasone (unsure), 6 mg (milligram) once daily and was feeling better, but condition started going back. On 30-APR-2021, the patient experienced skin as pale. The patient still had shortness of breath, not coughing much at the time of reporting. Laboratory data included: CT scan for diagnosing pneumonia and Weight (NR: not provided) lost 30 lbs.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from back hurting real bad, and had not recovered from pneumonia, lost 30 lbs (pound), skin is pale, hardly eating. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210518214-COVID-19 VACCINE AD26.COV2.S-Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy vagina, Cardiac monitoring, Electrocardiogram, Fatigue, Headache
Clinical narrative: STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, tachycardia issues, gi issues, esophageal issues, post nasal drip issues, nausea, gerd, acid reflux, and seasonal allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced stuffed nose. On 10-MAY-2021, the subject experienced felt to lay down and sleep. On 10-MAY-2021, the subject experienced arm soreness. On 10-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced felt very fatigued. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Abnormal, ECG (NR: not provided) Clear-Normal, and Vaginal biopsy (NR: not provided) Clear. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm soreness, headache, felt very fatigued, and stuffed nose, and the outcome of felt to lay down and sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Somnolence
Clinical narrative: STUFFED NOSE; FELT TO LAY DOWN AND SLEEP; ARM SORENESS; HEADACHE; FELT VERY FATIGUED; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies, tachycardia issues, gi issues, esophageal issues, post nasal drip issues, nausea, gerd, acid reflux, and seasonal allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 10-MAY-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced stuffed nose. On 10-MAY-2021, the subject experienced felt to lay down and sleep. On 10-MAY-2021, the subject experienced arm soreness. On 10-MAY-2021, the subject experienced headache. On 10-MAY-2021, the subject experienced felt very fatigued. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Abnormal, ECG (NR: not provided) Clear-Normal, and Vaginal biopsy (NR: not provided) Clear. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from arm soreness, headache, felt very fatigued, and stuffed nose, and the outcome of felt to lay down and sleep was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: ANOREXIA; GENERALIZED PAIN; FOGGY FEELING; FEVER; FATIGUE; This spontaneous report received from a health care professional concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included attention-deficit/hyperactivity disorder, and other pre-existing medical conditions included the patient does not have any allergies to medication, food, or other products, no other illnesses at the time of vaccination and up to one month prior, and no adverse event following any previous vaccine. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 16:45:00 for prophylactic vaccination. Concomitant medications included amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate, ergocalciferol, magnesium, and rhodiola rosea.  On MAY-2021, treatment medications included: paracetamol. On 09-MAY-2021 06:00:00, the subject experienced anorexia. On 09-MAY-2021 06:00:00, the subject experienced generalized pain. On 09-MAY-2021 06:00:00, the subject experienced foggy feeling. On 09-MAY-2021 06:00:00, the subject experienced fever. On 09-MAY-2021 06:00:00, the subject experienced fatigue. The action taken with covid-19 vaccine was not applicable. The patient was recovering from fatigue, fever, foggy feeling, generalized pain, and anorexia. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: VOMITING; CHEST PAIN; TOTAL BODY PAIN; DIARRHOEA; NAUSEA; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, asthma, and allergic to nuts.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced vomiting. On 06-APR-2021, the subject experienced chest pain. On 06-APR-2021, the subject experienced total body pain. On 06-APR-2021, the subject experienced diarrhoea. On 06-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from total body pain, vomiting, nausea, chest pain, and diarrhoea. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SORE ARM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age.  Initial information was processed along with the additional information received on 12-May-2021.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. 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. Consumer called to report her side effects and mentioned that her boyfriend received the Janssen vaccine and on 18-APR-2021 patient experienced suspected clinical vaccination failure, suspected covid-19 infection and on 18-PR-2021 patient tested positive for Covid-19.On an unspecified date the patient experienced sore arm for four days. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000179160.; Sender's Comments: V0:20210520726 covid-19 vaccine ad26.cov2.s - suspected clinical vaccination failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 in total, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient was not developed antibodies (coded as suspected immunological vaccine failure). Laboratory data (dates unspecified) included: COVID-19 antibody test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210520747-covid-19 vaccine ad26.cov2.s-Suspected 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: Fatigue, Injection site pain, Myalgia, Pain, Pyrexia
Clinical narrative: BLURRED VISION; BODY ACHES; FEVER; MUSCLE ACHES; TIREDNESS; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patients 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) dose was not reported, 1 total administered on 10-MAY-2021 17:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-MAY-2021, she had injection site soreness (described as soreness around where she got the shot), then was okay during the day and night and had no immediate reaction. She also felt tired. She had usual side effects but on 11-MAY-2021, was experiencing blurred vision at the report time. On 11-MAY-2021, she started with fever. There was no measurement of fever but had all symptoms of fever, body aches and muscle aches. She had to do some work and did not rest then started with blurry vision. She had heard that it was a more dangerous side effect. She also did not have her vaccination card on hand and could not share the lot number or expiry of the vaccine. She indicated she would find it and call back. The caller was asking for advice on how to manage the blurred vision. She was advised during the call to seek the attention of a health care provider. She indicated that she had already contacted a pharmacy and was told to contact the vaccination provider. She was not able to obtain help. She did not know any providers in the area as she was a visitor.  The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from blurred vision, and the outcome of body aches, injection site soreness, fever, muscle aches and tiredness was not reported. This report was not serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; BODY ACHES; FEVER; MUSCLE ACHES; TIREDNESS; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patients 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) dose was not reported, 1 total administered on 10-MAY-2021 17:30 on left arm for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 10-MAY-2021, she had injection site soreness (described as soreness around where she got the shot), then was okay during the day and night and had no immediate reaction. She also felt tired. She had usual side effects but on 11-MAY-2021, was experiencing blurred vision at the report time. On 11-MAY-2021, she started with fever. There was no measurement of fever but had all symptoms of fever, body aches and muscle aches. She had to do some work and did not rest then started with blurry vision. She had heard that it was a more dangerous side effect. She also did not have her vaccination card on hand and could not share the lot number or expiry of the vaccine. She indicated she would find it and call back. The caller was asking for advice on how to manage the blurred vision. She was advised during the call to seek the attention of a health care provider. She indicated that she had already contacted a pharmacy and was told to contact the vaccination provider. She was not able to obtain help. She did not know any providers in the area as she was a visitor.  The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from blurred vision, and the outcome of body aches, injection site soreness, fever, muscle aches and tiredness was not reported. This report was not serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: U
Vaccine: COVID19
Symptoms: Abscess limb, Blood pressure measurement, Body temperature, Cellulitis, Erythema
Clinical narrative: CELLULITIS; HIGH BLOOD PRESSURE; ABSCESS IN ARM; HEADACHE; SEPSIS; PAIN; REDNESS IN ARM; FEVER; This spontaneous report received from a 49 year old patient of unspecified sex and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included seizure disorder but had not experienced since 1998. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 13:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the patient experienced redness in arm and fever. On 06-MAY-2021, the patient experienced pain. Laboratory data included: Pain scale (NR: not provided) Level 8-10. On 07-MAY-2021, the patient experienced sepsis, headache, abscess in arm. On the same date, the patient reported initially low fever and later high fever, body temperature was (NR: not provided) 101.9 (unit not reported). On unspecified date MAY-2021 the patient went to emergency room for fever. Patient went to physician where took blood work .On 10-MAY-2021, patient's White blood cell count was high 18.53 (unit not reported) and the patient experienced cellulitis, was treated with liquid Augmentin and blood pressure was high 159/108 (unit not reported), Heart rate was high 147 (unit not reported). On an unspecified date in MAY-2021, second attempt White blood cell count was high 14.63. diagnosed as sepsis and treated with dose of antibiotic unasyn. Currently on unspecified date in MAY-2021 patient had fever of 101.4 (unit not reported). Patient had to be cautious of fevers due to a seizure disorder. On 12-MAY-2021 patient went to ortho surgeon and went back to hospital to treat arm abscess drained.100 cc was removed and still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, pain, redness in arm, cellulitis, high blood pressure, headache, sepsis and abscess This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521005-covid-19 vaccine ad26.cov2.s-Sepsis, cellulitis and abscess in arm. 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: Headache, Heart rate, Hypertension, Laboratory test, Pain
Clinical narrative: CELLULITIS; HIGH BLOOD PRESSURE; ABSCESS IN ARM; HEADACHE; SEPSIS; PAIN; REDNESS IN ARM; FEVER; This spontaneous report received from a 49 year old patient of unspecified sex and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included seizure disorder but had not experienced since 1998. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 13:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the patient experienced redness in arm and fever. On 06-MAY-2021, the patient experienced pain. Laboratory data included: Pain scale (NR: not provided) Level 8-10. On 07-MAY-2021, the patient experienced sepsis, headache, abscess in arm. On the same date, the patient reported initially low fever and later high fever, body temperature was (NR: not provided) 101.9 (unit not reported). On unspecified date MAY-2021 the patient went to emergency room for fever. Patient went to physician where took blood work .On 10-MAY-2021, patient's White blood cell count was high 18.53 (unit not reported) and the patient experienced cellulitis, was treated with liquid Augmentin and blood pressure was high 159/108 (unit not reported), Heart rate was high 147 (unit not reported). On an unspecified date in MAY-2021, second attempt White blood cell count was high 14.63. diagnosed as sepsis and treated with dose of antibiotic unasyn. Currently on unspecified date in MAY-2021 patient had fever of 101.4 (unit not reported). Patient had to be cautious of fevers due to a seizure disorder. On 12-MAY-2021 patient went to ortho surgeon and went back to hospital to treat arm abscess drained.100 cc was removed and still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, pain, redness in arm, cellulitis, high blood pressure, headache, sepsis and abscess This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521005-covid-19 vaccine ad26.cov2.s-Sepsis, cellulitis and abscess in arm. 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: Pain assessment, Pyrexia, Sepsis, White blood cell count
Clinical narrative: CELLULITIS; HIGH BLOOD PRESSURE; ABSCESS IN ARM; HEADACHE; SEPSIS; PAIN; REDNESS IN ARM; FEVER; This spontaneous report received from a 49 year old patient of unspecified sex and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included seizure disorder but had not experienced since 1998. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 13:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the patient experienced redness in arm and fever. On 06-MAY-2021, the patient experienced pain. Laboratory data included: Pain scale (NR: not provided) Level 8-10. On 07-MAY-2021, the patient experienced sepsis, headache, abscess in arm. On the same date, the patient reported initially low fever and later high fever, body temperature was (NR: not provided) 101.9 (unit not reported). On unspecified date MAY-2021 the patient went to emergency room for fever. Patient went to physician where took blood work .On 10-MAY-2021, patient's White blood cell count was high 18.53 (unit not reported) and the patient experienced cellulitis, was treated with liquid Augmentin and blood pressure was high 159/108 (unit not reported), Heart rate was high 147 (unit not reported). On an unspecified date in MAY-2021, second attempt White blood cell count was high 14.63. diagnosed as sepsis and treated with dose of antibiotic unasyn. Currently on unspecified date in MAY-2021 patient had fever of 101.4 (unit not reported). Patient had to be cautious of fevers due to a seizure disorder. On 12-MAY-2021 patient went to ortho surgeon and went back to hospital to treat arm abscess drained.100 cc was removed and still draining puss. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, pain, redness in arm, cellulitis, high blood pressure, headache, sepsis and abscess This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210521005-covid-19 vaccine ad26.cov2.s-Sepsis, cellulitis and abscess in arm. 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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Loss of consciousness, Shock
Clinical narrative: UNCONSCIOUSNESS WITHIN MINUTES AND COULD NOT REGAIN SUSTAINED CONSCIOUSNESS; BODY IMMEDIATELY WENT INTO SHOCK; This spontaneous report received from social media from a parent via a company representative concerned a 19 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The parent reported that the healthy patient after receiving vaccine on 10-MAY-2021, experienced unconsciousness within minutes and could not regain sustained consciousness. He was rushed to the emergency room via ambulance and ran some tests, found nothing of significance. His body immediately went into shock. The patient seemed stable now. He was admitted to the hospital on 10-MAY-2021 and the duration of hospitalization was not reported. Laboratory data included: Lab test (NR: not provided) Found nothing of significance. Discharge date of hospitalization was not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from unconsciousness within minutes and could not regain sustained consciousness, and body immediately went into shock. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210521196-JANSSEN COVID-19 VACCINE-unconscious within minutes and could not regain sustained consciousness, body immediately went into shock. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Skin haemorrhage
Clinical narrative: EASY TO BLEED; This spontaneous report received from a White, not Hispanic and Latino female patient 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 report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient found herself easy to bleed every time she touched anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of easy to bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522266-Covid-19 vaccine ad26.cov2.s-A White, not Hispanic and Latino female patient of unspecified age presents with Easy to bleed. 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).