chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Nausea
Clinical narrative: SYNCOPE EPISODE; NECK PAIN; LOSS OF APPETITE; BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, hepatitis C, HIV, opioid dependence, polysubstance abuse, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021 about one hour after the vaccination, the patient experienced neck pain, loss of appetite, body ache, dizziness, vomiting, chills, headache, and nausea. On 13-APR-2021, the patient experienced syncope episode and other symptoms got worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from syncope episode, chills, neck pain, loss of appetite, headache, nausea, vomiting, body ache, and dizziness. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked.; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-syncope. 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, UNDERLYING DISEASE
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Syncope, Vomiting
Clinical narrative: SYNCOPE EPISODE; NECK PAIN; LOSS OF APPETITE; BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a health care professional concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, hepatitis C, HIV, opioid dependence, polysubstance abuse, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021 about one hour after the vaccination, the patient experienced neck pain, loss of appetite, body ache, dizziness, vomiting, chills, headache, and nausea. On 13-APR-2021, the patient experienced syncope episode and other symptoms got worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from syncope episode, chills, neck pain, loss of appetite, headache, nausea, vomiting, body ache, and dizziness. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked.; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-syncope. 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, UNDERLYING DISEASE
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Chills, Dizziness
Clinical narrative: NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Feeling hot, Headache
Clinical narrative: NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypoaesthesia, Injection site pain, Insomnia
Clinical narrative: NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. 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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: NUMBNESS IN HAND; HEADACHE; BRAIN FOG; INSOMNIA; BODY PAIN; NAUSEA; CHILLS; TIREDNESS; PAIN AT SITE OF INJECTION; RAPID HEARTBEAT; RESTRICTED BREATHING; INCREASED BLOOD PRESSURE; HEAT SENSATION THAT WENT FROM HER FEET TO HER HANDS; LIGHT HEADEDNESS/DIZZINESS; SWEATS; ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and over weight, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced anxiety. On 09-APR-2021, the subject experienced rapid heartbeat. On 09-APR-2021, the subject experienced restricted breathing. On 09-APR-2021, the subject experienced increased blood pressure. On 09-APR-2021, the subject experienced heat sensation that went from her feet to her hands. On 09-APR-2021, the subject experienced light headedness/dizziness. On 09-APR-2021, the subject experienced sweats. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced tiredness. On 09-APR-2021, the subject experienced pain at site of injection. Laboratory data included: Blood pressure (NR: not provided) Increased. On 10-APR-2021, the subject experienced insomnia. On 10-APR-2021, the subject experienced body pain. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced brain fog. On 11-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced numbness in hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, restricted breathing, increased blood pressure, heat sensation that went from her feet to her hands, light headedness/dizziness, and sweats on 09-APR-2021, brain fog on 12-APR-2021, anxiety on APR-2021, chills, and nausea on 10-APR-2021, was recovering from pain at site of injection, insomnia, body pain, and headache, and had not recovered from tiredness, and numbness in hand. 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.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Burning sensation, Chest discomfort, Pruritus, SARS-CoV-2 test
Clinical narrative: PINCH IN HEART; BURNING SENSATION; PIMPLES ON CHEST; ITCHINESS IN CHEST AREA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included confirmed covid-19 infection, and concurrent conditions included non smoker, non alcohol user, and benadryl intolerance, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the subject experienced pinch in heart. On 02-APR-2021, the subject experienced burning sensation. On 02-APR-2021, the subject experienced pimples on chest. On 02-APR-2021, the subject experienced itchiness in chest area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pimples on chest, pinch in heart, burning sensation, and itchiness in chest area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache
Clinical narrative: MULTIPLE NOSE BLEEDS; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 20 year old of unspecified sex. 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: 1808609, expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced multiple nose bleeds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 31-MAR-2021, and had not recovered from multiple nose bleeds. This report was non-serious.; Sender's Comments: V0: As per standard procedure , comment is not required for non-serious case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Headache, Motor dysfunction
Clinical narrative: LOSS OF FINE MOTOR CONTROL IN RIGHT ARM; HEADACHE; This spontaneous report received from a patient concerned a 76 year old female. The patient's weight was 130 pounds, and height was 65 inches. The patient's past medical history included pacemaker for nerve block (4-5 years ago), appendectomy (10 years ago), cataract surgery, and concurrent conditions included alcohol user (occasional, not often), and ex-smoker (used to smoke for 30 years (half pack a day), but quit 10 years ago) and bladder cancer growth (7 years ago). The patient experienced drug allergy with opioids (deathly ill, sick to stomach and passes out). The patient was not pregnant at the time of reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, 1 total, administered on right arm on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the patient experienced headache. On 21-MAR-2021, the patient lost fine motor control in right arm, and was hospitalized for 2 days. It was reported that, the patient had 2 computerized tomography scans showed no evidence of clot however according to the patient's physician, the patient might have had small clot that dissolved. The patient had no high blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of fine motor control in right arm on 21-MAR-2021, and headache on 2021. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0 This report concerns a 76-year-old female patient who experienced headache and loss fine motor control in right arm, 8 and 12 days after receiving Jansen COVID-19 vaccine respectively. Patient's medical history included pacemaker insertion, ex-smoker, bladder cancer, and drug allergy with opioids. Eight days after vaccination, the patient had headache. Four days later, the patient lost fine motor control in right arm and was hospitalized for one and a half days. Two CT scans showed no evidence of clot. The patient's physician commented that the patient might have had small clot that dissolved. The treatment was not reported, and patient was recovered from the events.  Based on the reported information, the causality is considered possible to vaccine for headache and unassessable for the event of loss fine motor control in right arm.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID 19; This spontaneous report received from a parent concerned a 26 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 admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced covid 19. On 09-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 12-APR-2021, 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 covid 19 was not reported. This report was non-serious. This case is associated with the Product quality complaint number 90000176258.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pain in extremity
Clinical narrative: CHEST PAIN; RIGHT ARM PAIN; HEADACHE; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 150 pounds, and height was 59 inches. No past medical history or concurrent conditions were reported. 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: Unknown) dose was not reported, administered on 24-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the patient experienced chest pain, right arm pain, headache and was hospitalized (date unspecified). She was en route to MRI and had to hang up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm pain, chest pain, and headache.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210427406-covid-19 vaccine ad26.cov2.s-Chest 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).  20210427406-covid-19 vaccine ad26.cov2.s-Right arm pain, headache. This event(s) is labeled per Agency and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: MINOR COUGH/NAUSEA/FATIGUE/CONFIRMED COVID-19 INFECTION; 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: 1805018 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced minor cough/nausea/fatigue/confirmed covid-19 infection. Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from minor cough/nausea/fatigue/confirmed covid-19 infection. This report was non-serious. This case was associate with PQC no.90000176214 The suspected product quality complaint has been confirmed to be the patient received the vaccine on (18-apr-2021) and had a positive covid-19 test on (02-apr-2021) with (15) days elapsed between vaccine and test. there was not sufficient time elapsed for the patient to achieve immunity therefore this report is not considered a lack of effect. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypersomnia, Lethargy, Loss of consciousness
Clinical narrative: LETHARGIC; DIZZY, LIGHTHEADEDNESS; SLEPT THE WHOLE DAY; FLUTTERY HEART  PALPITATIONS; SUPER BAD ACHES; HEADACHE; LOST CONSCIOUSNESS; This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient experienced lost consciousness (for couple of minutes) immediately after vaccination, she stayed around at vaccination site for 30 minutes. On 09-MAR-2021, the patient experienced super bad aches and headache. On unspecified date, the patient was lethargic, slept the whole day, fluttery heart palpitations, dizzy and lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness on 08-MAR-2021, and the outcome of headache, super bad aches, lethargic, fluttery heart palpitations, dizzy, lightheadedness and slept the whole day was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked. Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-Lost consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: LETHARGIC; DIZZY, LIGHTHEADEDNESS; SLEPT THE WHOLE DAY; FLUTTERY HEART  PALPITATIONS; SUPER BAD ACHES; HEADACHE; LOST CONSCIOUSNESS; This spontaneous report received from a patient 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the patient experienced lost consciousness (for couple of minutes) immediately after vaccination, she stayed around at vaccination site for 30 minutes. On 09-MAR-2021, the patient experienced super bad aches and headache. On unspecified date, the patient was lethargic, slept the whole day, fluttery heart palpitations, dizzy and lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost consciousness on 08-MAR-2021, and the outcome of headache, super bad aches, lethargic, fluttery heart palpitations, dizzy, lightheadedness and slept the whole day was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked. Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-Lost consciousness. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Muscle disorder
Clinical narrative: RIGHT GLAND BESIDE THROAT WAS SORE AND TENDER TO TOUCH BUT TOLERABLE; SLIGHT AND INTERMITTENT HEADACHE; FELT LIKE WHOLE MUSCLE EXPANDED AFTER THE INJECTION; 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 concurrent conditions included rheumatoid arthritis, and sinus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-MAR-2021, the subject experienced felt like whole muscle expanded after the injection. Treatment medications included: paracetamol. On 22-MAR-2021, the subject experienced right gland beside throat was sore and tender to touch but tolerable. On 22-MAR-2021, the subject experienced slight and intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like whole muscle expanded after the injection, and right gland beside throat was sore and tender to touch but tolerable on 24-MAR-2021, and had not recovered from slight and intermittent headache. 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Hypoacusis, Injection site mass, Injection site swelling
Clinical narrative: WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Mixed incontinence, Mobility decreased, Pain, Pain in extremity, Somnolence
Clinical narrative: WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. 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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Musculoskeletal stiffness, Pain, Thrombosis
Clinical narrative: BLOOD CLOT FROM NOSE; TEMPORARILY UNABLE TO WALK, RICKETY KNEES; BURNING LEG PAIN; JOINT PAIN/ SHOULDER PAIN; SHOULDER FEEL TIGHT; This spontaneous report received from a patient concerned a 30 year old  male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker (occasional pot; rarely). The patient's grandfather died from blot clot under knee (thrombosis). The patient had no history of bloody nose.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on left arm on 28-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021 (two days after vaccination) the patient experienced really bad burning leg pain for few days and his joints in shoulder and knees were affected two days after vaccination and he could not walk (temporarily unable to walk). The patient also experienced rickety knees. On the same day, the patient blew out a huge blood clot from his nose. On 2021, the patient's shoulder felt tight. At the time of this report, the patient's knees and shoulders were still feeling tight like there was hardly any cartilage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clot from nose, and temporarily unable to walk, rickety knees, was recovering from joint pain/ shoulder pain, and the outcome of burning leg pain and shoulder feel tight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-Covid-19 vaccine ad26.cov2.s-blood clot from nose. 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
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: STOMACH CRAMPS; BODY ACHES; HEART RATE HIGH; HEADACHE; NAUSEA; This spontaneous report received from a consumer 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) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced stomach cramps. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced heart rate high. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, stomach cramps, body aches, nausea and heart rate high was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: STOMACH CRAMPS; BODY ACHES; HEART RATE HIGH; HEADACHE; NAUSEA; This spontaneous report received from a consumer 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) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced stomach cramps. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced heart rate high. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, stomach cramps, body aches, nausea and heart rate high was not reported. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Parkinson's disease
Clinical narrative: PARKINSON SYMPTOMS WORSENED; EXCRUCIATINGLY PAINFUL PRESSURE POINT IN THE WRIST/HAND; NUMBNESS LEFT ARM TO A POINT IN WRIST AND FINGERS; SORENESS IN LEFT ARM TO A POINT IN WRIST AND FINGERS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinson's disease affecting left arm and hand, alcohol use, seasonal sinus problems, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the patient experienced parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, balance loss, numbness left arm to a point in wrist and fingers, muscle tightness in neck, intensified shaking of left arm and soreness in left arm to a point in wrist and fingers. The patient had not visited his physician but consulted a chiropractor. Chiropractor was unable to do anything with his neck to do improve movements. On an unknown date in APR-2021, the patient experienced balance loss over the last 4 to 5 days. On 13-Apr-2021, by the third visit to the chiropractor, the patient had some relief as chiropractor could do some movements. The patient would try to visit the physician next week. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from parkinson's symptoms worsened, excruciatingly painful pressure point in the wrist/hand, numbness left arm to a point in wrist and fingers, and soreness in left arm to a point in wrist and fingers. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender's Comments: V0: 20210428449-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Parkinson symptoms worsened. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received via social media/news from a consumer 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) dose was not reported, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in APR-2021, the patient experienced stroke three weeks after vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-covid-19 vaccine ad26.cov2. s- stroke This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Haematology test, Pyrexia
Clinical narrative: LOW FEVER; TIREDNESS; This spontaneous report received from a patient via a company representative concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cholesterol, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 12:30 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for cholesterol, and valsartan for hypertension.  On 18-MAR-2021, the subject experienced low fever. On 18-MAR-2021, the subject experienced tiredness. On 07-APR-2021, Laboratory data included: Hematology test (NR: not provided) Blood coagulated (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the low fever and tiredness 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.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: COLOR CHANGE AND ASHED SKIN; CRAMPS CALF; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 10:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-APR-2021, the subject experienced cramps calf. On an unspecified date, the subject experienced color change and ashed skin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cramps calf and color change and ashed skin was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest pain, Chills, Chromaturia, Dyspepsia
Clinical narrative: FOGGY FEELING IN HEAD; BURNING IN THE HEART MUSCLE; EVERY BONE WAS HURT; HEADACHE; CHILLS; FEVER; SWOLLEN HEART MUSCLE; CHEST PAIN; URINE COLORING YELLOW ORANGE; BODY ACHE; VOICE WAS HOARSE; This spontaneous report received from a patient concerned a 69 year old female. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced voice was hoarse. On APR-2021, the subject experienced body ache. On 07-APR-2021, the subject experienced swollen heart muscle. On 07-APR-2021, the subject experienced chest pain. On 07-APR-2021, the subject experienced urine coloring yellow orange. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced foggy feeling in head. On 08-APR-2021, the subject experienced burning in the heart muscle. On 08-APR-2021, the subject experienced every bone was hurt. On 08-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, foggy feeling in head, voice was hoarse, fever, chills, and headache on 11-APR-2021, burning in the heart muscle, and every bone was hurt on 09-APR-2021, urine coloring yellow orange on 10-APR-2021, and body ache on APR-2021, and was recovering from swollen heart muscle. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.