chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia oral, Injection site pain, Migraine, Muscular weakness
Clinical narrative: NUMBNESS LIPS; FELT COLD AIR IN THE NECK; WEAKNESS IN THE LEFT ARM; INJECTION ARM HURT; MIGRAINE (DIZZY, HEADACHE, NAUSEA, FELT LIKE SOMETHING WAS RATTLING IN HER HEAD, FELT LIKE THERE WAS A HOLE ON HER HEAD); This spontaneous report received from a consumer concerned an 18 year old female. The patient's height, and weight were not reported. The patient had no medical history. 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, 1 total administered on 06-APR-2021around 10:30 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, around 5 pm, the patient was dizzy, and had a headache and her injection arm hurt. On 07-APR-2021, the patient experienced numbness lips, and reported that "felt like something was rattling in her head, felt like there was a hole on her head, felt cold air in the neck", weakness in the left arm, nausea for which she was put on IV. On an unspecified date, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness lips, injection arm hurt, felt cold air in the neck, and weakness in the left arm 08-APR-2021, and was recovering from migraine. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210419870-covid-19 vaccine ad26.cov2.s-Migraine, numbness lips, felt cold air in the neck and weakness in the left 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). 20210419870-covid-19 vaccine ad26.cov2.s-injection arm hurt. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: INSUFFICIENT DOSE GIVEN; This spontaneous report received from a pharmacist concerned a 40-year-old female. The patient's weight was 145 pounds, and height was 177.8 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1808982 expiry: 31-JUN-2021) dose was not reported, 1 total administered on 10-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  It was reported that on 10-APR-2021, during the process of injecting the vaccine to the patient, reporter noticed that the tip of syringe was leaking that caused to inject an insufficient dose (approximately 0.1 ml had leaked) of JANSSEN COVID-19 vaccine. Repetition of dose will depend on patient's clinical judgement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of insufficient dose given was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210420047-covid-19 vaccine ad26.cov2.s-insufficient dose given. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Head discomfort, Headache
Clinical narrative: SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN  IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Insomnia, Pain in extremity, Psychiatric symptom
Clinical narrative: SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN  IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. 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: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Suicidal ideation, Tremor
Clinical narrative: SEVERE INSOMNIA; ELEVATED HEART RATE; CHEST PAIN; STOMACH ACHE; WEAKNESS; WHOLE BODY SHAKING; SWEATING; SEVERE PSYCHIATRIC REACTION; SUICIDAL IDEATION; HEAD TURNED INTO A CLOUD; EXCRUCIATING PAIN  IN THE PALM PART OF LEFT HAND NEAR THUMB; FRONTAL LOBE HEADACHE, TO THE LEFT AND RIGHT OF FRONT LOBE; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and nonsmoker. The patient had no known allergies or drug abuse. The patient's genetic test showed he came from all around the world. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 19-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, 1.5 hours later, the patient experienced "severe brain symptoms". He has developed several incidences of severe insomnia (no sleeping pills have help), for which has been awake for 24 hours at a time. He experienced head turned into a cloud, frontal lobe headache, excruciating pain in the palm part of his left hand near his thumb in which he had previously injured. On 20-MAR-2021, he developed severe psychiatric reaction to brain, he could not have control over his body, and he was afraid of the Psychological Evaluation Team. His health care professional (HCP) deployed a team to arrest his for-psych evaluation. On Mar-2021; event head turned into a cloud was resolved. On 09-APR-2021, he developed most severe symptoms of entire body shaking, nervous feeling of shaking, weakness, sweating profusely, unsure if he has a fever or not. On an unspecified date, he also developed stomach aches, elevated heart rate, chest pain and weakness. There were days where his heart rate was high around 160 bpm for 3-4 days in a row (normal 80-100 bpm). His chest pain was still ongoing. Laboratory data (dates unspecified) included: Heart rate increased (NR: 80 - 100) 160 BPM. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head turned into a cloud, had not recovered from frontal lobe headache, to the left and right of front lobe, excruciating pain in the palm part of left hand near thumb, suicidal ideation, severe psychiatric reaction, severe insomnia, whole body shaking, weakness, sweating, and chest pain, and the outcome of elevated heart rate and stomachache was not reported. This report was serious (Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: 20210420137 - COVID-19 VACCINE AD26.COV2.S - SUICIDAL IDEATION. 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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Decreased appetite, Headache, Injection site pain, Paraesthesia
Clinical narrative: LACK OF APPETITE; HEADACHE; SYSTEMIC PAIN AT THE INJECTION  SITE; TINGLING IN LEFT ARM DOWN TO  FINGER TIPS; ACHING BONES/ACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 127 pounds, and height was 164 centimeters. The patient's concurrent conditions included hypertension, non-alcoholic, and non-smoker, and other pre-existing medical conditions included no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A2221A 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 tingling in left arm down to finger tips. On 06-APR-2021, the subject experienced aching bones/ache. On 06-APR-2021, the subject experienced systemic pain at the injection site. On 07-APR-2021, the subject experienced lack of appetite. On 07-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aching bones/ache on 07-APR-2021, and lack of appetite, and headache on 08-APR-2021, and had not recovered from tingling in left arm down to finger tips, and systemic pain at the injection site. This report was non-serious. This case is associated with PQC number: 90000175947, 90000175948. The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: PANCREATITIS; This spontaneous report received from a patient concerned a 55-year-old not Hispanic/Latino white male. The patient's height, and weight were not reported. The patient's concurrent conditions included pancreatic cyst, and alcohol use. The patient had no known allergies and no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On approximately 09-APR-2021, at the night of Thursday/Friday (overnight), suddenly the patient experienced pancreatitis. It was reported that, on day of vaccination the patient was fine and drank 1/2 glass of wine in the evening after receiving vaccine and before he experienced pancreatitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pancreatitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: -COVID-19 VACCINE AD26.COV2.S-Pancreatitis. 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: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Dysstasia, Heart rate
Clinical narrative: FAINTING; ABNORMAL HEART BEAT; DIZZINESS; BLADDER CONTROL LOST/URINATED ON HERSELF; COULDN'T STAND UP; NAUSEA; CHILLS; DIDN'T HAVE APPETITE; 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 little asthma, cardiac resynchronization therapy (CRTS), and allergic to red tide. The patient was previously treated with gabapentin. 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 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2020, Laboratory data included: COVID-19 antigen test (NR: not provided) negative (units unspecified). On an unspecified date in MAR-2021, the subject didn't have appetite. On 13-MAR-2021, the patient experienced chills at night. On 14-MAR-2021, morning the patient experienced dizziness, nausea, she couldn't stand up and fainted (dead weight) and she reported that she was a dead weight and she didn't have control of bladder and urinated on herself (she was lying in a pool of urine. Also her heart rate went up to 84 b/p per min after she fainted and lasted for the whole day, next day it came down to 74 b/p. Her normal heart beat were 64 b/m. She was nauseous and dizzy for the past 3 weeks. Laboratory data included: Heart rate (NR: not provided) 84 (units unspecified). On 15-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 72 (units unspecified). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 64 b/p.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal heart beat on MAR-2021, and bladder control lost/urinated on herself, chills, and nausea, and the outcome of dizziness, fainting, didn't have appetite and couldn't stand up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210420179-COVID-19 VACCINE AD26.COV2.S-Fainted. 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Nausea, SARS-CoV-2 test, Syncope, Urinary incontinence
Clinical narrative: FAINTING; ABNORMAL HEART BEAT; DIZZINESS; BLADDER CONTROL LOST/URINATED ON HERSELF; COULDN'T STAND UP; NAUSEA; CHILLS; DIDN'T HAVE APPETITE; 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 little asthma, cardiac resynchronization therapy (CRTS), and allergic to red tide. The patient was previously treated with gabapentin. 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 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in 2020, Laboratory data included: COVID-19 antigen test (NR: not provided) negative (units unspecified). On an unspecified date in MAR-2021, the subject didn't have appetite. On 13-MAR-2021, the patient experienced chills at night. On 14-MAR-2021, morning the patient experienced dizziness, nausea, she couldn't stand up and fainted (dead weight) and she reported that she was a dead weight and she didn't have control of bladder and urinated on herself (she was lying in a pool of urine. Also her heart rate went up to 84 b/p per min after she fainted and lasted for the whole day, next day it came down to 74 b/p. Her normal heart beat were 64 b/m. She was nauseous and dizzy for the past 3 weeks. Laboratory data included: Heart rate (NR: not provided) 84 (units unspecified). On 15-MAR-2021, Laboratory data included: Heart rate (NR: not provided) 72 (units unspecified). Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 64 b/p.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from abnormal heart beat on MAR-2021, and bladder control lost/urinated on herself, chills, and nausea, and the outcome of dizziness, fainting, didn't have appetite and couldn't stand up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210420179-COVID-19 VACCINE AD26.COV2.S-Fainted. 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: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included allergic to non-steroidal anti-inflammatory drugs: swelling. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 101.6 F. On 09-APR-2021 21:00, the subject experienced fever. On 10-APR-2021, Laboratory data included: Body temperature (NR: not provided) 104.4 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious. This case, involving the same patient is linked to 20210423938.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Muscle spasms
Clinical narrative: BREATHING ISSUES; BAD MUSCLE CRAMPS; BAD CHILLS; HEADACHE; FEELING TIRED; 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 sulfonamide allergy, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the subject experienced breathing issues. On 09-APR-2021, the subject experienced bad muscle cramps. On 09-APR-2021, the subject experienced bad chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced feeling tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breathing issues, bad muscle cramps, bad chills, and headache on 09-APR-2021, and had not recovered from feeling tired. 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Injection site bruising
Clinical narrative: NAUSEA; TIREDNESS/SLUGGISHNESS; BRUISED ARM AT THE ADMINISTRATION SITE; DIZZINESS; FEELS A LITTLE OFF; HEADACHE; This spontaneous report received from a patient concerned a 40 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bruised arm at the administration site. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced feels a little off. On 04-APR-2021, the subject experienced tiredness/sluggishness. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-APR-2021, was recovering from nausea, dizziness, and tiredness/sluggishness, and had not recovered from bruised arm at the administration site, and feels a little off. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: NAUSEA; TIREDNESS/SLUGGISHNESS; BRUISED ARM AT THE ADMINISTRATION SITE; DIZZINESS; FEELS A LITTLE OFF; HEADACHE; This spontaneous report received from a patient concerned a 40 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: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, the subject experienced headache. On 04-APR-2021, the subject experienced bruised arm at the administration site. On 04-APR-2021, the subject experienced dizziness. On 04-APR-2021, the subject experienced feels a little off. On 04-APR-2021, the subject experienced tiredness/sluggishness. On 06-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 06-APR-2021, was recovering from nausea, dizziness, and tiredness/sluggishness, and had not recovered from bruised arm at the administration site, and feels a little off. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Influenza like illness, Panic disorder
Clinical narrative: PERIODIC PANIC; ANXIETY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 32 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, batch number: 1805029, and expiry: 25-MAY-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, the subject experienced flu like symptoms. On 21-MAR-2021, the subject experienced periodic panic. On 21-MAR-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 19-MAR-2021, and had not recovered from anxiety, and periodic panic. 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Dysarthria, Fall, Loss of consciousness
Clinical narrative: LOSS OF CONSCIOUSNESS; RECURRENT EPISODES OF SLURRED SPEECH; FALL; SCRAPPED HEAD; BALANCE PROBLEMS; This spontaneous report received from a consumer concerned an 85 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: 043A21A expiry: unknown) dose was not reported,1 total  administered on 02-APR-2021 14:18 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, after 18:30 the patient experienced slurred speech while finishing his dinner and it lasted for 30 seconds. The patient still had difficulty responding. On 03-APR-2021, at night the patient experienced loss of consciousness and fell to the ground with a little scrapped head and ten minutes later he was able to get up and felt better. On 04-APR-2021 at 13:15, he was finishing his lunch and had slurred speech again; he had repeated episode within five minutes. The paramedics had been called and checked his vitals (not specified). The patient was taken to emergency room on 04-APR-2021 at 14:30 and taken X-ray and CT (Computed Tomography) scan (unknown). The patient was admitted to hospital on 04-APR-2021 at 22:00 and was kept overnight for observation. The patient had not anything concerning and got discharged on 05-APR-2021 to follow-up with his treating physician. The patient was using cane for balance and was home bound but kept active. The duration of hospitalization was 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and fall on 03-APR-2021, and recurrent episodes of slurred speech on 05-APR-2021, was recovering from balance problems, and the outcome of scrapped head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210420526-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Loss of consciousness, Recurrent episodes of slurred speech, Fall, Balance problems, Scrapped head. 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: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Skin abrasion, X-ray
Clinical narrative: LOSS OF CONSCIOUSNESS; RECURRENT EPISODES OF SLURRED SPEECH; FALL; SCRAPPED HEAD; BALANCE PROBLEMS; This spontaneous report received from a consumer concerned an 85 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: 043A21A expiry: unknown) dose was not reported,1 total  administered on 02-APR-2021 14:18 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 03-APR-2021, after 18:30 the patient experienced slurred speech while finishing his dinner and it lasted for 30 seconds. The patient still had difficulty responding. On 03-APR-2021, at night the patient experienced loss of consciousness and fell to the ground with a little scrapped head and ten minutes later he was able to get up and felt better. On 04-APR-2021 at 13:15, he was finishing his lunch and had slurred speech again; he had repeated episode within five minutes. The paramedics had been called and checked his vitals (not specified). The patient was taken to emergency room on 04-APR-2021 at 14:30 and taken X-ray and CT (Computed Tomography) scan (unknown). The patient was admitted to hospital on 04-APR-2021 at 22:00 and was kept overnight for observation. The patient had not anything concerning and got discharged on 05-APR-2021 to follow-up with his treating physician. The patient was using cane for balance and was home bound but kept active. The duration of hospitalization was 1 day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness, and fall on 03-APR-2021, and recurrent episodes of slurred speech on 05-APR-2021, was recovering from balance problems, and the outcome of scrapped head was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210420526-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Loss of consciousness, Recurrent episodes of slurred speech, Fall, Balance problems, Scrapped head. 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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hypoaesthesia
Clinical narrative: REALLY COLD; SHIVERING; NUMBNESS IN THE INJECTED ARM; This spontaneous report received from a patient concerned a 59 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: 201A21A, and  expiry: unknown) dose was not reported,1 total administered on 08-APR-2021 14:40 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021 about two hours after vaccination, the patient had numbness in the injected arm. She took two paracetamol (Tylenol) to treat numbness and went to bed. The patient woke up at around 23:30 and she was really cold and put on as much blankets since she was shivering. The patient's arm was still numb; the coldness and shivering are not quite as bad. On an unspecified date, the patient died from shivering. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from really cold, and shivering, and had not recovered from numbness in the injected arm. This report was non-serious
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Palpitations
Clinical narrative: PALPITATIONS; ITCH; JOINT ACHE; TIRED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 57 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, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced palpitations, itch, joint ache, tired, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the palpitations, tired, headache, itch, joint ache and nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: PALPITATIONS; ITCH; JOINT ACHE; TIRED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 57 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, batch number: 1805025,expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced palpitations, itch, joint ache, tired, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the palpitations, tired, headache, itch, joint ache and nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Product label issue
Clinical narrative: PRODUCT LOT WAS VERY SLOPPY AND HARD TO READ (PRODUCT LABEL ISSUE); DIZZY AND FELT LIKE FAINTING; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included feeling faint. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: OU1A71A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021 15:03, the subject experienced dizzy and felt like fainting. On an unspecified date, the subject experienced product lot was very sloppy and hard to read (product label issue). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy and felt like fainting on 08-APR-2021, and the outcome of product lot was very sloppy and hard to read (product label issue) was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; 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 past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Syncope
Clinical narrative: FAINTING; DIZZINESS/LIGHTHEADEDNESS; This spontaneous report received from a pharmacist concerned multiple patients of unspecified age and gender (specific number of patients unknown, reported as handful/bunch of patients). The patients' weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose, start therapy date was not reported, 1 total, for prophylactic vaccination. The batch number was not reported and will not be requested because the pharmacist does not have the lot number of the vaccine used. No concomitant medications were reported.  On an unspecified date, the patients fainted and experienced lightheadedness/dizziness. It was reported that the patients experienced these side-effects not only during vaccination which were from the anxiety or stress of the injection itself but, also during the 15 minutes that the patients were kept for surveillance. The patients did not require any hospitalization or any additional medical care. They just got monitored by a nurse and some of them became better after drinking water and taking rest on the chair for 15 minutes or a bit longer than that. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and lightheadedness/dizziness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420689-Covid-19 vaccine ad26.cov2.s-Fainting. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SHOOTING PAIN LIKE CHARLEY HORSES GOING DOWN BOTH LEGS; This spontaneous report received from a parent 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 01-APR-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 01-APR-2021, the subject experienced shooting pain like charley horses going down both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shooting pain like charley horses going down both legs on 02-APR-2021. This report was non-serious.; Sender's Comments: V0: MAC comment is not required for nonserious case as per standard protocol
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Mammogram, Pain in extremity, Ultrasound scan
Clinical narrative: PAIN ON LEFT BREAST; PAIN IN LEFT SIDE OF CHEST ON SIDE  OF INJECTION; PAIN UNDER LEFT ARM; 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: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced pain on left breast. On 15-MAR-2021, the subject experienced pain in left side of chest on side of injection. On 15-MAR-2021, the subject experienced pain under left arm. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) awaiting result, and Mammogram (NR: not provided) awaiting result. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on left breast, pain in left side of chest on side of injection, and pain under left arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed as non serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Nausea, Oropharyngeal pain, Pain
Clinical narrative: SEVERE STOMACH ACHE; BODY ACHE; VOMITING; SORE THROAT; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included mycosis fungoides, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-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 10-APR-2021, the subject experienced severe stomach ache. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, body ache, nausea, vomiting, sore throat, headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: SEVERE STOMACH ACHE; BODY ACHE; VOMITING; SORE THROAT; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included mycosis fungoides, and concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 10-APR-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 10-APR-2021, the subject experienced severe stomach ache. On 10-APR-2021, the subject experienced body ache. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, body ache, nausea, vomiting, sore throat, headache, and fever. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness, Musculoskeletal pain, Pyrexia, Vital signs measurement
Clinical narrative: FEVER; PASSED OUT/ 'FELT REALLY BAD/TERRIBLE/HORRIBLE, VITALS VERY LOW, FELT WARM, SWEAT, CHILLS, FELT WEAK, FEELING TIRED/EXHAUSTION; CRASHING TO THE FLOOR; LEFT BUTT CHEEK HURTS; This spontaneous report received from a patient concerned a 40 year old female.. The patient's height, and weight were not reported. The patient's past medical history included passed out, and other pre-existing medical conditions included the patient had passed out when getting blood work done previously. The patient was previously treated with influenza vaccine for prophylactic vaccination. 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: 205A21A, and expiry: UNKNOWN) dose was not reported, 1 total dose administered on 09-APR-2021 13:15 in left deltoid for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Vital signs measurement (NR: not provided) Not reported.  On 10-APR-2021, the patient experienced passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion. On 10-APR-2021, the patient experienced crashing to the floor. On 10-APR-2021, the subject experienced left butt cheek hurts. On 11-APR-2021, the subject experienced fever. the patient woke up in the morning, and while washing her hands in the bathroom, she began to feel really bad and started to lower herself down and she passed out, then she ended up crashing to the floor, she did not hit her head, and her left butt cheek got hurt. Her husband called emergency medical services (EMS) who treated her until she regained consciousness. Patient also stated that she felt terrible and horrible. Emergency medical services recommended that she be taken to the hospital for further evaluation, but she declined. She had a history of passing out after bloodwork, but had never had this delayed of a reaction with bloodwork or any reaction to the flu shot. EMS called and her vitals were all very low. She did not go to the hospital. She felt improved and had been taking it easy at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crashing to the floor on 10-APR-2021, and was recovering from passed out/ felt really bad/terrible/horrible, vitals very low, felt warm, sweat, chills, felt weak, feeling tired/exhaustion, left butt cheek hurts, and fever. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210420904-covid-19 vaccine ad26.cov2.s-Passed out. 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).