chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Rash, Solar lentigo
Clinical narrative: SHORTNESS OF BREATH; LIVER SPOTS; RASH LEFT THIGH; 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 copd. 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 09-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced liver spots. On 11-APR-2021, the subject experienced rash left thigh. Laboratory data included: O2 saturation (NR: not provided) 97 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from rash left thigh, and the outcome of liver spots was not reported. This report was non-serious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain
Clinical narrative: SWOLLEN LYMPH NODE; BODY ACHES; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced swollen lymph node. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, fatigue, nausea, and swollen lymph node. This report was non-serious.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fall, Headache, Loss of consciousness, Nasopharyngitis
Clinical narrative: PASSED OUT; FALL OVER; COLD; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old white, not Hispanic or Latino 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that day after vaccination on 11-APR-2021 in early morning, the patient had chills and fever. The patient went down to get some unspecified medications and he passed out for roughly 5 minutes and fell over. The patient had headache at the time of this report. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, cold, chills, and fever on 11-APR-2021, had not recovered from headache, and the outcome of fall over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421495 - 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).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: PASSED OUT; FALL OVER; COLD; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old white, not Hispanic or Latino 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: 203A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 at 16:00 to left arm for prophylactic vaccination. No concomitant medications were reported.  It was reported that day after vaccination on 11-APR-2021 in early morning, the patient had chills and fever. The patient went down to get some unspecified medications and he passed out for roughly 5 minutes and fell over. The patient had headache at the time of this report. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, cold, chills, and fever on 11-APR-2021, had not recovered from headache, and the outcome of fall over was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421495 - 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).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Dizziness, Feeling cold, Hyperhidrosis, Loss of consciousness
Clinical narrative: PASSED OUT; EXTREMELY COLD; LIGHT HEADED; SWEATING; CHANGES IN BODY TEMPERATURE; 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: 207A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient experienced passed out, extremely cold, light headed, sweating and changes in body temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 09-APR-2021, was recovering from light headed, and had not recovered from extremely cold, sweating, and changes in body temperature. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210421673- 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).
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Diarrhoea, Dizziness, Fatigue
Clinical narrative: DIARRHEA; PAIN IN NECK; LIGHTHEADEDNESS; LOWER BACK PAIN; FEVER; NAUSEA; FATIGUE; 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 2021, the subject experienced pain in neck. On 2021, the subject experienced lightheadedness. On 2021, the subject experienced lower back pain. On 2021, the subject experienced fever. On 2021, the subject experienced nausea. On 2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 to103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, pain in neck, lower back pain, and nausea on 2021, had not recovered from lightheadedness, and fatigue, and the outcome of fever was not reported. 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.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pyrexia
Clinical narrative: DIARRHEA; PAIN IN NECK; LIGHTHEADEDNESS; LOWER BACK PAIN; FEVER; NAUSEA; FATIGUE; 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced diarrhea. On 2021, the subject experienced pain in neck. On 2021, the subject experienced lightheadedness. On 2021, the subject experienced lower back pain. On 2021, the subject experienced fever. On 2021, the subject experienced nausea. On 2021, the subject experienced fatigue. Laboratory data included: Body temperature (NR: not provided) 102 to103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea, pain in neck, lower back pain, and nausea on 2021, had not recovered from lightheadedness, and fatigue, and the outcome of fever was not reported. 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.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Burning sensation, Cough, Dysstasia, Feeling of body temperature change
Clinical narrative: SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 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: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Pain in extremity, Pulmonary pain, Pyrexia
Clinical narrative: SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 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: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract irritation, Tremor
Clinical narrative: SHAKES; COULD NOT SLEEP; HOT AND COLD CHILLS; COUGHING WAS DRY TODAY BUT PRODUCTIVE YESTERDAY (STUFF WAS COMING OUT); LUNGS WITH BURNING SENSATION LIKE BRONCHITIS; SORE LUNGS; COULD NOT STAND UP; STOMACH ACHE; BURNING ARM FROM SHOT; PAINFUL /SORE ARM; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 63 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: 203A21A expiry: 23/JUN/2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced shakes. On 06-APR-2021, the subject experienced could not sleep. On 06-APR-2021, the subject experienced hot and cold chills. On 06-APR-2021, the subject experienced coughing was dry today but productive yesterday (stuff was coming out). On 06-APR-2021, the subject experienced lungs with burning sensation like bronchitis. On 06-APR-2021, the subject experienced sore lungs. On 06-APR-2021, the subject experienced could not stand up. On 06-APR-2021, the subject experienced stomach ache. On 06-APR-2021, the subject experienced burning arm from shot. On 06-APR-2021, the subject experienced painful /sore arm. On 06-APR-2021, the subject experienced nausea. On 06-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not sleep on 07-APR-2021, and lungs with burning sensation like bronchitis, stomach ache, and burning arm from shot on 11-APR-2021, was recovering from painful /sore arm, had not recovered from hot and cold chills, shakes, nausea, fever, and coughing was dry today but productive yesterday (stuff was coming out), and the outcome of sore lungs and could not stand up was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Dysphagia, Mastication disorder
Clinical narrative: BACTERIAL INFECTION; DIFFICULTY SWALLOWING; DIFFICULTY CHEWING; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included myasthenia gravis, 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: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 at Left Arm as prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced difficulty in swallowing and chewing . He was diagnosed also with a bacterial infection of unknown origin. On 23-MAR-2021, the patient was hospitalized for 11 days in the ICU. The patient was recovered from the infection but continues to experience symptoms of myasthenia gravis. The patient was discharged from the hospital on 02-Apr-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bacterial infection on 02-APR-2021, and had not recovered from difficulty swallowing, and difficulty chewing. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422146-covid-19 vaccine ad26.cov2.s-bacterial infection. 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. 20210422146-covid-19 vaccine ad26.cov2.s-difficulty swallowing and difficulty chewing. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: UNDERLYING DISEASE
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Product complaint, Sleep disorder
Clinical narrative: PRODUCT COMPLAINT; INTERFERED WITH HIS SLEEP; REMAINS TIRED; NAUSEA; This spontaneous report received from a parent 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: 207A21A expiry: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced interfered with his sleep, remains tired and nausea. On an unspecified date, the subject experienced product complaint. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, had not recovered from remains tired, and the outcome of interfered with his sleep and product complaint was not reported. This report was non-serious. This report was associated with a product quality compliant : 90000176058 This suspected product quality complaint has been confirmed to be void (does not meet criteria) based on PQC evaluation/investigation performed.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure measurement, Blood test, Blood triglycerides, Cardiac function test
Clinical narrative: SHOOTING PAIN IN THE HEART; This spontaneous report received from a consumer concerned a 24 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, treatment medications included: acetylsalicylic acid. On 06-APR-2021, the subject experienced shooting pain in the heart. On 09-APR-2021, Laboratory data included: Blood glucose normal (NR: not provided) okay, Blood pressure (NR: not provided) okay, Blood test (NR: not provided) okay, Cardiac function test (NR: not provided) okay, EKG (NR: not provided) okay, Oxygen saturation (NR: not provided) okay, and Triglycerides (NR: not provided) okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shooting pain in the heart. 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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Oxygen saturation
Clinical narrative: SHOOTING PAIN IN THE HEART; This spontaneous report received from a consumer concerned a 24 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, treatment medications included: acetylsalicylic acid. On 06-APR-2021, the subject experienced shooting pain in the heart. On 09-APR-2021, Laboratory data included: Blood glucose normal (NR: not provided) okay, Blood pressure (NR: not provided) okay, Blood test (NR: not provided) okay, Cardiac function test (NR: not provided) okay, EKG (NR: not provided) okay, Oxygen saturation (NR: not provided) okay, and Triglycerides (NR: not provided) okay. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shooting pain in the heart. 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: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: MASSIVE STROKE(PARALYZED ON THE LEFT SIDE); This spontaneous report received from a consumer concerned a 84 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: Unknown) dose was not reported, 1 total administered on 08-APR-2021 17:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient had a massive stroke and got paralyzed on the left side (arm and leg). The patient was admitted to the hospital on the morning of 10-APR-2021 and was still in the hospital at the time of this report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from massive stroke(paralyzed on the left side). This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210422228-Covid-19 vaccine ad26.cov2.s -Massive 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.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Seizure
Clinical narrative: SHAKING/DIZZY/IMBALANCE/DISORIENTED/CONVULSION; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the patient experienced shaking/dizzy/imbalance/disoriented/convulsion and chills. After about 48 hours later the patient reported that the adverse event did not get resolved and in addition the patient felt dizzy, experienced imbalance and disoriented. Through call it was not possible to provide medical advice for which he was upset and he was asked to get in touch with local HCP.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and shaking/dizzy/imbalance/disoriented/convulsion. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422232-covid-19 vaccine ad26.cov2.s -CONVULSION. 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: U
Vaccine: COVID19
Symptoms: Nephrotic syndrome, Protein urine, Swelling
Clinical narrative: NEPHROTIC SYNDROME; SWELLING; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included minimal change disease, diagnosed in 2009 and was in remission since 2015. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin were not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021, soon after vaccination, the patient experienced swelling. Approximately 4 weeks later, patient experienced nephrotic syndrome with 5 grams of protein in urine. The patient believed that vaccine triggered the relapse. On 12-APR-2021, patient visited the nephrologist who agreed that vaccine might have been the cause of relapse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nephrotic syndrome and swelling was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210422260-covid-19 vaccine ad26.cov2. s-nephrotic syndrome. 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
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, SARS-CoV-2 antibody test, Suspected COVID-19
Clinical narrative: MILD FEVER; HEADACHE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no medical history and no known drug allergies. 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 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) positive. On 09-APR-2021, the subject experienced suspected covid-19 infection. On an unspecified date, the subject experienced mild fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild fever, and headache, and had not recovered from suspected covid-19 infection. This report was non-serious. The suspected product quality complaint has been confirmed to be the patient received the vaccine on (03/15/2021) and had a positive . covid-19 test on (04/07/2021) with (23) 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. this record was considered as void. 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.
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked 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).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye contusion, Face injury, Fall, Fatigue
Clinical narrative: DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked 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).
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Head injury, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked 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).
Sex: F
Vaccine: COVID19
Symptoms: Lip injury, Loss of consciousness, Nausea, Ocular hyperaemia, Skin haemorrhage
Clinical narrative: DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked 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).
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; 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) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked 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).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: INJECTION SITE PAIN; SUSPECTED COVD-19 INFECTION; 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced suspected covd-19 infection. On 08-APR-2021, the subject experienced injection site pain. On 11-APR-2021, Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 11-APR-2021, and the outcome of suspected covd-19 infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Migraine, Mobility decreased
Clinical narrative: IMMOBILE IN BED WITH ICING; MIGRAINES; UNABLE TO WALK; RIGHT HIP PAIN; This spontaneous report received from a patient 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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, the subject experienced immobile in bed with icing, migraines, unable to walk, and right hip pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the right hip pain, migraines, immobile in bed with icing and unable to walk was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Fatigue, Hypersensitivity, Muscle spasms, Oral mucosal blistering
Clinical narrative: HEAVY BLISTER ON THROAT; HEAVY BLISTER ON MOUTH; HEAVY BLISTER ON SKIN; CRAMPS; SHAKES; FATIGUE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerning himself, a 75 year white old male patient. Initial information was received on 10-APR-2021 and processed with additional information received on 12-APR-2021 from the patient's son in law. The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 041A21A,  expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 between 1130am and 2.30pm for prophylactic vaccination. Vaccination site was not reported. No concomitant medications were reported.  On 09-APR-2021, the patient was admitted to the ER for an allergic reaction and variety of symptoms included fatigue, cramps, shakes, heavy blisters on skin, inside mouth, and throat. ER doctor mentioned that the appearance of symptoms were similar to Steven Johnson's syndrome but patient was not formerly diagnosed. Patient was discharged on 10-APR-2021 with steroids for the blisters.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events heavy blister on throat, mouth, and skin, cramps, shakes, fatigue, and allergic reaction was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210422654- Covid-19 vaccine ad26.cov2.s-Throat Blister, Blistering in mouth, Blister, cramps, shakes. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210422654-covid-19 vaccine ad26.cov2.s Fatigue and Allergic reaction. These events are labeled per RSI and are therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal blistering, Tremor
Clinical narrative: HEAVY BLISTER ON THROAT; HEAVY BLISTER ON MOUTH; HEAVY BLISTER ON SKIN; CRAMPS; SHAKES; FATIGUE; ALLERGIC REACTION; This spontaneous report received from a patient via a company representative concerning himself, a 75 year white old male patient. Initial information was received on 10-APR-2021 and processed with additional information received on 12-APR-2021 from the patient's son in law. The patient's weight, height, and medical history were not reported.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 041A21A,  expiry: 21-JUN-2021) dose was not reported, administered on 08-APR-2021 between 1130am and 2.30pm for prophylactic vaccination. Vaccination site was not reported. No concomitant medications were reported.  On 09-APR-2021, the patient was admitted to the ER for an allergic reaction and variety of symptoms included fatigue, cramps, shakes, heavy blisters on skin, inside mouth, and throat. ER doctor mentioned that the appearance of symptoms were similar to Steven Johnson's syndrome but patient was not formerly diagnosed. Patient was discharged on 10-APR-2021 with steroids for the blisters.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of events heavy blister on throat, mouth, and skin, cramps, shakes, fatigue, and allergic reaction was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210422654- Covid-19 vaccine ad26.cov2.s-Throat Blister, Blistering in mouth, Blister, cramps, shakes. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210422654-covid-19 vaccine ad26.cov2.s Fatigue and Allergic reaction. These events are labeled per RSI and are therefore considered potentially related.