chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Photosensitivity reaction, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; HEAD AND NECK HOT; SENSITIVITY TO LIGHT; This spontaneous report received from a patient concerned a 44 year old female of unknown ethnicity. The patient's weight was 140 pounds, and height was 64 inches. The patient's concurrent conditions included alcohol user(socially), and non smoker. The patient had no known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 04-AUG-2021 patient was working with her boss all day, and went into client doctors offices. On 05-AUG-2021 patient had experienced headache, chills, body aches, runny nose, sore throat, sensitivity to light, fatigue, and while she had no fever, her head and neck were hot. On 07-AUG-2021 patient had test positive for COVID-19 (Suspected clinical vaccination failure). Patient had not informed her health care provider. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, suspected clinical vaccine failure, head and neck hot and sensitivity to light was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000189143.; Sender's Comments: V0:20210818569- covid-19 vaccine ad26.cov2.s-Suspected Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT UNDER 18 YRS AT TIME OF VACCINATION
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: PT UNDER 18 YRS AT TIME OF VACCINATION
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bone pain, Dizziness, Hypoaesthesia, Joint swelling, Nausea
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, X-ray normal
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Joint swelling, Malaise, Nausea, Pain in extremity, Skin discolouration
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: pt received flu vaccine one  3-11-2021day prior to  covid-19 vaccine  3-12-2021 per her report given through the military pt presented to my office 8-2-2021 relating after her covid 19 vaccine ( this was her second dose) she had 2 week history of malaise, followed by numbness in her hands and pain in hands in wrists accompanied by swelling in wrists and discoloration of fingers,  associated nausea and vomitting with the joint pain , she complains of brain fog and headaches since her immunizations
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood electrolytes normal, Computerised tomogram normal, Dysphagia
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Fall, Full blood count normal, Headache, International normalised ratio normal
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Liver function test normal, Lumbar puncture, Magnetic resonance imaging head, Metabolic function test normal, Mobility decreased
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Neck pain, Paraesthesia, Prothrombin level normal, Pyuria, Scan with contrast
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Speech disorder, Spinal pain, Urine analysis abnormal
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Diagnostic procedure, Endotracheal intubation, Guillain-Barre syndrome, Miller Fisher syndrome
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pneumonia, Respiratory failure
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Death, Guillain-Barre syndrome, Infection, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: 28 days post injection developed Guillain-Barre  syndrome which she ultimately died from due to infectious complications.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Allergy to vaccine, Aspartate aminotransferase increased, Condition aggravated, Contusion
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Immunoglobulin therapy, Laboratory test normal, Leukopenia, Parasitic blood test negative
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Platelet transfusion, Thrombocytopenia, Transaminases increased
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Contusion, Petechiae, Platelet count decreased
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet transfusion, Ultrasound scan
Clinical narrative: Petechiae, easy bad bruising, severe low levels ( less than 10)  of platelets began approximately 1-2 weeks after vaccine.  Hospitilized for 5 days.  Received countless platelet & hemo-globin infusions along with multiple steroids.  Currently under multiple physician care.   Team of doctors agreed it was related to the antibodies from the Pfizer vaccine attacking my platelets.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Platelet count decreased, Thrombocytopenia
Clinical narrative: LOW PLATELETS; CONGESTION; LOWER ABDOMINAL PAIN; HIGH WBC; BRUISED EASILY; NOT FEEL WELL; FEELING TIRED; SLIGHT FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported,1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in FEB-2021, the patient got an annual blood work done that showed normal platelets at around 217. On 02-APR-2021, after getting the vaccine the patient only had slight fever for about 24 hours. Around 21-APR-2021, patient began to not feel well and went to the emergency room (ER). The patient got tired and bruised easily. Bruising was most obvious at spots where bloodwork was done. When patient was in the hospital, platelets were normal (190) but WBC (white blood cell) count was high (13.9). Later, the WBC came down to normal. The physician then noticed an abnormally low platelet count. The tiredness and low platelets still occurred. Some congestion and lower abdominal pain also started around the same time, but both went away in about 7 to 10 days. On an unspecified date in JUN-2021, platelets were averaging around 75, but on an unspecified date in JUL-2021, it increased a little to 78. The patient was currently seeing hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from congestion, and lower abdominal pain on 01-MAY-2021, high wbc on 21-APR-2021, and slight fever on 03-APR-2021, had not recovered from feeling tired, bruised easily, and low platelets, and the outcome of not feel well was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801868-Covid-19 vaccine ad26.cov2.s-Low platelets. 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain lower, Contusion, Fatigue, Malaise, Platelet count
Clinical narrative: LOW PLATELETS; CONGESTION; LOWER ABDOMINAL PAIN; HIGH WBC; BRUISED EASILY; NOT FEEL WELL; FEELING TIRED; SLIGHT FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported,1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in FEB-2021, the patient got an annual blood work done that showed normal platelets at around 217. On 02-APR-2021, after getting the vaccine the patient only had slight fever for about 24 hours. Around 21-APR-2021, patient began to not feel well and went to the emergency room (ER). The patient got tired and bruised easily. Bruising was most obvious at spots where bloodwork was done. When patient was in the hospital, platelets were normal (190) but WBC (white blood cell) count was high (13.9). Later, the WBC came down to normal. The physician then noticed an abnormally low platelet count. The tiredness and low platelets still occurred. Some congestion and lower abdominal pain also started around the same time, but both went away in about 7 to 10 days. On an unspecified date in JUN-2021, platelets were averaging around 75, but on an unspecified date in JUL-2021, it increased a little to 78. The patient was currently seeing hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from congestion, and lower abdominal pain on 01-MAY-2021, high wbc on 21-APR-2021, and slight fever on 03-APR-2021, had not recovered from feeling tired, bruised easily, and low platelets, and the outcome of not feel well was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801868-Covid-19 vaccine ad26.cov2.s-Low platelets. 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: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Platelet count decreased, Pyrexia, Sinus congestion, White blood cell count, White blood cell count increased
Clinical narrative: LOW PLATELETS; CONGESTION; LOWER ABDOMINAL PAIN; HIGH WBC; BRUISED EASILY; NOT FEEL WELL; FEELING TIRED; SLIGHT FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 19-SEP-2021) dose was not reported,1 total administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in FEB-2021, the patient got an annual blood work done that showed normal platelets at around 217. On 02-APR-2021, after getting the vaccine the patient only had slight fever for about 24 hours. Around 21-APR-2021, patient began to not feel well and went to the emergency room (ER). The patient got tired and bruised easily. Bruising was most obvious at spots where bloodwork was done. When patient was in the hospital, platelets were normal (190) but WBC (white blood cell) count was high (13.9). Later, the WBC came down to normal. The physician then noticed an abnormally low platelet count. The tiredness and low platelets still occurred. Some congestion and lower abdominal pain also started around the same time, but both went away in about 7 to 10 days. On an unspecified date in JUN-2021, platelets were averaging around 75, but on an unspecified date in JUL-2021, it increased a little to 78. The patient was currently seeing hematologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from congestion, and lower abdominal pain on 01-MAY-2021, high wbc on 21-APR-2021, and slight fever on 03-APR-2021, had not recovered from feeling tired, bruised easily, and low platelets, and the outcome of not feel well was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801868-Covid-19 vaccine ad26.cov2.s-Low platelets. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Neuralgia, Pain, Pain of skin
Clinical narrative: has developed another a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2021, 11 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Reporter was the patient himself. The patient received the 1st Shingrix vaccine in left arm and on next day he experienced fever at 5 pm and resolved at 3 am on 25th July 2021 but developed another fever on the day of reporting and was not sure what was the body temperature. On the day of reporting, the patient had a third appointment to see the health care professional. The reporter did not consent to follow-up and did not give permission to contact HCP. This case was linked with case US2021165569, 1st episode of fever, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165569:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Axillary pain, Back pain, Breast pain, Herpes zoster, Pain
Clinical narrative: has developed another a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2021, 11 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Reporter was the patient himself. The patient received the 1st Shingrix vaccine in left arm and on next day he experienced fever at 5 pm and resolved at 3 am on 25th July 2021 but developed another fever on the day of reporting and was not sure what was the body temperature. On the day of reporting, the patient had a third appointment to see the health care professional. The reporter did not consent to follow-up and did not give permission to contact HCP. This case was linked with case US2021165569, 1st episode of fever, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165569:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: has developed another a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2021, 11 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Reporter was the patient himself. The patient received the 1st Shingrix vaccine in left arm and on next day he experienced fever at 5 pm and resolved at 3 am on 25th July 2021 but developed another fever on the day of reporting and was not sure what was the body temperature. On the day of reporting, the patient had a third appointment to see the health care professional. The reporter did not consent to follow-up and did not give permission to contact HCP. This case was linked with case US2021165569, 1st episode of fever, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165569:same patient/reporter
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: has developed another a fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd August 2021, 11 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details provided were as follows: Reporter was the patient himself. The patient received the 1st Shingrix vaccine in left arm and on next day he experienced fever at 5 pm and resolved at 3 am on 25th July 2021 but developed another fever on the day of reporting and was not sure what was the body temperature. On the day of reporting, the patient had a third appointment to see the health care professional. The reporter did not consent to follow-up and did not give permission to contact HCP. This case was linked with case US2021165569, 1st episode of fever, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165569:same patient/reporter
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Pt complained of dizziness approximately 5 minutes after injection. Patient laid down and was given a cool towel for her forehead. Symptoms resolved 10 min later.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coma, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Chest discomfort for two weeks leading up to Coronary Artery Dissection causing heart attack and 9 days in a coma.  LAD Dissection was repaired by Stent. Total hospital stay was around 28 days.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial repair, Chest discomfort, Coma, Coronary arterial stent insertion, Coronary artery dissection
Clinical narrative: Chest discomfort for two weeks leading up to Coronary Artery Dissection causing heart attack and 9 days in a coma.  LAD Dissection was repaired by Stent. Total hospital stay was around 28 days.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: Chest discomfort for two weeks leading up to Coronary Artery Dissection causing heart attack and 9 days in a coma.  LAD Dissection was repaired by Stent. Total hospital stay was around 28 days.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Fall, Loss of consciousness, Syncope
Clinical narrative: Pt was at Pharmacy on 8/7/21 and received her covid vaccine. Per pharmacist, she fainted but dad was there with her comforting her. She was kept in the waiting room 30 minutes at Pharmacy to monitor her and then was released.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tension, Urinary incontinence
Clinical narrative: Pt was at Pharmacy on 8/7/21 and received her covid vaccine. Per pharmacist, she fainted but dad was there with her comforting her. She was kept in the waiting room 30 minutes at Pharmacy to monitor her and then was released.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Pt was at Pharmacy on 8/7/21 and received her covid vaccine. Per pharmacist, she fainted but dad was there with her comforting her. She was kept in the waiting room 30 minutes at Pharmacy to monitor her and then was released.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Ear pain, SARS-CoV-2 test positive
Clinical narrative: SEVERE EAR ACHE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FELT CLOUDY (FOGGY); NAUSEA; This spontaneous report received from a patient concerned a 41 year old female. Initial information was processed with the additional information received on 09-AUG-2021. The patient's height, and weight were not reported. The patient's past medical history included: melanoma 2 years ago for which she was treated with surgery and was under watch, and concurrent conditions included: penicillin allergy (rash when was child), social and mild alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient had nausea, and felt cloudy (foggy) which lasted for couple of days and then rectified. On 04-AUG-2021, she had stuffy runny nose, slight fever of low grade and felt tired. On 05-AUG-2021, she got tested in by PCR test and was told that she was positive and had an active case (also given as lack of effect and coded as confirmed COVID-19 infection and confirmed clinical vaccination failure). On 06-AUG-2021, she experienced severe ear ache and contacted the tele-doc and talked to a physician and was given a steroid pack (methylprednisolone). On 07-AUG-2021, the ear ache continued and she called the tele-doc again and they provided her with an antibiotic Z-Pack (azithromycin). On 08-AUG-2021, she had cold-like symptoms and a low grade fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cloudy (foggy), and nausea on 12-APR-2021, was recovering from severe ear ache, had not recovered from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188856.; Sender's Comments: V0: 20210816019-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Ear pain, Feeling abnormal, Nausea, SARS-CoV-2 test
Clinical narrative: SEVERE EAR ACHE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FELT CLOUDY (FOGGY); NAUSEA; This spontaneous report received from a patient concerned a 41 year old female. Initial information was processed with the additional information received on 09-AUG-2021. The patient's height, and weight were not reported. The patient's past medical history included: melanoma 2 years ago for which she was treated with surgery and was under watch, and concurrent conditions included: penicillin allergy (rash when was child), social and mild alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient had nausea, and felt cloudy (foggy) which lasted for couple of days and then rectified. On 04-AUG-2021, she had stuffy runny nose, slight fever of low grade and felt tired. On 05-AUG-2021, she got tested in by PCR test and was told that she was positive and had an active case (also given as lack of effect and coded as confirmed COVID-19 infection and confirmed clinical vaccination failure). On 06-AUG-2021, she experienced severe ear ache and contacted the tele-doc and talked to a physician and was given a steroid pack (methylprednisolone). On 07-AUG-2021, the ear ache continued and she called the tele-doc again and they provided her with an antibiotic Z-Pack (azithromycin). On 08-AUG-2021, she had cold-like symptoms and a low grade fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cloudy (foggy), and nausea on 12-APR-2021, was recovering from severe ear ache, had not recovered from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188856.; Sender's Comments: V0: 20210816019-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: SEVERE EAR ACHE; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FELT CLOUDY (FOGGY); NAUSEA; This spontaneous report received from a patient concerned a 41 year old female. Initial information was processed with the additional information received on 09-AUG-2021. The patient's height, and weight were not reported. The patient's past medical history included: melanoma 2 years ago for which she was treated with surgery and was under watch, and concurrent conditions included: penicillin allergy (rash when was child), social and mild alcohol user, and non-smoker. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 10-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient had nausea, and felt cloudy (foggy) which lasted for couple of days and then rectified. On 04-AUG-2021, she had stuffy runny nose, slight fever of low grade and felt tired. On 05-AUG-2021, she got tested in by PCR test and was told that she was positive and had an active case (also given as lack of effect and coded as confirmed COVID-19 infection and confirmed clinical vaccination failure). On 06-AUG-2021, she experienced severe ear ache and contacted the tele-doc and talked to a physician and was given a steroid pack (methylprednisolone). On 07-AUG-2021, the ear ache continued and she called the tele-doc again and they provided her with an antibiotic Z-Pack (azithromycin). On 08-AUG-2021, she had cold-like symptoms and a low grade fever.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt cloudy (foggy), and nausea on 12-APR-2021, was recovering from severe ear ache, had not recovered from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000188856.; Sender's Comments: V0: 20210816019-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. 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: SPECIAL SITUATIONS
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Brain natriuretic peptide normal, C-reactive protein normal, Chest X-ray normal
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Haematocrit normal, Haemoglobin normal
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Intensive care, Pain, Palpitations, Red blood cell sedimentation rate normal
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Supraventricular extrasystoles, Troponin, Ventricular tachycardia, White blood cell count increased
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Arthralgia, Blood electrolytes normal, Brain natriuretic peptide decreased, C-reactive protein increased
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Cardiac telemetry abnormal, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram ambulatory, Electrocardiogram repolarisation abnormality, Full blood count abnormal
Clinical narrative: Patient noted pain that started on 8/9  initially with some slight discomfort over his sternum accompanied by palpitations. Later that night the pain and palpitations returned, more intense than previous describing it as intense sharp pain over his heart, sternum, below his heart and radiating up to his L shoulder.  This lasted approx 30 minutes after which his family brought him to the  ED for evaluation. Pt arrived to ED and given the following interventions: Tylenol x2, with Trop elevated at 0.063, EKG: normal sinus rhythm with PAC. Patient was transferred to pediatric floor. Troponin was repeated and downtrending, but still borderline elevated at 0.04. BNP remained low at <10. Cardiology was consulted, EKG repeated (similar to prior) and echo performed (normal). Pt found to have episodic VT on telemetry, decision made to transfer to ICU for closer monitoring.  Pt arrived to ICU and placed on continuous cardiac monitoring with continued palpitations.  His chest pain was mostly resolved upon arrival to the ICU and did not persist aside from some substernal pressure  He was noted to have intermittent PACs and PVCs on telemetry which was confirmed by EKG the following day.  His troponin was checked q12h and downtrended quickly from 0.064 >> 0.04 >> < 0.01 >> 0.01.  His electrolytes were monitored closely and maintained within normal limits to avoid risk of a worsening arrhythmia. Given the amount of ectopy seen on telemetry and his EKG, a cardiac MRI to investigate for myocarditis was not advised by the Cardiology team at this time given the likely amount of unusable data it would produce.  This will be arranged as an outpatient and he will follow up with Cardiology on Monday 8/16. A holter monitor was placed prior to discharge (8/11).