chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; PAIN IN LEFT ARM WHERE PATIENT GOT VACCINE; This spontaneous report received from a patient concerned a 39 year old, white and Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, non alcoholic, and cigarette smoker, and she had no known drug allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 10-MAR-2021 at left arm for prophylactic vaccination. She takes sleep aid at night. On 11-MAR-2021, the patient experienced little pain in the arm where she got the vaccine. On 03-JUN-2021, she got an antibody test done (AC Anti- SARS-COV2 IgG S1-S2 Test). The test result came back negative (her result was 8.36) and the test indicates that anything less than 12 was considered negative (confirmed immunological vaccine failure). The patient consulted 3 different doctors who told her not to worry.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in left arm on 12-MAR-2021, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000181890.  The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed. A manufacturing related root cause could not be identified.; Sender's Comments: V0:20210612013 -COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hunger, Hypoaesthesia, Injection site bruising
Clinical narrative: STARVING IN MORNING; HEAD OR BRAIN FUZZY, FEEL DRUGGED, FEEL WEIRD; DIZZINESS; A PALE YELLOW BRUISE WHERE THE INJECTION WENT IN; DIDN'T FEEL A THING IN THE ARM; MINIMAL ARM SORENESS; SHOT DID HURT A LITTLE WHEN IT WENT IN; This spontaneous report received from a patient concerned an adult of unspecified sex. 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 and batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced shot did hurt a little when it went in. On 04-JUN-2021, the subject experienced starving in morning. On 04-JUN-2021, the subject experienced head or brain fuzzy, feel drugged, feel weird. On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced a pale yellow bruise where the injection went in. On 04-JUN-2021, the subject experienced didn't feel a thing in the arm. On 04-JUN-2021, the subject experienced minimal arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shot did hurt a little when it went in on 03-JUN-2021, and the outcome of starving in morning, dizziness, head or brain fuzzy, feel drugged, feel weird, minimal arm soreness, a pale yellow bruise where the injection went in and didn't feel a thing in the arm was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as Non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: STARVING IN MORNING; HEAD OR BRAIN FUZZY, FEEL DRUGGED, FEEL WEIRD; DIZZINESS; A PALE YELLOW BRUISE WHERE THE INJECTION WENT IN; DIDN'T FEEL A THING IN THE ARM; MINIMAL ARM SORENESS; SHOT DID HURT A LITTLE WHEN IT WENT IN; This spontaneous report received from a patient concerned an adult of unspecified sex. 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 and batch number: 205A21A and expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced shot did hurt a little when it went in. On 04-JUN-2021, the subject experienced starving in morning. On 04-JUN-2021, the subject experienced head or brain fuzzy, feel drugged, feel weird. On 04-JUN-2021, the subject experienced dizziness. On 04-JUN-2021, the subject experienced a pale yellow bruise where the injection went in. On 04-JUN-2021, the subject experienced didn't feel a thing in the arm. On 04-JUN-2021, the subject experienced minimal arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shot did hurt a little when it went in on 03-JUN-2021, and the outcome of starving in morning, dizziness, head or brain fuzzy, feel drugged, feel weird, minimal arm soreness, a pale yellow bruise where the injection went in and didn't feel a thing in the arm was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as Non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test, Therapy non-responder
Clinical narrative: This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included left lobectomy with 20 percent removal of left lung. The patient had no known allergies and was a very healthy individual with a little more risk than the normal person. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAR-2021, the patient had SARS-CoV-2 PCR test which was negative. On 29-MAY-2021, the patient had SARS COVID 2 antibody (Ab) Ig G semi-quantitative test which was negative (confirmed immunological vaccine failure). On 02-JUN-2021, the patient had SARS COVID 2 antibody (Ab) Ig G semi-quantitative tests again and which was negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0-20210613988-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Off label use, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: FEVER; INJECTION SITE PAIN IN LEFT ARM; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an adolescent female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-JUN-2021, the subject experienced product administered to subject of inappropriate age. On 03-JUN-2021, the subject experienced off label use. On 05-JUN-2021, the subject experienced fever. On 05-JUN-2021, the subject experienced injection site pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, injection site pain in left arm, product administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SICK WITH SOME SYMPTOMS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced sick with some symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick with some symptoms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Body temperature, Dyspnoea, Pyrexia
Clinical narrative: BREATHING DIFFICULTIES; UNSPECIFIED SIDE EFFECTS; FEVER MORE THAN 103 FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and other pre-existing medical conditions included it is unknown the patient had drug abuse or illicit drug usage, consumption of alcohol and smoking.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) 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 breathing difficulties, unspecified side effects, and fever more than 103 for 3 days. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) more than 103 (103+). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever more than 103 for 3 days, breathing difficulties and unspecified side effects was not reported. This report was non-serious.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Decreased appetite, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Positive covid test; shortness of breathe; diarrhea; no eating; tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive covid test) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired). The patient was hospitalized from 17-Feb-2021 to 21-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive covid test), DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Positive covid test; shortness of breathe; diarrhea; no eating; tired; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive covid test) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired). The patient was hospitalized from 17-Feb-2021 to 21-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Positive covid test), DYSPNOEA (shortness of breathe), DIARRHOEA (diarrhea), DECREASED APPETITE (no eating) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Pain in extremity
Clinical narrative: Dull pain in heart; Left arm hurt a bit; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Dull pain in heart) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced ANGINA PECTORIS (Dull pain in heart) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Left arm hurt a bit). At the time of the report, ANGINA PECTORIS (Dull pain in heart) and PAIN IN EXTREMITY (Left arm hurt a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Colonoscopy, Crohn's disease
Clinical narrative: Crohns disease flare up; This spontaneous case was reported by a physician and describes the occurrence of CROHN'S DISEASE (Crohns disease flare up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a day. On an unknown date, the patient experienced CROHN'S DISEASE (Crohns disease flare up) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (Crohns disease flare up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: inconclusive (Inconclusive) reports not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided. Action taken with mRNA 1273 in response to event was not applicable.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, flares are inherent to the nature of the underlying Crohn's disease.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  However, flares are inherent to the nature of the underlying Crohn's disease.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Loss of consciousness, Somnolence
Clinical narrative: Rolls over in bed it feels like he is going to pass out even though he is lying down; Sleep over a whole day, for more than 24 hours; Severe fatigue; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV infection.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down) (seriousness criterion medically significant), SOMNOLENCE (Sleep over a whole day, for more than 24 hours) and FATIGUE (Severe fatigue). At the time of the report, LOSS OF CONSCIOUSNESS (Rolls over in bed it feels like he is going to pass out even though he is lying down), SOMNOLENCE (Sleep over a whole day, for more than 24 hours) and FATIGUE (Severe fatigue) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Pain, Pain in extremity, Skin warm
Clinical narrative: pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid; radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth; Initial information received on 02-Jun-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 47 year old female patient who experienced pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth (pain) and (inflammation), while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 28-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot U6855AA and expiry date: 25-Nov-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On 02-JUN-2021, the patient developed a non-serious pain about an inch away from the injection site, radiating from the left upper deltoid to the lower deltoid, with inflammation and warmth (pain) and (inflammation), five days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported that the caller is calling on behalf of the patient who received the ADACEL vaccine on Sunday. The caller stated that the patient had pain not at the injection site, but an inch away from it. The pain travels from tricep to bicep and wanted to know if this was normal. That is the only description that was received. Reporter relationship: health care professional (HCP) Product used: used still using product: no  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was reported as unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Blood lactic acid, Body temperature increased, Chest X-ray abnormal
Clinical narrative: Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head normal, Confusional state, Culture urine negative, Dehydration, Diastolic dysfunction
Clinical narrative: Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Interstitial lung disease, Lactic acidosis, Left atrial dilatation
Clinical narrative: Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, Malaise, Nausea, Pulmonary oedema, Sepsis
Clinical narrative: Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Back pain, Blood test, Dysstasia, Gait disturbance
Clinical narrative: I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Intervertebral disc protrusion, Nerve compression, Pain, Pain in extremity
Clinical narrative: I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I woke up with terrible lower back pain and shooting pains in legs. I had difficulty and extreme pain standing and walking. Doctor's examination revealed inflammation of lower back around spine. X-rays revealed arthritis in lower back and minor disc slippage/bulging, as expected for age. Since no back injury or strain, Doctor diagnosed it as probable immune system going into over-drive due to vaccine and attacking lower back arthritis resulting in inflammation and pinched nerves. Treatment was muscle relaxers for a few days and Physical Therapy for lower back. Cleared sufficiently in 2 weeks to get second dose of vaccine on time, with no problem.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: G51.0 - Bell's palsy
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Electrocardiogram, Facial paresis
Clinical narrative: G51.0 - Bell's palsy
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Neurological symptom
Clinical narrative: G51.0 - Bell's palsy
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: G61.0 - Guillain-Barre syndrome
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Diarrhoea, Pulse absent, Unresponsive to stimuli
Clinical narrative: Went unresponsive at home after experiencing diarrhea.  Pulses were lost at home and regained by EMS prior to transport to the emergency room.  Pulses lost again in the emergency room.  ACLS performed for approximately 40 minutes before pronouncement of death was made.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: swollen lymph node in armpit Low grade fever Chills Sore joints Muscle ache Fatigue
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: swollen lymph node in armpit Low grade fever Chills Sore joints Muscle ache Fatigue
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac function test, Palpitations
Clinical narrative: Heart palpitations two weeks post vaccine and lasting for six to eight weeks.  Full cardiac work up done with no major findings.  EF at 65% and mild valve issues noted on 2D.  Symptoms have somewhat stabilized at this time but I still have irregular heart beats.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute kidney injury, Thrombocytopenia
Clinical narrative: N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Night sweats, Rhinorrhoea
Clinical narrative: HEADACHE, CHILLS, NIGHT SWEATS, RUNNY NOSE, TEMPERATURE
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Total body/joint aching and fever for 36 hours
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abortion threatened, Vaginal haemorrhage
Clinical narrative: O20.0 - Threatened abortion "HREATENED MISCARRIAGE ABDOMINAL CRAMPING VAGINAL BLEEDING - PREGNANT
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Swollen tongue
Clinical narrative: Patient states that she is having numbness to face.  Feels like tongue is swollen.  Reports stiffness to neck.  Patient instructed to massage area.  Patient reports symptoms no longer persist.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion induced, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: 16 week Anatomy scan showed crembrem hyplasia amnd fluid in ventricles  that resulted in pregnancy termination
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Angiogram cerebral normal, Anticoagulant therapy, Aphasia, Arteriogram carotid normal
Clinical narrative: Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative.  Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head normal, Facial paralysis, Fall, Full blood count abnormal
Clinical narrative: Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative.  Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Hemiparesis, Hyponatraemia, Low density lipoprotein normal, Lymphocyte count decreased
Clinical narrative: Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative.  Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head normal, Metabolic function test normal, NIH stroke scale score increased, SARS-CoV-2 test negative, Troponin
Clinical narrative: Pt had her 2nd covid 19 vaccine on 5/4/21 and was admitted to the hospital with an acute cryptogenic stroke on 5/28/21 with sudden R sided facial droop with NIHSS of 6, R sided weakness, expressive aphasia and was given TPA as ct head was neg for hemorrhage. CTA head and neck negative for any stenosis, ldl was 74, follow up mri brain post TPA was negative.  Pt also had hyponatremia on admit of which was corrected by discharge. She also fell pta and was admitted with a colles fracture which was reduced at the bedside by orthopedics and casted. She was admitted from 5/28-5/31 and discharged home with her family.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Electrocardiogram, Heart rate increased, Myocardial necrosis marker, Palpitations
Clinical narrative: Heart palpatations, rapid beat,dehadration,
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Heart palpatations, rapid beat,dehadration,
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: 3 days after 2nd dose Ic started having pain in left side of chest which got stronger
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Body temperature increased, Headache, Influenza like illness
Clinical narrative: Flu like symptoms, injection site tenderness, muscle and joint ache, head ache, temperature 99.9, general weakness.  Symptoms began 10 hours following injection and lasted approximately 36 hours, full recovery in 48 hours.  Treatment: ibuprofen and acetaminophen.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia
Clinical narrative: Flu like symptoms, injection site tenderness, muscle and joint ache, head ache, temperature 99.9, general weakness.  Symptoms began 10 hours following injection and lasted approximately 36 hours, full recovery in 48 hours.  Treatment: ibuprofen and acetaminophen.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Parosmia
Clinical narrative: Racing heart rate, dizziness from this symptoms. Smoke smell, which I continue to smell to even now as I type this note.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Blood thyroid stimulating hormone normal, C-reactive protein normal, Chest X-ray normal
Clinical narrative: Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermittent palpitations which came and went  before they persisted with associated near syncope prompting him to come to the emergency room on 6/1/21 where he was diagnosed and admitted with new onset rapid atrial fibrillation. He has no history of sleep apnea, does not drink alcohol, his tsh was normal, troponins were normal, cardiac crp was normal, d dimer was neg and PE was ruled out. he was started on metoprolol and eliquis and broke to sinus rhythm. echo was normal with no atrial enlargement and normal ejection fraction, no valvular disease, chest x ray normal, cmp and cbc normal. He was discharged home on 6/2/21. He will need follow up with cardiology.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram normal, Ejection fraction normal, Fibrin D dimer normal, Full blood count normal, Metabolic function test
Clinical narrative: Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermittent palpitations which came and went  before they persisted with associated near syncope prompting him to come to the emergency room on 6/1/21 where he was diagnosed and admitted with new onset rapid atrial fibrillation. He has no history of sleep apnea, does not drink alcohol, his tsh was normal, troponins were normal, cardiac crp was normal, d dimer was neg and PE was ruled out. he was started on metoprolol and eliquis and broke to sinus rhythm. echo was normal with no atrial enlargement and normal ejection fraction, no valvular disease, chest x ray normal, cmp and cbc normal. He was discharged home on 6/2/21. He will need follow up with cardiology.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test normal, Palpitations, Presyncope, Sinus rhythm, Troponin normal
Clinical narrative: Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermittent palpitations which came and went  before they persisted with associated near syncope prompting him to come to the emergency room on 6/1/21 where he was diagnosed and admitted with new onset rapid atrial fibrillation. He has no history of sleep apnea, does not drink alcohol, his tsh was normal, troponins were normal, cardiac crp was normal, d dimer was neg and PE was ruled out. he was started on metoprolol and eliquis and broke to sinus rhythm. echo was normal with no atrial enlargement and normal ejection fraction, no valvular disease, chest x ray normal, cmp and cbc normal. He was discharged home on 6/2/21. He will need follow up with cardiology.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test normal, Erythema, Nasal congestion, Rash
Clinical narrative: Red hot right ear, red rash right cheek, right nostril side completed blocked, severe vertigo , disequilibrium, wavy imbalance feeling
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin warm, Vertigo
Clinical narrative: Red hot right ear, red rash right cheek, right nostril side completed blocked, severe vertigo , disequilibrium, wavy imbalance feeling
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Visual impairment
Clinical narrative: Patient reported that an hour or two after receiving second dose of Moderna vaccine, he had excrutiating pain on the left side of his skull and vision problems. He has been seen by his PCP for follow-up and other causes of symptoms are being investigted.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspepsia, Headache, Lethargy, Pyrexia
Clinical narrative: Severe heartburn, headache, chills, fever, lethargy
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site rash, Palpitations
Clinical narrative: Extreme headache, tired, tingles all over, dizziness, palpitations, rash on arm by injection site, rash is spreading
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Extreme headache, tired, tingles all over, dizziness, palpitations, rash on arm by injection site, rash is spreading
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Persistent soreness  and pain in left upper arm, continuing to date (2 1/2 months after vaccination)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Systemic: swelling in both feet and ankles-Medium, Additional Details: Patient reported swelling of the feet and ankles at around 9pm the night of vaccination. Patient has since recovered since then and reported the event the following day.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Head injury, Hypotension, Injection site pain, Pallor
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel.  Pt got up immediately and sat back on the chair.  Pt was pale but allert and responsive.  After drinking some water and extended observation time, pt was able to walk away.  EMT was called but pt refused service.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Hypotension-Mild, Additional Details: Pt was sitting on chair in the observation area and he fell over hitting his head on the side panel.  Pt got up immediately and sat back on the chair.  Pt was pale but allert and responsive.  After drinking some water and extended observation time, pt was able to walk away.  EMT was called but pt refused service.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain at injection site, warm to touch, extremely tender and sore. Increased breathing difficulty, fever, fatigue,
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Swelling, redness, pain at injection site, warm to touch, extremely tender and sore. Increased breathing difficulty, fever, fatigue,
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Mobility decreased, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Joint Pain-Mild, Additional Details: Pt claimed that after 6 days after vaccination, his left arm is still sore when moved.  He also claimed that he is limited mobility of his left arm due to the vaccine with out feeling some level of pain.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt did not have breakfast before her shot at 11am. She got the shot and sit down. Mom came over and said her daughter passed out. Rph and techs rushed over. We laid her down to the floor and call emergency number. After a few minutes, she wake up and feel better. Mom said thank you and took her to eat.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea
Clinical narrative: Client was feeling al little bit anxious about vaccination symptoms and stating that she was having difficulty breathing.  Pt. instructed on relaxation, breathing techniques.  Pt. fully recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac tamponade, Dyspnoea, Pericardial drainage, Pericardial effusion, Viral pericarditis
Clinical narrative: Patient received 1st dose 2/10/21, 2nd dose on 3/10/2021 She presented to the ED on 4/27 with dyspnea and found to have large pericardial effusion with early tamponade.  Was transferred to hospital and on 4/28 had therapeutic pericardiocentesis.  Started on colchicine for presumed viral/immune pericarditis.  Seen in cardiologist office on 6/9/2021.  Doing wqell with resolution of effusion.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Discomfort, Full blood count
Clinical narrative: Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to upper arm pain. Treating with steroids. Treating with occupational therapy. So far refractory to steroids.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Metabolic function test, Pain in extremity, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: Started out as joint pain and heaviness. Progressed to extreme swelling in both hands. Progressed to upper arm pain. Treating with steroids. Treating with occupational therapy. So far refractory to steroids.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Head discomfort, Headache, Hypoaesthesia, Immediate post-injection reaction, Magnetic resonance imaging head
Clinical narrative: Left foot went numb immediately after vaccine. 5 days later i got a headache with throbbing and pressure and tingling that has lasted 3 weeks and 4 days. No medication helps the headache
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Left foot went numb immediately after vaccine. 5 days later i got a headache with throbbing and pressure and tingling that has lasted 3 weeks and 4 days. No medication helps the headache