chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Concussion, Eating disorder, Fall, Feeling abnormal, Headache
Clinical narrative: Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw up; Concussion; Buzzing in ears; Did not eat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 02-Jun-2021, the patient experienced ASTHENIA (Little weak) and FEELING ABNORMAL (Foggy head). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) (seriousness criterion medically significant), ANXIETY (Anxiety) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out), CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), ASTHENIA (Little weak), FEELING ABNORMAL (Foggy head), ANXIETY (Anxiety), FALL (Fall), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose abnormal: abnormal (abnormal) abnormal. On 01-Jun-2021, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  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.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Tinnitus, Vomiting
Clinical narrative: Woke up on floor/ Past out; Anxiety; Fall; Little weak; Foggy head; Shiver; Headache; Nausea; Throw up; Concussion; Buzzing in ears; Did not eat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 02-Jun-2021, the patient experienced ASTHENIA (Little weak) and FEELING ABNORMAL (Foggy head). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out) (seriousness criterion medically significant), ANXIETY (Anxiety) and FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Woke up on floor/ Past out), CONCUSSION (Concussion), TINNITUS (Buzzing in ears), EATING DISORDER (Did not eat), ASTHENIA (Little weak), FEELING ABNORMAL (Foggy head), ANXIETY (Anxiety), FALL (Fall), CHILLS (Shiver), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Blood glucose abnormal: abnormal (abnormal) abnormal. On 01-Jun-2021, Blood pressure measurement: abnormal (abnormal) abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported .  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.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Chills, Dyspnoea, Gait disturbance, Loss of consciousness
Clinical narrative: worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost weight; has no muscle left; teeth chattering; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe) and LOSS OF CONSCIOUSNESS (passed out/unconscious) in a 44-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.     The patient's past medical history included Intubation (The doctor told him that he would have died if they had not intubated him.) from 14-May-2021 to 21-May-2021. Concurrent medical conditions included Asthma (The patient had asthma since childhood.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced ASTHMA (worst asthma attack he had ever had) (seriousness criteria hospitalization prolonged and life threatening), DYSPNOEA (unable to breathe) (seriousness criteria hospitalization prolonged and life threatening), LOSS OF CONSCIOUSNESS (passed out/unconscious) (seriousness criteria hospitalization prolonged, medically significant and life threatening), TREMOR (shaking) and CHILLS (teeth chattering). On an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk), WEIGHT DECREASED (lost weight) and MUSCULAR WEAKNESS (has no muscle left). The patient was hospitalized from 14-May-2021 to 31-May-2021 due to ASTHMA, DYSPNOEA and LOSS OF CONSCIOUSNESS. The patient was treated with Physical therapy for Gait disturbance. On 21-May-2021, LOSS OF CONSCIOUSNESS (passed out/unconscious) had resolved. At the time of the report, ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe), GAIT DISTURBANCE (cannot walk), TREMOR (shaking), WEIGHT DECREASED (lost weight), MUSCULAR WEAKNESS (has no muscle left) and CHILLS (teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included many medications and physical therapy.   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
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Tremor, Weight decreased
Clinical narrative: worst asthma attack he had ever had; unable to breathe; passed out/unconscious; cannot walk; lost weight; has no muscle left; teeth chattering; shaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe) and LOSS OF CONSCIOUSNESS (passed out/unconscious) in a 44-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.     The patient's past medical history included Intubation (The doctor told him that he would have died if they had not intubated him.) from 14-May-2021 to 21-May-2021. Concurrent medical conditions included Asthma (The patient had asthma since childhood.). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALBUTEROL [SALBUTAMOL] for Asthma.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, the patient experienced ASTHMA (worst asthma attack he had ever had) (seriousness criteria hospitalization prolonged and life threatening), DYSPNOEA (unable to breathe) (seriousness criteria hospitalization prolonged and life threatening), LOSS OF CONSCIOUSNESS (passed out/unconscious) (seriousness criteria hospitalization prolonged, medically significant and life threatening), TREMOR (shaking) and CHILLS (teeth chattering). On an unknown date, the patient experienced GAIT DISTURBANCE (cannot walk), WEIGHT DECREASED (lost weight) and MUSCULAR WEAKNESS (has no muscle left). The patient was hospitalized from 14-May-2021 to 31-May-2021 due to ASTHMA, DYSPNOEA and LOSS OF CONSCIOUSNESS. The patient was treated with Physical therapy for Gait disturbance. On 21-May-2021, LOSS OF CONSCIOUSNESS (passed out/unconscious) had resolved. At the time of the report, ASTHMA (worst asthma attack he had ever had), DYSPNOEA (unable to breathe), GAIT DISTURBANCE (cannot walk), TREMOR (shaking), WEIGHT DECREASED (lost weight), MUSCULAR WEAKNESS (has no muscle left) and CHILLS (teeth chattering) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included many medications and physical therapy.   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
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Transfusion, Ulcer haemorrhage
Clinical narrative: Massive bleeding ulcer, not related to vaccine; Blood Transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Quinolones).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) (seriousness criterion medically significant) and TRANSFUSION (Blood Transfusion). At the time of the report, ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) and TRANSFUSION (Blood Transfusion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) and TRANSFUSION (Blood Transfusion) to be not related.    No concomitant medication was not given. No treatment information was not given.  Treatment included Blood Transfusion.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Electrocardiogram, Hypertension, Muscle spasms
Clinical narrative: diagnosed with hypertension; muscle cramps and spasms all over her body; pain in joints/persisted in hands, feet and knees; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (diagnosed with hypertension) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023c21a and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (diagnosed with hypertension) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees). At the time of the report, HYPERTENSION (diagnosed with hypertension), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 192/99 (High) Highest and 150-160 (High) averaging 150-160 after medication. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.         No concomitant medication was provided.  Patient explains that shortly after getting the second dose, she started having muscle cramps and spasm all over her body.  She called her doctor who advised her to drink more water.  The muscle cramps and spasms continued even after drinking more water.  Then a week or so after that, she noticed pain in her joints.  This also persisted in her hands, feet and knees.  She was seen by a doctor who also checked her blood pressure and noticed it was high and sent her to the hospital.  She was not admitted but they ran tests, EKG and XRay, which came back normal.  She was diagnosed with hypertension.    Patient was prescribed a medication for her HBP but says the highest its been was 192/99 and after medication it is averaging 150-160.  Prescribed treatment medication was not reported.  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.   Reporter did not allow further contact; 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.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: diagnosed with hypertension; muscle cramps and spasms all over her body; pain in joints/persisted in hands, feet and knees; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (diagnosed with hypertension) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023c21a and 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (diagnosed with hypertension) (seriousness criterion medically significant), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees). At the time of the report, HYPERTENSION (diagnosed with hypertension), MUSCLE SPASMS (muscle cramps and spasms all over her body) and ARTHRALGIA (pain in joints/persisted in hands, feet and knees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 192/99 (High) Highest and 150-160 (High) averaging 150-160 after medication. On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, X-ray: normal (normal) normal.         No concomitant medication was provided.  Patient explains that shortly after getting the second dose, she started having muscle cramps and spasm all over her body.  She called her doctor who advised her to drink more water.  The muscle cramps and spasms continued even after drinking more water.  Then a week or so after that, she noticed pain in her joints.  This also persisted in her hands, feet and knees.  She was seen by a doctor who also checked her blood pressure and noticed it was high and sent her to the hospital.  She was not admitted but they ran tests, EKG and XRay, which came back normal.  She was diagnosed with hypertension.    Patient was prescribed a medication for her HBP but says the highest its been was 192/99 and after medication it is averaging 150-160.  Prescribed treatment medication was not reported.  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.   Reporter did not allow further contact; 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: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Stroke; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Blood clot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant) and THROMBOSIS (Blood clot) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and THROMBOSIS (Blood clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided.  No laboratory data was provided. No treatment information was provided.  The patient did not have any family history of stroke.  The patient received the vaccine 3 months prior to AEs.  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.   Reporter did not allow further contact; 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Bronchitis, Influenza like illness, Mental impairment, Personality change
Clinical narrative: Loss of memory; Difficulty answering questions; Bronchitis; Major personality change; Flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions), BRONCHITIS (Bronchitis) and PERSONALITY CHANGE (Major personality change) in a 63-year-old female 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced AMNESIA (Loss of memory) (seriousness criterion hospitalization), MENTAL IMPAIRMENT (Difficulty answering questions) (seriousness criteria hospitalization and medically significant), BRONCHITIS (Bronchitis) (seriousness criterion hospitalization) and PERSONALITY CHANGE (Major personality change) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was hospitalized on sometime in April 2021 due to AMNESIA, BRONCHITIS, MENTAL IMPAIRMENT and PERSONALITY CHANGE. At the time of the report, AMNESIA (Loss of memory), MENTAL IMPAIRMENT (Difficulty answering questions) and PERSONALITY CHANGE (Major personality change) had not resolved and BRONCHITIS (Bronchitis) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not reported. The patient received her first shot in early April 2021. She could not remember the exact date or lot number. Within a few minutes, the vaccination provider noticed that the patient had a major personality change, loss of memory, and difficulty answering questions. The patient was sent to the hospital because of this. While there, they informed her that she had bronchitis. The hospital sent her home and the patient was asked to monitor herself for three days. The patient's mental symptoms were reported as still ongoing. The patient also mentioned that she experienced two weeks of flu-like symptoms.  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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Death, Pain
Clinical narrative: loss sense of taste; Lost sense of smell; pain in body; chills; Patient died; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills). The patient died on 06-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, AGEUSIA (loss sense of taste), ANOSMIA (Lost sense of smell), PAIN (pain in body) and CHILLS (chills) was resolving.            Concomitant medications were not reported.  No treatment information was provided.  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.   This case was linked to MOD-2021-201255 (Patient Link).; 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.; Reported Cause(s) of Death: unknown casue of death
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bone tuberculosis, Burning sensation, Ear discomfort, Ear pain, Feeling abnormal
Clinical narrative: neuropathy got worse; flare ups of her Pott's disease; faint; severe jaw pain; tailbone burning really bad; felt really off; ear pain; ear pressure; heart palpitations; migraine; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease) and SYNCOPE (faint) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX), VITAMINS NOS and GABAPENTIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy got worse) (seriousness criterion medically significant), BONE TUBERCULOSIS (flare ups of her Pott's disease) (seriousness criterion medically significant), SYNCOPE (faint) (seriousness criterion medically significant), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease), SYNCOPE (faint), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was 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.   This case was linked to MOD-2021-201988 (Patient Link).; 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Neuropathy peripheral, Pain in jaw, Palpitations
Clinical narrative: neuropathy got worse; flare ups of her Pott's disease; faint; severe jaw pain; tailbone burning really bad; felt really off; ear pain; ear pressure; heart palpitations; migraine; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease) and SYNCOPE (faint) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX), VITAMINS NOS and GABAPENTIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy got worse) (seriousness criterion medically significant), BONE TUBERCULOSIS (flare ups of her Pott's disease) (seriousness criterion medically significant), SYNCOPE (faint) (seriousness criterion medically significant), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease), SYNCOPE (faint), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was 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.   This case was linked to MOD-2021-201988 (Patient Link).; 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.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope
Clinical narrative: neuropathy got worse; flare ups of her Pott's disease; faint; severe jaw pain; tailbone burning really bad; felt really off; ear pain; ear pressure; heart palpitations; migraine; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease) and SYNCOPE (faint) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ALPRAZOLAM (XANAX), VITAMINS NOS and GABAPENTIN for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (neuropathy got worse) (seriousness criterion medically significant), BONE TUBERCULOSIS (flare ups of her Pott's disease) (seriousness criterion medically significant), SYNCOPE (faint) (seriousness criterion medically significant), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy got worse), BONE TUBERCULOSIS (flare ups of her Pott's disease), SYNCOPE (faint), PAIN IN JAW (severe jaw pain), BURNING SENSATION (tailbone burning really bad), FEELING ABNORMAL (felt really off), EAR PAIN (ear pain), EAR DISCOMFORT (ear pressure), PALPITATIONS (heart palpitations), MIGRAINE (migraine), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was 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.   This case was linked to MOD-2021-201988 (Patient Link).; 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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Product dose omission issue, Renal disorder, Syncope
Clinical narrative: Renal conditions leading to hospital stay; Fainted due to low Blood Pressure; low Blood Pressure; Missed Second dose Beyond day 36; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder and Blood pressure abnormal.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RENAL DISORDER (Renal conditions leading to hospital stay) (seriousness criterion hospitalization), SYNCOPE (Fainted due to low Blood Pressure) (seriousness criteria hospitalization and medically significant), HYPOTENSION (low Blood Pressure) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36). At the time of the report, RENAL DISORDER (Renal conditions leading to hospital stay), SYNCOPE (Fainted due to low Blood Pressure) and HYPOTENSION (low Blood Pressure) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed Second dose Beyond day 36) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medications as blood thinners, for High Blood Pressure, Insulin and for renal conditions . Treatment information was not provided. Caller also mentioned that her grand mother fainted recently due to low blood pressure.  Company comment:Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension,  a causal relationship cannot be excluded.; Sender's Comments: Causality for the event Missed Second dose is not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events Renal disorder, Syncope and Hypotension,  a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthritis, Arthrogram, Arthroscopy, Haemorrhage
Clinical narrative: Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis, Fibromyalgia and Osteoarthritis.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced ARTHRITIS (arthritis waking up) and PAIN (pain). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip). At the time of the report, HAEMORRHAGE (Bleeding), ARTHRITIS (arthritis waking up), INFLUENZA (Flu) and PAIN (pain) outcome was unknown and ARTHRALGIA (Pain in hip) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Arthrogram: abnormal (abnormal) found blood in it. On an unknown date, Arthroscopy: unknown (Inconclusive) unknown and unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab tests also included Left and right hip arthroscopy but the results were unknown. She got arthrogram of her hip done and there was blood in it and she got injected with an unspecified steroid gel. The patient also underwent a total knee replacement. 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.
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza, Pain
Clinical narrative: Bleeding; Pain in hip; Flu; pain; arthritis waking up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis, Fibromyalgia and Osteoarthritis.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Apr-2021, the patient experienced INFLUENZA (Flu). In April 2021, the patient experienced ARTHRITIS (arthritis waking up) and PAIN (pain). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant) and ARTHRALGIA (Pain in hip). At the time of the report, HAEMORRHAGE (Bleeding), ARTHRITIS (arthritis waking up), INFLUENZA (Flu) and PAIN (pain) outcome was unknown and ARTHRALGIA (Pain in hip) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Arthrogram: abnormal (abnormal) found blood in it. On an unknown date, Arthroscopy: unknown (Inconclusive) unknown and unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Lab tests also included Left and right hip arthroscopy but the results were unknown. She got arthrogram of her hip done and there was blood in it and she got injected with an unspecified steroid gel. The patient also underwent a total knee replacement. 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.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash erythematous, Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson syndrome; Sunburn-like rash; This spontaneous case was reported by a physician and describes the occurrence of STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) (seriousness criterion medically significant) and RASH ERYTHEMATOUS (Sunburn-like rash). At the time of the report, STEVENS-JOHNSON SYNDROME (Stevens Johnson syndrome) and RASH ERYTHEMATOUS (Sunburn-like rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Treatment information was not provided.  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.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Abdominal discomfort, Abdominal pain, Chills, Coccidioidomycosis, Condition aggravated
Clinical narrative: Pulmonary coccidioides; Rheumatoid arthritis flare up; condition aggravated; Patient was on the continuous positive airway pressure machine; arm was sore; weight gain; urinary tract infection; stomach upset; abdominal pain; chills; vomiting; This spontaneous case was reported by a physician and describes the occurrence of COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), URINARY TRACT INFECTION (urinary tract infection), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting). At the time of the report, COCCIDIOIDOMYCOSIS (Pulmonary coccidioides), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications 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.
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Continuous positive airway pressure, Pain in extremity, Rheumatoid arthritis, Urinary tract infection, Vomiting
Clinical narrative: Pulmonary coccidioides; Rheumatoid arthritis flare up; condition aggravated; Patient was on the continuous positive airway pressure machine; arm was sore; weight gain; urinary tract infection; stomach upset; abdominal pain; chills; vomiting; This spontaneous case was reported by a physician and describes the occurrence of COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), URINARY TRACT INFECTION (urinary tract infection), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting). At the time of the report, COCCIDIOIDOMYCOSIS (Pulmonary coccidioides), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications 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.