chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cough, Therapeutic response unexpected
Clinical narrative: Coughing; COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs) and COUGH (Coughing) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs). On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (COPD has gotten a lot better, able to walk across the room without getting out of breath, wheezing upon standing has calmed down so much, breathing a lot better, getting a lot more air into lungs) and COUGH (Coughing) had not resolved.            No concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 and contains non-significant information. On 01-Jul-2021: Non-Significant follow-up received On 01-Jul-2021: Non significant follow up received
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was scheduled 13 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was scheduled 13 days after the first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039V28) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included DARUNAVIR ETHANOLATE (PREZISTA) for AIDS, ROSUVASTATIN for an unknown indication.    On 23-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was scheduled 13 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was scheduled 13 days after the first dose) had resolved.        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 treatment information was provided. Concomitant Rosuvastatin indication was reported as virus. Patient received her first dose of vaccine on 23-Apr-2021 and was scheduled to receive her second dose on 05-May-2021,which was 13 days post receiving the first dose of vaccine but the patient stated that she missed to receive her second dose. The patient has provided the Lot number as Moderna 039V28 but was unsure about the number.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received. Patient denied further follow up
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a male 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymph node pain, Vision blurred
Clinical narrative: Blurry vision; Dizzy; Lymph node hurt the next day in her neck; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), LYMPH NODE PAIN (Lymph node hurt the next day in her neck) and FATIGUE (Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), LYMPH NODE PAIN (Lymph node hurt the next day in her neck) and FATIGUE (Tired). The patient was treated with AMOXICILLIN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, VISION BLURRED (Blurry vision), DIZZINESS (Dizzy), LYMPH NODE PAIN (Lymph node hurt the next day in her neck) and FATIGUE (Tired) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-142223 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Syringe slipped and vaccine went into her fats & not administer it on her muscles; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Syringe slipped and vaccine went into her fats & not administer it on her muscles) had resolved.            The patient reported that the vaccine provider didn't administer the vaccine on their muscles and the syringe slipped and all vaccine went into their fats.  No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: back surgery two days before scheduled for second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPROPION, OMEPRAZOLE, OXYBUTYNIN, LOSARTAN, VENLAFAXINE, PRAVASTATIN and GLIPIZIDE for an unknown indication.    On 19-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 PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (back surgery two days before scheduled for second dose of vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reports no adverse event after first dose and is scheduled to have back surgery on 14Apr2021 and that is two days before her scheduled appointment for the second dose of the vaccine on 16Apr2021. she believes will not be able to attend her appointment for the second dose. she might not be able to get second dose within the recommended timeframe.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Influenza, Myalgia, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (all the flu symptoms), DIARRHOEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication as reported , No treatment medication was reported. Reporter did not allow further contact.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (all the flu symptoms), DIARRHOEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, INFLUENZA (all the flu symptoms), DIARRHEA (diarrhea), MYALGIA (whole body ache), HEADACHE (headache), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medication as reported , No treatment medication was reported. Reporter did not allow further contact.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site induration
Clinical narrative: Hardness around the Vaccination area; Headache after the second dose; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0211A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired). At the time of the report, VACCINATION SITE INDURATION (Hardness around the Vaccination area), HEADACHE (Headache after the second dose) and FATIGUE (Tired) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-031409 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: An elevated Heart rate; Headaches; Body aches; Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish). At the time of the report, HEART RATE INCREASED (An elevated Heart rate), HEADACHE (Headaches), MYALGIA (Body aches) and PYREXIA (Feeling feverish) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Heart rate: 100 (High) Elevated heart rate. Heart rate was over 100 Beats Per Minute for two hours.. On 18-May-2021, Heart rate: 120 (High) Heart rate has been over 120 Beats Per Minute..         The Patient did not experience any adverse events after the first dose of vaccination. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. .
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Ear pain, Fatigue
Clinical narrative: Felt bad; Night sweats; Ear ache on left side that radiated down to shoulder; Sinus congestion; weak legs; Weak; Blurred vision; dizziness; Lymph node on left side of throat was swollen; Tired; Ear ache on left side that radiated down to shoulder; Continuing Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion) and PAIN IN EXTREMITY (weak legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever). The patient was treated with AMOXICILLIN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: positive (Positive) Positive.         Treatment medication included steroid shot and pain medicine.   This case was linked to MOD-2021-142164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up received and it contains information about laboratory information and events were updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lymphadenopathy, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: Felt bad; Night sweats; Ear ache on left side that radiated down to shoulder; Sinus congestion; weak legs; Weak; Blurred vision; dizziness; Lymph node on left side of throat was swollen; Tired; Ear ache on left side that radiated down to shoulder; Continuing Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion) and PAIN IN EXTREMITY (weak legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever). The patient was treated with AMOXICILLIN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: positive (Positive) Positive.         Treatment medication included steroid shot and pain medicine.   This case was linked to MOD-2021-142164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up received and it contains information about laboratory information and events were updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Sinus congestion, Vision blurred
Clinical narrative: Felt bad; Night sweats; Ear ache on left side that radiated down to shoulder; Sinus congestion; weak legs; Weak; Blurred vision; dizziness; Lymph node on left side of throat was swollen; Tired; Ear ache on left side that radiated down to shoulder; Continuing Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion) and PAIN IN EXTREMITY (weak legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 007A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-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 FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever). The patient was treated with AMOXICILLIN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Felt bad), NIGHT SWEATS (Night sweats), EAR PAIN (Ear ache on left side that radiated down to shoulder), SINUS CONGESTION (Sinus congestion), PAIN IN EXTREMITY (weak legs), ASTHENIA (Weak), VISION BLURRED (Blurred vision), DIZZINESS (dizziness), LYMPHADENOPATHY (Lymph node on left side of throat was swollen), FATIGUE (Tired), ARTHRALGIA (Ear ache on left side that radiated down to shoulder) and PYREXIA (Continuing Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: positive (Positive) Positive.         Treatment medication included steroid shot and pain medicine.   This case was linked to MOD-2021-142164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: follow up received and it contains information about laboratory information and events were updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window) 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine came back out and rolled down the patient's arm; Approximately 0.2cc of vaccine leaked at site of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection). On 01-May-2021, UNDERDOSE (Vaccine came back out and rolled down the patient's arm) and DEVICE CONNECTION ISSUE (Approximately 0.2cc of vaccine leaked at site of injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. No Treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-MAY-2021 was added the patient details and provided the vaccination dates. On 21-Jul-2021: Significant FU-patient chose to take another vaccine and no adverse events reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis
Clinical narrative: Colitis; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colitis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. SA113102) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-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 COLITIS (Colitis). The patient was treated with PREDNISONE for Colitis, at a dose of UNK, qd. At the time of the report, COLITIS (Colitis) 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.  Second dose was scheduled on 18 May 2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: when fever broke, I was in a pool of water in bed; developed tenderness and sores in mouth; feels like I have COVID again; both arms were bad; achiness; chills; felt the injection; injection site became red; high fever; very tired; warm to touch; miserable; no appetite; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed) and ORAL PAIN (developed tenderness and sores in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, ASCORBIC ACID (VIT C), ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), ORAL PAIN (developed tenderness and sores in mouth), PAIN IN EXTREMITY (both arms were bad), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired). 13-May-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN (achiness), CHILLS (chills) and PYREXIA (high fever). 13-May-2021, the patient experienced COVID-19 (feels like I have COVID again). On 14-May-2021, the patient experienced HYPERHIDROSIS (when fever broke, I was in a pool of water in bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-May-2021, PYREXIA (high fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed), ORAL PAIN (developed tenderness and sores in mouth), COVID-19 (feels like I have COVID again), PAIN IN EXTREMITY (both arms were bad), PAIN (achiness), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired) outcome was unknown and CHILLS (chills) had resolved.            This case was linked to MOD-2021-142492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received contains no new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oral pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: when fever broke, I was in a pool of water in bed; developed tenderness and sores in mouth; feels like I have COVID again; both arms were bad; achiness; chills; felt the injection; injection site became red; high fever; very tired; warm to touch; miserable; no appetite; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed) and ORAL PAIN (developed tenderness and sores in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, ASCORBIC ACID (VIT C), ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), ORAL PAIN (developed tenderness and sores in mouth), PAIN IN EXTREMITY (both arms were bad), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired). 13-May-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN (achiness), CHILLS (chills) and PYREXIA (high fever). 13-May-2021, the patient experienced COVID-19 (feels like I have COVID again). On 14-May-2021, the patient experienced HYPERHIDROSIS (when fever broke, I was in a pool of water in bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-May-2021, PYREXIA (high fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed), ORAL PAIN (developed tenderness and sores in mouth), COVID-19 (feels like I have COVID again), PAIN IN EXTREMITY (both arms were bad), PAIN (achiness), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired) outcome was unknown and CHILLS (chills) had resolved.            This case was linked to MOD-2021-142492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received contains no new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: when fever broke, I was in a pool of water in bed; developed tenderness and sores in mouth; feels like I have COVID again; both arms were bad; achiness; chills; felt the injection; injection site became red; high fever; very tired; warm to touch; miserable; no appetite; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed) and ORAL PAIN (developed tenderness and sores in mouth) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, ASCORBIC ACID (VIT C), ZINC, COLECALCIFEROL (VITAMIN D3) and LOTEPREDNOL ETABONATE (LOTEMAX) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), ORAL PAIN (developed tenderness and sores in mouth), PAIN IN EXTREMITY (both arms were bad), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired). 13-May-2021, the patient experienced DECREASED APPETITE (no appetite), PAIN (achiness), CHILLS (chills) and PYREXIA (high fever). 13-May-2021, the patient experienced COVID-19 (feels like I have COVID again). On 14-May-2021, the patient experienced HYPERHIDROSIS (when fever broke, I was in a pool of water in bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 14-May-2021, PYREXIA (high fever) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch), FEELING ABNORMAL (miserable), DECREASED APPETITE (no appetite), HYPERHIDROSIS (when fever broke, I was in a pool of water in bed), ORAL PAIN (developed tenderness and sores in mouth), COVID-19 (feels like I have COVID again), PAIN IN EXTREMITY (both arms were bad), PAIN (achiness), VACCINATION SITE PAIN (felt the injection), VACCINATION SITE ERYTHEMA (injection site became red) and FATIGUE (very tired) outcome was unknown and CHILLS (chills) had resolved.            This case was linked to MOD-2021-142492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow-up received contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Lethargy, Myalgia
Clinical narrative: Running nose; Feverish / temperature 101.6 degree fahrenheit; Achy; chills; slight headache; lethargy; Sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit) and MYALGIA (Achy) in a male patient of an unknown age 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced LETHARGY (lethargy). 18-May-2021, the patient experienced HYPERHIDROSIS (Sweats), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache). On 21-May-2021, the patient experienced RHINORRHOEA (Running nose) and PYREXIA (Feverish / temperature 101.6 degree fahrenheit). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache) outcome was unknown.            No concomitant medication information was provided. Action taken with mRNA-1273 is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU added on 21-MAY-2021, No new information was provided in FU source document.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Running nose; Feverish / temperature 101.6 degree fahrenheit; Achy; chills; slight headache; lethargy; Sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 18-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit) and MYALGIA (Achy) in a male patient of an unknown age 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced LETHARGY (lethargy). 18-May-2021, the patient experienced HYPERHIDROSIS (Sweats), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache). On 21-May-2021, the patient experienced RHINORRHOEA (Running nose) and PYREXIA (Feverish / temperature 101.6 degree fahrenheit). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, LETHARGY (lethargy), HYPERHIDROSIS (Sweats), RHINORRHOEA (Running nose), PYREXIA (Feverish / temperature 101.6 degree fahrenheit), MYALGIA (Achy), CHILLS (chills) and HEADACHE (slight headache) outcome was unknown.            No concomitant medication information was provided. Action taken with mRNA-1273 is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU added on 21-MAY-2021, No new information was provided in FU source document.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Didn't have allergies this season; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Didn't have allergies this season) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Wrong technique in device usage process
Clinical narrative: Drawing up .6ml vaccine instead of .5ml of vaccine; Drawing up .6ml vaccine instead of .5ml of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A201107) for COVID-19 immunisation.     The patient's past medical history included No adverse event (Product used for unknown indication).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (Drawing up .6ml vaccine instead of .5ml of vaccine) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Drawing up .6ml vaccine instead of .5ml of vaccine) 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.   No concomitant product use was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up received and included no new information pertaining to the patients involved with the events. It was reported that the clinic was no longer using the device in question and they have notified the manufacturer.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Amino acid level, Blood test, Decreased appetite, Dysphagia, Dysstasia
Clinical narrative: Weakness of the hands; Muscle weakness; Memory is "funky"; Slow speech; Unable to stand; Difficulty swallowing; Lost a lot of weight; Not eating; Rashes all over the body; Feeling tired all the time; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech) and DYSSTASIA (Unable to stand) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0308218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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 MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight), RASH (Rashes all over the body), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site). 04-Apr-2021, the patient experienced DECREASED APPETITE (Not eating). At the time of the report, MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site) had not resolved, DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight) and DECREASED APPETITE (Not eating) outcome was unknown and RASH (Rashes all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amino acid level: high (High) high. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Protein total: high (High) high. On an unknown date, Protein urine: high (High) high. On an unknown date, Red blood cell count: 4.48 (Low) 4.48. On an unknown date, Urine analysis: normal (normal) normal.         No treatment medications were reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Memory impairment, Muscular weakness, Protein total, Protein urine
Clinical narrative: Weakness of the hands; Muscle weakness; Memory is "funky"; Slow speech; Unable to stand; Difficulty swallowing; Lost a lot of weight; Not eating; Rashes all over the body; Feeling tired all the time; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech) and DYSSTASIA (Unable to stand) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0308218) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-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 MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight), RASH (Rashes all over the body), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site). 04-Apr-2021, the patient experienced DECREASED APPETITE (Not eating). At the time of the report, MUSCULAR WEAKNESS (Weakness of the hands), MUSCULAR WEAKNESS (Muscle weakness), MEMORY IMPAIRMENT (Memory is "funky"), SLOW SPEECH (Slow speech), FATIGUE (Feeling tired all the time) and VACCINATION SITE PAIN (Pain at the injection site) had not resolved, DYSSTASIA (Unable to stand), DYSPHAGIA (Difficulty swallowing), WEIGHT DECREASED (Lost a lot of weight) and DECREASED APPETITE (Not eating) outcome was unknown and RASH (Rashes all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Amino acid level: high (High) high. On an unknown date, Blood test: normal (normal) normal. On an unknown date, Protein total: high (High) high. On an unknown date, Protein urine: high (High) high. On an unknown date, Red blood cell count: 4.48 (Low) 4.48. On an unknown date, Urine analysis: normal (normal) normal.         No treatment medications were reported.