chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Lip swelling, Throat tightness
Clinical narrative: lips swollen; throat has some tightness; chest has some tightness; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swollen), THROAT TIGHTNESS (throat has some tightness) and CHEST DISCOMFORT (chest has some tightness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced LIP SWELLING (lips swollen), THROAT TIGHTNESS (throat has some tightness) and CHEST DISCOMFORT (chest has some tightness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (lips swollen), THROAT TIGHTNESS (throat has some tightness) and CHEST DISCOMFORT (chest has some tightness) outcome was unknown.            No concomitant medication was provided.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Cough, Headache
Clinical narrative: Upset stomach; Cough; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-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 ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), COUGH (Cough), HEADACHE (Headache) and ARTHRALGIA (Joint pain) outcome was unknown.             Treatment included cold compresses.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Given a dose of Moderna vaccine  from a vial which was opened @ 1.55 pm the previous day; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Given a dose of Moderna vaccine  from a vial which was opened @ 1.55 pm the previous day) in a 38-year-old female patient 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 04-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Given a dose of Moderna vaccine  from a vial which was opened @ 1.55 pm the previous day). At the time of the report, PRODUCT ADMINISTRATION ERROR (Given a dose of Moderna vaccine  from a vial which was opened @ 1.55 pm the previous day) 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 medication were reported No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pharmacist gave two doses of the Moderna Covid 19 vaccine to two patients after the vial was opened for more than 12 hours.) 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.   As reported Pharmacist gave two doses of the Moderna COVID 19 vaccine to two patients after the vial was opened for more than 12 hours. Concomitant medications were not reported. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: I Get a Rash Where You Got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (I Get a Rash Where You Got the shot) in an elderly patient of an unknown gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (I Get a Rash Where You Got the shot). At the time of the report, VACCINATION SITE RASH (I Get a Rash Where You Got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: fever; aches and pains; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 08-May-2021, PYREXIA (fever), CHILLS (chills), MYALGIA (aches and pains) and VOMITING (Vomiting) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027C21A) for COVID-19 vaccination.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 07-May-2021, the patient experienced CHILLS (chills). On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (aches and pains). On 08-May-2021, CHILLS (chills) outcome was unknown. At the time of the report, PYREXIA (fever) and MYALGIA (aches and pains) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Fatigue, Underdose
Clinical narrative: the needle getting loose from the hub; tiredness; only 2/3 of the vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (tiredness), UNDERDOSE (only 2/3 of the vaccine was administered) and DEVICE CONNECTION ISSUE (the needle getting loose from the hub) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced FATIGUE (tiredness) and UNDERDOSE (only 2/3 of the vaccine was administered). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (the needle getting loose from the hub). At the time of the report, FATIGUE (tiredness), UNDERDOSE (only 2/3 of the vaccine was administered) and DEVICE CONNECTION ISSUE (the needle getting loose from the hub) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No relevant concomitant medications reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Illness, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: diarrhea; first dose been over 42 days; cold and flu symptoms; low grade fever 99F; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days), ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Lymphedema (Patient is known to have lymphedema in the left arm.) and Autoimmune disorder. Concomitant products included PHENYTOIN SODIUM (DILANTIN [PHENYTOIN SODIUM]), MINOCYCLINE, METFORMIN and GLIMEPIRIDE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days), ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F). The patient was treated with ZINC for Adverse event, at an unspecified dose and frequency. On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose been over 42 days) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown and ILLNESS (cold and flu symptoms) and PYREXIA (low grade fever 99F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99 (High) 99F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also included Cold and flu medicine (unspecified).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and reporter information updated.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Influenza like illness
Clinical narrative: Nosebleeds have been going on for past 2 days and on Wednesday her friend woke up in pool of blood from nosebleed; Feeling achy, flu-like; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feeling achy, flu-like) and EPISTAXIS (Nosebleeds have been going on for past 2 days and on Wednesday her friend woke up in pool of blood from nosebleed) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 01-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feeling achy, flu-like). On 02-Jun-2021, the patient experienced EPISTAXIS (Nosebleeds have been going on for past 2 days and on Wednesday her friend woke up in pool of blood from nosebleed). At the time of the report, INFLUENZA LIKE ILLNESS (Feeling achy, flu-like) and EPISTAXIS (Nosebleeds have been going on for past 2 days and on Wednesday her friend woke up in pool of blood from nosebleed) outcome was unknown.            No treatment was reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19
Clinical narrative: tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: negative (Negative) nasopharyngeal RT-PCR test negative. On 25-May-2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal RT-PCR test positive. On 01-Jun-2021, Blood pressure measurement: 115/75 (normal) 115/75.         Concomitant information was not reported. Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up information received on 12-jun-2021 contains significant information. patient details was added. Both dose information provided, event start date provided. On 04-Jul-2021: Follow up information received on 04-jul-2021 contains significant information. Patient lab data updated.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 28-year-old female patient 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 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Bladder hypertrophy, Hypersensitivity, Kidney enlargement, Renal pain
Clinical narrative: bad kidney pain; bladder is swollen; kidneys swollen; wasn't able too fight off allergies; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney infection (Kidney was septic) in October 2019.   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 RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies). At the time of the report, RENAL PAIN (bad kidney pain), BLADDER HYPERTROPHY (bladder is swollen), KIDNEY ENLARGEMENT (kidneys swollen) and HYPERSENSITIVITY (wasn't able too fight off allergies) outcome was unknown.            Concomitant drug was not reported.  Treatment medication included antibiotics for 7 days tid.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Added events swelling and hypersensitivity.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Insomnia, Pain
Clinical narrative: sore; impossible to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache) in a patient of an unknown age and gender 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 PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache). At the time of the report, PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache) outcome was unknown.            No concomitant information was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: sore arm; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced MYALGIA (sore arm), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (sore arm), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Possible side effect; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE EVENT (Possible side effect) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, the patient experienced ADVERSE EVENT (Possible side effect). At the time of the report, ADVERSE EVENT (Possible side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Pain in extremity, Rash papular
Clinical narrative: slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking; Had usual side effects; ill for 3 days; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache) in a 45-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 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking). On 07-Jun-2021, ILLNESS (ill for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 104 (High) Patient had fever of 104 F.         No relevant concomitant medications reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant follow up includes patient age and illness event was added On 30-Jul-2021: Non significant follow up received
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking; Had usual side effects; ill for 3 days; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache) in a 45-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 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Had usual side effects), ILLNESS (ill for 3 days) and HEADACHE (Headache). On 05-Jun-2021, the patient experienced RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking). On 07-Jun-2021, ILLNESS (ill for 3 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH PAPULAR (slightly raised rash on back, center of back ,does not itch, not particularly red but odd looking), VACCINATION COMPLICATION (Had usual side effects) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 104 (High) Patient had fever of 104 F.         No relevant concomitant medications reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Significant follow up includes patient age and illness event was added On 30-Jul-2021: Non significant follow up received
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus (Lupus), Immunosuppression (Immunosuppressed) and Kidney disorder (Kidney disease).    On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided          Concomitant medication were not reported  Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Inappropriate dose of vaccine administered; syringe connection issue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue). At the time of the report, INCORRECT DOSE ADMINISTERED (Inappropriate dose of vaccine administered) and DEVICE CONNECTION ISSUE (syringe connection issue) 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.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: One patient received a dose from one of the vials which were incorrectly stored; Upon receiving the vials in the frozen state, and were directly stored in the refrigerator.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One patient received a dose from one of the vials which were incorrectly stored) and PRODUCT STORAGE ERROR (Upon receiving the vials in the frozen state, and were directly stored in the refrigerator.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One patient received a dose from one of the vials which were incorrectly stored) and PRODUCT STORAGE ERROR (Upon receiving the vials in the frozen state, and were directly stored in the refrigerator.). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (One patient received a dose from one of the vials which were incorrectly stored) and PRODUCT STORAGE ERROR (Upon receiving the vials in the frozen state, and were directly stored in the refrigerator.) 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 provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A big red rash to arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A big red rash to arm at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    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 RASH (A big red rash to arm at injection site). At the time of the report, RASH (A big red rash to arm at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter was calling on behalf of their wife who received Moderna vaccine and post receiving the vaccine the patient developed a big red rash to arm at injection site which resolved 5 days after the first vaccine. The patient did not seek any medical attention.  Concomitant medication included blood pressure medication.   This case was linked to MOD-2021-067353, MOD-2021-106494, MOD-2021-244811 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Erythema, Fatigue, Feeling hot
Clinical narrative: Warm to touch; Bruises on her arms, 2 inches from her wrist all the way up to her elbows; Arms are painful when touched rating pain as 4 out of 10, 10 being the highest; Major headaches, rated pain as 7 and 1/2; Chills; redness; Feeling of being tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2) and CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows) in a 32-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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (Feeling of being tired), PYREXIA (Fever) and ERYTHEMA (redness). On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch), ERYTHEMA (redness) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to US-irms-MOD21-107778 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Warm to touch; Bruises on her arms, 2 inches from her wrist all the way up to her elbows; Arms are painful when touched rating pain as 4 out of 10, 10 being the highest; Major headaches, rated pain as 7 and 1/2; Chills; redness; Feeling of being tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2) and CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows) in a 32-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.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (Feeling of being tired), PYREXIA (Fever) and ERYTHEMA (redness). On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feeling of being tired), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Major headaches, rated pain as 7 and 1/2), CONTUSION (Bruises on her arms, 2 inches from her wrist all the way up to her elbows), FEELING HOT (Warm to touch), ERYTHEMA (redness) and PAIN IN EXTREMITY (Arms are painful when touched rating pain as 4 out of 10, 10 being the highest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to US-irms-MOD21-107778 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Lots of pain in my shoulder for three months; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Lots of pain in my shoulder for three months) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Lots of pain in my shoulder for three months). At the time of the report, ARTHRALGIA (Lots of pain in my shoulder for three months) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Pyrexia
Clinical narrative: redness; major headaches, rated pain as 7 and 1/2; fever; chills; Feeling of being tired/fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), FATIGUE (Feeling of being tired/fatigue), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills) in a 32-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FATIGUE (Feeling of being tired/fatigue). On an unknown date, the patient experienced ERYTHEMA (redness), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (redness), FATIGUE (Feeling of being tired/fatigue), HEADACHE (major headaches, rated pain as 7 and 1/2), PYREXIA (fever) and CHILLS (chills) 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 relevant concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at injection site) in a patient of an unknown age and gender 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 an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was given.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: injection done too low; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (injection done too low) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (injection done too low). At the time of the report, ACCIDENTAL UNDERDOSE (injection done too low) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Some blurred vision after the 2nd dose; Upset stomach after the 2nd dose; Fever after the 2nd dose; Chills after the 2nd dose; Muscle pain after the 2nd dose; Headache after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Some blurred vision after the 2nd dose), ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose) and MYALGIA (Muscle pain after the 2nd dose) in a patient of an unknown age and gender 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 04-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose). On 06-Jun-2021, the patient experienced VISION BLURRED (Some blurred vision after the 2nd dose). On 06-Jun-2021, ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose) had resolved. At the time of the report, VISION BLURRED (Some blurred vision after the 2nd dose) outcome was unknown.            Concomitants and treatments were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Some blurred vision after the 2nd dose; Upset stomach after the 2nd dose; Fever after the 2nd dose; Chills after the 2nd dose; Muscle pain after the 2nd dose; Headache after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Some blurred vision after the 2nd dose), ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose) and MYALGIA (Muscle pain after the 2nd dose) in a patient of an unknown age and gender 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 04-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose). On 06-Jun-2021, the patient experienced VISION BLURRED (Some blurred vision after the 2nd dose). On 06-Jun-2021, ABDOMINAL DISCOMFORT (Upset stomach after the 2nd dose), PYREXIA (Fever after the 2nd dose), CHILLS (Chills after the 2nd dose), MYALGIA (Muscle pain after the 2nd dose) and HEADACHE (Headache after the 2nd dose) had resolved. At the time of the report, VISION BLURRED (Some blurred vision after the 2nd dose) outcome was unknown.            Concomitants and treatments were not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia, Pain in extremity, Vaccination site rash
Clinical narrative: legs hurt; very weak; Rash appeared at point of Vaccination; Mussels around elbow are began to hurt; exhausted all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), VACCINATION SITE RASH (Rash appeared at point of Vaccination), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), VACCINATION SITE RASH (Rash appeared at point of Vaccination), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time). At the time of the report, PAIN IN EXTREMITY (legs hurt), ASTHENIA (very weak), MYALGIA (Mussels around elbow are began to hurt) and FATIGUE (exhausted all the time) had not resolved and VACCINATION SITE RASH (Rash appeared at point of Vaccination) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Additional information received included additional events (weakness, leg pain and fatigue).
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Erythema, Pruritus, Skin mass
Clinical narrative: Small lump on lower left leg; Same type of lump on upper left arm; Redness; Itching; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching). At the time of the report, SKIN MASS (Small lump on lower left leg), AXILLARY MASS (Same type of lump on upper left arm), ERYTHEMA (Redness) and PRURITUS (Itching) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I was unable to find an alternate source within the 42 day timeframe.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I was unable to find an alternate source within the 42 day timeframe.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: no energy,nothing in her; tired and not functioning; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning) in a 72-year-old female patient 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, the patient experienced ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning). At the time of the report, ASTHENIA (no energy,nothing in her) and FATIGUE (tired and not functioning) outcome was unknown.            No treatment information provided by Reporter.