chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Illness, Pyrexia
Clinical narrative: She's been having a fever for the last 3 days; Lost of appetite; Weak - almost collapsed half way to the bathroom; Never been so sick; it's been up to 103 degrees; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick), PYREXIA (it's been up to 103 degrees) and PYREXIA (She's been having a fever for the last 3 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick) and PYREXIA (it's been up to 103 degrees). On an unknown date, the patient experienced PYREXIA (She's been having a fever for the last 3 days). On 08-Feb-2021, DECREASED APPETITE (Lost of appetite), ASTHENIA (Weak - almost collapsed half way to the bathroom), ILLNESS (Never been so sick) and PYREXIA (it's been up to 103 degrees) had resolved. At the time of the report, PYREXIA (She's been having a fever for the last 3 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 103 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included high blood pressure pills. Treatment medications included Fever reducers- over the counter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2021: Adverse event information was updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Asthenia, Fall
Clinical narrative: Didn't have the strength to stand/wife could not pull  patient up; Standing up and fell backwards; Daughter said I was acting kinda funny; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny), ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 630MZOA) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny). On 19-Feb-2021, the patient experienced ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards). On 21-Feb-2021, ABNORMAL BEHAVIOUR (Daughter said I was acting kinda funny), ASTHENIA (Didn't have the strength to stand/wife could not pull  patient up) and FALL (Standing up and fell backwards) had resolved.            Concomitant medications were not provided.  Treatment medications were not provided.  Action taken with the product mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non-significant Follow-up received: Email address obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pyrexia, Rash
Clinical narrative: rash on their forearms, back and stomach; chills; fever; redness on their arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), ERYTHEMA (redness on their arm) and RASH (rash on their forearms, back and stomach) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Rash.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and ERYTHEMA (redness on their arm). On 11-Feb-2021, the patient experienced RASH (rash on their forearms, back and stomach). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, CHILLS (chills), PYREXIA (fever), ERYTHEMA (redness on their arm) and RASH (rash on their forearms, back and stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red round circle 1.5 by 3.5 inches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches). At the time of the report, VACCINATION SITE ERYTHEMA (Red round circle 1.5 by 3.5 inches) 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.   Treatment and concomitant medications were not provided by reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: her vein on left arm is alleviated and is dark blue in color; hard to touch; sore; site of injection has big red mark; chills; Bodyache; Joint ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection has big red mark), CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore). On 11-Feb-2021, the patient experienced VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color). On 06-Feb-2021, CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had resolved. On 10-Feb-2021, VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore) had resolved. At the time of the report, VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.4. On 06-Feb-2021, Pyrexia: 100.4.         Treatment information was included Tylenol  No concomitant product was provided
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vein discolouration
Clinical narrative: her vein on left arm is alleviated and is dark blue in color; hard to touch; sore; site of injection has big red mark; chills; Bodyache; Joint ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (site of injection has big red mark), CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No past medical history was provided.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore). On 11-Feb-2021, the patient experienced VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color). On 06-Feb-2021, CHILLS (chills), MYALGIA (Bodyache), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had resolved. On 10-Feb-2021, VACCINATION SITE ERYTHEMA (site of injection has big red mark), VACCINATION SITE INDURATION (hard to touch) and VACCINATION SITE PAIN (sore) had resolved. At the time of the report, VEIN DISCOLOURATION (her vein on left arm is alleviated and is dark blue in color) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Pyrexia: 100.4. On 06-Feb-2021, Pyrexia: 100.4.         Treatment information was included Tylenol  No concomitant product was provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Peripheral swelling
Clinical narrative: HEADACHE; BODY ACHES; FEVER OF 102.4; SWOLLEN ARM SIZE OF TENNIS BALL; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 102.4 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE; BODY ACHES; FEVER OF 102.4; SWOLLEN ARM SIZE OF TENNIS BALL; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (HEADACHE), MYALGIA (BODY ACHES), PYREXIA (FEVER OF 102.4), PERIPHERAL SWELLING (SWOLLEN ARM SIZE OF TENNIS BALL) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Body temperature: 102.4 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Product colour issue, Pyrexia, Vaccination site discolouration
Clinical narrative: site of injection changed to pink; site of injection color was red; vaccine had a tan color.; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PRODUCT COLOUR ISSUE (vaccine had a tan color.), PYREXIA (fever) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PRODUCT COLOUR ISSUE (vaccine had a tan color.), PYREXIA (fever) and NAUSEA (nausea). On 12-Feb-2021, PRODUCT COLOUR ISSUE (vaccine had a tan color.) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 101.3-101.5 (High) 101.3-101.5 F.         Treatment medication not provided. Concomitant medication not provided   This case was linked to MOD-2021-032836 (E2B Linked Report).; Sender's Comments:  MOD-2021-032836:1st dose case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: site of injection changed to pink; site of injection color was red; vaccine had a tan color.; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PRODUCT COLOUR ISSUE (vaccine had a tan color.), PYREXIA (fever) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PRODUCT COLOUR ISSUE (vaccine had a tan color.), PYREXIA (fever) and NAUSEA (nausea). On 12-Feb-2021, PRODUCT COLOUR ISSUE (vaccine had a tan color.) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (site of injection changed to pink), VACCINATION SITE ERYTHEMA (site of injection color was red), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 101.3-101.5 (High) 101.3-101.5 F.         Treatment medication not provided. Concomitant medication not provided   This case was linked to MOD-2021-032836 (E2B Linked Report).; Sender's Comments:  MOD-2021-032836:1st dose case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Swelling, Urticaria
Clinical narrative: arm was extremely red; it swelled; very itchy; has those welts; the size is now much bigger like her fist size; it's very large; black and blue mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black and blue mark), ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy) and URTICARIA (has those welts) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (black and blue mark). On 11-Feb-2021, the patient experienced ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy), URTICARIA (has those welts), SWELLING (the size is now much bigger like her fist size) and ERYTHEMA (it's very large). At the time of the report, VACCINATION SITE DISCOLOURATION (black and blue mark), ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy), URTICARIA (has those welts), SWELLING (the size is now much bigger like her fist size) and ERYTHEMA (it's very large) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was born in the year 1946 Treatment medications included cortisone cream. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow information received on 13 Jul 2021 and reporter information was updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: arm was extremely red; it swelled; very itchy; has those welts; the size is now much bigger like her fist size; it's very large; black and blue mark; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (black and blue mark), ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy) and URTICARIA (has those welts) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (black and blue mark). On 11-Feb-2021, the patient experienced ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy), URTICARIA (has those welts), SWELLING (the size is now much bigger like her fist size) and ERYTHEMA (it's very large). At the time of the report, VACCINATION SITE DISCOLOURATION (black and blue mark), ERYTHEMA (arm was extremely red), PERIPHERAL SWELLING (it swelled), PRURITUS (very itchy), URTICARIA (has those welts), SWELLING (the size is now much bigger like her fist size) and ERYTHEMA (it's very large) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was born in the year 1946 Treatment medications included cortisone cream. No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow information received on 13 Jul 2021 and reporter information was updated.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: "COVID Arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("COVID Arm") 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("COVID Arm"). At the time of the report, PAIN IN EXTREMITY ("COVID Arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Emotional distress, Fatigue, Feeling abnormal, Nervousness
Clinical narrative: Wanted to cry; Really upset; Very nervous; Felt like can't back in; Extremely tired; Arm sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and PAIN IN EXTREMITY (Arm sore and hot) in a 69-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.     Concurrent medical conditions included Allergy (when patient reacts to things patient is allergic to, it makes her nauseous.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore and hot). On an unknown date, the patient experienced CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and FATIGUE (Extremely tired). At the time of the report, CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in), PAIN IN EXTREMITY (Arm sore and hot) and FATIGUE (Extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Wanted to cry; Really upset; Very nervous; Felt like can't back in; Extremely tired; Arm sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and PAIN IN EXTREMITY (Arm sore and hot) in a 69-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.     Concurrent medical conditions included Allergy (when patient reacts to things patient is allergic to, it makes her nauseous.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore and hot). On an unknown date, the patient experienced CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and FATIGUE (Extremely tired). At the time of the report, CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in), PAIN IN EXTREMITY (Arm sore and hot) and FATIGUE (Extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash erythematous, Vaccination site pruritus
Clinical narrative: delayed reaction arm has red bump; delayed reaction arm itching; delayed reaction arm sore; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (delayed reaction arm has red bump), VACCINATION SITE PRURITUS (delayed reaction arm itching) and MYALGIA (delayed reaction arm sore) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20Q) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 RASH ERYTHEMATOUS (delayed reaction arm has red bump), VACCINATION SITE PRURITUS (delayed reaction arm itching) and MYALGIA (delayed reaction arm sore). At the time of the report, RASH ERYTHEMATOUS (delayed reaction arm has red bump), VACCINATION SITE PRURITUS (delayed reaction arm itching) and MYALGIA (delayed reaction arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site was sore and tender to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On an unknown date, patient experienced injection site was sore and tender to touch. No treatment information was provided.  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.   The outcome of events injection site was sore and tender to touch was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13M20A) for COVID-19 vaccination.     Concurrent medical conditions included UTI.    On 04-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 URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Vaccination site pain
Clinical narrative: tested positive for COVID-19; chills; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   On 27-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) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at injection site). On 24-Feb-2021, the patient experienced COVID-19 (tested positive for COVID-19) and CHILLS (chills). At the time of the report, COVID-19 (tested positive for COVID-19), CHILLS (chills) and VACCINATION SITE PAIN (Sore arm at injection site) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-033338 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Additional information received on 20-Jul-2021 and included no new information.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (started getting rash), URTICARIA (Hives upper part of the arm) and PRURITUS (itchy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RASH (started getting rash), URTICARIA (Hives upper part of the arm) and PRURITUS (itchy). At the time of the report, RASH (started getting rash) had not resolved and URTICARIA (Hives upper part of the arm) and PRURITUS (itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided. Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Hypoaesthesia, Injection site nerve damage
Clinical narrative: Fast heart beat; Felt like it hit a nerve; Burning feeling in arm/burning moved up her face; Started feeling so sick; Whole left side of face from ear to head was numb; Was not able to sleep; Headache; Felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick) and HYPOAESTHESIA (Whole left side of face from ear to head was numb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired). At the time of the report, TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Malaise, Tachycardia
Clinical narrative: Fast heart beat; Felt like it hit a nerve; Burning feeling in arm/burning moved up her face; Started feeling so sick; Whole left side of face from ear to head was numb; Was not able to sleep; Headache; Felt tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick) and HYPOAESTHESIA (Whole left side of face from ear to head was numb) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired). At the time of the report, TACHYCARDIA (Fast heart beat), INJECTION SITE NERVE DAMAGE (Felt like it hit a nerve), BURNING SENSATION (Burning feeling in arm/burning moved up her face), MALAISE (Started feeling so sick), HYPOAESTHESIA (Whole left side of face from ear to head was numb), INSOMNIA (Was not able to sleep), HEADACHE (Headache) and FATIGUE (Felt tired) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tenderness, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Tenderness; Pain; Little swollen in the injection site; Redness; Fever in the arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Little swollen in the injection site), VACCINATION SITE ERYTHEMA (Redness) and PYREXIA (Fever in the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced TENDERNESS (Tenderness), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Little swollen in the injection site), VACCINATION SITE ERYTHEMA (Redness) and PYREXIA (Fever in the arm). At the time of the report, TENDERNESS (Tenderness), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Little swollen in the injection site) and PYREXIA (Fever in the arm) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided. Concomitant details not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Further information has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: 2-3-inch rash where the vaccine was administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (2-3-inch rash where the vaccine was administered) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (2-3-inch rash where the vaccine was administered). At the time of the report, VACCINATION SITE RASH (2-3-inch rash where the vaccine was administered) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Fatigue; Chills; An unusual headache with pressure "like something you would expect with the dengue fever"; Chills for three days; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00J20A) 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 FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days). At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (An unusual headache with pressure "like something you would expect with the dengue fever") and CHILLS (Chills for three days) outcome was unknown. Not Provided      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.   Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the 1st dose of mRNA-1273 (lot#00J20A) and  start date of the events of fatigue and chills, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Swelling
Clinical narrative: Rash is getting worse; Itchy rash; Swollen red color rash; Red color rash on her arm about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash), SWELLING (Swollen red color rash), RASH ERYTHEMATOUS (Red color rash on her arm about 6 inches) and RASH (Rash is getting worse) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 5293) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash), SWELLING (Swollen red color rash) and RASH ERYTHEMATOUS (Red color rash on her arm about 6 inches). On an unknown date, the patient experienced RASH (Rash is getting worse). At the time of the report, RASH PRURITIC (Itchy rash), SWELLING (Swollen red color rash), RASH ERYTHEMATOUS (Red color rash on her arm about 6 inches) and RASH (Rash is getting worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Cortisone. No concomitant medications were provided by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Hot to the touch Injection Site; Itchy Injection Site; Swollen Injection Site; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site). At the time of the report, INJECTION SITE WARMTH (Hot to the touch Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE SWELLING (Swollen Injection Site) and INJECTION SITE ERYTHEMA (Red Injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received from initial reporter: Event outcome updated and the reporter declined for a follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Could not lift her arm; Slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm) and VACCINATION SITE PAIN (Slightly sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, 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 MOVEMENT IMPAIRMENT (Could not lift her arm) and VACCINATION SITE PAIN (Slightly sore arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift her arm) and VACCINATION SITE PAIN (Slightly sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-031154.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-031154
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pain, Vaccination site vesicles
Clinical narrative: Pea-sized water blister showed up at the injection site/blister the size of a dime near the injection site; redness around it; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Pea-sized water blister showed up at the injection site/blister the size of a dime near the injection site), ERYTHEMA (redness around it) and VACCINATION SITE PAIN (sore at the injection site) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE VESICLES (Pea-sized water blister showed up at the injection site/blister the size of a dime near the injection site), ERYTHEMA (redness around it) and VACCINATION SITE PAIN (sore at the injection site). In March 2021, VACCINATION SITE VESICLES (Pea-sized water blister showed up at the injection site/blister the size of a dime near the injection site) had resolved. At the time of the report, ERYTHEMA (redness around it) and VACCINATION SITE PAIN (sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Event (PT: Vaccination site vesicles) outcome was updated to resolved with duration and end date details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Fever of 100.8.Degrees Farenheight; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever of 100.8.Degrees Farenheight), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided          No treatment information was provided.