chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain
Clinical narrative: left brest sore; Lympho nodes; 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 BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes) 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 BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes). At the time of the report, BREAST PAIN (left brest sore) and LYMPH NODE PAIN (Lympho nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm
Clinical narrative: arm was red; arm was warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch). At the time of the report, ERYTHEMA (arm was red) and SKIN WARM (arm was warm to the touch) outcome was unknown.            No concomitant medications provided. No treatment information provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Achy; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PYREXIA (Slight fever) and HEADACHE (Headache) in a 20-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, 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 (Achy), PYREXIA (Slight fever) and HEADACHE (Headache). At the time of the report, PAIN (Achy), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Just pain in my arm; 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 (Just pain in my arm) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Just pain in my arm). At the time of the report, MYALGIA (Just pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache) and HEADACHE (headache) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache) and HEADACHE (headache). At the time of the report, MYALGIA (Body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: His legs are especially painful; Got real sore that night and hasn't gone away; Achy joints from the hips down; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His legs are especially painful), MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620a) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down). On an unknown date, the patient experienced PAIN IN EXTREMITY (His legs are especially painful). At the time of the report, PAIN IN EXTREMITY (His legs are especially painful), MYALGIA (Got real sore that night and hasn't gone away) and ARTHRALGIA (Achy joints from the hips down) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: my eyes are swollen; 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 EYE SWELLING (my eyes are swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 EYE SWELLING (my eyes are swollen). At the time of the report, EYE SWELLING (my eyes are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: Migraine; Body aches; 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 MIGRAINE (Migraine) and MYALGIA (Body aches) 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 COVID-19.    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 MIGRAINE (Migraine) and MYALGIA (Body aches). At the time of the report, MIGRAINE (Migraine) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Oral herpes
Clinical narrative: cold sore in my mouth; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 002B21A) 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) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue). At the time of the report, ORAL HERPES (cold sore in my mouth) and FATIGUE (fatigue) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Tachycardia
Clinical narrative: Feeling Weak; Fast heartbeat; 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 ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat) 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 ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat). At the time of the report, ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site mass
Clinical narrative: a lump that formed under a finger length size away from injection site; the first 3 days I was running high fevers; had terrible head aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history provided.     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 VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills). At the time of the report, VACCINATION SITE MASS (a lump that formed under a finger length size away from injection site), PYREXIA (the first 3 days I was running high fevers), HEADACHE (had terrible head aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Heart rate irregular, Infection
Clinical narrative: infection; extremely fatigue; Fever; flu like symptoms; coughing; sneezing; injection site reactions; feeling few lumps around the injection site; Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down; chills; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing) and VACCINATION SITE REACTION (injection site reactions) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills) and MYALGIA (sore). On an unknown date, the patient experienced INFECTION (infection), FATIGUE (extremely fatigue) and PYREXIA (Fever). At the time of the report, INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills), MYALGIA (sore), FATIGUE (extremely fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient went to her health care provider and she got diagnosed with infection and got prescribed antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Event information updated
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pyrexia, Sneezing, Vaccination site mass
Clinical narrative: infection; extremely fatigue; Fever; flu like symptoms; coughing; sneezing; injection site reactions; feeling few lumps around the injection site; Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down; chills; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing) and VACCINATION SITE REACTION (injection site reactions) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills) and MYALGIA (sore). On an unknown date, the patient experienced INFECTION (infection), FATIGUE (extremely fatigue) and PYREXIA (Fever). At the time of the report, INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills), MYALGIA (sore), FATIGUE (extremely fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient went to her health care provider and she got diagnosed with infection and got prescribed antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Event information updated
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: infection; extremely fatigue; Fever; flu like symptoms; coughing; sneezing; injection site reactions; feeling few lumps around the injection site; Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down; chills; sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing) and VACCINATION SITE REACTION (injection site reactions) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills) and MYALGIA (sore). On an unknown date, the patient experienced INFECTION (infection), FATIGUE (extremely fatigue) and PYREXIA (Fever). At the time of the report, INFECTION (infection), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (coughing), SNEEZING (sneezing), VACCINATION SITE REACTION (injection site reactions), VACCINATION SITE MASS (feeling few lumps around the injection site), HEART RATE IRREGULAR (Her heart beat dropped from 95 to 50 till about midnight and it will go up and down and up and down), CHILLS (chills), MYALGIA (sore), FATIGUE (extremely fatigue) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient went to her health care provider and she got diagnosed with infection and got prescribed antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Event information updated
Sex: U
Vaccine: COVID19
Symptoms: Facial spasm
Clinical narrative: facial tick, Muscle or nerve spasms in 1 side of my face; 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 FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face) 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 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face). At the time of the report, FACIAL SPASM (facial tick, Muscle or nerve spasms in 1 side of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Not Feeling great; Pain in left side of neck; No energy; Little warm; Feeling as if coming out with a flu; Pain in right arm; Drained feeling & tired; Chills; Enlarged lymph nodes on right side; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm) and FEELING COLD (Feeling as if coming out with a flu) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills) and LYMPHADENOPATHY (Enlarged lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (Enlarged lymph nodes on right side) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided by the reporter.   This case was linked to MOD-2021-228327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up containing Dose-2 details and associated events. Updated the action taken Unknown to No change
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: Not Feeling great; Pain in left side of neck; No energy; Little warm; Feeling as if coming out with a flu; Pain in right arm; Drained feeling & tired; Chills; Enlarged lymph nodes on right side; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm) and FEELING COLD (Feeling as if coming out with a flu) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills) and LYMPHADENOPATHY (Enlarged lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (Enlarged lymph nodes on right side) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided by the reporter.   This case was linked to MOD-2021-228327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up containing Dose-2 details and associated events. Updated the action taken Unknown to No change
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Not Feeling great; Pain in left side of neck; No energy; Little warm; Feeling as if coming out with a flu; Pain in right arm; Drained feeling & tired; Chills; Enlarged lymph nodes on right side; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm) and FEELING COLD (Feeling as if coming out with a flu) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On an unknown date, the patient experienced FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills) and LYMPHADENOPATHY (Enlarged lymph nodes on right side). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Not Feeling great), NECK PAIN (Pain in left side of neck), ASTHENIA (No energy), FEELING HOT (Little warm), FEELING COLD (Feeling as if coming out with a flu), PAIN IN EXTREMITY (Pain in right arm), FATIGUE (Drained feeling & tired), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (Enlarged lymph nodes on right side) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not provided by the reporter.   This case was linked to MOD-2021-228327 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Significant follow-up containing Dose-2 details and associated events. Updated the action taken Unknown to No change
Age: 71.0
Sex: M
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 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-186802 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: red rash; soreness last at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the injection site). At the time of the report, RASH ERYTHEMATOUS (red rash) and VACCINATION SITE PAIN (soreness last at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: She has been itching all over the body after 2nd dose.; She has hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She has been itching all over the body after 2nd dose.) and URTICARIA (She has hives all over the body) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 021B21A) for COVID-19 vaccination.     Concomitant products included TENOFOVIR DISOPROXIL FUMARATE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced PRURITUS (She has been itching all over the body after 2nd dose.) and URTICARIA (She has hives all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency; CORTISONE at an unspecified dose and frequency; PREDNISONE for Symptomatic treatment, at an unspecified dose and frequency; FAMOTIDINE for Symptomatic treatment, at an unspecified dose and frequency and CETIRIZINE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PRURITUS (She has been itching all over the body after 2nd dose.) and URTICARIA (She has hives all over the body) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritic rash (this rash isn't red but it's in different parts of my face and it itches) and rash (this rash isn't red but it's in different parts of my face) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pruritic rash (this rash isn't red but it's in different parts of my face and it itches) and rash (this rash isn't red but it's in different parts of my face). At the time of the report, pruritic rash (this rash isn't red but it's in different parts of my face and it itches) and rash (this rash isn't red but it's in different parts of my face) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dry skin, Lip dry, Weight increased
Clinical narrative: Dry mouth; Dry lips; Dry feet; gain weight; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight) 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 an unknown date, the patient experienced DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight). At the time of the report, DRY MOUTH (Dry mouth), LIP DRY (Dry lips), DRY SKIN (Dry feet) and WEIGHT INCREASED (gain weight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No medical history was reported.    On 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 28-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Chills; Bodyache; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    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 CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, CHILLS (Chills), MYALGIA (Bodyache), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drugs were  not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia; 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 TACHYCARDIA (Tachycardia) 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 TACHYCARDIA (Tachycardia). At the time of the report, TACHYCARDIA (Tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: Weak legs; 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 MUSCULAR WEAKNESS (Weak legs) 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 MUSCULAR WEAKNESS (Weak legs). At the time of the report, MUSCULAR WEAKNESS (Weak legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatment medicines were reported.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: slight sinus infection; 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 SINUSITIS (slight sinus infection) 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 SINUSITIS (slight sinus infection). At the time of the report, SINUSITIS (slight sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Vertigo). The patient was treated with MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-May-2021, VERTIGO (Vertigo) was resolving.               Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: My body started to itch; 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 PRURITUS (My body started to itch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     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 PRURITUS (My body started to itch). At the time of the report, PRURITUS (My body started to itch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown Treatment information was unknown
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Nausea, Sleep disorder, Vaccination site erythema
Clinical narrative: "big red spot grapefruit size on injection site"; injection site was swollen; cannot sleep; stomach upset; headache; nausea; throw up; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE (Hydrocholorothiazide), BISOPROLOL, NICOTINIC ACID (NIACIN) and LETROZOLE for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up). On 28-May-2021, the patient experienced VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen). At the time of the report, SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea), VOMITING (throw up), VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.            Other concomitant medicine: Calcium +D complex    No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: patient went to doctor and got treated for AE. No consent for further follow up.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: "big red spot grapefruit size on injection site"; injection site was swollen; cannot sleep; stomach upset; headache; nausea; throw up; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer. Concomitant products included LEVOTHYROXINE, HYDROCHLOROTHIAZIDE (Hydrocholorothiazide), BISOPROLOL, NICOTINIC ACID (NIACIN) and LETROZOLE for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea) and VOMITING (throw up). On 28-May-2021, the patient experienced VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen). At the time of the report, SLEEP DISORDER (cannot sleep), ABDOMINAL DISCOMFORT (stomach upset), HEADACHE (headache), NAUSEA (nausea), VOMITING (throw up), VACCINATION SITE ERYTHEMA ("big red spot grapefruit size on injection site") and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.            Other concomitant medicine: Calcium +D complex    No treatment information was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: patient went to doctor and got treated for AE. No consent for further follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 46th day between doses; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46th day between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 HEADACHE (headache) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Deathly ill from the Moderna vaccine 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Deathly ill from the Moderna vaccine 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 ILLNESS (Deathly ill from the Moderna vaccine 1st dose). At the time of the report, ILLNESS (Deathly ill from the Moderna vaccine 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: Leg cramps; Sharp pain localized to one spot; 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 MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot) 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 MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot). At the time of the report, MUSCLE SPASMS (Leg cramps) and MYALGIA (Sharp pain localized to one spot) outcome was unknown.            Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chills, Decreased appetite, Hypersomnia, Malaise
Clinical narrative: Sore arm; Slept a lot; bone pain; No appetite; wrists and hands/fingers; Felt ill; muscle pain; slight fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite) and PAIN (wrists and hands/fingers) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu Vaccine. Concurrent medical conditions included Hypertension, Hyperthyroidism (Post ablative hyperthyroidism), Osteoarthritis (experienced much more pain than usual) since 2019, Osteoporosis (experienced much more pain than usual) since 2019 and Reactive airways disease. Concomitant products included METOPROLOL, PRAVASTATIN, LEVOTHYROXINE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) for an unknown indication.   On 26-Feb-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021 at 11:20 AM, the patient experienced PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite), PAIN (wrists and hands/fingers), MALAISE (Felt ill), MYALGIA (muscle pain), PYREXIA (slight fever) and CHILLS (Chills). The patient was treated with NAPROXEN at an unspecified dose and frequency. On 29-Mar-2021, PAIN IN EXTREMITY (Sore arm), HYPERSOMNIA (Slept a lot), BONE PAIN (bone pain), DECREASED APPETITE (No appetite), PAIN (wrists and hands/fingers), MALAISE (Felt ill), MYALGIA (muscle pain), PYREXIA (slight fever) and CHILLS (Chills) had resolved.