chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have heart palpitations.; It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.; site is red, warm to the touch, and swollen; swollen with a lump; site is red, warm to the touch, and swollen; Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump), INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) and VACCINATION SITE PAIN (Vaccination site pain). On 14-Apr-2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved. At the time of the report, PALPITATIONS (I have heart palpitations.), INJECTION SITE MASS (It feels like its a lump where I got the shot. It's a big circle of red and it's swollen.), INJECTION SITE ERYTHEMA (site is red, warm to the touch, and swollen), INJECTION SITE SWELLING (swollen with a lump) and INJECTION SITE WARMTH (site is red, warm to the touch, and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no concomitant and treatment medications provided in source document.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia, Tremor
Clinical narrative: could not sleep; shakes; aches, top of the bottom all the body; headache, persistent headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), TREMOR (shakes), MYALGIA (aches, top of the bottom all the body), HEADACHE (headache, persistent headache) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D3, MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ALLOPURINOL, NIFEDIPINE, OMEPRAZOLE, ATORVASTATIN, VITAMIN B COMPLEX and ASCORBIC ACID (VIT C) for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (could not sleep), TREMOR (shakes), MYALGIA (aches, top of the bottom all the body), HEADACHE (headache, persistent headache) and CHILLS (chills). At the time of the report, INSOMNIA (could not sleep), TREMOR (shakes), MYALGIA (aches, top of the bottom all the body) and CHILLS (chills) had resolved and HEADACHE (headache, persistent headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-083155 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Dyspnoea, Erythema
Clinical narrative: not feeling good; Feelings of weakness; skin was burning; felt like someone was sitting on her throat and she couldn't breath; left arm tingly-all  body tingly; lip quivering; ache; fever; chills; head hurt; bone were hurting; sore arm; both arms blotchy; both arms red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness) and RASH MACULAR (both arms blotchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE, ALPRAZOLAM (XANAX) and Duexis                                                         for her stomach as needed for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced BONE PAIN (bone were hurting), CHILLS (chills) and HEADACHE (head hurt). On an unknown date, the patient experienced SKIN BURNING SENSATION (skin was burning), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Apr-2021, RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red) had resolved. At the time of the report, SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), BONE PAIN (bone were hurting), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache), CHILLS (chills), HEADACHE (head hurt) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Muscle twitching, Pain, Pain in extremity
Clinical narrative: not feeling good; Feelings of weakness; skin was burning; felt like someone was sitting on her throat and she couldn't breath; left arm tingly-all  body tingly; lip quivering; ache; fever; chills; head hurt; bone were hurting; sore arm; both arms blotchy; both arms red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness) and RASH MACULAR (both arms blotchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE, ALPRAZOLAM (XANAX) and Duexis                                                         for her stomach as needed for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced BONE PAIN (bone were hurting), CHILLS (chills) and HEADACHE (head hurt). On an unknown date, the patient experienced SKIN BURNING SENSATION (skin was burning), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Apr-2021, RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red) had resolved. At the time of the report, SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), BONE PAIN (bone were hurting), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache), CHILLS (chills), HEADACHE (head hurt) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Rash macular, Skin burning sensation
Clinical narrative: not feeling good; Feelings of weakness; skin was burning; felt like someone was sitting on her throat and she couldn't breath; left arm tingly-all  body tingly; lip quivering; ache; fever; chills; head hurt; bone were hurting; sore arm; both arms blotchy; both arms red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness) and RASH MACULAR (both arms blotchy) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), HYDROCODONE, ALPRAZOLAM (XANAX) and Duexis                                                         for her stomach as needed for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red). On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Apr-2021, the patient experienced BONE PAIN (bone were hurting), CHILLS (chills) and HEADACHE (head hurt). On an unknown date, the patient experienced SKIN BURNING SENSATION (skin was burning), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache) and PYREXIA (fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Apr-2021, RASH MACULAR (both arms blotchy) and ERYTHEMA (both arms red) had resolved. At the time of the report, SKIN BURNING SENSATION (skin was burning), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (not feeling good), ASTHENIA (Feelings of weakness), DYSPNOEA (felt like someone was sitting on her throat and she couldn't breath), BONE PAIN (bone were hurting), PARAESTHESIA (left arm tingly-all  body tingly), MUSCLE TWITCHING (lip quivering), PAIN (ache), CHILLS (chills), HEADACHE (head hurt) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child under the age of 18 received the Moderna COVID-19 vaccination; 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child under the age of 18 received the Moderna COVID-19 vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child under the age of 18 received the Moderna COVID-19 vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child under the age of 18 received the Moderna COVID-19 vaccination) had resolved. Not Provided      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 no provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-Jun-2021 contains no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: warm redness from her shoulder down to the elbow; redness from her shoulder down to the elbow; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm redness from her shoulder down to the elbow), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness from her shoulder down to the elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (warm redness from her shoulder down to the elbow) and VACCINATION SITE ERYTHEMA (redness from her shoulder down to the elbow). At the time of the report, VACCINATION SITE WARMTH (warm redness from her shoulder down to the elbow), VACCINATION SITE PAIN (soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness from her shoulder down to the elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included ice and acetaminophen.  There were no concomitant medications provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Pain, Vaccination site pain
Clinical narrative: Body ache; Back ache; Arm sore; Chills; Headache; (headache) it gets worse; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), BACK PAIN (Back ache), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM, COLECALCIFEROL (VITAMIN D 3), HYDROXYCHLOROQUINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Body ache), BACK PAIN (Back ache), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills), HEADACHE (Headache) and HEADACHE ((headache) it gets worse). At the time of the report, PAIN (Body ache), BACK PAIN (Back ache), VACCINATION SITE PAIN (Arm sore), CHILLS (Chills), HEADACHE (Headache) and HEADACHE ((headache) it gets worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with drug is not applicable. No treatment drugs are not provided by reporter.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood urine, Blood urine present, Fatigue, Headache
Clinical narrative: Blood in urine; Headaches; Muscle pain; Joint pain; Fatigue; not plan to take second dose; kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (kidney problems), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (cipro), Food allergy (gluten), Chronic kidney disease stage 3 since 01-Jan-2000 and Thyroid cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid cancer, FISH OIL, VITAMIN E [VITAMIN E NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-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 RENAL DISORDER (kidney problems). On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose). At the time of the report, RENAL DISORDER (kidney problems) had not resolved, BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine: Urine was tea color 10 days after the vaccination date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Patient demographics, and concomitant medications updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue, Renal disorder
Clinical narrative: Blood in urine; Headaches; Muscle pain; Joint pain; Fatigue; not plan to take second dose; kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (kidney problems), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (cipro), Food allergy (gluten), Chronic kidney disease stage 3 since 01-Jan-2000 and Thyroid cancer. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid cancer, FISH OIL, VITAMIN E [VITAMIN E NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-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 RENAL DISORDER (kidney problems). On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), FATIGUE (Fatigue) and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose). At the time of the report, RENAL DISORDER (kidney problems) had not resolved, BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headaches), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not plan to take second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood urine: Urine was tea color 10 days after the vaccination date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Patient demographics, and concomitant medications updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered around 16 hours passed puncture time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time). On 20-Apr-2021, EXPIRED PRODUCT ADMINISTERED (dose administered around 16 hours passed puncture time) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant details were provided No treatment details were provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from dose punctured 19 hours before administration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from dose punctured 19 hours before administration) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to unk dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from dose punctured 19 hours before administration). On 20-Apr-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from dose punctured 19 hours before administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: dizziness; typical sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VACCINATION SITE PAIN (typical sore arm) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (dizziness) and VACCINATION SITE PAIN (typical sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness) and VACCINATION SITE PAIN (typical sore arm) outcome was unknown. Not Provided          No concomitant medications reported . The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Soreness in my arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in my arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Soreness in my arm). At the time of the report, INJECTION SITE PAIN (Soreness in my arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Ginger ale was reported to be used for treatment.   This case was linked to MOD-2021-083249 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain in extremity, Pruritus, Swelling face
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills), HEADACHE (headache) and PRURITUS (itchy legs). On 25-Mar-2021, PAIN IN EXTREMITY (sore right arm), SWELLING FACE (cheeks felt swollen/puffy), PRURITUS (itchy everywhere (arms, torso, legs,)), CHILLS (chills), HEADACHE (headache) and PRURITUS (itchy legs) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication history was not provided by reporter. Treatment information included Ibuprofen. This case was linked to MOD-2021-083248. Reporter did not allow further contact.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Warm to the touch; Itchiness at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Warm to the touch), INJECTION SITE PRURITUS (Itchiness at the injection site), INJECTION SITE INDURATION (Hardness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: cervical lymphadenopathy on right side; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (cervical lymphadenopathy on right side) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-076122, MOD21-076477 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-076122:dose 1 MOD21-076477:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Myalgia, Nausea, Pyrexia
Clinical narrative: Cough; Body and muscle aches; Nausea; Fever of 101.8F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient used asthma inhaler and laid around).   On 20-Apr-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 an unknown date, the patient experienced COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), MYALGIA (Body and muscle aches), NAUSEA (Nausea) and PYREXIA (Fever of 101.8F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) Fever of 101.8F and 103 (High) Temp of 103 for 3 days.         No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: TCR document received on 05 Aug 2021 and added lab data, vaccine dose number updated from dose 1 to dose 2.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after the 1st dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore left arm after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 Tylenol, every 4 hours. At the time of the report, PAIN IN EXTREMITY (sore left arm after the 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include, blood pressure medication.   This case was linked to MOD-2021-083238 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Electrocardiogram, Fatigue, Hyperhidrosis
Clinical narrative: Sweating really bad; Light headed, "off center"; Feeling tired, really tired; Vomited 3 times; Heart started racing; Aches in arms and legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Heart started racing), PAIN IN EXTREMITY (Aches in arms and legs), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center") and FATIGUE (Feeling tired, really tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concomitant products included OXYCODONE for Pain, BISOPROLOL FUMARATE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Aches in arms and legs). On 20-Apr-2021, the patient experienced TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times) outcome was unknown and PAIN IN EXTREMITY (Aches in arms and legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: normal (normal) Normal. On 20-Apr-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included unspecified ophthalmic antibiotics post-cataract surgery.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tachycardia, Vomiting
Clinical narrative: Sweating really bad; Light headed, "off center"; Feeling tired, really tired; Vomited 3 times; Heart started racing; Aches in arms and legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Heart started racing), PAIN IN EXTREMITY (Aches in arms and legs), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center") and FATIGUE (Feeling tired, really tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cataract operation. Concomitant products included OXYCODONE for Pain, BISOPROLOL FUMARATE and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Aches in arms and legs). On 20-Apr-2021, the patient experienced TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times). The patient was treated with PARACETAMOL (TYLENOL) for Ache, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Heart started racing), HYPERHIDROSIS (Sweating really bad), DIZZINESS (Light headed, "off center"), FATIGUE (Feeling tired, really tired) and VOMITING (Vomited 3 times) outcome was unknown and PAIN IN EXTREMITY (Aches in arms and legs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Blood pressure measurement: normal (normal) Normal. On 20-Apr-2021, Electrocardiogram: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also included unspecified ophthalmic antibiotics post-cataract surgery.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Diarrhea; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Product dose omission issue
Clinical narrative: HCP told him not to take the second dose; started getting weak; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose), PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose), PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP told him not to take the second dose) had resolved and PAIN IN EXTREMITY (sore arm), ASTHENIA (started getting weak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia, Vaccination site pain
Clinical narrative: flu like symptoms; achiness; shot hurt going in; super tired; 100.6 Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness), VACCINATION SITE PAIN (shot hurt going in), FATIGUE (super tired) and PYREXIA (100.6 Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness), VACCINATION SITE PAIN (shot hurt going in), FATIGUE (super tired) and PYREXIA (100.6 Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. On 09-Apr-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (achiness), VACCINATION SITE PAIN (shot hurt going in), FATIGUE (super tired) and PYREXIA (100.6 Fever) had resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body ache/ soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache/ soreness) and FATIGUE (Tiredness) 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 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache/ soreness) and FATIGUE (Tiredness). At the time of the report, PAIN (Body ache/ soreness) and FATIGUE (Tiredness) outcome was unknown. Not Provided          Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Back pain, Chills, Feeling abnormal, Gait inability
Clinical narrative: lying on the bed she was cold; thought she was not going to be able to wake up from bed,; felt miserable; the hip muscle hurts; back hurts; made her woke up on the middle of the night 2 times; whole body hurts/muscle pain; had Chills; sore left arm,; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts) and BACK PAIN (back hurts) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore left arm,). On 21-Apr-2021, the patient experienced NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills). At the time of the report, NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), PAIN IN EXTREMITY (sore left arm,), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes ¨Tylenol every 4 hours¨. Caller has taken 3 Tylenols ( does not know the dosage of each pill , since 2AM of 21Apr2021). Concomitant medications were not provided.   This case was linked to MOD-2021-083220.