chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Hyperhidrosis, Illness, Malaise
Clinical narrative: soaking wet; temperature of 99.9; her hands and feet swelled like balloons; felt very sick; dizzy; itchy; rash; did not feel well; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy) and PRURITUS (itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (did not feel well) and NAUSEA (nauseous). On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), DIZZINESS (dizzy), PRURITUS (itchy) and RASH (rash). On 19-Apr-2021, the patient experienced HYPERHIDROSIS (soaking wet) and PYREXIA (temperature of 99.9). At the time of the report, PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy), PRURITUS (itchy), MALAISE (did not feel well), RASH (rash), PYREXIA (temperature of 99.9) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Body temperature: 99.9 (High) 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  Treatment drug include Benadryl, Zyrtec, Tylenol for her symptoms. The patient's rash felt better with a shower.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081607 (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 events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081607:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: soaking wet; temperature of 99.9; her hands and feet swelled like balloons; felt very sick; dizzy; itchy; rash; did not feel well; nauseous; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy) and PRURITUS (itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (did not feel well) and NAUSEA (nauseous). On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), DIZZINESS (dizzy), PRURITUS (itchy) and RASH (rash). On 19-Apr-2021, the patient experienced HYPERHIDROSIS (soaking wet) and PYREXIA (temperature of 99.9). At the time of the report, PERIPHERAL SWELLING (her hands and feet swelled like balloons), ILLNESS (felt very sick), HYPERHIDROSIS (soaking wet), DIZZINESS (dizzy), PRURITUS (itchy), MALAISE (did not feel well), RASH (rash), PYREXIA (temperature of 99.9) and NAUSEA (nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Body temperature: 99.9 (High) 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.  Treatment drug include Benadryl, Zyrtec, Tylenol for her symptoms. The patient's rash felt better with a shower.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-081607 (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 events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081607:
Age: 47.0
Sex: M
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 a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Rash; itchy near injection area; spread to the elbow with redness; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness). On 25-Feb-2021, RASH (Rash), VACCINATION SITE PRURITUS (itchy near injection area) and VACCINATION SITE ERYTHEMA (spread to the elbow with redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-081754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: The follow up received on 11-JUN-2021 and contains no new information
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: vision was off; seeing black shapes, lines, specks floating in the air; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (vision was off) and VISUAL IMPAIRMENT (seeing black shapes, lines, specks floating in the air) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2-A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VISION BLURRED (vision was off) and VISUAL IMPAIRMENT (seeing black shapes, lines, specks floating in the air). On 29-Mar-2021, VISION BLURRED (vision was off) and VISUAL IMPAIRMENT (seeing black shapes, lines, specks floating in the air) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: Part of his girlfriends tooth came off; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Part of his girlfriends tooth came off) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced TOOTH FRACTURE (Part of his girlfriends tooth came off). At the time of the report, TOOTH FRACTURE (Part of his girlfriends tooth came off) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site pain
Clinical narrative: felt dizzy during the 15 minute observation time; beasting of arm from the injection site made from the needle; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy during the 15 minute observation time) and VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (felt dizzy during the 15 minute observation time) and VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle). In March 2021, DIZZINESS (felt dizzy during the 15 minute observation time) had resolved. At the time of the report, VACCINATION SITE PAIN (beasting of arm from the injection site made from the needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081769 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081769:Second Dose
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Headache; itchy rash near the injection site; red bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (red bumps) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash near the injection site) and VACCINATION SITE RASH (red bumps). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, VACCINATION SITE PRURITUS (itchy rash near the injection site), VACCINATION SITE RASH (red bumps) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information included Calamyl, ice and water and soap.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Tinnitus, Vertigo
Clinical narrative: Tinnitus gotten worse after receiving COVID19 vaccines; dizzy; vertigo; brain fog like when people get COVID-19; 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 TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus.    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 TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19). At the time of the report, TINNITUS (Tinnitus gotten worse after receiving COVID19 vaccines), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (brain fog like when people get COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the tinnitus,  in 25% of the patients who already had the condition, had gotten worse and this was accompanied by a cluster of symptoms like vertigo, dizziness and brain fog. No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow up received on 21-MAY-2021 contains no new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Foggy; Mild Thirst; Mild Body Aches; Tired; Mild Chills; Low grade Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever) and FATIGUE (Tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Low grade Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), FATIGUE (Tired) and CHILLS (Mild Chills). On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever), FATIGUE (Tired) and CHILLS (Mild Chills) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD21-079122, MOD21-079074 (E2B Linked Report).; Sender's Comments:  MOD21-079122:Crosslinked MOD21-079074:Crosslinked
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: Foggy; Mild Thirst; Mild Body Aches; Tired; Mild Chills; Low grade Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever) and FATIGUE (Tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (Low grade Fever). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), FATIGUE (Tired) and CHILLS (Mild Chills). On 18-Apr-2021, FEELING ABNORMAL (Foggy), THIRST (Mild Thirst), MYALGIA (Mild Body Aches), PYREXIA (Low grade Fever), FATIGUE (Tired) and CHILLS (Mild Chills) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD21-079122, MOD21-079074 (E2B Linked Report).; Sender's Comments:  MOD21-079122:Crosslinked MOD21-079074:Crosslinked
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Communication disorder, Headache, Illness, Injection site pain
Clinical narrative: having difficulty to communicate.; Arms are heavy; She sounds very ill; headache; NAUSEA; Fever 101F; vomiting; chills; severe Body Aches on movement; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache) and NAUSEA (NAUSEA) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040G21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Apr-2021, the patient experienced COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site). At the time of the report, COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site) outcome was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: having difficulty to communicate.; Arms are heavy; She sounds very ill; headache; NAUSEA; Fever 101F; vomiting; chills; severe Body Aches on movement; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache) and NAUSEA (NAUSEA) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040G21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Apr-2021, the patient experienced COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site). At the time of the report, COMMUNICATION DISORDER (having difficulty to communicate.), LIMB DISCOMFORT (Arms are heavy), ILLNESS (She sounds very ill), HEADACHE (headache), NAUSEA (NAUSEA), PYREXIA (Fever 101F), VOMITING (vomiting), CHILLS (chills), MYALGIA (severe Body Aches on movement) and INJECTION SITE PAIN (Sore Injection Site) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Muscle tightness, Neck pain
Clinical narrative: neck remains sore; Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting; Felt a real pressure on left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck remains sore), MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck) 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 20-Apr-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced NECK PAIN (neck remains sore), MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck). On 20-Apr-2021, MUSCLE TIGHTNESS (Felt a real pressure on the left side of neck, like tightening on the artery, restraining, constricting) and DISCOMFORT (Felt a real pressure on left side of neck) had resolved. At the time of the report, NECK PAIN (neck remains sore) outcome was unknown.            A male consumer reported that he received his second dose of the vaccine on 20-Apr-2021 around 2 p.m. and that during the 15 minute observation time, he felt a "real pressure on the left side of his neck, like tightening on the artery as an outcome(?)", it was restraining, constricting and sore for a few minutes and subsided a little after 15 minutes, however, his neck remained sore for the rest of the day.   Concomitant product use and treatment information was not provided.     This case was linked to US-MODERNATX, INC.-MOD-2021-081752 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081752:First Dose
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node under the Right arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node under the Right arm swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph node under the Right arm swollen). At the time of the report, LYMPHADENOPATHY (lymph node under the Right arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment information was provided.  Reportedly, her lymph node under her right arm is swollen, not painful but is uncomfortable. She says she usually gets the same swelling with a flu shot that occurs the first day after the shot then will go away in about a day, does not last long. She has not iced or taken a pill like Tylenol.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: injection arm turned blue and black; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection arm turned blue and black) and VACCINATION SITE PAIN (injection arm soreness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZIRTEC) for Allergy, VITAMIN A [RETINOL], ATORVASTATIN and MONTELUKAST for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (injection arm turned blue and black) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, VACCINATION SITE DISCOLOURATION (injection arm turned blue and black) and VACCINATION SITE PAIN (injection arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication were not reported.   This case was linked to MOD-2021-154043 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Nausea
Clinical narrative: nausea; tiredness; "no energy"; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy") in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 030M21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided. ). Concomitant products included Montebello for Fibro, DULAGLUTIDE (TRULICITY), INSULIN ASPART (NOVOLOG), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy"). At the time of the report, NAUSEA (nausea), FATIGUE (tiredness) and ASTHENIA ("no energy") outcome was unknown. Not Provided          Concomitant product code for fibro myology.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the second dose and want to schedule 2nd dose now.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second dose and want to schedule 2nd dose now.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat, Dyspnoea, Erythema, Mobility decreased
Clinical narrative: difficulty breathing; terrible pain throughout body including back; horrible pain in hands/pain in feet; hands and fingers have become locked and that he cannot fully open his hands; redness and a prickling sensation like pins and needles that started in a few finger and has now; redness and a prickling sensation like pins and needles that started in a few finger and has now; dry mouth; dry throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands) and ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoedema, Kidney disorder (Stage 3 kidney disease), Ulcer, COPD, Acid reflux (esophageal) and Heart disease, unspecified.    On 01-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 DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat). At the time of the report, DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) 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.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: difficulty breathing; terrible pain throughout body including back; horrible pain in hands/pain in feet; hands and fingers have become locked and that he cannot fully open his hands; redness and a prickling sensation like pins and needles that started in a few finger and has now; redness and a prickling sensation like pins and needles that started in a few finger and has now; dry mouth; dry throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands) and ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lymphoedema, Kidney disorder (Stage 3 kidney disease), Ulcer, COPD, Acid reflux (esophageal) and Heart disease, unspecified.    On 01-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 DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat). At the time of the report, DYSPNOEA (difficulty breathing), MYALGIA (terrible pain throughout body including back), PAIN IN EXTREMITY (horrible pain in hands/pain in feet), MOBILITY DECREASED (hands and fingers have become locked and that he cannot fully open his hands), ERYTHEMA (redness and a prickling sensation like pins and needles that started in a few finger and has now), PARAESTHESIA (redness and a prickling sensation like pins and needles that started in a few finger and has now), DRY MOUTH (dry mouth) and DRY THROAT (dry throat) 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On 20-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include Prenatal vitamins.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second vaccine has been administered 14 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccine has been administered 14 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pain in extremity
Clinical narrative: Redness on arm; Sore arm; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness on arm), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness). On 05-Apr-2021, the patient experienced ERYTHEMA (Redness on arm). On 25-Mar-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. On 12-Apr-2021, ERYTHEMA (Redness on arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment medications were unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-081867 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-MAY-2021 contains non-significant information (Email updated).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081867:For Second dose
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: 17year old received the Moderna Covid-19 vaccine; Pregnant patient receive the Moderna Covid-19 vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the Moderna Covid-19 vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receive the Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the Moderna Covid-19 vaccine) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receive the Moderna Covid-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received the Moderna Covid-19 vaccine) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient receive the Moderna Covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Asthenia, Feeding disorder, Influenza like illness, Myalgia
Clinical narrative: unable to eat; nausea; weak; flu like reaction; Very mild symptoms; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea) and ASTHENIA (weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder. Concurrent medical conditions included Diabetes and Kidney disorder (Has kidney issues.). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms) and MYALGIA (myalgia). On 27-Mar-2021, the patient experienced NAUSEA (nausea) and ASTHENIA (weak). On 20-Apr-2021, the patient experienced FEEDING DISORDER (unable to eat). At the time of the report, INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea), ASTHENIA (weak) and FEEDING DISORDER (unable to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081880:Case for second dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: unable to eat; nausea; weak; flu like reaction; Very mild symptoms; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea) and ASTHENIA (weak) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008b21-2a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder. Concurrent medical conditions included Diabetes and Kidney disorder (Has kidney issues.). Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and INSULIN for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms) and MYALGIA (myalgia). On 27-Mar-2021, the patient experienced NAUSEA (nausea) and ASTHENIA (weak). On 20-Apr-2021, the patient experienced FEEDING DISORDER (unable to eat). At the time of the report, INFLUENZA LIKE ILLNESS (flu like reaction), ADVERSE REACTION (Very mild symptoms), MYALGIA (myalgia), NAUSEA (nausea), ASTHENIA (weak) and FEEDING DISORDER (unable to eat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-081880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081880:Case for second dose
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Tinnitus, Vertigo
Clinical narrative: onset of tinnitus after receiving vaccines.; dizzy; vertigo; m brain fog like when people get COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19) 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 TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19). At the time of the report, TINNITUS (onset of tinnitus after receiving vaccines.), DIZZINESS (dizzy), VERTIGO (vertigo) and FEELING ABNORMAL (m brain fog like when people get COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. no treatment medication was provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: felt sore on the left arm of the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection). On 04-Apr-2021, VACCINATION SITE PAIN (felt sore on the left arm of the site of the injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test: positive (Positive) Patient tested Positive 3 days after vaccination took place. On 18-Apr-2021, SARS-CoV-2 test: negative (Negative) Patient tested Negative for COVID virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Additional information includes patient second dose is scheduled for 30/APR/2021  Concomitant product use was not provided. Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Facial pain, Pruritus
Clinical narrative: burning cheeks; hurt and itchy allergy cheeks area; hurt and itchy allergy cheeks area; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) 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 25-Mar-2021, the patient experienced BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area). On 31-Mar-2021, BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient took Benadryl as treatment for the symptoms.    This case was linked to US-MODERNATX, INC.-MOD-2021-081428 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081428:Crossed linked
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) 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) (Intramuscular) 1 dosage form. On 19-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 PYREXIA (Fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, Body temperature: 100.4 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-081834 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up received on 20 May 2021 contains non-significant information included update on reporter information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081834:For First dose