chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Scratch, Somnolence, Swelling
Clinical narrative: stomach ache; warm to touch; headache; fever; she was just sick,; injection site was very hard like rock; she was just scratching and scratching; soreness is pretty bad; its been terrible and scary.; Soreness; redness; swelling; could not lift her arm,; its itchy; she felt sleepy only.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,) and PRURITUS (its itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SOMNOLENCE (she felt sleepy only.). On 09-Apr-2021, the patient experienced PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,), PRURITUS (its itchy), HEADACHE (headache), ILLNESS (she was just sick,), INJECTION SITE INDURATION (injection site was very hard like rock), SCRATCH (she was just scratching and scratching), PAIN (soreness is pretty bad), MALAISE (its been terrible and scary.) and PYREXIA (fever). On an unknown date, the patient experienced FEELING HOT (warm to touch) and ABDOMINAL PAIN UPPER (stomach ache). At the time of the report, PAIN (Soreness), ERYTHEMA (redness), SWELLING (swelling), HYPOKINESIA (could not lift her arm,), PRURITUS (its itchy), FEELING HOT (warm to touch), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), ILLNESS (she was just sick,), INJECTION SITE INDURATION (injection site was very hard like rock), SCRATCH (she was just scratching and scratching), PAIN (soreness is pretty bad), MALAISE (its been terrible and scary.), SOMNOLENCE (she felt sleepy only.) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medication, diabetic medication, thyroid medication, cholesterol medication. Treatment medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain
Clinical narrative: Received vaccine from a vial that had been puctured from more than 3 weeks; Soreness at both injection sites; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D25iT2D-2A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites). On 26-Jan-2021, INJECTION SITE PAIN (Soreness at both injection sites) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine from a vial that had been puctured from more than 3 weeks) and INJECTION SITE PAIN (Soreness at both injection sites) to be not related.    No treatment information and concomitant medications were reported.   This case was linked to MOD-2021-079045 (E2B Linked Report).; Sender's Comments:  MOD-2021-079045:Split case
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes on body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on body) 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 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced RASH (Rashes on body). At the time of the report, RASH (Rashes on body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication were not reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Feeling hot, Influenza, SARS-CoV-2 test
Clinical narrative: Body feels hot; Chills; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FEELING HOT (Body feels hot) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.    On 03-Apr-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 DYSPNOEA (shortness of breath) and CHILLS (Chills). On an unknown date, the patient experienced FEELING HOT (Body feels hot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), FEELING HOT (Body feels hot) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Influenza: negative (Negative) Negative. On 15-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Influenza like illness
Clinical narrative: big, huge, red spot; around her arm/ soreness/ arm was in such a condition; injection site hot; tenderness; severe flu-like symptoms; redness; chills; exhaustion; fever; achiness; dropped down two inches from injection site towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness) and INFLUENZA LIKE ILLNESS (severe flu-like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow). At the time of the report, RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Pain in extremity, Pyrexia, Rash macular
Clinical narrative: big, huge, red spot; around her arm/ soreness/ arm was in such a condition; injection site hot; tenderness; severe flu-like symptoms; redness; chills; exhaustion; fever; achiness; dropped down two inches from injection site towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness) and INFLUENZA LIKE ILLNESS (severe flu-like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow). At the time of the report, RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: big, huge, red spot; around her arm/ soreness/ arm was in such a condition; injection site hot; tenderness; severe flu-like symptoms; redness; chills; exhaustion; fever; achiness; dropped down two inches from injection site towards elbow; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness) and INFLUENZA LIKE ILLNESS (severe flu-like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 an unknown date, the patient experienced RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow). At the time of the report, RASH MACULAR (big, huge, red spot), PAIN IN EXTREMITY (around her arm/ soreness/ arm was in such a condition), INJECTION SITE WARMTH (injection site hot), TENDERNESS (tenderness), INFLUENZA LIKE ILLNESS (severe flu-like symptoms), ERYTHEMA (redness), CHILLS (chills), FATIGUE (exhaustion), PYREXIA (fever), MYALGIA (achiness) and ARTHRALGIA (dropped down two inches from injection site towards elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, COVID-19, Chills, Dizziness, Headache
Clinical narrative: Pain in bone; Dizzy; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-079209
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pain in bone; Dizzy; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-079209
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swollen bump on collar bone; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen bump on collar bone) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included ALBUTEROL [SALBUTAMOL] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 08-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 SWELLING (Swollen bump on collar bone). At the time of the report, SWELLING (Swollen bump on collar bone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: Bruise near injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise near injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION SITE BRUISING (Bruise near injection site). At the time of the report, VACCINATION SITE BRUISING (Bruise near injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: ; 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Fatigue, Headache
Clinical narrative: ear ache; terrible sore throat; arm pain; fatigue; muscle pain; joint pain; chills; Nausea; vomiting; Headache; severe swelling at the injection site; low grade fever (99 to 101.9F) daily; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 64-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.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE for Product used for unknown indication, HYDROCORTISONE and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily). At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: ear ache; terrible sore throat; arm pain; fatigue; muscle pain; joint pain; chills; Nausea; vomiting; Headache; severe swelling at the injection site; low grade fever (99 to 101.9F) daily; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 64-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.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE for Product used for unknown indication, HYDROCORTISONE and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily). At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vomiting
Clinical narrative: ear ache; terrible sore throat; arm pain; fatigue; muscle pain; joint pain; chills; Nausea; vomiting; Headache; severe swelling at the injection site; low grade fever (99 to 101.9F) daily; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 64-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.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE for Product used for unknown indication, HYDROCORTISONE and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily). At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dysstasia, Fatigue, Feeling jittery
Clinical narrative: chills; dizzy; sweaty; lethargic; difficulty standing; weak leg muscles; sore arm,; jittery; low grade fever; aches and pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic) and DYSSTASIA (difficulty standing) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-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) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), PAIN IN EXTREMITY (sore arm,), FEELING JITTERY (jittery), PYREXIA (low grade fever), MYALGIA (aches and pains) and FATIGUE (fatigue). On 21-Mar-2021, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), MYALGIA (aches and pains) and FATIGUE (fatigue) had resolved, PAIN IN EXTREMITY (sore arm,) outcome was unknown. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown. Not Provided          Treatment medication included Ibuprofen and Tylenol. Concomitant  medication were not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079100:1st dose vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: chills; dizzy; sweaty; lethargic; difficulty standing; weak leg muscles; sore arm,; jittery; low grade fever; aches and pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic) and DYSSTASIA (difficulty standing) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-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) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), PAIN IN EXTREMITY (sore arm,), FEELING JITTERY (jittery), PYREXIA (low grade fever), MYALGIA (aches and pains) and FATIGUE (fatigue). On 21-Mar-2021, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), MYALGIA (aches and pains) and FATIGUE (fatigue) had resolved, PAIN IN EXTREMITY (sore arm,) outcome was unknown. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown. Not Provided          Treatment medication included Ibuprofen and Tylenol. Concomitant  medication were not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079100:1st dose vaccine
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; dizzy; sweaty; lethargic; difficulty standing; weak leg muscles; sore arm,; jittery; low grade fever; aches and pains; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic) and DYSSTASIA (difficulty standing) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-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) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), PAIN IN EXTREMITY (sore arm,), FEELING JITTERY (jittery), PYREXIA (low grade fever), MYALGIA (aches and pains) and FATIGUE (fatigue). On 21-Mar-2021, DIZZINESS (dizzy), HYPERHIDROSIS (sweaty), LETHARGY (lethargic), DYSSTASIA (difficulty standing), MUSCULAR WEAKNESS (weak leg muscles), FEELING JITTERY (jittery), MYALGIA (aches and pains) and FATIGUE (fatigue) had resolved, PAIN IN EXTREMITY (sore arm,) outcome was unknown. At the time of the report, CHILLS (chills) and PYREXIA (low grade fever) outcome was unknown. Not Provided          Treatment medication included Ibuprofen and Tylenol. Concomitant  medication were not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079100 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079100:1st dose vaccine
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Pain in extremity, Vomiting
Clinical narrative: sore arm; diarrhea like crazy; throwing up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea like crazy), VOMITING (throwing up) and NAUSEA (nausea) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Diabetes.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea like crazy), VOMITING (throwing up) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), DIARRHOEA (diarrhea like crazy), VOMITING (throwing up) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included  antidiabetic medication and high blood pressure medication Treatment medication we.re not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Movement disorder, Nausea
Clinical narrative: low energy; Sore arm; feeling like flu; could not move arm; feeling very fatigue after first dose; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm) and FATIGUE (feeling very fatigue after first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided,.  Concomitant products included THYROID (ARMOUR THYROID) and LEVOTHYROXINE SODIUM (UNITHROID) 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 ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous). At the time of the report, ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 contains non-significant information
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: low energy; Sore arm; feeling like flu; could not move arm; feeling very fatigue after first dose; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm) and FATIGUE (feeling very fatigue after first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided,.  Concomitant products included THYROID (ARMOUR THYROID) and LEVOTHYROXINE SODIUM (UNITHROID) 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 ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous). At the time of the report, ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 contains non-significant information
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives all over the body after receiving the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives all over the body after receiving the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Developed hives all over the body after receiving the Moderna vaccine). At the time of the report, URTICARIA (Developed hives all over the body after receiving the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blister rupture, Peripheral swelling, Pruritus, Rash
Clinical narrative: Arm got swollen "really bad"and swelling of toes; Rock  hard lumps, then they turn into blisters and then there is pus coming out of them; Toes  extremely itchy; Rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes), BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them), PRURITUS (Toes  extremely itchy) and RASH (Rash on the arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Patient has a sensitive skin and that she usually gets hives from climate changes.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes), BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them), PRURITUS (Toes  extremely itchy) and RASH (Rash on the arm). On 09-Apr-2021, PERIPHERAL SWELLING (Arm got swollen "really bad"and swelling of toes) and RASH (Rash on the arm) had resolved. At the time of the report, BLISTER RUPTURE (Rock  hard lumps, then they turn into blisters and then there is pus coming out of them) and PRURITUS (Toes  extremely itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Nauseous; Fever 99.1F; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), PYREXIA (Fever 99.1F) and FATIGUE (Extremely tired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 an unknown date, the patient experienced NAUSEA (Nauseous), PYREXIA (Fever 99.1F) and FATIGUE (Extremely tired). At the time of the report, NAUSEA (Nauseous), PYREXIA (Fever 99.1F) and FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of somnolence and severe fatigue in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19  vaccine) for COVID-19 immunization. No medical history reported. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 22, 2021, patient experienced somnolence and severe fatigue. On Mar 29, 2021, severe fatigue resolved. At the time of the report, somnolence resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site rash, Pyrexia
Clinical narrative: Fever; Chills; Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE RASH (Injection site rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE RASH (Injection site rash). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and INJECTION SITE RASH (Injection site rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-079093 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079093:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: tested positive for covid-19; swollen arm; fever; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) 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 03-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 SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: postive (Positive) positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19; swollen arm; fever; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) 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 03-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 SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19), PERIPHERAL SWELLING (swollen arm), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, COVID-19: postive (Positive) positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleed) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (Nose bleed). At the time of the report, EPISTAXIS (Nose bleed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not provided. Treatment information were not provided.   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Product dose omission issue
Clinical narrative: came down with cough; he came down with cold; he was on antibiotics so missed 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (came down with cough), NASOPHARYNGITIS (he came down with cold) and PRODUCT DOSE OMISSION ISSUE (he was on antibiotics so missed 2nd dose) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (came down with cough), NASOPHARYNGITIS (he came down with cold) and PRODUCT DOSE OMISSION ISSUE (he was on antibiotics so missed 2nd dose). At the time of the report, COUGH (came down with cough), NASOPHARYNGITIS (he came down with cold) and PRODUCT DOSE OMISSION ISSUE (he was on antibiotics so missed 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness/redness in her arm; swelling/swelling in her arm; hardness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness/redness in her arm), VACCINATION SITE SWELLING (swelling/swelling in her arm) and INJECTION SITE INDURATION (hardness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient wanted to know can she take 2nd dose of Moderna vaccine after these side effects?   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: event verbatim updated, recoded and DOB added.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Oropharyngeal pain
Clinical narrative: sore throat; pain under his armpit; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 047A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included AMLODIPINE BESYLATE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and AXILLARY PAIN (pain under his armpit) outcome was unknown. Not Provided          Treatment medications included aspirin Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-079099 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079099: