chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Feeling abnormal, Illness, Symptom recurrence
Clinical narrative: everything came back; major discomfort; felt bad Saturday/felt bad Sunday; really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine; very weak /was not flu-like; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like), DISCOMFORT (major discomfort), SYMPTOM RECURRENCE (everything came back) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concurrent medical conditions included Illness on 23-Jan-2021, Asthenia on 23-Jan-2021, Discomfort on 23-Jan-2021, Symptom recurrence on 28-Jan-2021 and Allergy (fosamax). Concomitant products included LISINOPRIL and METOPROLOL for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday). On 25-Jan-2021, the patient experienced DISCOMFORT (major discomfort). On 28-Jan-2021, the patient experienced SYMPTOM RECURRENCE (everything came back). At the time of the report, ILLNESS (really sick/felt sick all over/ like she "had some kind of disease"/extremely sick after receiving the vaccine), ASTHENIA (very weak /was not flu-like), DISCOMFORT (major discomfort), SYMPTOM RECURRENCE (everything came back) and FEELING ABNORMAL (felt bad Saturday/felt bad Sunday) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: stayed in bed; driving headache; felt like throat had something in it; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FISH OIL and RIVAROXABAN (XARELTO) for an unknown indication.    On 10-Feb-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 ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm). At the time of the report, ASTHENIA (stayed in bed), HEADACHE (driving headache), OROPHARYNGEAL DISCOMFORT (felt like throat had something in it) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Fatigue, Myalgia, Pain in extremity
Clinical narrative: experiencing side effects; arm hurts; muscle ache; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired). At the time of the report, ADVERSE DRUG REACTION (experiencing side effects), PAIN IN EXTREMITY (arm hurts), MYALGIA (muscle ache) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Skin tightness, Vaccination site reaction
Clinical narrative: Very large area of erythema that persists; Slight induration; Skin is tense; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration), SKIN TIGHTNESS (Skin is tense) and VACCINATION SITE REACTION (COVID arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration) and SKIN TIGHTNESS (Skin is tense). 15-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). At the time of the report, ERYTHEMA (Very large area of erythema that persists), INDURATION (Slight induration), SKIN TIGHTNESS (Skin is tense) and VACCINATION SITE REACTION (COVID arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-252560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received: Contains reporter address, demographics, 2nd dose details, new adverse event and event outcome updated.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: arm sore; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (arm sore), PYREXIA (fever) and CHILLS (chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (arm sore), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (arm sore), PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medicine for his cholesterol and his heart rate. No relevant concomitant medications reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received on 21-Apr-2021,patient received second dose and no adverse event reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Pain in their arm; felt tired, stayed in bed all day.; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Pain in their arm), FATIGUE (felt tired, stayed in bed all day.), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-027768 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-027768:Crosslinked case
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Pain
Clinical narrative: Coughing; Headache; Soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue). At the time of the report, COUGH (Coughing), HEADACHE (Headache), PAIN (Soreness) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Illness, Nausea
Clinical narrative: weakness; nausea; a couple of people at my clinic  have gotten really ill from the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the vaccine) 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 ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the vaccine). At the time of the report, ASTHENIA (weakness), NAUSEA (nausea) and ILLNESS (a couple of people at my clinic have gotten really ill from the 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.   No relevant concomitant medications were reported. Treatment details included Not provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Lost sense of taste and smell; Lost sense of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost sense of taste and smell) and ANOSMIA (Lost sense of taste and smell) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced AGEUSIA (Lost sense of taste and smell) and ANOSMIA (Lost sense of taste and smell). At the time of the report, AGEUSIA (Lost sense of taste and smell) and ANOSMIA (Lost sense of taste and smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Dizziness, Erythema, Feeling hot
Clinical narrative: little bit of pain at the injection site; heart racing; Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body; itchy chest; red dots under skin on chest as if rash is about to form; rash on face; face being warm; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest) and ERYTHEMA (red dots under skin on chest as if rash is about to form) in a 79-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.     The patient's past medical history included Breast cancer (previous breast cancer patient,(occurred 20 years ago).). Concurrent medical conditions included Asthma (Patient has severe asthma). Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest), ERYTHEMA (red dots under skin on chest as if rash is about to form), RASH (rash on face), FEELING HOT (face being warm) and DIZZINESS (dizziness). At the time of the report, VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest), ERYTHEMA (red dots under skin on chest as if rash is about to form), RASH (rash on face), FEELING HOT (face being warm) and DIZZINESS (dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 163/n/a..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Rash, Vaccination site pain
Clinical narrative: little bit of pain at the injection site; heart racing; Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body; itchy chest; red dots under skin on chest as if rash is about to form; rash on face; face being warm; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest) and ERYTHEMA (red dots under skin on chest as if rash is about to form) in a 79-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.     The patient's past medical history included Breast cancer (previous breast cancer patient,(occurred 20 years ago).). Concurrent medical conditions included Asthma (Patient has severe asthma). Concomitant products included SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest), ERYTHEMA (red dots under skin on chest as if rash is about to form), RASH (rash on face), FEELING HOT (face being warm) and DIZZINESS (dizziness). At the time of the report, VACCINATION SITE PAIN (little bit of pain at the injection site), PALPITATIONS (heart racing), BLOOD PRESSURE ABNORMAL (Blood pressure of 163/n/a/could feel the high blood pressure in head and throughout the body), PRURITUS (itchy chest), ERYTHEMA (red dots under skin on chest as if rash is about to form), RASH (rash on face), FEELING HOT (face being warm) and DIZZINESS (dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 163/n/a..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Felt fatigue; chills; 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 FATIGUE (Felt fatigue) and CHILLS (chills) 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 FATIGUE (Felt fatigue) and CHILLS (chills). At the time of the report, FATIGUE (Felt fatigue) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Fatigue, Headache
Clinical narrative: fatigue; headache; muscle pain; cough; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), COUGH (cough) and CHILLS (chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), COUGH (cough), CHILLS (chills) and DIARRHOEA (diarrhea). On 30-Jan-2021, DIARRHOEA (diarrhea) had resolved. On 03-Feb-2021, HEADACHE (headache) had resolved. On 06-Feb-2021, FATIGUE (fatigue), MYALGIA (muscle pain), COUGH (cough) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for events included Emergen-C, Pedialyte and Waltussin-DMX.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: fatigue; headache; muscle pain; cough; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), COUGH (cough) and CHILLS (chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), COUGH (cough), CHILLS (chills) and DIARRHOEA (diarrhea). On 30-Jan-2021, DIARRHOEA (diarrhea) had resolved. On 03-Feb-2021, HEADACHE (headache) had resolved. On 06-Feb-2021, FATIGUE (fatigue), MYALGIA (muscle pain), COUGH (cough) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for events included Emergen-C, Pedialyte and Waltussin-DMX.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: lymphadenopathy; Fused rash; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash). At the time of the report, LYMPHADENOPATHY (lymphadenopathy) and RASH (Fused rash) 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.   No relevant concomitant medications were reported. Treatment details included Tylenol, Antiallergy medication
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Experience side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Experience side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Experience side effects). At the time of the report, VACCINATION COMPLICATION (Experience side effects) 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity
Clinical narrative: feels her arm sore; body aches; feels her arm sore, had a low grade headache and body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches). At the time of the report, PAIN IN EXTREMITY (feels her arm sore), MYALGIA (body aches) and HEADACHE (feels her arm sore, had a low grade headache and body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lip) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LIP SWELLING (Swollen lip). The patient was treated with CETOMACROGOL, PARAFFIN, LIQUID, PROPYLENE GLYCOL, WHITE SOFT PARAFFIN (VASELINE CETOMACROGOL CREAM) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swollen lip) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included VALSARTAN and ATENOLOL for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pallor, Pyrexia
Clinical narrative: yellowing and pale skin on both arms; fever of 101 degrees; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, PALLOR (yellowing and pale skin on both arms), PYREXIA (fever of 101 degrees), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101.     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.   Treatment details included None.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Insomnia, Pruritus, Rash, Rash erythematous
Clinical narrative: Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.; Blisters; Itching; Spent two sleepless nights; Rash was red; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), BLISTER (Blisters), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), BLISTER (Blisters), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red). On 11-Feb-2021, BLISTER (Blisters) outcome was unknown. At the time of the report, RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Tired; Didn't feel well; red rash below the injection site; Nausea; Headache; Fever; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), MALAISE (Didn't feel well), VACCINATION SITE ERYTHEMA (red rash below the injection site), FATIGUE (Tired) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia, Drug allergy (Codeine Allergy), Drug allergy (Sulfa drugs), Penicillin allergy, Drug allergy (Doxycycline allergy), Drug allergy (Z-Pack) and Epinephrine. Concomitant products included DEXLANSOPRAZOLE (DEXILANT), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Tachycardia). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash below the injection site), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (Didn't feel well) and FATIGUE (Tired). On 29-Jan-2021, TACHYCARDIA (Tachycardia) had resolved. On 31-Jan-2021, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 06-Feb-2021, VACCINATION SITE ERYTHEMA (red rash below the injection site) had resolved. At the time of the report, MALAISE (Didn't feel well) had resolved and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: unknown (Inconclusive) SARCOV2 serology (covid-19) abigg and the results were positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vaccination site erythema
Clinical narrative: Tired; Didn't feel well; red rash below the injection site; Nausea; Headache; Fever; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), MALAISE (Didn't feel well), VACCINATION SITE ERYTHEMA (red rash below the injection site), FATIGUE (Tired) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tachycardia, Drug allergy (Codeine Allergy), Drug allergy (Sulfa drugs), Penicillin allergy, Drug allergy (Doxycycline allergy), Drug allergy (Z-Pack) and Epinephrine. Concomitant products included DEXLANSOPRAZOLE (DEXILANT), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TACHYCARDIA (Tachycardia). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red rash below the injection site), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). On an unknown date, the patient experienced MALAISE (Didn't feel well) and FATIGUE (Tired). On 29-Jan-2021, TACHYCARDIA (Tachycardia) had resolved. On 31-Jan-2021, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) had resolved. On 06-Feb-2021, VACCINATION SITE ERYTHEMA (red rash below the injection site) had resolved. At the time of the report, MALAISE (Didn't feel well) had resolved and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: unknown (Inconclusive) SARCOV2 serology (covid-19) abigg and the results were positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Vaccination site rash
Clinical narrative: warm injection site; sore-to-the-touch injection site; big red blotch a few inches above the elbow; rash above the arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm) 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 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm). At the time of the report, INJECTION SITE WARMTH (warm injection site), INJECTION SITE PAIN (sore-to-the-touch injection site), INJECTION SITE ERYTHEMA (big red blotch a few inches above the elbow) and VACCINATION SITE RASH (rash above the arm) outcome was unknown.            No concomitant medication was provided  No treatment medication was provided   This case was linked to MOD-2021-028898 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 contains non-significant information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: arm was hot; her arm started to itch; again a large welt (3,25 inch diameter), pink in her arm; arm was Swollen; arm was swollen; she had a large welt,pink in her arm; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was a little sore), VACCINATION SITE URTICARIA (she had a large welt,pink in her arm), VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PRURITUS (her arm started to itch) and VACCINATION SITE WARMTH (arm was hot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN for Clotting disorder, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MONTELUKAST for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm was a little sore). On 06-Feb-2021, the patient experienced VACCINATION SITE URTICARIA (she had a large welt,pink in her arm) and VACCINATION SITE SWELLING (arm was swollen). On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (her arm started to itch), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE URTICARIA (again a large welt (3,25 inch diameter), pink in her arm) and VACCINATION SITE SWELLING (arm was Swollen). On 06-Feb-2021, VACCINATION SITE PAIN (arm was a little sore), VACCINATION SITE URTICARIA (she had a large welt,pink in her arm) and VACCINATION SITE SWELLING (arm was swollen) had resolved. At the time of the report, VACCINATION SITE PRURITUS (her arm started to itch), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE URTICARIA (again a large welt (3,25 inch diameter), pink in her arm) and VACCINATION SITE SWELLING (arm was Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications included high blood pressure medication and diuretic.  Treatment included ice and allergy pill.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenopia, Facial discomfort, Ocular discomfort, Vaccination site discomfort
Clinical narrative: right arm discomfort; eyelids became heavy; small slits of eyes; brow was brought down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (right arm discomfort), ASTHENOPIA (eyelids became heavy), OCULAR DISCOMFORT (small slits of eyes) and FACIAL DISCOMFORT (brow was brought down) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Scar. Previously administered products included for an unreported indication: JUVEDERM. Concurrent medical conditions included Drug allergy, Drug allergy, Drug allergy, Seasonal allergy and Complex regional pain syndrome Type II (affects left arm). Concomitant products included POTASSIUM, PROPRANOLOL, LISDEXAMFETAMINE MESILATE (VYVANSE), VITAMIN D NOS and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Jan-2021, the patient experienced VACCINATION SITE DISCOMFORT (right arm discomfort), ASTHENOPIA (eyelids became heavy), OCULAR DISCOMFORT (small slits of eyes) and FACIAL DISCOMFORT (brow was brought down). On 14-Jan-2021, VACCINATION SITE DISCOMFORT (right arm discomfort), ASTHENOPIA (eyelids became heavy), OCULAR DISCOMFORT (small slits of eyes) and FACIAL DISCOMFORT (brow was brought down) had resolved.            Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2021-029855 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-029855:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache
Clinical narrative: Loss of appetite; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient's second shot was due on 12 Feb 2021.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Periarthritis, Vaccination site pain
Clinical narrative: diarrhea; feeling nauseous; soreness at the site of the injection; she felt like she was having a frozen shoulder again; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again), DIARRHOEA (diarrhea), NAUSEA (feeling nauseous) and VACCINATION SITE PAIN (soreness at the site of the injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Frozen shoulder.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again) and VACCINATION SITE PAIN (soreness at the site of the injection). On 11-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and NAUSEA (feeling nauseous). On 11-Feb-2021, PERIARTHRITIS (soreness progressed, felt like she was having a frozen shoulder again) and VACCINATION SITE PAIN (soreness at the site of the injection) had resolved. On 13-Feb-2021, DIARRHOEA (diarrhea) had resolved. On 15-Feb-2021, NAUSEA (feeling nauseous) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pruritus, Rash
Clinical narrative: malaise; itching on the side of his neck (From under the ear to shoulder); Rash on the side of his neck (From under the ear to shoulder); This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)). At the time of the report, MALAISE (malaise), PRURITUS (itching on the side of his neck (From under the ear to shoulder)) and RASH (Rash on the side of his neck (From under the ear to shoulder)) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not reported.  The patient had a rash and itching on the side of his neck (from under the ear to shoulder) which looked like shingles. The patient used a Steroid cream that he had at home and it looked better.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Chills, Eyelid ptosis, Fatigue, Feeling hot
Clinical narrative: Arm started to aches; felt agitated; Crown of head really hurt; Couldnt Sleep; Eyes were droopy; body hurt; got hot; Bad headache; Woke up fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep) and EYELID PTOSIS (Eyes were droopy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep), EYELID PTOSIS (Eyes were droopy), PAIN (body hurt), FEELING HOT (got hot), HEADACHE (Bad headache), FATIGUE (Woke up fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep), EYELID PTOSIS (Eyes were droopy), PAIN (body hurt), FEELING HOT (got hot), HEADACHE (Bad headache), FATIGUE (Woke up fatigue) and CHILLS (Chills) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Insomnia, Pain, Pain in extremity
Clinical narrative: Arm started to aches; felt agitated; Crown of head really hurt; Couldnt Sleep; Eyes were droopy; body hurt; got hot; Bad headache; Woke up fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep) and EYELID PTOSIS (Eyes were droopy) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep), EYELID PTOSIS (Eyes were droopy), PAIN (body hurt), FEELING HOT (got hot), HEADACHE (Bad headache), FATIGUE (Woke up fatigue) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm started to aches), AGITATION (felt agitated), HEAD DISCOMFORT (Crown of head really hurt), INSOMNIA (Couldnt Sleep), EYELID PTOSIS (Eyes were droopy), PAIN (body hurt), FEELING HOT (got hot), HEADACHE (Bad headache), FATIGUE (Woke up fatigue) and CHILLS (Chills) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pain, Vaccination site warmth
Clinical narrative: warm to the touch at the injection site; knot at the injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site), VACCINATION SITE WARMTH (warm to the touch at the injection site) and VACCINATION SITE NODULE (knot at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. The patient did not use any treatment medication.