chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test, Tinnitus
Clinical narrative: Not taking the 2nd dose; Itchy after the 1st dose; Ringing in ears after 1st dose; Felt like had the worst flu ever had after 1st dose; Arm swollen after 1st dose; Arm hot after 1st dose; Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose; Neck stiff after 1st dose; Couldn't eat after 1st dose; Nauseous after 1st dose; Temperature of 101.4 F after 1st dose; Exploding headache after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose) and PERIPHERAL SWELLING (Arm swollen after 1st dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in August 2020, Nausea and Diarrhea.    On 12-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 PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), FEELING HOT (Arm hot after 1st dose), PAIN IN EXTREMITY (Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose), MUSCULOSKELETAL STIFFNESS (Neck stiff after 1st dose), FEEDING DISORDER (Couldn't eat after 1st dose), NAUSEA (Nauseous after 1st dose), PYREXIA (Temperature of 101.4 F after 1st dose) and HEADACHE (Exploding headache after 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not taking the 2nd dose), PRURITUS (Itchy after the 1st dose), TINNITUS (Ringing in ears after 1st dose), INFLUENZA (Felt like had the worst flu ever had after 1st dose), PERIPHERAL SWELLING (Arm swollen after 1st dose), FEELING HOT (Arm hot after 1st dose), PAIN IN EXTREMITY (Feet hurt after 1st dose/ Arm felt like bees biting after the 1st dose), MUSCULOSKELETAL STIFFNESS (Neck stiff after 1st dose), FEEDING DISORDER (Couldn't eat after 1st dose), NAUSEA (Nauseous after 1st dose), PYREXIA (Temperature of 101.4 F after 1st dose) and HEADACHE (Exploding headache after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body temperature: high (High) high and 101.4 (High) Temperature of 101.4 F after 1st dose.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment using  tylenol, gatorade,green tea was reported Concomitant medication information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: nni
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Peripheral swelling
Clinical narrative: Arm sore; arm being a little swollen; took breath away / shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, MONTELUKAST SODIUM (SINGULAIR) and Breo Inhaler for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath). At the time of the report, PAIN IN EXTREMITY (Arm sore), PERIPHERAL SWELLING (arm being a little swollen) and DYSPNOEA (took breath away / shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-076350 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076350:Dose 2
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: fever; 3 bumps: one in the palm and two big ones in the lower arm; big rash; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm), RASH (big rash) and PYREXIA (fever) in a 37-year-old female patient 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) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm) and RASH (big rash). On 11-Apr-2021, the patient experienced PYREXIA (fever). At the time of the report, PERIPHERAL SWELLING (3 bumps: one in the palm and two big ones in the lower arm), RASH (big rash) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Possible cause of AE was covid infection as patient was tested positive.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Discomfort, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: feels tired; aches & pains; Quite out; breathing troubles; diarrhea; not felt good; sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good) and FATIGUE (feels tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included medication for blood pressure, medication for COPD, medication for heart, medication for high sugar and pain medication for neck and back pain for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (sore arm). On 31-Mar-2021, the patient experienced DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea) and FEELING ABNORMAL (not felt good). On 04-Apr-2021, the patient experienced DISCOMFORT (Quite out). On 12-Apr-2021, the patient experienced FATIGUE (feels tired) and PAIN (aches & pains). At the time of the report, MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good), FATIGUE (feels tired), PAIN (aches & pains) and DISCOMFORT (Quite out) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: feels tired; aches & pains; Quite out; breathing troubles; diarrhea; not felt good; sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good) and FATIGUE (feels tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included medication for blood pressure, medication for COPD, medication for heart, medication for high sugar and pain medication for neck and back pain for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (sore arm). On 31-Mar-2021, the patient experienced DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea) and FEELING ABNORMAL (not felt good). On 04-Apr-2021, the patient experienced DISCOMFORT (Quite out). On 12-Apr-2021, the patient experienced FATIGUE (feels tired) and PAIN (aches & pains). At the time of the report, MYALGIA (sore arm), DYSPNOEA (breathing troubles), DIARRHOEA (diarrhea), FEELING ABNORMAL (not felt good), FATIGUE (feels tired), PAIN (aches & pains) and DISCOMFORT (Quite out) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Adverse drug reaction, Blood pressure increased, Dizziness, Fatigue
Clinical narrative: very tired; Nausea; tired; threw up; Dizzy; Abdominal pain; very pain and cold; very pain and cold; blood pressure went up little bit; sweating a lot; mouth change of color kind like purple or blue; weird episode that never had before; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold) and BLOOD PRESSURE INCREASED (blood pressure went up little bit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003ACIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for Reflux esophagitis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up). On 20-Mar-2021, the patient experienced FATIGUE (very tired). On 19-Mar-2021, DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasopharyngitis, Nausea, Oral pigmentation, Pain
Clinical narrative: very tired; Nausea; tired; threw up; Dizzy; Abdominal pain; very pain and cold; very pain and cold; blood pressure went up little bit; sweating a lot; mouth change of color kind like purple or blue; weird episode that never had before; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold) and BLOOD PRESSURE INCREASED (blood pressure went up little bit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003ACIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for Reflux esophagitis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up). On 20-Mar-2021, the patient experienced FATIGUE (very tired). On 19-Mar-2021, DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: very tired; Nausea; tired; threw up; Dizzy; Abdominal pain; very pain and cold; very pain and cold; blood pressure went up little bit; sweating a lot; mouth change of color kind like purple or blue; weird episode that never had before; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold) and BLOOD PRESSURE INCREASED (blood pressure went up little bit) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003ACIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history were reported.  Concomitant products included PANTOPRAZOLE for Reflux esophagitis.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up). On 20-Mar-2021, the patient experienced FATIGUE (very tired). On 19-Mar-2021, DIZZINESS (Dizzy), ABDOMINAL PAIN (Abdominal pain), PAIN (very pain and cold), NASOPHARYNGITIS (very pain and cold), BLOOD PRESSURE INCREASED (blood pressure went up little bit), HYPERHIDROSIS (sweating a lot), ORAL PIGMENTATION (mouth change of color kind like purple or blue), ADVERSE DRUG REACTION (weird episode that never had before), NAUSEA (Nausea), FATIGUE (tired) and VOMITING (threw up) had resolved. At the time of the report, FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: experiencing itching, extreme itching, around where the shot was given; the area is really red; very hard like a hard nut; is very swollen; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen) in a 76-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. Concomitant products included blood pressure pill for an unknown indication.    On 05-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 VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen). At the time of the report, VACCINATION SITE PRURITUS (experiencing itching, extreme itching, around where the shot was given), VACCINATION SITE ERYTHEMA (the area is really red), VACCINATION SITE INDURATION (very hard like a hard nut) and VACCINATION SITE SWELLING (is very swollen) 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.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Large Red Spot at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Large Red Spot at Injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 INJECTION SITE ERYTHEMA (Large Red Spot at Injection site). At the time of the report, INJECTION SITE ERYTHEMA (Large Red Spot at Injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include Halls with honey throat lozenges.   This case was linked to US-MODERNATX, INC.-MOD-2021-076546 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076546:LINKED WITH DOSE 2
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue
Clinical narrative: Lost appetite; feels very fatigued.; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.). At the time of the report, DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076538 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076538:CROSS LINKED WITH DOSE 1
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Pain in extremity, Pyrexia
Clinical narrative: Head does not hurt but it feels heavy; High temperature; Sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (High temperature) and HEAD DISCOMFORT (Head does not hurt but it feels heavy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PAIN IN EXTREMITY (Sore arm). On 14-Apr-2021, the patient experienced PYREXIA (High temperature). On an unknown date, the patient experienced HEAD DISCOMFORT (Head does not hurt but it feels heavy). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (High temperature) and HEAD DISCOMFORT (Head does not hurt but it feels heavy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Feeling abnormal, Hypersensitivity, Illness
Clinical narrative: felt like collapsing; not good feelings; felt very uncomfortable; cramping mouth; breathing got deeper; felt like sick; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth) and DYSPNOEA (breathing got deeper) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Cholesterol medicine and High blood pressure medicine for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy). At the time of the report, PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Presyncope
Clinical narrative: felt like collapsing; not good feelings; felt very uncomfortable; cramping mouth; breathing got deeper; felt like sick; Allergy; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth) and DYSPNOEA (breathing got deeper) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Cholesterol medicine and High blood pressure medicine for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy). At the time of the report, PRESYNCOPE (felt like collapsing), FEELING ABNORMAL (not good feelings), DISCOMFORT (felt very uncomfortable), ORAL PAIN (cramping mouth), DYSPNOEA (breathing got deeper), ILLNESS (felt like sick) and HYPERSENSITIVITY (Allergy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness in the arm (left arm); tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the arm (left arm)) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 007M20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concurrent medical conditions included Allergy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in the arm (left arm)) and FATIGUE (tired). On 04-Feb-2021, FATIGUE (tired) had resolved. On 05-Feb-2021, VACCINATION SITE PAIN (soreness in the arm (left arm)) had resolved. 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.   This case was linked to MOD-2021-009093, MOD-2021-076768 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Nausea, SARS-CoV-2 test positive
Clinical narrative: Seems like covid all over again; chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (Nausea) and COVID-19 (Seems like covid all over again) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Mar-2021, the patient experienced CHILLS (chills) and NAUSEA (Nausea). On an unknown date, the patient experienced COVID-19 (Seems like covid all over again). At the time of the report, CHILLS (chills), NAUSEA (Nausea) and COVID-19 (Seems like covid all over again) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Nov-2021, SARS-CoV-2 test positive: positive Positive.   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.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Injection site bump; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No medical history was provided by reporter.  No concomitant medication reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness). At the time of the report, INJECTION SITE NODULE (Injection site bump) and INJECTION SITE PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concurrent medication not provided. Treatment medication not provided.    Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Eye pain, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: throat pain; back pain; Headache; right eye pain; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), EYE PAIN (right eye pain), OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 12-Apr-2021, the patient experienced EYE PAIN (right eye pain). On 14-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Apr-2021, EYE PAIN (right eye pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm Pain), OROPHARYNGEAL PAIN (throat pain), BACK PAIN (back pain) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-101123 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Fear, Headache, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; little blurred vision; straight to double vision; Very scared; headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little blurred vision), PAIN IN EXTREMITY (sore arm), DIPLOPIA (straight to double vision), FEAR (Very scared) and HEADACHE (headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), FEAR (Very scared) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). On 13-Apr-2021, VISION BLURRED (little blurred vision) and DIPLOPIA (straight to double vision) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FEAR (Very scared) and PYREXIA (fever) outcome was unknown and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was unknown  Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-077907 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077907:Dose 1
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: sore arm; fever; little blurred vision; straight to double vision; Very scared; headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (little blurred vision), PAIN IN EXTREMITY (sore arm), DIPLOPIA (straight to double vision), FEAR (Very scared) and HEADACHE (headache) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VISION BLURRED (little blurred vision), DIPLOPIA (straight to double vision), FEAR (Very scared) and HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (fever). On 13-Apr-2021, VISION BLURRED (little blurred vision) and DIPLOPIA (straight to double vision) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), FEAR (Very scared) and PYREXIA (fever) outcome was unknown and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was unknown  Treatment information was unknown   This case was linked to US-MODERNATX, INC.-MOD-2021-077907 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077907:Dose 1
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Runny nose; Nasal Congestion; Cough; This spontaneous case was reported by a physician and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-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 RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (Nasal Congestion) and COUGH (Cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test: positiive (Positive) Positive.     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 treatment and concomitant medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyskinesia, Moaning, Pain in extremity
Clinical narrative: After 2 hours, arm hurt a little bit; Laid in bed and groaned for 18 hours; not wanting to move; started feeling weak; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After 2 hours, arm hurt a little bit), ASTHENIA (started feeling weak), MOANING (Laid in bed and groaned for 18 hours) and DYSKINESIA (not wanting to move) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021 at 10:00 PM, the patient experienced ASTHENIA (started feeling weak). On an unknown date, the patient experienced PAIN IN EXTREMITY (After 2 hours, arm hurt a little bit), MOANING (Laid in bed and groaned for 18 hours) and DYSKINESIA (not wanting to move). At the time of the report, PAIN IN EXTREMITY (After 2 hours, arm hurt a little bit), ASTHENIA (started feeling weak), MOANING (Laid in bed and groaned for 18 hours) and DYSKINESIA (not wanting to move) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received her first dose of the Moderna COVID-19 vaccine on 30Mar2021 at 3:10PM, in her upper left arm. After 2 hours, her arm hurt a little bit. By 10pm, patient started feeling weak and in pain, not wanting to move. She described that she laid in bed and groaned for 18 hours. Patient took Tylenol to alleviate the discomfort. At this time, all symptoms have subsided. Her vaccine was administered at the Health Department. Patient has a medical history of diabetes. She has a second appointment scheduled on 27April2021, however, she is going away and wanted to know what she can do about rescheduling.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Myalgia, Paraesthesia oral
Clinical narrative: tingling of the lips; Joint pain; muscle pain; felt dizzy after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy after vaccination), PARAESTHESIA ORAL (tingling of the lips), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (felt dizzy after vaccination). On 12-Apr-2021, the patient experienced PARAESTHESIA ORAL (tingling of the lips), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN at a dose of 600 mg. On 10-Apr-2021, DIZZINESS (felt dizzy after vaccination) had resolved. At the time of the report, PARAESTHESIA ORAL (tingling of the lips), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain) 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.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 1805031) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. no treatment medications reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus of the left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus of the left ear) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced TINNITUS (Tinnitus of the left ear). At the time of the report, TINNITUS (Tinnitus of the left ear) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used over the counter ear drops to try to alleviate the symptoms. No concomitant medications reported by investigator
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: feet and hand were red; itchy hand and feet; all of sudden redness at the injection site,another sort of horizontal lines at the injection site; Itchy at injection site; 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 ERYTHEMA (feet and hand were red), PRURITUS (itchy hand and feet), VACCINATION SITE ERYTHEMA (all of sudden redness at the injection site,another sort of horizontal lines at the injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced ERYTHEMA (feet and hand were red), PRURITUS (itchy hand and feet), VACCINATION SITE ERYTHEMA (all of sudden redness at the injection site,another sort of horizontal lines at the injection site) and VACCINATION SITE PRURITUS (Itchy at injection site). On 14-Apr-2021, ERYTHEMA (feet and hand were red), VACCINATION SITE ERYTHEMA (all of sudden redness at the injection site,another sort of horizontal lines at the injection site) and VACCINATION SITE PRURITUS (Itchy at injection site) had resolved and PRURITUS (itchy hand and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral coldness
Clinical narrative: Soreness on the left arm; left hand felt cold; barely use left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin infection, Skin swelling
Clinical narrative: left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"; liquid filled under the skin, accumulation of lymphatic fluid on arm; Soft to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No  medical history was provided.     On 29-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 PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch). At the time of the report, PERIPHERAL SWELLING (left arm is /Swelling on arm "volume is one of a small egg - perhaps 60 cm^3"), SKIN INFECTION (liquid filled under the skin, accumulation of lymphatic fluid on arm) and SKIN SWELLING (Soft to touch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Significant follow up appended
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Bedridden, Chills, Dizziness, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache) and BEDRIDDEN (2 days she was in bed) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A - 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Blood pressure med, LISINOPRIL, carvedilol                                                     Heart, ezetimibe                                                      Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) and ESZOPICLONE (8 HORAS) for an unknown indication.    On 28-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 UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting). At the time of the report, UNEVALUABLE EVENT (had reaction after second dose), CHILLS (Chills), PAIN (body aches), HEADACHE (very terrible headache.Very very bad headache), BEDRIDDEN (2 days she was in bed), TINNITUS (ringing earing and tinnitus.they never gone away, almost 2 month ago), INSOMNIA (preventing her from sleeping), DIZZINESS (Dizziness), BALANCE DISORDER (balance issue), NAUSEA (Nausea), MALAISE (Today is in bed again feeling is going to been sick again), MYALGIA (muscle pain) and VOMITING (Vomitting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, the age units corrected to years.