chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: I got sick last week; pain on the insides felt like insides were tearing and felt like back or kidney pain; pain on the insides felt like insides were tearing and felt like back or kidney pain; I had a temperature; fatigue,exhaustion; got sick with my stomach on 5/16; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16) and PYREXIA (I had a temperature) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RIVAROXABAN (XARELTO) and FAMOTIDINE (PEPCID AC) for an unknown indication.   On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16). On an unknown date, the patient experienced ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), PYREXIA (I had a temperature) and FATIGUE (fatigue,exhaustion). At the time of the report, ILLNESS (I got sick last week), BACK PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), RENAL PAIN (pain on the insides felt like insides were tearing and felt like back or kidney pain), PYREXIA (I had a temperature) and FATIGUE (fatigue,exhaustion) had resolved and ABDOMINAL DISCOMFORT (got sick with my stomach on 5/16) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: the syringe did not work well; Patient received less of the dose/ not had launch the hole dose/received less than half of the dose and not repeating dose if patient received more that half of the; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received less of the dose/ not had launch the hole dose/received less than half of the dose and not repeating dose if patient received more that half of the) and DEVICE CONNECTION ISSUE (the syringe did not work well) in a 121-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-May-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 12-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received less of the dose/ not had launch the hole dose/received less than half of the dose and not repeating dose if patient received more that half of the). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (the syringe did not work well). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received less of the dose/ not had launch the hole dose/received less than half of the dose and not repeating dose if patient received more that half of the) and DEVICE CONNECTION ISSUE (the syringe did not work well) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Pharmacist called in to report that a patient received the second dose of the Moderna vaccine on 12 May 2021, and the syringe did not work well, and patient may not had launch the hole dose. Pharmacist said he knew the recommendation of repeating dose in opposite arm if patient received less than half of the dose and not repeating dose if patient received more that half of the dose, but wanted to know if there was any problem repeating the dose 5 or more days after the administration error. The patient is not experiencing any symptoms, but complained about receiving less dose.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Pyrexia, Somnolence
Clinical narrative: Sleeping; Total lethargy; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever) 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 SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (Sleeping), LETHARGY (Total lethargy), MYALGIA (Muscle aches) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2021-132792 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-132792:Crosslinked case of reporter
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue, Underdose
Clinical narrative: Vaccine underdose; Syringe Leaked; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked). On 16-May-2021, UNDERDOSE (Vaccine underdose) and SYRINGE ISSUE (Syringe Leaked) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-091127 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Followup received on 11-may-2021, contact details updated.; Sender's Comments:  MOD21-091127:
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a health care professional and describes the occurrence of HERPES ZOSTER (Shingles) 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) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) 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.   The concomitant medications were not reported. The treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-137830, US-MODERNATX, INC.-MOD-2021-137922 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-137830:Same reporter, different patient US-MODERNATX, INC.-MOD-2021-137922:Same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: severe pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN (severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (severe pain). At the time of the report, PAIN (severe pain) outcome was unknown.        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 and Concomitant medicines were not reported.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: could not lift arms above her shoulder; still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift arms above her shoulder) and ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]), ENALAPRIL MALEATE (LOTRIL [ENALAPRIL MALEATE]) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift arms above her shoulder). The patient was treated with Physical therapy (Ice pack) for Arthralgia. In June 2021, ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) had resolved. At the time of the report, MOBILITY DECREASED (could not lift arms above her shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-138290 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-Significant Information. On 20-Jul-2021: Concomitant Product updated, Event outcome updated.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Illness, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: could not lift arms above her shoulder; still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift arms above her shoulder) and ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]), ENALAPRIL MALEATE (LOTRIL [ENALAPRIL MALEATE]) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm). On an unknown date, the patient experienced MOBILITY DECREASED (could not lift arms above her shoulder). The patient was treated with Physical therapy (Ice pack) for Arthralgia. In June 2021, ARTHRALGIA (still had ongoing shoulder pain from the first shot on left arm\1st shot gave her shoulder pain on her left arm) had resolved. At the time of the report, MOBILITY DECREASED (could not lift arms above her shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-138290 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-Significant Information. On 20-Jul-2021: Concomitant Product updated, Event outcome updated.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: hurting all over like she had flu, slowly aching; sick; really bad, had really high fever/temperature was really high; hurting all over like she had flu, slowly aching; Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LEVOTHYROXINE and CLOTRIMAZOLE (LOTRIL [CLOTRIMAZOLE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching). The patient was treated with TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) outcome was unknown and ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-138214 (1st dose) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received and contact information was updated. On 20-Jul-2021: Follow up received  and updated date of second vaccine administrated, lot/batch number, new events and event outcome.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Illness, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: hurting all over like she had flu, slowly aching; sick; really bad, had really high fever/temperature was really high; hurting all over like she had flu, slowly aching; Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013M20A) for COVID-19 vaccination.     No medical history reported by the reporter.  Concomitant products included LEVOTHYROXINE and CLOTRIMAZOLE (LOTRIL [CLOTRIMAZOLE]) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-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 INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching). The patient was treated with TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (hurting all over like she had flu, slowly aching), ILLNESS (sick), PYREXIA (really bad, had really high fever/temperature was really high) and MYALGIA (hurting all over like she had flu, slowly aching) outcome was unknown and ARTHRALGIA (Shoulder pain at the injection site right arm so bad I would not get the vaccine/ right shoulder pain, both shoulder pain at that point) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-138214 (1st dose) (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received and contact information was updated. On 20-Jul-2021: Follow up received  and updated date of second vaccine administrated, lot/batch number, new events and event outcome.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (The patient's pre-existing medical condition includes left side heart failure,). Concurrent medical conditions included Asthma (The patient's pre-existing medical condition includes asthma) and Obesity (morbidly obese).    On 24-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 VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-138275 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Body ache; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (Left Side Heart Failure) and Asthma. Concurrent medical conditions included Obesity.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body ache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No treatment information provided by the reporter and no concomitant medication was reported.   This case was linked to MOD-2021-138232 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, Product dose omission issue
Clinical narrative: Deviation in the recommended dosing interval; Sore arm; 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 PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Deviation in the recommended dosing interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ATENOLOL for Blood pressure, CHLORTALIDONE (CHLORTHALIDONE) for Diuretic therapy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation in the recommended dosing interval). On 07-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation in the recommended dosing interval) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Heart rate: increase (High) Increase.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Hormone therapy twice weekly for Menopause. no treatment details reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Funny taste in mouth; Dizziness; Eyes hurt; Knee gave out; Cant stand up; Blood pressure was high at175/high blood pressure of 175; Chest pain; Shortness of breath; Shaking; Blurry vison; Fatigue; Pain in left shoulder/knee is sore; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out) and DYSSTASIA (Cant stand up) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, PROPRANOLOL, LORATADINE (CLARITIN [LORATADINE]) and COLCHICINE for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Eye pain, Fatigue, Hypertension, Pyrexia
Clinical narrative: Funny taste in mouth; Dizziness; Eyes hurt; Knee gave out; Cant stand up; Blood pressure was high at175/high blood pressure of 175; Chest pain; Shortness of breath; Shaking; Blurry vison; Fatigue; Pain in left shoulder/knee is sore; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out) and DYSSTASIA (Cant stand up) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, PROPRANOLOL, LORATADINE (CLARITIN [LORATADINE]) and COLCHICINE for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Tremor, Vision blurred
Clinical narrative: Funny taste in mouth; Dizziness; Eyes hurt; Knee gave out; Cant stand up; Blood pressure was high at175/high blood pressure of 175; Chest pain; Shortness of breath; Shaking; Blurry vison; Fatigue; Pain in left shoulder/knee is sore; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out) and DYSSTASIA (Cant stand up) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, PROPRANOLOL, LORATADINE (CLARITIN [LORATADINE]) and COLCHICINE for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, TASTE DISORDER (Funny taste in mouth), DIZZINESS (Dizziness), EYE PAIN (Eyes hurt), ARTHRALGIA (Knee gave out), DYSSTASIA (Cant stand up), HYPERTENSION (Blood pressure was high at175/high blood pressure of 175), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), TREMOR (Shaking), VISION BLURRED (Blurry vison), FATIGUE (Fatigue), ARTHRALGIA (Pain in left shoulder/knee is sore), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash, Vaccination site pain
Clinical narrative: tingling throughout arm; rash on left buttocks; constant pain in arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 11-May-2021, the patient experienced PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (tingling throughout arm), RASH (rash on left buttocks) and VACCINATION SITE PAIN (constant pain in arm of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Felt a in knot in the left arm) and CONTUSION (Bruise in the  left arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced PERIPHERAL SWELLING (Felt a in knot in the left arm) and CONTUSION (Bruise in the  left arm). At the time of the report, PERIPHERAL SWELLING (Felt a in knot in the left arm) and CONTUSION (Bruise in the  left arm) 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. This case was linked to US-MODERNATX, INC.-MOD-2021-137973 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-137973:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose administered too early (21 days); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered too early (21 days)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Illness, Myalgia, Pain
Clinical narrative: felt very weak; For 3 days, I felt very sick.; pain everywhere; arm hurt; some parts of my body hurt so much; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much) 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 COVID-19 from 16-Jan-2021 to 09-Feb-2021.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much). At the time of the report, ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Blood work came out with positive antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: felt very weak; For 3 days, I felt very sick.; pain everywhere; arm hurt; some parts of my body hurt so much; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much) 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 COVID-19 from 16-Jan-2021 to 09-Feb-2021.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much). At the time of the report, ASTHENIA (felt very weak), ILLNESS (For 3 days, I felt very sick.), PAIN (pain everywhere), PAIN IN EXTREMITY (arm hurt) and MYALGIA (some parts of my body hurt so much) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) Blood work came out with positive antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 Positive after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 Positive after the first dose) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced COVID-19 (COVID-19 Positive after the first dose). At the time of the report, COVID-19 (COVID-19 Positive after the first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-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.   It was reported that patient was around 50-years of age.  No concomitant medications reported.  Treatment of the events were not reported.  It was reported that the patient was scheduled for the second dose on 22-MAY-2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Palpitations, Vomiting
Clinical narrative: Palpitations worse than chemical stress test; Headache; Vomiting; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpitations worse than chemical stress test), HEADACHE (Headache) and VOMITING (Vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PALPITATIONS (Palpitations worse than chemical stress test), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, PALPITATIONS (Palpitations worse than chemical stress test), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided.  No laboratory data was provided.   No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness of right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of right arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C2A and 027B21A) for COVID-19 vaccination.     No medical history was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (Soreness of right arm). The patient was treated with DIPHENHYDRAMINE CITRATE, IBUPROFEN (MOTRIN PM) at a dose of UNK dosage form and PREDNISONE at a dose of UNK dosage form. On 08-May-2021, PAIN IN EXTREMITY (Soreness of right arm) had resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Patient received it in her right arm and patient experienced sore arm but resolved after 2-3 days.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Myalgia, Sneezing
Clinical narrative: I have allergies; coughing; sneezing; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (I have allergies), COUGH (coughing), SNEEZING (sneezing) and MYALGIA (a sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (She mentioned that she gets allergies around this time of the year and there was lot of pollen.). Concomitant products included METFORMIN, LISINOPRIL, ATORVASTATIN, GLIPIZIDE, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 [VITAMIN B12 NOS] and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced MYALGIA (a sore arm). On 01-May-2021, the patient experienced HYPERSENSITIVITY (I have allergies), COUGH (coughing) and SNEEZING (sneezing). On 17-May-2021, MYALGIA (a sore arm) had resolved. At the time of the report, HYPERSENSITIVITY (I have allergies), COUGH (coughing) and SNEEZING (sneezing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took an over-the-counter allergy medication since 01-May-2021, but it has not helped her allergies.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain in extremity
Clinical narrative: feeling terrible; severe headache; body aches; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (feeling terrible), HEADACHE (severe headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Peripheral swelling, Pruritus, Rash
Clinical narrative: Feeling tired and week; Swollen arm and itch; Swollen arm and itch; Bright red cherry rash on right arm; Feeling tired and week; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032A21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for Fibrodysplasia ossificans progressiva, AMLODIPINE for Hypertension, LEVOTHYROXINE for Hypothyroidism.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Feeling tired and week), PERIPHERAL SWELLING (Swollen arm and itch), PRURITUS (Swollen arm and itch), RASH (Bright red cherry rash on right arm) and FATIGUE (Feeling tired and week) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: pain in the arm; headache; a lot of sneezing; I think I have flu; a lot of snot; a lot of cough; body ache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and VACCINATION SITE PAIN (pain in the arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (very tired) and MYALGIA (body ache). On 03-May-2021, the patient experienced SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SNEEZING (a lot of sneezing), INFLUENZA LIKE ILLNESS (I think I have flu), RHINORRHOEA (a lot of snot), COUGH (a lot of cough), VACCINATION SITE PAIN (pain in the arm), FATIGUE (very tired), HEADACHE (headache) and MYALGIA (body ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included medication for blood pressure, cholesterol and medication used for sleep. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.