chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Paraesthesia
Clinical narrative: Slight nasal congestion; Almost tickling sensation on top of the affected nose; 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 NASAL CONGESTION (Slight nasal congestion) and PARAESTHESIA (Almost tickling sensation on top of the affected nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Slight nasal congestion) and PARAESTHESIA (Almost tickling sensation on top of the affected nose). At the time of the report, NASAL CONGESTION (Slight nasal congestion) and PARAESTHESIA (Almost tickling sensation on top of the affected nose) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate, Oropharyngeal pain, Pustule
Clinical narrative: deep breath and it has gradually gotten worse, she noticed it started happening more frequently; Anxiety; rash over both arms and one of her legs; white pustules; soaring in the back of her throat; got a big rash on the arm where she got the infection and she read that it was the Moderna rash; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), PUSTULE (white pustules), OROPHARYNGEAL PAIN (soaring in the back of her throat), ANXIETY (Anxiety) and VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TOPIRAMATE for Migraine, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash). On 20-Jun-2021, the patient experienced PUSTULE (white pustules) and OROPHARYNGEAL PAIN (soaring in the back of her throat). On an unknown date, the patient experienced DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), ANXIETY (Anxiety) and RASH (rash over both arms and one of her legs). The patient was treated with PREDNISONE on 19-Jun-2021 for Adverse event, at a dose of UNK dosage form, qd and AZITHROMYCIN on 19-Jun-2021 for Adverse event, at a dose of for 5 days.. At the time of the report, DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), PUSTULE (white pustules), OROPHARYNGEAL PAIN (soaring in the back of her throat), ANXIETY (Anxiety), VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash) and RASH (rash over both arms and one of her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Heart rate: 130 (High) heart rate elevated..         Other concomitant medications include MUscle relaxer, Pain medication  for vertebra compressing spinal cord and Steroid injection in Lumbar spine and neck and centermin on and off for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No Significant information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: deep breath and it has gradually gotten worse, she noticed it started happening more frequently; Anxiety; rash over both arms and one of her legs; white pustules; soaring in the back of her throat; got a big rash on the arm where she got the infection and she read that it was the Moderna rash; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), PUSTULE (white pustules), OROPHARYNGEAL PAIN (soaring in the back of her throat), ANXIETY (Anxiety) and VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TOPIRAMATE for Migraine, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash). On 20-Jun-2021, the patient experienced PUSTULE (white pustules) and OROPHARYNGEAL PAIN (soaring in the back of her throat). On an unknown date, the patient experienced DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), ANXIETY (Anxiety) and RASH (rash over both arms and one of her legs). The patient was treated with PREDNISONE on 19-Jun-2021 for Adverse event, at a dose of UNK dosage form, qd and AZITHROMYCIN on 19-Jun-2021 for Adverse event, at a dose of for 5 days.. At the time of the report, DYSPNOEA (deep breath and it has gradually gotten worse, she noticed it started happening more frequently), PUSTULE (white pustules), OROPHARYNGEAL PAIN (soaring in the back of her throat), ANXIETY (Anxiety), VACCINATION SITE RASH (got a big rash on the arm where she got the infection and she read that it was the Moderna rash) and RASH (rash over both arms and one of her legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Heart rate: 130 (High) heart rate elevated..         Other concomitant medications include MUscle relaxer, Pain medication  for vertebra compressing spinal cord and Steroid injection in Lumbar spine and neck and centermin on and off for an unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No Significant information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Myalgia, Nausea
Clinical narrative: Pregnant while vaccination; Nauseous; Body aches; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant while vaccination), FATIGUE (Tired), NAUSEA (Nauseous) and MYALGIA (Body aches) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN and Prenatal for an unknown indication.    On 26-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Dec-2020 and the estimated date of delivery was 08-Sep-2021. On 24-May-2021, the patient experienced FATIGUE (Tired). On 24-Jun-2021, the patient experienced NAUSEA (Nauseous) and MYALGIA (Body aches). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant while vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant while vaccination), FATIGUE (Tired), NAUSEA (Nauseous) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Extended interval between doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001647) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Extended interval between doses). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Extended interval between doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       Concomitant product use was not provided. Treatment information was not provided.  It was reported that the patient scheduled her second dose on 03-Aug-2021.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site induration, Vaccination site pain
Clinical narrative: hardness on the site of injection; sorenes on the site of injection; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE INDURATION (hardness on the site of injection), VACCINATION SITE PAIN (sorenes on the site of injection) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: experienced very sore arm and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (experienced very sore arm and shoulder) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 (experienced very sore arm and shoulder). At the time of the report, MYALGIA (experienced very sore arm and shoulder) outcome was unknown. Not Provided          Treatment medication was not provided.  Concomitant medication was not provided.   This case was linked to MOD-2021-029887 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Non-significant information.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vaccination site erythema
Clinical narrative: Significant energy drop; Red arm 4-5 days later; (Reference number: MOD21-116875   ) on 29-Jun-2021. The most recent information was received on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concomitant products included CITALOPRAM from 2011 to an unknown date, ATORVASTATIN CALCIUM (LIPITOR) from 2011 to an unknown date and BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) from 2011 to an unknown date for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ASTHENIA (Significant energy drop) and VACCINATION SITE ERYTHEMA (Red arm 4-5 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-240672 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information was  received and event was added. On 09-Aug-2021: Follow-up received contains additional information of patient demographics (height, weight and race), updated lot number, added route of administration from unknown to oral and start date of concomitant products.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered after vial was opened for 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started (unknown route) at an unspecified dose. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants  medications were not reported.  Treatments medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: updated primary reporter,
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Product dose omission issue
Clinical narrative: not receiving the 2nd dose of the vaccine; having "a cold" after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) and NASOPHARYNGITIS (having "a cold" after vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) and NASOPHARYNGITIS (having "a cold" after vaccination). In April 2021, PRODUCT DOSE OMISSION ISSUE (not receiving the 2nd dose of the vaccine) had resolved. In June 2021, NASOPHARYNGITIS (having "a cold" after vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medicines were reported  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: AE Outcome Provided and 2nd dose was taken by the patient with no side effects reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Animal bite
Clinical narrative: Bitten by an animal; This spontaneous case was reported by a pharmacist and describes the occurrence of ANIMAL BITE (Bitten by an animal) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B28A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANIMAL BITE (Bitten by an animal). The patient was treated with RABIES VACCINE for Rabies, at a dose of 1 dosage form and IMMUNOGLOBULIN ANTI-RABIES for Rabies, at a dose of 1 dosage form. At the time of the report, ANIMAL BITE (Bitten by an animal) 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.   Concomitant medication information was not reported by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dysphonia, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: coughing; my voice sounds scratchy...voice has changed; hard time breathing; chest is heavy; very bad cold; got the second dose 3 days earlier; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy), NASOPHARYNGITIS (very bad cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier). At the time of the report, COUGH (coughing), DYSPHONIA (my voice sounds scratchy..voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier) had resolved.            Concomitant medications were not provided.  The patient refused to provided any contact or demographic information and hung up the phone when her doctor called.  Treatment information was not provided.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: coughing; my voice sounds scratchy...voice has changed; hard time breathing; chest is heavy; very bad cold; got the second dose 3 days earlier; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), DYSPHONIA (my voice sounds scratchy...voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy), NASOPHARYNGITIS (very bad cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier). At the time of the report, COUGH (coughing), DYSPHONIA (my voice sounds scratchy..voice has changed), DYSPNOEA (hard time breathing), CHEST DISCOMFORT (chest is heavy) and NASOPHARYNGITIS (very bad cold) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the second dose 3 days earlier) had resolved.            Concomitant medications were not provided.  The patient refused to provided any contact or demographic information and hung up the phone when her doctor called.  Treatment information was not provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Whole body sore to the touch; Chills; temperature of 104; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole body sore to the touch), FATIGUE (Extreme fatigue), CHILLS (Chills) and PYREXIA (temperature of 104) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESTRADIOL, GABAPENTIN and ATORVASTATIN for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced FATIGUE (Extreme fatigue). On 23-Jun-2021, the patient experienced PAIN (Whole body sore to the touch), CHILLS (Chills) and PYREXIA (temperature of 104). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 24-Jun-2021, CHILLS (Chills) and PYREXIA (temperature of 104) had resolved. On 25-Jun-2021, PAIN (Whole body sore to the touch) and FATIGUE (Extreme fatigue) had resolved.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Peripheral swelling
Clinical narrative: LUMP UNDER ARM; SWOLLEN ARM; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (LUMP UNDER ARM), PERIPHERAL SWELLING (SWOLLEN ARM) and FATIGUE (FATIGUE) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25288185) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (LUMP UNDER ARM), PERIPHERAL SWELLING (SWOLLEN ARM) and FATIGUE (FATIGUE). At the time of the report, AXILLARY MASS (LUMP UNDER ARM) and FATIGUE (FATIGUE) 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.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Product dose omission issue
Clinical narrative: missed her 2nd dose (1st dose given 23Mar2021 - more than 36 days); got sick with flu-like symptoms; migraine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (got sick with flu-like symptoms), MIGRAINE (migraine) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose (1st dose given 23Mar2021 - more than 36 days)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (got sick with flu-like symptoms) and MIGRAINE (migraine). On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose (1st dose given 23Mar2021 - more than 36 days)). On 26-Mar-2021, INFLUENZA LIKE ILLNESS (got sick with flu-like symptoms) and MIGRAINE (migraine) had resolved. On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose (1st dose given 23Mar2021 - more than 36 days)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash on my left arm about two inches below where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on my left arm about two inches below where I got the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on my left arm about two inches below where I got the vaccine). At the time of the report, VACCINATION SITE RASH (rash on my left arm about two inches below where I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Irregular heartbeat, speed of heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat). The patient was treated with APIXABAN (ELIQUIS) for Adverse event, at a dose of 5 mg twice a day and METOPROLOL at a dose of 25 mg. At the time of the report, HEART RATE IRREGULAR (Irregular heartbeat, speed of heartbeat) outcome was unknown.            Concomitant medications were not reported .
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I coudnt attend 2nd dose on June 18; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I coudnt attend 2nd dose on June 18) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I coudnt attend 2nd dose on June 18). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I coudnt attend 2nd dose on June 18) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Muscular weakness
Clinical narrative: thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb; got worse/Before vaccine he had some thigh muscle weakness which got worse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse) 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 Muscle weakness (muscle weakness of thigh.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse). At the time of the report, MUSCULAR WEAKNESS (thigh muscle weakness / something strange/e had something strange happen to his fingers unable to move his thumb) and CONDITION AGGRAVATED (got worse/Before vaccine he had some thigh muscle weakness which got worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       after 2 wees of vaccine patient had something strange happen to his fingers and  unable to move his thumb. Before vaccine he had some thigh muscle weakness which got worse,  leg muscle got worse after his second dose and they diagnosed him with ALS.  no concomitant medications are provided. treatment to the events not provided.   This case was linked to MOD-2021-240745 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Not yet had 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not yet had 2nd vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Treatment Information was not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Vaccination site pain
Clinical narrative: feels that "her body is not her body anymore; no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store); injection site was kind of sore; body fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A710) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue). At the time of the report, FEELING ABNORMAL (feels that "her body is not her body anymore), ASTHENIA (no/lack of energy (cannot do much of anything without resting for 15-20 minutes, cannot go to the store)), VACCINATION SITE PAIN (injection site was kind of sore) and FATIGUE (body fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose. 4 months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. U11A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose). On 29-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose. 4 months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment was mentioned.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Contained Update information- No AE after first dose; no new information (Possible NNI)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Got the first Moderna COVID-19 vaccination 27Apr2021. Has not gotten the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Follow-up on 26 Jul 2021 consumer stated that she is doing good, got her second dose of vaccination, not experienced any side effects.  No Concomitant medications were provided.  No Treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received, contains second dose information.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Myalgia, Pyrexia, Rash pruritic
Clinical narrative: itchy prickly rash; Fever; Sore arm; Genral fatigue; Dizziness; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (Genral fatigue), DIZZINESS (Dizziness) and RASH PRURITIC (itchy prickly rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Shingrix. Past adverse reactions to the above products included Influenza like illness with Shingrix. Concurrent medical conditions included Meniere's disease since May 2000. Concomitant products included GLICLAZIDE (DIAZIDE [GLICLAZIDE]) and ALPRAZOLAM (XANAX) for Meniere's disease, WARFARIN SODIUM (JANTOVEN) for Pulmonary embolism.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced DIZZINESS (Dizziness). On 23-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Sore arm) and FATIGUE (Genral fatigue). On an unknown date, the patient experienced RASH PRURITIC (itchy prickly rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 23-Jan-2021 to 30-Jan-2021 for Adverse event, at a dose of 1 dosage form once a day and CORTISONE (topical) from 23-Jan-2021 to 28-Jan-2021 for Adverse event, at a dose of 1 dosage form twice a day. On 28-Jan-2021, PYREXIA (Fever), MYALGIA (Sore arm) and FATIGUE (Genral fatigue) had resolved. At the time of the report, DIZZINESS (Dizziness) and RASH PRURITIC (itchy prickly rash) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she occasionally used an ice pack indicated for her itchy rash that occurred upon the first vaccination.   Patient reported about 48 hours after having the vaccination she suddenly started having severe nausea and dizziness that lasted about 5-6 hours. Patient reported she had to lie down during this period and she felt better afterwards.   Reporter did not allow further contact
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Rash
Clinical narrative: pain in heart; rash; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (pain in heart), RASH (rash) and HEADACHE (headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 CHEST PAIN (pain in heart), RASH (rash) and HEADACHE (headache). At the time of the report, CHEST PAIN (pain in heart), RASH (rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles, Fatigue, Somnolence
Clinical narrative: felt like my heart stopped for a second or two, then it was normal; had to take more naps; felt fatigued; This spontaneous case was reported by a patient and describes the occurrence of EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal), SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0358214) for COVID-19 vaccination.     The patient's past medical history included Depression, Anxiety and Sleep disorder. Concomitant products included LISINOPRIL and CRATAEGUS SPP. FRUIT (HAWTHORNE BERRY) for Blood pressure, OLEA EUROPAEA LEAF (OLIVE LEAF EXTRACT) and ZINC for Cold, OLIVE OIL for Inflammation, ECHINACEA PURPUREA ROOT, OLEA EUROPAEA LEAF, SAMBUCUS NIGRA FRUIT (ELDERBERRY ECHINACEA & OLIVE LEAF) for Pain and Inflammation, CLONAZEPAM for Panic attack, HONEY for Viral infection NOS, COCONUT OIL for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal), SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued). On 22-Jun-2021, EXTRASYSTOLES (felt like my heart stopped for a second or two, then it was normal) had resolved. On 25-Jun-2021, SOMNOLENCE (had to take more naps) and FATIGUE (felt fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Other concomitant medication information provided was Hemp oil with menthol, Alphalpha max in the morning and evening, Seaweed Kelp twice a day. Reporter stated that he wanted to know more about the pericarditis and enlarged heart after the second dose.  Company comment: 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   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up information received on29-JUN-2021 contains non-significant information.; Reporter's Comments: Expiration date of the Moderna Vaccine Vial was reported as 31-Jun-2021; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient was administered a third dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient was administered a third dose). On 29-Jun-2021, EXTRA DOSE ADMINISTERED (Patient was administered a third dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient received third dose on 29-Jun-2021 with lot number 007B21A.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 antibody test, Tinnitus, Vertigo
Clinical narrative: Then Vertigo turned into severe headache; About few days later it turned into ringing in the ears, It got louder on 10Jun2021. Now it stayed the same; Next day after receiving 2nd dose, he had a vertigo that lasted for few days.; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Next day after receiving 2nd dose, he had a vertigo that lasted for few days.), TINNITUS (About few days later it turned into ringing in the ears, It got louder on 10Jun2021. Now it stayed the same) and HEADACHE (Then Vertigo turned into severe headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 039B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced VERTIGO (Next day after receiving 2nd dose, he had a vertigo that lasted for few days.). On 10-Jun-2021, the patient experienced TINNITUS (About few days later it turned into ringing in the ears, It got louder on 10Jun2021. Now it stayed the same). On an unknown date, the patient experienced HEADACHE (Then Vertigo turned into severe headache). The patient was treated with PREDNISOLONE at a dose of UNK dosage form and GABAPENTIN at a dose of UNK dosage form. At the time of the report, VERTIGO (Next day after receiving 2nd dose, he had a vertigo that lasted for few days.) and TINNITUS (About few days later it turned into ringing in the ears, It got louder on 10Jun2021. Now it stayed the same) had not resolved and HEADACHE (Then Vertigo turned into severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) POSITIVE.         Action taken with m-RNA (Moderna vaccine) in response to events is not applicable. Antibiotic was also taken as a treatment. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received- Events outcome updated, Patient demographics updated, Medical history updated, and Type of Facility added.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intentional product use issue
Clinical narrative: After the the first dose of the vaccine they developed Covid; received first dose of the vaccine dose 12 weeks ago; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (After the the first dose of the vaccine they developed Covid) and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 COVID-19 (After the the first dose of the vaccine they developed Covid) and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago). At the time of the report, COVID-19 (After the the first dose of the vaccine they developed Covid) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (received first dose of the vaccine dose 12 weeks ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Aching injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Aching injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, LEVOTHYROXINE, PREDNISONE, PARACETAMOL (ACETAMINOPHEN), BUSPIRONE and CHLORTALIDONE (CHLORTHALIDONE) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Aching injection site). On 14-Jan-2021, VACCINATION SITE PAIN (Aching injection site) 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 information was unknown