chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sinus congestion, Somnolence
Clinical narrative: Extreme sinus congestion; Cough; Got sick; Fatigue; Slept half the day away; Night sweats where she was sweating through everything she was wearing and the sheets; Slight sore arm; low grade temp around 100 but never went higher than that; So fatigued could not even drive/got so fatigued had to lay down; This spontaneous case was reported by a nurse and describes the occurrence of SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm), SINUS CONGESTION (Extreme sinus congestion) and COUGH (Cough) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PAIN IN EXTREMITY (Slight sore arm) and PYREXIA (low grade temp around 100 but never went higher than that). 28-Apr-2021, the patient experienced FATIGUE (So fatigued could not even drive/got so fatigued had to lay down). On 02-Jun-2021, the patient experienced SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue). On 29-Apr-2021, SOMNOLENCE (Slept half the day away), HYPERHIDROSIS (Night sweats where she was sweating through everything she was wearing and the sheets), PYREXIA (low grade temp around 100 but never went higher than that) and FATIGUE (So fatigued could not even drive/got so fatigued had to lay down) had resolved. At the time of the report, PAIN IN EXTREMITY (Slight sore arm) had resolved and SINUS CONGESTION (Extreme sinus congestion), COUGH (Cough), ILLNESS (Got sick) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up information received included additional events and lab data.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received Pfizer vaccine for the 1st dose and Moderna for the 2nd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine for the 1st dose and Moderna for the 2nd dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine for the 1st dose and Moderna for the 2nd dose). On 30-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (received Pfizer vaccine for the 1st dose and Moderna for the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID-19 test) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Eye operation on 12-Apr-2021.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced COVID-19 (Positive COVID-19 test). At the time of the report, COVID-19 (Positive COVID-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, SARS-CoV-2 test: positive (Positive) 1st test. In April 2021, SARS-CoV-2 test: negative (Negative) 2nd test and positive (Positive) positive. On 28-Apr-2021, SARS-CoV-2 test: pending (Inconclusive) 3rd test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 02-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 007C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 01-May-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue
Clinical narrative: all of a sudden felt excessively tired, went to bed early that day; heart was racing so fast possibly due to anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (heart was racing so fast possibly due to anxiety) and FATIGUE (all of a sudden felt excessively tired, went to bed early that day) in an 83-year-old female patient who received mRNA-1273 (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lacunar stroke (affected their right side.) on 01-Dec-2018. Concomitant products included APIXABAN (ELIQUIS) from 01-Dec-2018 to an unknown date for Lacunar stroke.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. In March 2021, the patient experienced ANXIETY (heart was racing so fast possibly due to anxiety). On 19-Mar-2021, the patient experienced FATIGUE (all of a sudden felt excessively tired, went to bed early that day). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. On 19-Mar-2021, ANXIETY (heart was racing so fast possibly due to anxiety) and FATIGUE (all of a sudden felt excessively tired, went to bed early that day) had resolved.        The action taken with mRNA-1273 (Unknown) was unknown.       This case was linked to MOD-2021-100481, MOD-2021-100481, MOD-2021-101008 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching started 1 week post first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started 1 week post first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 PRURITUS (Itching started 1 week post first shot). At the time of the report, PRURITUS (Itching started 1 week post first shot) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia, Vaccination site discharge, Vaccination site haemorrhage
Clinical narrative: arm hurt a little; Small fever for couple of days,worse at night; Felt tired and slightly sick; water leaking down my arm; after squeezing the arm of the injection, more water began to leak and a small amount of blood, bleed water; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (after squeezing the arm of the injection, more water began to leak and a small amount of blood, bleed water), PAIN IN EXTREMITY (arm hurt a little), VACCINATION SITE DISCHARGE (water leaking down my arm), PYREXIA (Small fever for couple of days,worse at night) and FATIGUE (Felt tired and slightly sick) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048b21a and 025b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Ear ringing (More louder ear fullness and bilateral ringing Jul 2021.Still undiagnosed, dr shortage.) since 2021. Concomitant products included PARACETAMOL (TYLENOL) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (after squeezing the arm of the injection, more water began to leak and a small amount of blood, bleed water) and VACCINATION SITE DISCHARGE (water leaking down my arm). On 01-May-2021, the patient experienced PYREXIA (Small fever for couple of days,worse at night) and FATIGUE (Felt tired and slightly sick). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). On 03-May-2021, PYREXIA (Small fever for couple of days,worse at night) had resolved. On 04-May-2021, FATIGUE (Felt tired and slightly sick) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (after squeezing the arm of the injection, more water began to leak and a small amount of blood, bleed water), PAIN IN EXTREMITY (arm hurt a little) and VACCINATION SITE DISCHARGE (water leaking down my arm) outcome was unknown.             No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow up received - Updated reporter details, updated patient demographics, added events pyrexia, pain in extremities, fatigue and malaise and updated information about facility where vaccine was given On 22-Jul-2021: Follow up received -Vaccine Facility information updated ,Lot/Batch number added, and added chronic condition.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Lump in Neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK MASS (Lump in Neck) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced NECK MASS (Lump in Neck). At the time of the report, NECK MASS (Lump in Neck) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  Patient reported that concomitant medications are taken by her.  No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101938 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Feeling abnormal, Illness, Pain in extremity, Sleep disorder
Clinical narrative: sick; could not eat; could not sleep; felt terrible; arm still hurt; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), DECREASED APPETITE (could not eat), SLEEP DISORDER (could not sleep), FEELING ABNORMAL (felt terrible) and PAIN IN EXTREMITY (arm still hurt) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), DECREASED APPETITE (could not eat), SLEEP DISORDER (could not sleep), FEELING ABNORMAL (felt terrible) and PAIN IN EXTREMITY (arm still hurt). At the time of the report, ILLNESS (sick), DECREASED APPETITE (could not eat) and SLEEP DISORDER (could not sleep) outcome was unknown, FEELING ABNORMAL (felt terrible) had resolved and PAIN IN EXTREMITY (arm still hurt) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: hands and feet are itching constantly/[itching] kind of all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (hands and feet are itching constantly/[itching] kind of all over) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]) and ATORVASTATIN for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (hands and feet are itching constantly/[itching] kind of all over). At the time of the report, PRURITUS (hands and feet are itching constantly/[itching] kind of all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100 degrees Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever of 100 degrees Fahrenheit) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-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) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (Fever of 100 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 100 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature: 100 (High) 100 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received second dose a week after his first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose a week after his first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose a week after his first dose). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose a week after his first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: irregular heartbeat; 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 HEART RATE IRREGULAR (irregular heartbeat) 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.    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 HEART RATE IRREGULAR (irregular heartbeat). At the time of the report, HEART RATE IRREGULAR (irregular heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided . Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: back muscles are hurting; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (back muscles are hurting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and unknown) for COVID-19 vaccination.     medical history was not reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), FERROUS SULFATE and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (back muscles are hurting). At the time of the report, MYALGIA (back muscles are hurting) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable. No treatment medications were provided.    This case was linked to MOD-2021-101228 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Nausea, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: nauseas; when she goes to cough the right side of her head hurts; when she goes to cough the right side of her head hurts; injection site it was itchy; injection site it was red; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (when she goes to cough the right side of her head hurts), VACCINATION SITE PRURITUS (injection site it was itchy), NAUSEA (nauseas), HEADACHE (when she goes to cough the right side of her head hurts) and VACCINATION SITE ERYTHEMA (injection site it was red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen). On 30-Apr-2021, the patient experienced COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts) had not resolved and VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included hot compress on arm No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: nauseas; when she goes to cough the right side of her head hurts; when she goes to cough the right side of her head hurts; injection site it was itchy; injection site it was red; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (when she goes to cough the right side of her head hurts), VACCINATION SITE PRURITUS (injection site it was itchy), NAUSEA (nauseas), HEADACHE (when she goes to cough the right side of her head hurts) and VACCINATION SITE ERYTHEMA (injection site it was red) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 20-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen). On 30-Apr-2021, the patient experienced COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, COUGH (when she goes to cough the right side of her head hurts), NAUSEA (nauseas) and HEADACHE (when she goes to cough the right side of her head hurts) had not resolved and VACCINATION SITE PRURITUS (injection site it was itchy), VACCINATION SITE ERYTHEMA (injection site it was red) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included hot compress on arm No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Nausea, Oropharyngeal pain, Pain in extremity
Clinical narrative: Triggered her allergies; Sore throat; Coughing; Runny nose; Sore arm/ back of legs and thighs were very sore; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LORATADINE (CLARITIN [LORATADINE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Events out come added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vomiting
Clinical narrative: Triggered her allergies; Sore throat; Coughing; Runny nose; Sore arm/ back of legs and thighs were very sore; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LORATADINE (CLARITIN [LORATADINE]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, HYPERSENSITIVITY (Triggered her allergies), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing), RHINORRHOEA (Runny nose), PAIN IN EXTREMITY (Sore arm/ back of legs and thighs were very sore), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Events out come added.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dry throat, Dysphagia
Clinical narrative: Couldn't swallow; Throat was dry; no Saliva in mouth / mouth dry; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry). At the time of the report, DYSPHAGIA (Couldn't swallow), DRY THROAT (Throat was dry) and DRY MOUTH (no Saliva in mouth / mouth dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Really hot at injection site; really red injection site about 14 cm; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE INDURATION (really red injection site about 14 cm) and INJECTION SITE WARMTH (Really hot at injection site) in a female patient of an unknown age who received mRNA-1273 (batch no. Unknown) for COVID-19 vaccine.     No medical history was reported by the reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INJECTION SITE INDURATION (really red injection site about 14 cm). On an unknown date, the patient experienced INJECTION SITE WARMTH (Really hot at injection site). On 09-Apr-2021, INJECTION SITE INDURATION (really red injection site about 14 cm) had resolved. At the time of the report, INJECTION SITE WARMTH (Really hot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Eyelid rash, Nodule, Oral mucosal eruption, Pruritus
Clinical narrative: Rash all over her eye lids; Rash above her mouth; Burn kind of almost like sun burn/burns; Rash down the left side of her nose; Face was little itchy/itch; Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth) and BURNING SENSATION (Burn kind of almost like sun burn/burns) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression (since as a teenager), Bipolar disorder since 2013 and Shellfish allergy. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Face was little itchy/itch) and NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline). On 30-Apr-2021, the patient experienced EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose). At the time of the report, PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included unspecified birth control pill.  Treatment information was not reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over her eye lids; Rash above her mouth; Burn kind of almost like sun burn/burns; Rash down the left side of her nose; Face was little itchy/itch; Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth) and BURNING SENSATION (Burn kind of almost like sun burn/burns) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression (since as a teenager), Bipolar disorder since 2013 and Shellfish allergy. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Face was little itchy/itch) and NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline). On 30-Apr-2021, the patient experienced EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose). At the time of the report, PRURITUS (Face was little itchy/itch), NODULE (Tiny little tons of bumps all over/all along her lower chin area", "top of her forehead and along hairline), EYELID RASH (Rash all over her eye lids), ORAL MUCOSAL ERUPTION (Rash above her mouth), BURNING SENSATION (Burn kind of almost like sun burn/burns) and RASH (Rash down the left side of her nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication included unspecified birth control pill.  Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm is still hurting; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PAIN IN EXTREMITY (Arm is still hurting) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C20A and 031M20A) for COVID-19 vaccination.     No specified medical history has been reported.  Concomitant products included ATORVASTATIN, ACYCLOVIR [ACICLOVIR], MELOXICAM and TERAZOSIN for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is still hurting). At the time of the report, FATIGUE (fatigue) outcome was unknown and PAIN IN EXTREMITY (Arm is still hurting) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: follow up received contain event outcome detail
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of injection site rash (a rash with just a little raised area), injection site swelling (rash started to be raised again) and injection site pain in a 41-year-old female patient who received mRNA-1273 (batch# 014C21A) for COVID-19 immunization. No medical history reported. On Apr 22, 2021, patient received the first dose of mRNA-1273, (intramuscular); 1 dosage form. On Apr 23, 2021, patient experienced injection site rash (a rash with just a little raised area). Apr 23, 2021, patient experienced injection site pain. On Apr 30, 2021, patient experienced injection site swelling (rash started to be raised again). The patient treated with Benadryl (diphenhydramine hydrochloride), at an unspecified dose and frequency and ibuprofen, at an unspecified dose and frequency. On Apr 28, 2021, injection site pain resolved. At the time of the report, injection site rash (a rash with just a little raised area) and injection site swelling (rash started to be raised again): not resolved. The action taken with mRNA-1273, (intramuscular): unknown. Concomitant medications also included Zyrtec. Reportedly, patient due for the second dose on May 21, 2021.
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Half of the dose leaked on her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Half of the dose leaked on her arm) 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 UNDERDOSE (Half of the dose leaked on her arm). At the time of the report, UNDERDOSE (Half of the dose leaked on her arm) 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 relevant concomitant medications were provided.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: patient received a dose that was expired; not kept at an adequate temperature; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature). On 29-Apr-2021, EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature) 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 information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose of Moderna vaccine 21 days after the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose). On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose) had resolved.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided,
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was provided.  No treatment medication  was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Myalgia, Vaccination site pruritus, Vaccination site rash
Clinical narrative: diarrhea; vaccination site rash; myalgia; Fatigue; tiredness; Vaccination site pruritus; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (vaccination site rash), MYALGIA (myalgia), FATIGUE (Fatigue), FATIGUE (tiredness) and VACCINATION SITE PRURITUS (Vaccination site pruritus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced VACCINATION SITE RASH (vaccination site rash), MYALGIA (myalgia), FATIGUE (Fatigue), FATIGUE (tiredness) and VACCINATION SITE PRURITUS (Vaccination site pruritus). On 30-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, VACCINATION SITE RASH (vaccination site rash), MYALGIA (myalgia), FATIGUE (Fatigue), FATIGUE (tiredness), VACCINATION SITE PRURITUS (Vaccination site pruritus) and DIARRHOEA (diarrhea) 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.   No concomitant products and treatment medication were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema
Clinical narrative: Swelling lymph nodes under the jawline/ear; Redness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness in the injection site) and LYMPHADENOPATHY (Swelling lymph nodes under the jawline/ear) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Hypothyroidism, ALLOPURINOL (ELAVIL [ALLOPURINOL]) for Irritable bowel syndrome, PROPRANOLOL HYDROCHLORIDE (INDERAL) for Migraine, CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Seasonal allergy.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness in the injection site). On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (Swelling lymph nodes under the jawline/ear). On 20-Apr-2021, VACCINATION SITE ERYTHEMA (Redness in the injection site) had resolved. At the time of the report, LYMPHADENOPATHY (Swelling lymph nodes under the jawline/ear) outcome was unknown.            The patient took Ibuprofen as a corrective treatment.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Rash on thigh area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B7114 and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area). At the time of the report, PAIN IN EXTREMITY (Sore arm) and RASH (Rash on thigh area) outcome was unknown.            Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Action taken with mRNA-1273 in response to the events were not applicable.