chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Sluggishness, Somnolence
Clinical narrative: slept the whole day/woke up to the whole day had past by; felt sluggish; feels different,doesnt feel quite the same; headache; felt fatigue,very tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept the whole day/woke up to the whole day had past by), SLUGGISHNESS (felt sluggish), FEELING ABNORMAL (feels different,doesnt feel quite the same), HEADACHE (headache) and FATIGUE (felt fatigue,very tired) in a 58-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 Toe sprain (Stubbed toe). Concurrent medical conditions included Anemic and Decreased appetite (Not eating properly). Concomitant products included IBUPROFEN for Toe sprain.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SOMNOLENCE (slept the whole day/woke up to the whole day had past by), SLUGGISHNESS (felt sluggish), FEELING ABNORMAL (feels different,doesnt feel quite the same), HEADACHE (headache) and FATIGUE (felt fatigue,very tired). At the time of the report, SOMNOLENCE (slept the whole day/woke up to the whole day had past by), SLUGGISHNESS (felt sluggish), FEELING ABNORMAL (feels different,doesnt feel quite the same), HEADACHE (headache) and FATIGUE (felt fatigue,very tired) 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Body aches; Chills; Really bad headache; Really really tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023CZ1A and 042B21A) 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) (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 02-May-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired). At the time of the report, MYALGIA (Body aches), CHILLS (Chills), HEADACHE (Really bad headache) and FATIGUE (Really really tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral
Clinical narrative: Numbness on her lips; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History 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 HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA ORAL (Numbness on her lips) and HEADACHE (Headache) outcome was unknown.            Concomitant and treatment information were not provided.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching from top of chest to private parts; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching from top of chest to private parts) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A, and 023M20A) 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) 1 dosage form. On 01-Apr-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 PRURITUS (Itching from top of chest to private parts). At the time of the report, PRURITUS (Itching from top of chest to private parts) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment medication included unspecified skin cream.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient arrived to the pharmacy whit a second dose appointment for the Moderna Covid19 and it was revealed that the patient was 17 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment information was  not provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: Sick as a dog; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog) and FEELING ABNORMAL (Feeling bad) in a 36-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) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad). On 30-Apr-2021, the patient experienced ILLNESS (Sick as a dog). At the time of the report, ILLNESS (Sick as a dog) and FEELING ABNORMAL (Feeling bad) outcome was unknown.            No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-101610 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 20-May-2021 and does not contain any new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101610:Son Case
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: I tested positive for COVID; diarrhea; Sore throat; extreme fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for COVID), DIARRHEA (diarrhea), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (extreme fatigue) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHEA (diarrhea), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (extreme fatigue) and HEADACHE (headache). On 18-Apr-2021, the patient experienced COVID-19 (I tested positive for COVID). At the time of the report, COVID-19 (I tested positive for COVID), DIARRHEA (diarrhea), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (extreme fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  No treatment medications were provided by reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) outcome was unknown. Not Provided          The patient had symptoms post 3 weeks of having second dose of vaccine. He was worried if his wife can get the any of the symptoms from him. No concomitant or treatment information was provided by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Dyspnoea, Headache, Myalgia, Pyrexia
Clinical narrative: Could not breath well; Body ache; Fever; Headache; bee sting bite like on both legs and back; Skin is very dry; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Could not breath well), PAIN (bee sting bite like on both legs and back), DRY SKIN (Skin is very dry), MYALGIA (Body ache) and PYREXIA (Fever) in a 52-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.     Concomitant products included CLONIDINE, LOSARTAN and HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) for an unknown indication.   On 28-Apr-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (bee sting bite like on both legs and back) and DRY SKIN (Skin is very dry). On 28-Apr-2021 at 11:30 AM, the patient experienced DYSPNOEA (Could not breath well), MYALGIA (Body ache), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Could not breath well), PAIN (bee sting bite like on both legs and back), DRY SKIN (Skin is very dry), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable   It was reported that the patient took 1st dose a month before
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Lymphadenopathy, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: arm a little swollen; arm was hot/ it was really hot; the arm started to hurt again; The lymph nodes in her arm were also sore; muscles were aching; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore) and MYALGIA (muscles were aching) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness). On 01-May-2021, the patient experienced PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore) and MYALGIA (muscles were aching). At the time of the report, PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore), MYALGIA (muscles were aching) and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were  not provided. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm a little swollen; arm was hot/ it was really hot; the arm started to hurt again; The lymph nodes in her arm were also sore; muscles were aching; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore) and MYALGIA (muscles were aching) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness). On 01-May-2021, the patient experienced PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore) and MYALGIA (muscles were aching). At the time of the report, PERIPHERAL SWELLING (arm a little swollen), FEELING HOT (arm was hot/ it was really hot), PAIN IN EXTREMITY (the arm started to hurt again), LYMPHADENOPATHY (The lymph nodes in her arm were also sore), MYALGIA (muscles were aching) and VACCINATION SITE PAIN (injection site soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were  not provided. Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Myalgia, Pyrexia
Clinical narrative: felt very sick; fever of 100 during late afternoon; body was sore; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21 and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted). On 03-May-2021, ILLNESS (felt very sick), PYREXIA (fever of 100 during late afternoon), MYALGIA (body was sore) and FATIGUE (exhausted) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Treatment medication include Motrin Action taken with mRNA-1273 in response to the events was not applicable.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Improper preparation for thawed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) 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 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial). At the time of the report, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Improper preparation for thawed vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No concomitant medication information was provided.  "Follow-up received on 14-Jun-2021 included no new information"   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up information received on 14-JUN-2021 contains no new information.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swollen left foot) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 044A214) for COVID-19 immunization. No medical history reported. On Mar 31, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 29, 2021, patient experienced peripheral swelling (swollen left foot). At the time of the report, peripheral swelling (swollen left foot) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria, Vaccination site mass
Clinical narrative: breaking out into hives; still has a little knot on the outside of the left arm where she received the injection; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever). At the time of the report, URTICARIA (breaking out into hives), VACCINATION SITE MASS (still has a little knot on the outside of the left arm where she received the injection) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second dose outside the 42 day window; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose outside the 42 day window) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up was received on 03-MAY-2021. The reporter provided the Batch Lot number for the first dose # 013M20A.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17year old received Moderna COVID-19 vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old received Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores; 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 ORAL HERPES (Cold sores) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tachycardia. Concomitant products included ALENDRONATE SODIUM (ALENDRONIC) for an unknown indication.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced ORAL HERPES (Cold sores). At the time of the report, ORAL HERPES (Cold sores) outcome was unknown. Not Provided          Treatment include Valacyclovir for cold sores.   Reporter did not allow further contact
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: improper preparation of thawed vial; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (improper preparation of thawed vial) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) 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 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (improper preparation of thawed vial). At the time of the report, PRODUCT STORAGE ERROR (improper preparation of thawed vial) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue, Urinary tract infection
Clinical narrative: UTI; Second dose postponed 5 weeks from second scheduled dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose) and URINARY TRACT INFECTION (UTI) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 022M21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Heart disease, unspecified, Gout and Acid reflux (esophageal). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), ALLOPURINOL for Gout, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, METOPROLOL SUCCINATE (TOPROL) and SPIRONOLACTONE for Hypertension, CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) for UTI.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). On 16-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Second dose postponed 5 weeks from second scheduled dose) had resolved. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided          Concomitant medication include Flomad for Heart disease. Treatment Information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received on 14 Jul 2021 contains non-significant information.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Sensory disturbance, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site was hot to touch; Euphoric feeling; A physical buzz; Itchy injection site; Swollen injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-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 VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. The patient reports that she felt relieved and happy after her vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site was hot to touch; Euphoric feeling; A physical buzz; Itchy injection site; Swollen injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE SWELLING (Swollen injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-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 VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site was hot to touch), EUPHORIC MOOD (Euphoric feeling), SENSORY DISTURBANCE (A physical buzz), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. The patient reports that she felt relieved and happy after her vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HSV on the behind after getting the second dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (HSV on the behind after getting the second dose of Moderna) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES SIMPLEX (HSV on the behind after getting the second dose of Moderna). At the time of the report, HERPES SIMPLEX (HSV on the behind after getting the second dose of Moderna) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Feeling hot, Heart rate
Clinical narrative: Felt like collapse; Hot press; Tingling of the stomach; achy arms and shoulders; Extremely tired; Right side hurts as if some one kicked/ Right arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders) and FATIGUE (Extremely tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A21A and 017A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PARAESTHESIA (Tingling of the stomach), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts). On 02-May-2021, the patient experienced FEELING HOT (Hot press). On 03-May-2021, the patient experienced FEELING ABNORMAL (Felt like collapse). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: increased (High) Heart rate increased.         No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Paraesthesia
Clinical narrative: Felt like collapse; Hot press; Tingling of the stomach; achy arms and shoulders; Extremely tired; Right side hurts as if some one kicked/ Right arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders) and FATIGUE (Extremely tired) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017A21A and 017A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-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) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PARAESTHESIA (Tingling of the stomach), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts). On 02-May-2021, the patient experienced FEELING HOT (Hot press). On 03-May-2021, the patient experienced FEELING ABNORMAL (Felt like collapse). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of the stomach), FEELING HOT (Hot press), FEELING ABNORMAL (Felt like collapse), ARTHRALGIA (achy arms and shoulders), FATIGUE (Extremely tired) and MYALGIA (Right side hurts as if some one kicked/ Right arm still hurts) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Heart rate: increased (High) Heart rate increased.         No relevant concomitant medications were provided. The action taken for mRNA-1273 was not applicable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Feeling like a cold; nasal congestion; cough; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough). At the time of the report, NASOPHARYNGITIS (Feeling like a cold), NASAL CONGESTION (nasal congestion) and COUGH (cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: arm swollen at injection site; at the injection site, reallysore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore). On 28-Mar-2021, VACCINATION SITE SWELLING (arm swollen at injection site) and VACCINATION SITE PAIN (at the injection site, reallysore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment of events was not reported. Concomitant medication use was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness
Clinical narrative: lots of chills; lots of dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (lots of dizziness) and CHILLS (lots of chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0391321A and 045A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (lots of dizziness). On 26-Apr-2021, the patient experienced CHILLS (lots of chills). At the time of the report, DIZZINESS (lots of dizziness) and CHILLS (lots of chills) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: redness at injection site; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (sore arm at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     no medical history was reported.     On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (sore arm at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (sore arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There is no concomitant list   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: Trouble with his speech/aphasia; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Trouble with his speech/aphasia) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) .5 ml. On 21-Apr-2021, the patient experienced APHASIA (Trouble with his speech/aphasia). At the time of the report, APHASIA (Trouble with his speech/aphasia) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. The patient's sister reported that after having trouble with his speech on 21-Apr-2021, he went to talk to pharmacist. He was told to take Pedialyte and Tylenol but they didn't help him.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 26-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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.   Concomitant medication and treatment information were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Additional information was received from the initial reporter: Patient demography and dosage details were added. Upon follow up this case was upgraded to valid
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Nausea, Vomiting
Clinical narrative: cannot bend over/stomach feels like a constant knot; sick to his stomach when he stands; severe nausea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (cannot bend over/stomach feels like a constant knot), ABDOMINAL PAIN UPPER (sick to his stomach when he stands), NAUSEA (severe nausea) and VOMITING (throwing up) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced ABDOMINAL DISCOMFORT (cannot bend over/stomach feels like a constant knot), ABDOMINAL PAIN UPPER (sick to his stomach when he stands), NAUSEA (severe nausea) and VOMITING (throwing up). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at a dose of 1 dosage form; SIMETICONE (ALKA SELTZER ANTI GAS) at a dose of 1 dosage form and SIMETHICONE at a dose of 1 dosage form. At the time of the report, ABDOMINAL DISCOMFORT (cannot bend over/stomach feels like a constant knot), ABDOMINAL PAIN UPPER (sick to his stomach when he stands), NAUSEA (severe nausea) and VOMITING (throwing up) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter. Other treatment medications include some liquid for nausea, ginger ale  Action taken with mRNA-1273 in response to the event was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Addition information added include reporter contact details
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, COVID-19, Discomfort, Headache, Pain
Clinical narrative: Did not Sleep; Headache; Pain Injection Site; COVID-19 Symptoms all over again; Bad Aches and Pain; Discomfort; Little Appetite; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite) and SLEEP DISORDER (Did not Sleep) in a 48-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.     medical history was not reported.     On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site). On 03-May-2021, the patient experienced SLEEP DISORDER (Did not Sleep). The patient was treated with NAPROXEN SODIUM (ALEVE) for COVID-19, Ache, Headache, Injection site pain, Discomfort, Appetite decreased NOS and Sleep disturbance, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19 Symptoms all over again), PAIN (Bad Aches and Pain), DISCOMFORT (Discomfort), APPETITE DISORDER (Little Appetite), SLEEP DISORDER (Did not Sleep), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain Injection Site) outcome was unknown. Aleve      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.