chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Her injection arm swollen from her shoulder to her elbow; Extra sleepy the next day; A sore injection site for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Extra sleepy the next day), VACCINATION SITE PAIN (A sore injection site for a day or two) and VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (A sore injection site for a day or two). On 07-Mar-2021, the patient experienced HYPERSOMNIA (Extra sleepy the next day). On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow). On 07-Mar-2021, HYPERSOMNIA (Extra sleepy the next day) had resolved. On 08-Mar-2021, VACCINATION SITE PAIN (A sore injection site for a day or two) had resolved. At the time of the report, VACCINATION SITE SWELLING (Her injection arm swollen from her shoulder to her elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included supplements. Treatment medications were not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blister, Eructation, Erythema, Gait disturbance
Clinical narrative: upset stomach; developed rash inside elbow; broke out in hives on her right arm/hives looked like welts/hives was also under her feet; skin eruption started on the inside of her right elbow; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; difficult to walk; belched for 3 days; nauseated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.) and URTICARIA (hives looked like red, blistery, welts that itched.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Asthma.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, the patient experienced URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk) and RASH (developed rash inside elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and NAUSEA (nauseated). At the time of the report, URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk), ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and RASH (developed rash inside elbow) outcome was unknown and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. treatment medications includes Kenalog injection,oral antihistamine, prednisone.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: upset stomach; developed rash inside elbow; broke out in hives on her right arm/hives looked like welts/hives was also under her feet; skin eruption started on the inside of her right elbow; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; hives looked like red, blistery, welts that itched.; difficult to walk; belched for 3 days; nauseated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021 and was forwarded to Moderna on 16-Mar-2021.    This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.) and URTICARIA (hives looked like red, blistery, welts that itched.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Diabetes and Asthma.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Feb-2021, the patient experienced URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk) and RASH (developed rash inside elbow). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and NAUSEA (nauseated). At the time of the report, URTICARIA (broke out in hives on her right arm/hives looked like welts/hives was also under her feet), RASH (skin eruption started on the inside of her right elbow), ERYTHEMA (hives looked like red, blistery, welts that itched.), BLISTER (hives looked like red, blistery, welts that itched.), URTICARIA (hives looked like red, blistery, welts that itched.), PRURITUS (hives looked like red, blistery, welts that itched.), GAIT DISTURBANCE (difficult to walk), ABDOMINAL DISCOMFORT (upset stomach), ERUCTATION (belched for 3 days) and RASH (developed rash inside elbow) outcome was unknown and NAUSEA (nauseated) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. treatment medications includes Kenalog injection,oral antihistamine, prednisone.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported   No treatment medication reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Caller's father didn't receive 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Caller's father didn't receive 2nd dose on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, after receiving the first dose of mRNA-1273, patient underwent Brain surgery. Concomitant medication and treatment medication were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 contains no new information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Night sweats
Clinical narrative: Dizziness; Night sweat; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Feb-2021.    On 08-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 4:30 PM, the patient experienced DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), NIGHT SWEATS (Night sweat), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally got the Moderna COVID-19 vaccine on 15Mar2021 after receiving the Pfizer COVID-19 vaccine on 24Feb2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 001B21A) with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: raised red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (raised red rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (raised red rash). At the time of the report, RASH ERYTHEMATOUS (raised red rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Furuncle, Induration, Pain, Pain in extremity
Clinical narrative: Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb; Itches and hurts to the touch.; Itches and hurts to the touch.; Soreness on ring finger on the pinky side; Then something hard developed that turned dark red; Swelling; Similar to a boil and the size of a pencil eraser; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Similar to a boil and the size of a pencil eraser), ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.), PAIN IN EXTREMITY (Itches and hurts to the touch.) and PAIN (Soreness on ring finger on the pinky side) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced FURUNCLE (Similar to a boil and the size of a pencil eraser), PAIN (Soreness on ring finger on the pinky side), INDURATION (Then something hard developed that turned dark red) and SWELLING (Swelling). On 15-Mar-2021, the patient experienced ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.) and PAIN IN EXTREMITY (Itches and hurts to the touch.). At the time of the report, FURUNCLE (Similar to a boil and the size of a pencil eraser), ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.), PAIN IN EXTREMITY (Itches and hurts to the touch.), PAIN (Soreness on ring finger on the pinky side), INDURATION (Then something hard developed that turned dark red) and SWELLING (Swelling) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb; Itches and hurts to the touch.; Itches and hurts to the touch.; Soreness on ring finger on the pinky side; Then something hard developed that turned dark red; Swelling; Similar to a boil and the size of a pencil eraser; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Similar to a boil and the size of a pencil eraser), ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.), PAIN IN EXTREMITY (Itches and hurts to the touch.) and PAIN (Soreness on ring finger on the pinky side) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced FURUNCLE (Similar to a boil and the size of a pencil eraser), PAIN (Soreness on ring finger on the pinky side), INDURATION (Then something hard developed that turned dark red) and SWELLING (Swelling). On 15-Mar-2021, the patient experienced ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.) and PAIN IN EXTREMITY (Itches and hurts to the touch.). At the time of the report, FURUNCLE (Similar to a boil and the size of a pencil eraser), ACNE (Got a hard pimple on middle knuckle that itches and hurts to the touch,Then another one developed on my index finger towards thumb), PRURITUS (Itches and hurts to the touch.), PAIN IN EXTREMITY (Itches and hurts to the touch.), PAIN (Soreness on ring finger on the pinky side), INDURATION (Then something hard developed that turned dark red) and SWELLING (Swelling) outcome was unknown.            Concomitant medications were not provided.  Treatment medications were not provided by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Vaccination site pain, Vomiting
Clinical narrative: felt bad until 11 pm; vomiting; chills; headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad until 11 pm), VACCINATION SITE PAIN (sore arm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided b the reporter.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 15-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad until 11 pm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 15-Mar-2021, FEELING ABNORMAL (felt bad until 11 pm), VOMITING (vomiting), CHILLS (chills) and HEADACHE (headache) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Somnolence
Clinical narrative: low grade fever; tired; sleeping a lot; chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleeping a lot), CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Knee pain, Asthma, Chronic kidney disease stage 3 (Improved), Blood pressure high (Fairly stable), Depression (Increased Prozac dose), Allergic rhinitis, Drug allergy (Allergic to tylenol) and Environmental allergy (Allergic to (anything scented or fumes)). Concomitant products included NAPROXEN SODIUM (ALEVE) and PARACETAMOL (TYLENOL) for Knee pain.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (sleeping a lot) and CHILLS (chills). On 12-Mar-2021, the patient experienced PYREXIA (low grade fever) and FATIGUE (tired). At the time of the report, SOMNOLENCE (sleeping a lot) outcome was unknown and CHILLS (chills), PYREXIA (low grade fever) and FATIGUE (tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 99.9 (High) 99.9 F low grade fever..     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 treatment informations were provided by the reporter.   This case was linked to MOD-2021-114453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-Jul-2021. Event outcomes were updated. Current conditions and allergy were included.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion
Clinical narrative: I'm having difficulty breathing; My nose is very stuffy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I'm having difficulty breathing) and NASAL CONGESTION (My nose is very stuffy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD (Patient on oxygen for COPD from 10 months.), Blood pressure high, Diabetes, Gout, Restless leg syndrome and Neuropathy. Concomitant products included OXYGEN for COPD, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 15-Mar-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DYSPNOEA (I'm having difficulty breathing) and NASAL CONGESTION (My nose is very stuffy). The patient was treated with SODIUM CHLORIDE (SALINE SPRAY) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (I'm having difficulty breathing) had resolved and NASAL CONGESTION (My nose is very stuffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medications included unspecified medications for Blood pressure, Diabetes, Gout, Restless leg syndrome and Neuropathy. Stuffy nose was very common for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Form was added and outcome of an Event was updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, Tongue discomfort
Clinical narrative: numbness in my arms, legs, and feet; Nerves felt like burning in arms and legs, and tongue; tingling; Nerves felt like burning in arms and legs, and tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue). At the time of the report, HYPOAESTHESIA (numbness in my arms, legs, and feet), TONGUE DISCOMFORT (Nerves felt like burning in arms and legs, and tongue), PARAESTHESIA (tingling) and BURNING SENSATION (Nerves felt like burning in arms and legs, and tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not specified.  Treatment medication were given by doctor.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gastroenteritis viral, Pyrexia
Clinical narrative: had a stomach flu or virus that has past around the whole family; diarrhea; fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever). At the time of the report, GASTROENTERITIS VIRAL (had a stomach flu or virus that has past around the whole family), DIARRHOEA (diarrhea) and PYREXIA (fever) outcome was unknown. Not Provided          Concomitant medications were not provided.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered dose 1 in her right arm more than 6 hours after first vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose 1 in her right arm more than 6 hours after first vial puncture) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose 1 in her right arm more than 6 hours after first vial puncture). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose 1 in her right arm more than 6 hours after first vial puncture) 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 products were not reported.  Treatment medications were not provided by the reporter.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: chills; slight fever of 99.5; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (slight fever of 99.5) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 UNK. On 14-Mar-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever of 99.5). At the time of the report, CHILLS (chills) and PYREXIA (slight fever of 99.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: increased (High) temperature went up just a little bit but not a lot.. On an unknown date, Body temperature: normal (normal) Today, his temperature dropped to normal..         No concomitant medication details were provided. No treatment medication details were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Heart rate increased, Hypoaesthesia oral
Clinical narrative: lower lip was numb; rapid pulse; weakness; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lower lip was numb/Hypo aesthesia, rapid pulse/ heart rate increased, weakness/asthenia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: didn't wanted to provide that) via unknown route for prophylaxis of COVID-19 infection.  On 3 Mar 2021,10 minutes later  the patient experienced the event lower lip was numb and one half later had a rapid pulse, weakness.  Treatment was provided included Benadryl before second dose  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), lower lip was numb, rapid pulse, weakness was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Myalgia, Poor quality sleep
Clinical narrative: Bone aches; Body aches; Felt tired; Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night), BONE PAIN (Bone aches), MYALGIA (Body aches) and FATIGUE (Felt tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Reflux gastritis.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night). On 06-Mar-2021, the patient experienced BONE PAIN (Bone aches), MYALGIA (Body aches) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at a dose of 1 dosage form. On 07-Mar-2021, BONE PAIN (Bone aches) and FATIGUE (Felt tired) had resolved. At the time of the report, POOR QUALITY SLEEP (Problems sleeping, cannot sleep deeply and has only 3-4 hour of sleep per night) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unspecified high blood pressure medication and  reflux medication.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Tinnitus
Clinical narrative: pulsate tinnitus; red rash; itchy rash; hot rash; arm rash (2x3 inches); This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (pulsate tinnitus), RASH ERYTHEMATOUS (red rash), RASH (hot rash), RASH PRURITIC (itchy rash) and RASH (arm rash (2x3 inches)) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash), RASH (hot rash), RASH PRURITIC (itchy rash) and RASH (arm rash (2x3 inches)). On 03-Mar-2021, the patient experienced TINNITUS (pulsate tinnitus). On 25-Feb-2021, RASH ERYTHEMATOUS (red rash), RASH (hot rash) and RASH PRURITIC (itchy rash) had resolved. At the time of the report, TINNITUS (pulsate tinnitus) and RASH (arm rash (2x3 inches)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included muscle relaxer. Concomitant medications included muscle relaxer.   This case was linked to MOD-2021-046388 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Poor quality sleep, Pruritus
Clinical narrative: extreme itching; pimple like lesion within the area of his nose; cannot sleep at night; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (extreme itching), DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) and POOR QUALITY SLEEP (cannot sleep at night) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PRURITUS (extreme itching), DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) and POOR QUALITY SLEEP (cannot sleep at night). At the time of the report, PRURITUS (extreme itching) and DERMATITIS ACNEIFORM (pimple like lesion within the area of his nose) had not resolved and POOR QUALITY SLEEP (cannot sleep at night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: TCR, primary physicians contact details were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: She feels achy; She felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She feels achy) and FATIGUE (She felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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 13-Mar-2021, the patient experienced FATIGUE (She felt tired). On 16-Mar-2021, the patient experienced PAIN (She feels achy). At the time of the report, PAIN (She feels achy) and FATIGUE (She felt tired) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pain in extremity, Vaccination site erythema, Vaccination site pain
Clinical narrative: Pain in my arm; Pain in chest; Pain in back; Redness where I got the shot; Swollen; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot) and VACCINATION SITE SWELLING (Swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PREDNISONE, LEVOTHYROXINE SODIUM (LEVOXYL), FLUDROCORTISONE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back) and VACCINATION SITE SWELLING (Swollen) outcome was unknown, VACCINATION SITE ERYTHEMA (Redness where I got the shot) was resolving and VACCINATION SITE PAIN (Soreness) had not resolved.            The patient reported that the injection site started becoming red and swollen. She had been experiencing pain in her arm, chest, and back since then. She also said that the injection site was not as red anymore but she did have soreness there.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Pain in my arm; Pain in chest; Pain in back; Redness where I got the shot; Swollen; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot) and VACCINATION SITE SWELLING (Swollen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included PREDNISONE, LEVOTHYROXINE SODIUM (LEVOXYL), FLUDROCORTISONE, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN [VITAMINS NOS], UBIDECARENONE, VITAMIN E NOS (COQ10 COMPLEX) and VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back), VACCINATION SITE ERYTHEMA (Redness where I got the shot), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in my arm), CHEST PAIN (Pain in chest), BACK PAIN (Pain in back) and VACCINATION SITE SWELLING (Swollen) outcome was unknown, VACCINATION SITE ERYTHEMA (Redness where I got the shot) was resolving and VACCINATION SITE PAIN (Soreness) had not resolved.            The patient reported that the injection site started becoming red and swollen. She had been experiencing pain in her arm, chest, and back since then. She also said that the injection site was not as red anymore but she did have soreness there.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Tinnitus, Vaccination site rash
Clinical narrative: Ears are ringing, it sounds like 1,000 bees are in her ear, a real bad case of tinnitus.; Rash Near the Injection site; Fatigue; Chills; Cold to Hot Sensation Going Up and Down the Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), TINNITUS (Ears are ringing, it sounds like 1,000 bees are in her ear, a real bad case of tinnitus.), VACCINATION SITE RASH (Rash Near the Injection site), FATIGUE (Fatigue) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), VACCINATION SITE RASH (Rash Near the Injection site), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Mar-2021, the patient experienced TINNITUS (Ears are ringing, it sounds like 1,000 bees are in her ear, a real bad case of tinnitus.). The patient was treated with PARACETAMOL (TYLENOL) ongoing from March 2021 at an unspecified dose and frequency. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Cold to Hot Sensation Going Up and Down the Arm), TINNITUS (Ears are ringing, it sounds like 1,000 bees are in her ear, a real bad case of tinnitus.), VACCINATION SITE RASH (Rash Near the Injection site), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-041114 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Primary reporter's details was updated. On 04-May-2021: Follow-up information received on 04-May-2021 contains no new information. On 11-May-2021: Follow-up information received on 11-May-2021 contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-041114:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Myalgia, Vomiting
Clinical narrative: Hotness; Aches; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hotness), MYALGIA (Aches), CHILLS (Chills) and VOMITING (Vomiting) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FEELING HOT (Hotness), MYALGIA (Aches), CHILLS (Chills) and VOMITING (Vomiting). On 16-Mar-2021, VOMITING (Vomiting) had resolved. At the time of the report, FEELING HOT (Hotness), MYALGIA (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 16-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients). On 16-Mar-2021, INCORRECT DOSE ADMINISTERED (One of the nurses gave 1.ml dose instead of a 0.5 dose to three patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On morning of 16-Mar-2021, between  8:30 am to 9:15 am, one of the nurses gave 1 ml dose instead of a 0.5 dose to three patients.  No concomitant medications reported.  No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to event was not applicable.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypoaesthesia
Clinical narrative: Forehead numb; Face became red; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical information history was reported.  Concomitant products included ATENOLOL, LEVOTHYROXINE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red). On 11-Mar-2021, HYPOAESTHESIA (Forehead numb) and ERYTHEMA (Face became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Movement disorder, Somnolence, Vaccination site pain
Clinical narrative: Felt sleepy; "mouth movement"; Headache; Fatigue; Soreness arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm). On 16-Mar-2021, SOMNOLENCE (Felt sleepy), MOVEMENT DISORDER ("mouth movement"), HEADACHE (Headache), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Soreness arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.  Reportedly, the patient experienced the symptoms all weekend and felt all right on 16-Mar-2021.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Upon follow receipt: Contains and no new information.