chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Pyrexia, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: FELT CONFUSED AND OUT OF IT; ARM FELT LIKE FEVER IN IT; Fever; ARM VERY RED; RASH; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH) in an 88-year-old female 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, the patient experienced CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH). At the time of the report, CONFUSIONAL STATE (FELT CONFUSED AND OUT OF IT), VACCINATION SITE WARMTH (ARM FELT LIKE FEVER IN IT), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (ARM VERY RED) and VACCINATION SITE RASH (RASH) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Dyspnoea, Ear pain, Oropharyngeal discomfort
Clinical narrative: feels like a ball in her throat; Chest is very tight; Stomach pain; Weird pain deep in ear through the core of her crown of her head like electricity; Had a hard time breathing; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a hard time breathing), PRURITUS (Very itchy), ABDOMINAL PAIN UPPER (Stomach pain), EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) and OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) in a 38-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.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Had a hard time breathing) and PRURITUS (Very itchy). On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity). On 12-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight). On 09-Mar-2021, PRURITUS (Very itchy) had resolved. On 11-Mar-2021, ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) had resolved. At the time of the report, DYSPNOEA (Had a hard time breathing), OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided aside from asthma inhaler.  Treatment of events as reported by patient included use of asthma Inhaler.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: feels like a ball in her throat; Chest is very tight; Stomach pain; Weird pain deep in ear through the core of her crown of her head like electricity; Had a hard time breathing; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Had a hard time breathing), PRURITUS (Very itchy), ABDOMINAL PAIN UPPER (Stomach pain), EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) and OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) in a 38-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.     Concurrent medical conditions included Asthma.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DYSPNOEA (Had a hard time breathing) and PRURITUS (Very itchy). On 09-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity). On 12-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight). On 09-Mar-2021, PRURITUS (Very itchy) had resolved. On 11-Mar-2021, ABDOMINAL PAIN UPPER (Stomach pain) and EAR PAIN (Weird pain deep in ear through the core of her crown of her head like electricity) had resolved. At the time of the report, DYSPNOEA (Had a hard time breathing), OROPHARYNGEAL DISCOMFORT (feels like a ball in her throat) and CHEST DISCOMFORT (Chest is very tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided aside from asthma inhaler.  Treatment of events as reported by patient included use of asthma Inhaler.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose not administered yet; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet). On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet) had resolved. 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.   No relevant concomitant medications were reported. Treatment information was not provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product preparation issue
Clinical narrative: Patients get the vaccines which were previously shaken; Vaccine boxes are not secured in the refrigerator; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT PREPARATION ISSUE (Patients get the vaccines which were previously shaken) and EXPIRED PRODUCT ADMINISTERED (Vaccine boxes are not secured in the refrigerator) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ISSUE (Patients get the vaccines which were previously shaken) and EXPIRED PRODUCT ADMINISTERED (Vaccine boxes are not secured in the refrigerator). At the time of the report, PRODUCT PREPARATION ISSUE (Patients get the vaccines which were previously shaken) and EXPIRED PRODUCT ADMINISTERED (Vaccine boxes are not secured in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Fast heartbeat) in a 61-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 08-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 HEART RATE INCREASED (Fast heartbeat). At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Concomitant product use was unknown by the reporter
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Left arm with mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Left arm with mild symptoms) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 VACCINATION COMPLICATION (Left arm with mild symptoms). At the time of the report, VACCINATION COMPLICATION (Left arm with mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided.   This case was linked to MOD-2021-042753 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm became swollen; Arm was little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was little sore) and VACCINATION SITE SWELLING (Arm became swollen) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 101A21A) for COVID-19 vaccination.     No medical history is provided and concomitant are produced.  Concomitant products included OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for an unknown indication.    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 VACCINATION SITE PAIN (Arm was little sore). On 10-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm became swollen). On 04-Mar-2021, VACCINATION SITE PAIN (Arm was little sore) had resolved. At the time of the report, VACCINATION SITE SWELLING (Arm became swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: "COVID arm"; rash circling the injection site; sensitivity and itching in the injection site; sensitivity in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) 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 09-Mar-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site). At the time of the report, VACCINATION SITE REACTION ("COVID arm"), VACCINATION SITE RASH (rash circling the injection site), VACCINATION SITE PRURITUS (sensitivity and itching in the injection site) and VACCINATION SITE PAIN (sensitivity in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Patient reported no treatment for events was provided.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pyrexia
Clinical narrative: Back pain; Muscle pain; Fever/ at 8am fever is gone back up; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PYREXIA (Fever/ at 8am fever is gone back up) and MYALGIA (Muscle pain) 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 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 PYREXIA (Fever/ at 8am fever is gone back up). On an unknown date, the patient experienced BACK PAIN (Back pain) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain) and MYALGIA (Muscle pain) outcome was unknown and PYREXIA (Fever/ at 8am fever is gone back up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient experienced fever gave paracetamol at 5am and went down. But on 12-Mar-2021, at 8am it is gone back up.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound uterus
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use in December 2020. Family history included Dwarfism (Mother had one child with dwarfism with no bones. Did not survive.) and Congenital heart disease NOS (Sister-in-law had a baby with heart syndrome. Did not survive.). Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 12-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 21-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive. On 05-Mar-2021, Ultrasound uterus: on track (normal) On track. In 2021, Ultrasound uterus: positive (Positive) Positive pregnancy confirmation at 6 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NIPT (Noninvasive Prenatal Testing) was performed on 05-Mar-2021, results are pending. Estimated Date of Conception: 29-Dec-2020
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pain
Clinical narrative: Tenderness and soreness at injection site, extremely tender; Redness at injection site on her upper arm, today her arm is super red; Arm where she received the injection had issues; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Arm where she received the injection had issues), VACCINATION SITE PAIN (Tenderness and soreness at injection site, extremely tender) and VACCINATION SITE ERYTHEMA (Redness at injection site on her upper arm, today her arm is super red) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) 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 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Arm where she received the injection had issues). On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness and soreness at injection site, extremely tender) and VACCINATION SITE ERYTHEMA (Redness at injection site on her upper arm, today her arm is super red). On 04-Mar-2021, VACCINATION COMPLICATION (Arm where she received the injection had issues) had resolved. At the time of the report, VACCINATION SITE PAIN (Tenderness and soreness at injection site, extremely tender) and VACCINATION SITE ERYTHEMA (Redness at injection site on her upper arm, today her arm is super red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 12-Mar-2021, her arm where she received the vaccine was super red, extremely tender. Concomitant product used was not provided by the reporter. The patient did not receive any treatment medications.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hypokinesia, Muscular weakness, Peripheral swelling
Clinical narrative: Rosacea; Decrease range of motion and strength in arm; Little swelling; Decrease range of motion and strength in arm; Pain in shoulder, more localized to muscle of the injection site, increased pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). On 09-Mar-2021, the patient experienced ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain). The patient was treated with PENICILLIN NOS on 09-Mar-2021 for Rosacea, at an unspecified dose and frequency. On 24-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-042783 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rosacea
Clinical narrative: Rosacea; Decrease range of motion and strength in arm; Little swelling; Decrease range of motion and strength in arm; Pain in shoulder, more localized to muscle of the injection site, increased pain; Chills; This spontaneous case was reported by a nurse and describes the occurrence of ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). On 09-Mar-2021, the patient experienced ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain). The patient was treated with PENICILLIN NOS on 09-Mar-2021 for Rosacea, at an unspecified dose and frequency. On 24-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, ROSACEA (Rosacea), HYPOKINESIA (Decrease range of motion and strength in arm), PERIPHERAL SWELLING (Little swelling), MUSCULAR WEAKNESS (Decrease range of motion and strength in arm) and ARTHRALGIA (Pain in shoulder, more localized to muscle of the injection site, increased pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-042783 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccination on patient under 18 y/o; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No medical history reported.     On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o). On 12-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccination on patient under 18 y/o) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was doing well and did not experience an adverse reaction to the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Reporters details, patient demographics and event information updated.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Somnolence, Swelling
Clinical narrative: Sleepy; swollen; soreness; red; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SOMNOLENCE (Sleepy), SWELLING (swollen), PAIN (soreness), ERYTHEMA (red) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Terrible red rash that is the size of the grapefruit; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Terrible red rash that is the size of the grapefruit) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Terrible red rash that is the size of the grapefruit). At the time of the report, RASH ERYTHEMATOUS (Terrible red rash that is the size of the grapefruit) had resolved.            No concomitant medication was reported. Patient did not receive any treatment for the event.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: TCR : AE outcome updated to recovered. No treatment was received. The patient received second dose without any issues.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Peripheral swelling, Rash, Vaccination site induration
Clinical narrative: r rash spreading underneath her arm and approaching the elbow; Rash on her chest; Hard around injection site; Painful around injection site; Ache on the shoulder; Arm swollen around injection site; Hot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen around injection site), VACCINATION SITE WARMTH (Hot around injection site), CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow), RASH (Rash on her chest) and VACCINATION SITE INDURATION (Hard around injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (sulfur), Allergy (FLAXEN) and Shellfish allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen around injection site) and RASH (Rash on her chest). 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE PAIN (Painful around injection site) and ARTHRALGIA (Ache on the shoulder). On 09-Mar-2021, the patient experienced CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow). At the time of the report, PERIPHERAL SWELLING (Arm swollen around injection site), VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE PAIN (Painful around injection site) and ARTHRALGIA (Ache on the shoulder) had not resolved, CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow) outcome was unknown and RASH (Rash on her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow up received on 14 march 2021, Reporter Email id and alternate phone number has been updated, Added allergies sulfur, Flaxen and shellfish, updated drug start date from 02-MAR-2021 to 01-MAR-2021. Added additional events rash spreading underneath her arm and rash approaching the elbow.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: r rash spreading underneath her arm and approaching the elbow; Rash on her chest; Hard around injection site; Painful around injection site; Ache on the shoulder; Arm swollen around injection site; Hot around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen around injection site), VACCINATION SITE WARMTH (Hot around injection site), CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow), RASH (Rash on her chest) and VACCINATION SITE INDURATION (Hard around injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (sulfur), Allergy (FLAXEN) and Shellfish allergy.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen around injection site) and RASH (Rash on her chest). 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE PAIN (Painful around injection site) and ARTHRALGIA (Ache on the shoulder). On 09-Mar-2021, the patient experienced CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow). At the time of the report, PERIPHERAL SWELLING (Arm swollen around injection site), VACCINATION SITE WARMTH (Hot around injection site), VACCINATION SITE INDURATION (Hard around injection site), VACCINATION SITE PAIN (Painful around injection site) and ARTHRALGIA (Ache on the shoulder) had not resolved, CONDITION AGGRAVATED (r rash spreading underneath her arm and approaching the elbow) outcome was unknown and RASH (Rash on her chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2021: Follow up received on 14 march 2021, Reporter Email id and alternate phone number has been updated, Added allergies sulfur, Flaxen and shellfish, updated drug start date from 02-MAR-2021 to 01-MAR-2021. Added additional events rash spreading underneath her arm and rash approaching the elbow.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Lip swelling, Oropharyngeal swelling, Speech disorder
Clinical narrative: Swelling at throat; Swelling...tongue; Swelling...lips; Could not swallow well , now is better but is still having difficulties for talk and swallow; Could not talk well , now is better but is still having difficulties for talk and swallow; Reports headache; This spontaneous case was reported by an other caregiver and describes the occurrence of OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow) and SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling..tongue), LIP SWELLING (Swelling..lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swelling at throat; Swelling...tongue; Swelling...lips; Could not swallow well , now is better but is still having difficulties for talk and swallow; Could not talk well , now is better but is still having difficulties for talk and swallow; Reports headache; This spontaneous case was reported by an other caregiver and describes the occurrence of OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow) and SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling...tongue), LIP SWELLING (Swelling...lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL SWELLING (Swelling at throat), SWOLLEN TONGUE (Swelling..tongue), LIP SWELLING (Swelling..lips), DYSPHAGIA (Could not swallow well , now is better but is still having difficulties for talk and swallow), SPEECH DISORDER (Could not talk well , now is better but is still having difficulties for talk and swallow) and HEADACHE (Reports headache) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-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 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Aches in legs), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Pretty much on bed and could not do anything) and ARTHRALGIA (Aches in Hips) outcome was unknown.            No concomitant medications were reported.     Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow up document received on 23-06-2021. contain Non significant information On 28-Jun-2021: Reporter contact information updated.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria, Vaccination site rash
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of RASH (rash on back,  rash on torso), PRURITUS (itchy), VACCINATION SITE RASH (Rash at injection site) and URTICARIA (hives) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (rash on back,  rash on torso), PRURITUS (itchy), VACCINATION SITE RASH (Rash at injection site) and URTICARIA (hives). At the time of the report, RASH (rash on back,  rash on torso), PRURITUS (itchy) and VACCINATION SITE RASH (Rash at injection site) had not resolved and URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A nurse practitioner called on behalf of a patient to report events.  No concomitant medication use was provided by the reporter.  Treatment of events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (flare up on the knee). At the time of the report, ARTHRALGIA (flare up on the knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Disorientation, Dizziness, Emotional distress, Fatigue
Clinical narrative: muscles aching; light headed; distressed; like her brain is not working; arthritis been magnified; more tired than usual; dizzy; Disorientation; mild tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), VACCINATION SITE PAIN (mild tenderness on the injection site), MYALGIA (muscles aching), DIZZINESS (light headed) and EMOTIONAL DISTRESS (distressed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (mild tenderness on the injection site). On 10-Mar-2021, the patient experienced DISORIENTATION (Disorientation), MYALGIA (muscles aching), DIZZINESS (light headed), EMOTIONAL DISTRESS (distressed), FEELING ABNORMAL (like her brain is not working), ARTHRITIS (arthritis been magnified), FATIGUE (more tired than usual) and DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disorientation), FATIGUE (more tired than usual) and DIZZINESS (dizzy) had not resolved and VACCINATION SITE PAIN (mild tenderness on the injection site), MYALGIA (muscles aching), DIZZINESS (light headed), EMOTIONAL DISTRESS (distressed), FEELING ABNORMAL (like her brain is not working) and ARTHRITIS (arthritis been magnified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had received her 1st dose of vaccine on the left non-dominant arm.  No concomitant medication was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Vaccination site pain
Clinical narrative: muscles aching; light headed; distressed; like her brain is not working; arthritis been magnified; more tired than usual; dizzy; Disorientation; mild tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Disorientation), VACCINATION SITE PAIN (mild tenderness on the injection site), MYALGIA (muscles aching), DIZZINESS (light headed) and EMOTIONAL DISTRESS (distressed) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (mild tenderness on the injection site). On 10-Mar-2021, the patient experienced DISORIENTATION (Disorientation), MYALGIA (muscles aching), DIZZINESS (light headed), EMOTIONAL DISTRESS (distressed), FEELING ABNORMAL (like her brain is not working), ARTHRITIS (arthritis been magnified), FATIGUE (more tired than usual) and DIZZINESS (dizzy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (Disorientation), FATIGUE (more tired than usual) and DIZZINESS (dizzy) had not resolved and VACCINATION SITE PAIN (mild tenderness on the injection site), MYALGIA (muscles aching), DIZZINESS (light headed), EMOTIONAL DISTRESS (distressed), FEELING ABNORMAL (like her brain is not working) and ARTHRITIS (arthritis been magnified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had received her 1st dose of vaccine on the left non-dominant arm.  No concomitant medication was reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; pain, redness, and swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site) in a 33-year-old female patient who received mRNA-1273 (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain, redness, and swelling at injection site), VACCINATION SITE ERYTHEMA (pain, redness, and swelling at injection site) and VACCINATION SITE SWELLING (pain, redness, and swelling at injection site) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-042533 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site swelling, Pain in extremity, Pruritus, Vaccination site erythema
Clinical narrative: Sore arm; Chills; Swelling; Redness; Itching on her left arm (wrist and hand); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), INJECTION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and PRURITUS (Itching on her left arm (wrist and hand)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), INJECTION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and PRURITUS (Itching on her left arm (wrist and hand)). At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), INJECTION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and PRURITUS (Itching on her left arm (wrist and hand)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-046607 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-MAY-2021 and contains event itching on her left arm (wrist and hand). Update all events to resolved.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was not reported.