chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 17-Oct-2021. On 21-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 21-Mar-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Pregnancy test: positive (Positive) Positive.     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.   The patient wants to register for pregnancy registry.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia
Clinical narrative: Pain in the stomach; Very Weak; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, TAMSULOSIN, CALCIUM, METOPROLOL, LOSARTAN, METFORMIN and VITAMINS NOS for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak). At the time of the report, ABDOMINAL PAIN UPPER (Pain in the stomach) and ASTHENIA (Very Weak) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-054385 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash papular, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Injection site she found raised place on the arm, it seems to be going down; Right arm, below the injection site she found hardness; Right arm, below the injection site she found a little bit itchy; Right arm, below the injection site she found soreness; Right arm, below the injection site she found redness; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 FATIGUE (A little tired). On 23-Mar-2021, the patient experienced RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness). On 16-Mar-2021, FATIGUE (A little tired) had resolved. At the time of the report, RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Injection site she found raised place on the arm, it seems to be going down; Right arm, below the injection site she found hardness; Right arm, below the injection site she found a little bit itchy; Right arm, below the injection site she found soreness; Right arm, below the injection site she found redness; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 FATIGUE (A little tired). On 23-Mar-2021, the patient experienced RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness). On 16-Mar-2021, FATIGUE (A little tired) had resolved. At the time of the report, RASH PAPULAR (Injection site she found raised place on the arm, it seems to be going down), VACCINATION SITE INDURATION (Right arm, below the injection site she found hardness), VACCINATION SITE PRURITUS (Right arm, below the injection site she found a little bit itchy), VACCINATION SITE PAIN (Right arm, below the injection site she found soreness) and VACCINATION SITE ERYTHEMA (Right arm, below the injection site she found redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, SARS-CoV-2 antibody test
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (The liquid dripped down the arm and the needle stabbed into the 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 22-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (The liquid dripped down the arm and the needle stabbed into the arm.). On 22-Feb-2021, ACCIDENTAL EXPOSURE TO PRODUCT (The liquid dripped down the arm and the needle stabbed into the arm.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swelling in legs; Tightness in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038AH0) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs). At the time of the report, PERIPHERAL SWELLING (Swelling in legs) and MUSCULOSKELETAL STIFFNESS (Tightness in legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Localised infection, Pain in extremity
Clinical narrative: Left foot got infected; Difficulty to walk due to pain in left foot; Swelling left foot; Itching; Weakness; Swelling at injection arm; Red streaks at injection site; Headache; Fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching) and ASTHENIA (Weakness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PROPRANOLOL for Blood pressure high, ESOMEPRAZOLE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness). On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot) and PERIPHERAL SWELLING (Swelling left foot). On 28-Jan-2021, the patient experienced LOCALISED INFECTION (Left foot got infected). At the time of the report, PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 13 Jan 2021, the patient had an x-ray of the left foot (results not provided).  On 25 Jan 2021, the patient visited an oncologist who advised an ultrasound of the left foot to rule out a clot (not specified whether the ultrasound was done and/or what results were).  Treatment for the events included cefaclor, probiotics, and fexofenadine hydrochloride.  She was also fitted for ankle braces for the left foot.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Left foot got infected; Difficulty to walk due to pain in left foot; Swelling left foot; Itching; Weakness; Swelling at injection arm; Red streaks at injection site; Headache; Fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching) and ASTHENIA (Weakness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included PROPRANOLOL for Blood pressure high, ESOMEPRAZOLE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness). On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot) and PERIPHERAL SWELLING (Swelling left foot). On 28-Jan-2021, the patient experienced LOCALISED INFECTION (Left foot got infected). At the time of the report, PAIN IN EXTREMITY (Difficulty to walk due to pain in left foot), PERIPHERAL SWELLING (Swelling left foot), LOCALISED INFECTION (Left foot got infected), PRURITUS (Itching), ASTHENIA (Weakness), VACCINATION SITE SWELLING (Swelling at injection arm), VACCINATION SITE ERYTHEMA (Red streaks at injection site), HEADACHE (Headache) and FATIGUE (Fatigue/tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 13 Jan 2021, the patient had an x-ray of the left foot (results not provided).  On 25 Jan 2021, the patient visited an oncologist who advised an ultrasound of the left foot to rule out a clot (not specified whether the ultrasound was done and/or what results were).  Treatment for the events included cefaclor, probiotics, and fexofenadine hydrochloride.  She was also fitted for ankle braces for the left foot.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Pyrexia
Clinical narrative: soreness in the arm; fatigue; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), FATIGUE (fatigue) and PYREXIA (Low grade fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm), FATIGUE (fatigue) and PYREXIA (Low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in the arm), FATIGUE (fatigue) and PYREXIA (Low grade fever) outcome was unknown.            The patient was taking cholesterol medicines (unspecified).  No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site induration
Clinical narrative: Pruitius; Pain in leg; Vaccination site induration; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified. Concomitant products included GLIMEPIRIDE, METFORMIN and PRASUGREL for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, PRURITUS (Pruitius), PAIN IN EXTREMITY (Pain in leg), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient complained he was not able send the ADR form and write his story due to the limited space on the ADR form On 29-Apr-2021: Outcome of the events was reported as not recovered; 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.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Ageusia
Clinical narrative: Loss of Taste; Upper Torso Weighted Feeling; Pain in Upper Torso; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso). On 20-Mar-2021, AGEUSIA (Loss of Taste), ABDOMINAL DISTENSION (Upper Torso Weighted Feeling) and ABDOMINAL PAIN UPPER (Pain in Upper Torso) had resolved. Not Provided          No Concomitant medications were reported.  No treatment medications were reported.     This case was linked to MOD-2021-054395 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The patient stated the events reported are not true and did not want a call back again.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Erythema, Feeling hot, Headache
Clinical narrative: dry lips; back hurts; headache; muscular pain; nausea; dizziness; hands hot like when she has fever/face hot; pain on the arm of injection; swelling  two fingers below site of injection; redness two fingers below site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection), ERYTHEMA (redness two fingers below site of injection), DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Drug allergy (Sulfa Allergy) and Osteoporosis. Concomitant products included ROSUVASTATIN, LEVOTHYROXINE, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and CALCIUM 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 PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot). On 22-Mar-2021, the patient experienced MYALGIA (muscular pain) and NAUSEA (nausea). On an unknown date, the patient experienced LIP DRY (dry lips), BACK PAIN (back hurts) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection) had resolved and DIZZINESS (dizziness), FEELING HOT (hands hot like when she has fever/face hot), LIP DRY (dry lips), BACK PAIN (back hurts), HEADACHE (headache), MYALGIA (muscular pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication also includes Injection for osteoporosis every 3 months.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lip dry, Myalgia, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: dry lips; back hurts; headache; muscular pain; nausea; dizziness; hands hot like when she has fever/face hot; pain on the arm of injection; swelling  two fingers below site of injection; redness two fingers below site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection), ERYTHEMA (redness two fingers below site of injection), DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Drug allergy (Sulfa Allergy) and Osteoporosis. Concomitant products included ROSUVASTATIN, LEVOTHYROXINE, ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D3 and CALCIUM 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 PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection). On 02-Mar-2021, the patient experienced DIZZINESS (dizziness) and FEELING HOT (hands hot like when she has fever/face hot). On 22-Mar-2021, the patient experienced MYALGIA (muscular pain) and NAUSEA (nausea). On an unknown date, the patient experienced LIP DRY (dry lips), BACK PAIN (back hurts) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain on the arm of injection), PERIPHERAL SWELLING (swelling  two fingers below site of injection) and ERYTHEMA (redness two fingers below site of injection) had resolved and DIZZINESS (dizziness), FEELING HOT (hands hot like when she has fever/face hot), LIP DRY (dry lips), BACK PAIN (back hurts), HEADACHE (headache), MYALGIA (muscular pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication also includes Injection for osteoporosis every 3 months.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: feeling very tired; having chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling very tired) and CHILLS (having chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Bone cancer.   On 18-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 an unknown date, the patient experienced FATIGUE (feeling very tired) and CHILLS (having chills). At the time of the report, FATIGUE (feeling very tired) and CHILLS (having chills) outcome was unknown.            Concomitant Product included blood pressure medication   treatment product included Bone cancer medication.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Pain, Pyrexia
Clinical narrative: redness on arm; slight temperature; really bad body aches; body aches; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad body aches), PAIN (body aches), ERYTHEMA (redness on arm), PYREXIA (slight temperature) and PYREXIA (fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-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 18-Mar-2021, the patient experienced PAIN (body aches), PYREXIA (fever) and CHILLS (chills). On 22-Mar-2021, the patient experienced PAIN (really bad body aches), ERYTHEMA (redness on arm) and PYREXIA (slight temperature). On 20-Mar-2021, PAIN (body aches), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, PAIN (really bad body aches), ERYTHEMA (redness on arm) and PYREXIA (slight temperature) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: weakness in the right arm, but mainly in the hand and cannot grasp on anything; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in the right arm, but mainly in the hand and cannot grasp on anything) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the right arm, but mainly in the hand and cannot grasp on anything). At the time of the report, MUSCULAR WEAKNESS (weakness in the right arm, but mainly in the hand and cannot grasp on anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature abnormal, Chills, Dry mouth, Fatigue
Clinical narrative: headache; little tired; feeling so sick; dry mouth; body shaking temperature; could not get out of bed; night chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering). On 22-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 22-Mar-2021, MALAISE (feeling so sick), DRY MOUTH (dry mouth) and CHILLS (night chills/ teeth chattering) had resolved. At the time of the report, BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed), HEADACHE (headache) and FATIGUE (little tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-117279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient initials. No other new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117279:Reporter's case
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: headache; little tired; feeling so sick; dry mouth; body shaking temperature; could not get out of bed; night chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering). On 22-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 22-Mar-2021, MALAISE (feeling so sick), DRY MOUTH (dry mouth) and CHILLS (night chills/ teeth chattering) had resolved. At the time of the report, BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed), HEADACHE (headache) and FATIGUE (little tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-117279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient initials. No other new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117279:Reporter's case
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Erythema, Pruritus, Vaccination site pruritus
Clinical narrative: Redness and bums around the midriff area; Itching around midriff area, stomach, lower back; Burns around midriff area; Itching on injecction site arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm). At the time of the report, ERYTHEMA (Redness and bums around the midriff area), PRURITUS (Itching around midriff area, stomach, lower back), ABDOMINAL DISCOMFORT (Burns around midriff area) and VACCINATION SITE PRURITUS (Itching on injecction site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  This case was linked to MOD-2021-132958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: follow-up was received on 14-MAY-2021 and patient initial, new event were updated
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: soreness on her arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (soreness on her arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information was provided.  The patient stated she already reported to V-SAFE.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued for 1½ days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigued for 1½ days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigued for 1½ days). At the time of the report, FATIGUE (fatigued for 1½ days) had resolved. Not Provided          The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: registered in the Pregnancy Registry; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (registered in the Pregnancy Registry) in a 24-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Outcome: Live,full term birth) from May 2015 to 19-Jan-2016. Concomitant products included PARACETAMOL (TYLENOL A) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 11-Nov-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (registered in the Pregnancy Registry). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 23-Mar-2021, EXPOSURE DURING PREGNANCY (registered in the Pregnancy Registry) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included ATORVASTATIN, TAMSULOSIN, CALCIUM, METOPROLOL, LOSARTAN, METFORMIN and VITAMINS NOS for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-054357 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patients initials were added. Outcome of adverse event updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054357:MOD-2021-054357 Second dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Head discomfort
Clinical narrative: Tighter chest; Something with my breathing; Head felt heavy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tighter chest), DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats. Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced CHEST DISCOMFORT (Tighter chest), DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy). On 23-Mar-2021, DYSPNOEA (Something with my breathing) and HEAD DISCOMFORT (Head felt heavy) had resolved. At the time of the report, CHEST DISCOMFORT (Tighter chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Oral pain, Pyrexia
Clinical narrative: constantly thirsty; soreness inside the mouth; fever; body chills; vomiting (puking); body ache; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), THIRST (constantly thirsty), ORAL PAIN (soreness inside the mouth), PYREXIA (fever) and CHILLS (body chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (body chills), VOMITING (vomiting (puking)) and MYALGIA (body ache). On 16-Mar-2021, the patient experienced THIRST (constantly thirsty) and ORAL PAIN (soreness inside the mouth). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (body chills), VOMITING (vomiting (puking)) and MYALGIA (body ache) had resolved and THIRST (constantly thirsty) and ORAL PAIN (soreness inside the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication (unspecified).  No treatment information was provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Vomiting
Clinical narrative: constantly thirsty; soreness inside the mouth; fever; body chills; vomiting (puking); body ache; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), THIRST (constantly thirsty), ORAL PAIN (soreness inside the mouth), PYREXIA (fever) and CHILLS (body chills) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (body chills), VOMITING (vomiting (puking)) and MYALGIA (body ache). On 16-Mar-2021, the patient experienced THIRST (constantly thirsty) and ORAL PAIN (soreness inside the mouth). At the time of the report, DIARRHOEA (diarrhea), PYREXIA (fever), CHILLS (body chills), VOMITING (vomiting (puking)) and MYALGIA (body ache) had resolved and THIRST (constantly thirsty) and ORAL PAIN (soreness inside the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication (unspecified).  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (splitting headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (splitting headache), NAUSEA (nausea) and FATIGUE (extreme fatigue). At the time of the report, HEADACHE (splitting headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) had resolved. Not Provided          Concomitant medications were not reported.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid) in a 51-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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site swelling
Clinical narrative: with redness going down the side of the arm; left arm where she was injected was red and swollen; left arm where she was injected was red and swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen) 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 01-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 ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen). On 23-Mar-2021, ERYTHEMA (with redness going down the side of the arm), VACCINATION SITE SWELLING (left arm where she was injected was red and swollen) and VACCINATION SITE ERYTHEMA (left arm where she was injected was red and swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: area is a raised lump like a mosquito bite; area is hard; area is swollen; big red circle around the injection site/ red dot where the injection went into her arm; arm sore at injection site; red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (area is a raised lump like a mosquito bite), VACCINATION SITE INDURATION (area is hard), VACCINATION SITE PAIN (arm sore at injection site), VACCINATION SITE ERYTHEMA (red at injection site) and VACCINATION SITE SWELLING (area is swollen) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 15-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (arm sore at injection site) and VACCINATION SITE ERYTHEMA (red at injection site). On 23-Mar-2021, the patient experienced VACCINATION SITE MASS (area is a raised lump like a mosquito bite), VACCINATION SITE INDURATION (area is hard), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (big red circle around the injection site/ red dot where the injection went into her arm). On 17-Mar-2021, VACCINATION SITE PAIN (arm sore at injection site) and VACCINATION SITE ERYTHEMA (red at injection site) had resolved. At the time of the report, VACCINATION SITE MASS (area is a raised lump like a mosquito bite), VACCINATION SITE INDURATION (area is hard), VACCINATION SITE SWELLING (area is swollen) and VACCINATION SITE ERYTHEMA (big red circle around the injection site/ red dot where the injection went into her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.