chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness; Swollen; Left arm is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LOSARTAN and ATORVASTATIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Left arm is painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product also included thyroid medication.  Treatment information was not provided.  Patient reported that the reactions have gotten worse since she received the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site warmth
Clinical narrative: It's warm to the touch; Redness; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching). At the time of the report, VACCINATION SITE WARMTH (It's warm to the touch), ERYTHEMA (Redness) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details was not reported by the reporter. Treatment details was not reported by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Dizziness, Pyrexia
Clinical narrative: so dizzy; Chills; Fever; bedridden for two days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS for an unknown indication.    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 DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN. The patient was treated with TYLENOL at a dose of UNK dosage form. At the time of the report, DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Visual impairment
Clinical narrative: Numb cheek; Left arm was weak; left vision was messed up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20X-4) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up). On 03-Feb-2021, HYPOAESTHESIA (Numb cheek), MUSCULAR WEAKNESS (Left arm was weak) and VISUAL IMPAIRMENT (left vision was messed up) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash macular
Clinical narrative: Swollen rash; Rash that has not gone away for three days/swollen rash; covid arm; red splotch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm), RASH MACULAR (red splotch) and RASH (Swollen rash) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-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 RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm) and RASH MACULAR (red splotch). On an unknown date, the patient experienced RASH (Swollen rash). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form, qd. On 19-Feb-2021, RASH (Rash that has not gone away for three days/swollen rash), PAIN IN EXTREMITY (covid arm) and RASH MACULAR (red splotch) had resolved. At the time of the report, RASH (Swollen rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported Treatment medication used was topical ointment.    Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: No specific follow-up information recorded. On 18-May-2021: ADR, form with page 1 and 2 was received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Tenderness in her left under arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness in her left under arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced TENDERNESS (Tenderness in her left under arm). At the time of the report, TENDERNESS (Tenderness in her left under arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Vaccination site erythema
Clinical narrative: 2-2 1/2 inch spot that reds; felt like a black and blue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (2-2 1/2 inch spot that reds) and INJECTION SITE BRUISING (felt like a black and blue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (2-2 1/2 inch spot that reds) and INJECTION SITE BRUISING (felt like a black and blue). At the time of the report, VACCINATION SITE ERYTHEMA (2-2 1/2 inch spot that reds) and INJECTION SITE BRUISING (felt like a black and blue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications:- Arnica cream   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Updated events outcome as recovered/resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Malaise, Migraine, Myalgia
Clinical narrative: body aches; nausea; still lite headiness; Pain at the Injection Site; felt very sick; fever; migraine; chills; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, and CHILLS in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (post breads cancer). Concomitant products included EXCEDRIN for an unknown indication, TAMOXIFEN.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, and CHILLS. On an unknown date, the patient experienced MYALGIA, NAUSEA, and DIZZINESS. The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form and TYLENOL ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, CHILLS, NAUSEA, and DIZZINESS outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: body aches; nausea; still lite headiness; Pain at the Injection Site; felt very sick; fever; migraine; chills; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, and CHILLS in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer (post breads cancer). Concomitant products included EXCEDRIN for an unknown indication, TAMOXIFEN.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, and CHILLS. On an unknown date, the patient experienced MYALGIA, NAUSEA, and DIZZINESS. The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form and TYLENOL ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN, MALAISE, PYREXIA, MIGRAINE, CHILLS, NAUSEA, and DIZZINESS outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: was very tired and is still tired; arm was also sore; She felt lousy like she did not want to do anything; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (was very tired and is still tired), PAIN IN EXTREMITY (arm was also sore) and MALAISE (She felt lousy like she did not want to do anything) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 04-Feb-2021, the patient experienced FATIGUE (was very tired and is still tired), PAIN IN EXTREMITY (arm was also sore) and MALAISE (She felt lousy like she did not want to do anything). At the time of the report, FATIGUE (was very tired and is still tired), PAIN IN EXTREMITY (arm was also sore) and MALAISE (She felt lousy like she did not want to do anything) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: pain at injection site; fatigue; fever reemerged; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged). On 09-Feb-2021, VACCINATION SITE PAIN (pain at injection site), FATIGUE (fatigue) and PYREXIA (fever reemerged) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details included acetaminophen.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: persistent headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HEADACHE (persistent headaches) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (persistent headaches). At the time of the report, HEADACHE (persistent headaches) outcome was unknown. Related      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.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever; Nauseated; Joint pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Fever), NAUSEA (Nauseated) and ARTHRALGIA (Joint pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NAUSEA (Nauseated) and ARTHRALGIA (Joint pain). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Fever), NAUSEA (Nauseated) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Vaccination site erythema, Vaccination site pain
Clinical narrative: Red mark on the patient's arm the size of a quarter; Stiffness in arm; My left arm was swollen; Soreness in their arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness in arm), PERIPHERAL SWELLING (My left arm was swollen), VACCINATION SITE PAIN (Soreness in their arm) and VACCINATION SITE ERYTHEMA (Red mark on the patient's arm the size of a quarter) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Compazine) and Allergy to vaccine (Shingles shot). Concomitant products included SIMVASTATIN (ZOCOR), METFORMIN HCL, ESTRADIOL (YUVAFEM), METOPROLOL SUCCINATE (TOPROL XL) and TRAVOPROST for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness in arm), PERIPHERAL SWELLING (My left arm was swollen) and VACCINATION SITE PAIN (Soreness in their arm). On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark on the patient's arm the size of a quarter). On 25-Feb-2021, MUSCULOSKELETAL STIFFNESS (Stiffness in arm), PERIPHERAL SWELLING (My left arm was swollen) and VACCINATION SITE PAIN (Soreness in their arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red mark on the patient's arm the size of a quarter) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment for the events were not provided.   This case was linked to MOD-2021-235593 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient demographics, medical history, concomitant medications updated. Additional event was added.Start date and stop date for the events updated.; Reporter'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.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Pain, Tremor
Clinical narrative: body shaking; Diarrhea; high blood pressure; pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain). At the time of the report, TREMOR (body shaking), DIARRHOEA (Diarrhea), BLOOD PRESSURE INCREASED (high blood pressure) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: A little fatigued/tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little fatigued/tired) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (A little fatigued/tired). At the time of the report, FATIGUE (A little fatigued/tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Headache, Illness, Nausea
Clinical narrative: Extreme shakes; Vertigo; Mentally fuzzy; Sick; Extreme headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick) and HEADACHE (Extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   On 10-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever).   The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 3 dosage form.   At the time of the report, TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 102 (High) Patient had fever of 102 F.   Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vertigo
Clinical narrative: Extreme shakes; Vertigo; Mentally fuzzy; Sick; Extreme headache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick) and HEADACHE (Extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.   On 10-Feb-2021 at 9:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever).   The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at a dose of 3 dosage form.   At the time of the report, TREMOR (Extreme shakes), VERTIGO (Vertigo), FEELING ABNORMAL (Mentally fuzzy), ILLNESS (Sick), HEADACHE (Extreme headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: 102 (High) Patient had fever of 102 F.   Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Difficulty breathing after the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing after the Moderna shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 DYSPNOEA (Difficulty breathing after the Moderna shot). At the time of the report, DYSPNOEA (Difficulty breathing after the Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided  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.; 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.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Throat tightness
Clinical narrative: extremely sore arm,; had fatigue; muscle ache; headache; Immediately after receiving the shot she felt her throat was closing for a couple of seconds; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds), PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LISINOPRIL, LORAZEPAM, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) and MINERALS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds). On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache). On 05-Feb-2021, THROAT TIGHTNESS (Immediately after receiving the shot she felt her throat was closing for a couple of seconds) had resolved. At the time of the report, PAIN IN EXTREMITY (extremely sore arm,), FATIGUE (had fatigue), MYALGIA (muscle ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Maternal exposure before pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (ended in C sections). Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL (TYLENOL) for Headache, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Dec-2020 to an unknown date for an unknown indication.    On 17-Feb-2021 at 9:30 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 22-Nov-2020 and the estimated date of delivery was 29-Aug-2021. On 17-Feb-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 17-Feb-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2020, Pregnancy test: positive (Positive) Positive. On 08-Feb-2021, Blood test: normal (normal) blood work within normal limits. On 08-Feb-2021, Ultrasound scan: 160 (High) Heart beat 160. On 12-Feb-2021, Blood test: normal (normal) blood work within normal limits.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had conception on 06-Dec-2020. Number of fetus was found to be one.   Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Neck pain, Pain in jaw, Pyrexia
Clinical narrative: fever of 100.5; Shortness of breath; Jaw achy; Neck hurting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), PAIN IN JAW (Jaw achy), NECK PAIN (Neck hurting) and PYREXIA (fever of 100.5) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication, OMALIZUMAB (XOLAIR).   On 03-Feb-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 03-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath), PAIN IN JAW (Jaw achy) and NECK PAIN (Neck hurting). On 04-Feb-2021, the patient experienced PYREXIA (fever of 100.5). At the time of the report, DYSPNOEA (Shortness of breath), PAIN IN JAW (Jaw achy), NECK PAIN (Neck hurting) and PYREXIA (fever of 100.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 F.         Treatment details included Paracetamol and Naproxen.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Head discomfort, Headache, Inflammation, Migraine
Clinical narrative: The heated spot was hot, tender, and about 5 inches; heated spot was hot, tender, and about 5 inches; Tenderness and pressure/top left side of her head heated up; Head sore/tender on the side of  head; The top left side of head heated up and was sore/Severe migraine; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE, FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced MIGRAINE. On 20-Jan-2021, the patient experienced FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE. On 19-Jan-2021, MIGRAINE had resolved. On 20-Jan-2021, FEELING HOT, INFLAMMATION, HEAD DISCOMFORT, and HEADACHE 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. Treatment included Advil. This case was linked to MOD21-026177 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information received 27-APR-2021 on  contains non-significant information; Sender's Comments:  MOD21-026177:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Injection site pruritus, Vaccination site pain
Clinical narrative: Blisters on the arm at the injection site after the first dose; Itching at the injection site after the first dose; Pain at the injection site after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Blisters on the arm at the injection site after the first dose), INJECTION SITE PRURITUS (Itching at the injection site after the first dose) and VACCINATION SITE PAIN (Pain at the injection site after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLISTER (Blisters on the arm at the injection site after the first dose), INJECTION SITE PRURITUS (Itching at the injection site after the first dose) and VACCINATION SITE PAIN (Pain at the injection site after the first dose). At the time of the report, BLISTER (Blisters on the arm at the injection site after the first dose), INJECTION SITE PRURITUS (Itching at the injection site after the first dose) and VACCINATION SITE PAIN (Pain at the injection site after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medication were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I have had a very strong adverse reaction to the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    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 VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot). At the time of the report, VACCINATION COMPLICATION (I have had a very strong adverse reaction to the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site mass, Swelling
Clinical narrative: Warm (ring) on skin; Swelling; Bump (L) arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness) in a 70-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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness). The patient was treated with HYDROCORTISONE at a dose of UNK dosage form, bid and IBUPROFEN at a dose of UNK dosage form, bid. On 14-Feb-2021, FEELING HOT (Warm (ring) on skin), SWELLING (Swelling), INJECTION SITE MASS (Bump (L) arm) and ERYTHEMA (redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Vaccination site pain
Clinical narrative: Numbness on the hand; Fatigue; Headache; Soreness of the injection spot; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, HYPOAESTHESIA (Numbness on the hand), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness of the injection spot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: Swollen lymph nodes under right arm/ Swelling of groin lymph nodes; experienced swelling of arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes under right arm/ Swelling of groin lymph nodes) and PERIPHERAL SWELLING (experienced swelling of arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included TRAMADOL and PARACETAMOL (TYLENOL).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PERIPHERAL SWELLING (experienced swelling of arm). On 29-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes under right arm/ Swelling of groin lymph nodes). The patient was treated with CELECOXIB (COXIB [CELECOXIB]) for Phlebitis, at an unspecified dose and frequency and HYDROCORTISONE ACETATE (CORTIZONE [HYDROCORTISONE ACETATE]) at an unspecified dose and frequency. On 31-Jan-2021, LYMPHADENOPATHY (Swollen lymph nodes under right arm/ Swelling of groin lymph nodes) had resolved. In July 2021, PERIPHERAL SWELLING (experienced swelling of arm) outcome was unknown. Not provided.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  Treatment mediations includes alcohol cortisone cream salve   This case was linked to MOD-2021-029552 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Treatment medications updated.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome 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 was reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Around the injection site, it's little warmth; Around the injection site, it's still red; Around the injection site, it's still itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy). At the time of the report, VACCINATION SITE WARMTH (Around the injection site, it's little warmth), VACCINATION SITE ERYTHEMA (Around the injection site, it's still red) and VACCINATION SITE PRURITUS (Around the injection site, it's still itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR-event outcome, Patient endorsed she was feeling fine, and  didn't want no  further follow up
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Ache from the Moderna shot; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Ache from the Moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MYALGIA (Ache from the Moderna shot). At the time of the report, MYALGIA (Ache from the Moderna shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Pallor
Clinical narrative: almost fell; pale; very weak/loses power I start walking; very dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included HYDROXYCARBAMIDE (HYDROXYUREA EURECO PHARMA) and WARFARIN for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale). At the time of the report, ASTHENIA (very weak/loses power I start walking), DIZZINESS (very dizzy), FALL (almost fell) and PALLOR (pale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Vaccine not indicated; Sore arm; Pain at injection site; Headache; Body ache; Chills; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache) and MYALGIA (Body ache) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated), VACCINATION SITE PAIN (Pain at injection site), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever). 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. On 09-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine not indicated) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache), MYALGIA (Body ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102-103 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient will not be given second dose.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Added lab data. Added concomitant and treatment medications. Added second dose details of a patient. Added new events fever, sore arm. Updated reporter details. Updated patient details. Updated the time of first dose. Updated action taken. Updated event outcome. On 07-May-2021: Follow up information received on 07-MAY-2021 contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year  old male) for mRNA-1273 (lot number 030M20A) with associated AEs reported as pain at injection site, headache, body pain, and chills.