chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: she is miserable; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (she is miserable) 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 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 DEPRESSED MOOD (she is miserable). At the time of the report, DEPRESSED MOOD (she is miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: soreness in arm; Fever; body aches; tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), PYREXIA (Fever), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN) 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 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), PYREXIA (Fever), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. On 10-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in arm), MYALGIA (body aches), FATIGUE (tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: redness on injection site; swelling on injection site; itching on injection site; hardness on injection site; localized reaction; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness on injection site), INJECTION SITE SWELLING (swelling on injection site), INJECTION SITE PRURITUS (itching on injection site), INJECTION SITE INDURATION (hardness on injection site) and INJECTION SITE REACTION (localized reaction) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (redness on injection site), INJECTION SITE SWELLING (swelling on injection site), INJECTION SITE PRURITUS (itching on injection site), INJECTION SITE INDURATION (hardness on injection site) and INJECTION SITE REACTION (localized reaction). At the time of the report, INJECTION SITE ERYTHEMA (redness on injection site), INJECTION SITE SWELLING (swelling on injection site), INJECTION SITE PRURITUS (itching on injection site), INJECTION SITE INDURATION (hardness on injection site) and INJECTION SITE REACTION (localized reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea
Clinical narrative: Nauseated feeling returned; Feeling yucky and rotten; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling yucky and rotten), NAUSEA (Nauseated) and NAUSEA (Nauseated feeling returned) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included AMLODIPINE for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced FEELING ABNORMAL (Feeling yucky and rotten) and NAUSEA (Nauseated). On 07-Feb-2021, the patient experienced NAUSEA (Nauseated feeling returned). On 24-Jan-2021, FEELING ABNORMAL (Feeling yucky and rotten) and NAUSEA (Nauseated) had resolved. On 09-Feb-2021, NAUSEA (Nauseated feeling returned) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nervousness
Clinical narrative: Feeling dizzy; Felling shaky; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety attack since January 2021.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling dizzy) and NERVOUSNESS (Felling shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided          Treatment medications were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            Treatment and concomitant medications were not provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Faeces discoloured, Hypertension, Muscle spasms
Clinical narrative: elevated blood pressure; diarrhea; discoloured stool; a little cramping; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events elevated blood pressure, diarrhea, discoloured stool, a little cramping.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril, Potassium, Hydrochlorothiazide, Fenofibrate for drug use for unknown indication.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event(s) elevated blood pressure, diarrhea, discoloured stool, a little cramping.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), elevated blood pressure, diarrhea, discoloured stool, a little cramping was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Sore Arm; chills; Fever; Headache; A spontaneous report was received from a consumer concerning a 65-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, chills, fever, headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events sore arm, chills, fever, and headache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event sore arm, chills, fever, and headache 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. Further information has been requested
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: Chills; Itchy rash;  Big red rash; Swollen arm; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash), PERIPHERAL SWELLING (swollen arm) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.  Concurrent medical conditions included Allergic reaction to drug (allergy to omnicef.), Allergic reaction to drug (allergy to adhesive.), Allergic reaction to drug (Allergic to chlorhexidine) and Environmental allergy. Concomitant products included SPIRONOLACTONE for Acne, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, COENZYME Q10 [UBIDECARENONE] for Product used for adjunct to statin, MONTELUKAST SODIUM (SINGULAIR) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for Vitamin D deficiency.    On 26-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash) and CHILLS (Chills). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PREDNISONE at a dose of 1 dosage form every other day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (Big red rash), RASH PRURITIC (Itchy rash) and PERIPHERAL SWELLING (swollen arm) had resolved and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-230100 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Patient demography, medical history, lab data, concomitant drugs
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurts to lift arm day after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Hurts to lift arm day after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm was swollen; hard; warm to touch; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (itching) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 023M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METFORMIN, VITAMINS NOS (MULTIVITAMINUM) and LISINOPRIL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (itching). On 25-Feb-2021, VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE INDURATION (hard) and VACCINATION SITE WARMTH (warm to touch) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching) 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.   Treatment medications were not provided by reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness Injection Site wrapping around the arm (Fist Size); Swelling Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness Injection Site wrapping around the arm (Fist Size)) and VACCINATION SITE SWELLING (Swelling Injection Site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness Injection Site wrapping around the arm (Fist Size)) and VACCINATION SITE SWELLING (Swelling Injection Site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness Injection Site wrapping around the arm (Fist Size)) and VACCINATION SITE SWELLING (Swelling Injection Site) had not resolved. Fist size      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Nurse told to put cold compress, but the swelling and redness still in her arm.  No corrective treatment was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Fatigue, Feeling abnormal, Lymphadenopathy
Clinical narrative: Stiff in her joints; Feeling worse; Very fatigued; Joint pain all over the body; Swelling in her lymph nodes in neck and under both arms; Metallic taste in her mouth; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) in a 44-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 was provided by reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), CEFIXIME (FLEXERIL [CEFIXIME]), VITAMIN D NOS, MULTIVITAMINS [VITAMINS NOS], ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms). On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain all over the body). On 09-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse) and FATIGUE (Very fatigued). At the time of the report, DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body), LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) and FATIGUE (Very fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff in her joints; Feeling worse; Very fatigued; Joint pain all over the body; Swelling in her lymph nodes in neck and under both arms; Metallic taste in her mouth; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) in a 44-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 was provided by reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]), CEFIXIME (FLEXERIL [CEFIXIME]), VITAMIN D NOS, MULTIVITAMINS [VITAMINS NOS], ATORVASTATIN CALCIUM (LIPITOR) and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth) and LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms). On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain all over the body). On 09-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse) and FATIGUE (Very fatigued). At the time of the report, DYSGEUSIA (Metallic taste in her mouth), MUSCULOSKELETAL STIFFNESS (Stiff in her joints), FEELING ABNORMAL (Feeling worse), ARTHRALGIA (Joint pain all over the body), LYMPHADENOPATHY (Swelling in her lymph nodes in neck and under both arms) and FATIGUE (Very fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Rash
Clinical narrative: Swelling in the bags under the eyes, 3 times as the normal size; Rash on cheek and forehead, both temples, then down bridge of nose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on cheek and forehead, both temples, then down bridge of nose) and PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), ALLOPURINOL, BOSWELLIA SERRATA RESIN, COLECALCIFEROL, COLLAGEN (OSTEO BI-FLEX EASE) and VITAMIN D NOS for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (Rash on cheek and forehead, both temples, then down bridge of nose). On 25-Feb-2021, the patient experienced PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size). At the time of the report, RASH (Rash on cheek and forehead, both temples, then down bridge of nose) and PERIORBITAL SWELLING (Swelling in the bags under the eyes, 3 times as the normal size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment to the events not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: vomitting; really dizzy; nausea; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea), VOMITING (vomitting) and DIZZINESS (really dizzy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 NAUSEA (nausea) and DIZZINESS (really dizzy). On an unknown date, the patient experienced VOMITING (vomitting). On 25-Feb-2021, NAUSEA (nausea), VOMITING (vomitting) and DIZZINESS (really dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Vials straight from refrigerator and immediately administered; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and mentioned that she believed the pharmacist removed vial from refrigerator and immediately filled syringe allowing no time for vaccination to thaw.(PT  The consumer's medical history was not provided. Concomitant product use was not provided by the reporter.  On 24 Feb 2021, prior to the onset of the events, the patient received dose of mRNA-1273 (Batch no: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  She reported that she watched the pharmacist administer the vaccine and believed the pharmacist removed the vial from refrigerator and immediately filled syringe allowing no time for vaccination to thaw.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event, vials straight from refrigerator and immediately administered was recovered on 24 Feb 2021.; Reporter's Comments: This report refers to a case of "wrong technique in product usage process".for mRNA-1273 (lot # unknown) with no associated AEs reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Pain which he reported as being on a scale of 4 out of 5 /Soreness; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 42L20A and 023V120A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension and High cholesterol. Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and CROMOGLICATE SODIUM (NASALCROM) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue). On 27-Jan-2021, PAIN (Pain which he reported as being on a scale of 4 out of 5 /Soreness) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided by reporter.   This case was linked to MOD-2021-028027 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hot flush, Product administration error
Clinical narrative: Hot flashes; Diarrhea; Vaccine was administered too high in the upper arm; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Spinal disorder and Pain. Concomitant products included ETODOLAC (LODINE) for Pain.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm), FATIGUE (Fatigue) and CHILLS (Chills). On 12-Feb-2021, PRODUCT ADMINISTRATION ERROR (Vaccine was administered too high in the upper arm) had resolved. At the time of the report, HOT FLUSH (Hot flashes), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided  by reporter.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Haematoma, Injection site bruising, Pain in extremity
Clinical narrative: tired/fatigued; arm was bruised/arm turned blue from the site of injection to elbow to under armpit; arm is red; arm is achy - still hurts; hematoma on arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm). At the time of the report, FATIGUE (tired/fatigued), INJECTION SITE BRUISING (arm was bruised/arm turned blue from the site of injection to elbow to under armpit), ERYTHEMA (arm is red), PAIN IN EXTREMITY (arm is achy - still hurts) and HAEMATOMA (hematoma on arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not provided.  Action taken with mRNA-1273 in response to the event was not applicable
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: can't see well the next day; This spontaneous case was reported by an other and describes the occurrence of VISUAL IMPAIRMENT (can't see well the next day) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-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 26-Feb-2021, the patient experienced VISUAL IMPAIRMENT (can't see well the next day). At the time of the report, VISUAL IMPAIRMENT (can't see well the next day) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 contains no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site is red; Injection site swelling; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Had hot circle on arm; Had itchy circle on arm; Red circle on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had hot circle on arm), VACCINATION SITE PRURITUS (Had itchy circle on arm) and VACCINATION SITE ERYTHEMA (Red circle on 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 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Had hot circle on arm), VACCINATION SITE PRURITUS (Had itchy circle on arm) and VACCINATION SITE ERYTHEMA (Red circle on arm). At the time of the report, VACCINATION SITE WARMTH (Had hot circle on arm), VACCINATION SITE PRURITUS (Had itchy circle on arm) and VACCINATION SITE ERYTHEMA (Red circle on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: it is very itchy,; red at vaccination site; at the time her arm hurt/painful for two days; today it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (at the time her arm hurt/painful for two days), VACCINATION SITE PAIN (today it hurts), VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (at the time her arm hurt/painful for two days) and VACCINATION SITE PAIN (today it hurts). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site). At the time of the report, PAIN IN EXTREMITY (at the time her arm hurt/painful for two days), VACCINATION SITE PAIN (today it hurts), VACCINATION SITE PRURITUS (it is very itchy,) and VACCINATION SITE ERYTHEMA (red at vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow up
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Pain in extremity, Pruritus, Rash
Clinical narrative: Had a rash all over it; Reaction to the vaccine; Red; Irritating; Itching; Painful; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reaction to the vaccine/Vaccination site reaction, started at the injection site and expanded all over her arm, red/Injection site erythema, irritating/Injection site irritation, itching/Pruritus, painful/Pain in extremity, had a rash all over it/Rash.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it.  Treatment details included Cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Had a rash all over it; Reaction to the vaccine; Red; Irritating; Itching; Painful; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reaction to the vaccine/Vaccination site reaction, started at the injection site and expanded all over her arm, red/Injection site erythema, irritating/Injection site irritation, itching/Pruritus, painful/Pain in extremity, had a rash all over it/Rash.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it.  Treatment details included Cream.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), reaction to the vaccine, started at the injection site and expanded all over her arm, red, irritating, itching, painful, had a rash all over it was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Leakage while administering vaccine; Leakage while administering vaccine; A spontaneous report was received from a pharmacist concerning a 31-year-old, male patient who experienced leakage while administering vaccine (underdose and device connection issue).   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 27 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly for prophylaxis of COVID-19 infection.   The reporter stated that there was a leakage while administering vaccine to the patient. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, leakage while administering vaccine (underdose and device connection issue) was considered resolved.; Reporter's Comments: This report refers to a case Underdose and device connection issue for mRNA-1273, lot # 030M20A, with no associated AEs
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching over their legs and their arms (both of each); have some raised surfaces, It's constantly annoying; sleeping has been hard at times; expected little pain in the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (expected little pain in the injection site), VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, SIMVASTATIN and AMLODIPINE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (expected little pain in the injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times). On 03-Feb-2021, VACCINATION SITE PAIN (expected little pain in the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching over their legs and their arms (both of each)), VACCINATION SITE SWELLING (have some raised surfaces, It's constantly annoying) and SLEEP DISORDER (sleeping has been hard at times) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included topical lotions.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness and pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness and pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm soreness and pain). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 24-Jan-2021, VACCINATION SITE PAIN (arm soreness and pain) had resolved.            Relevant concomitant product usage were not reported by the reporter.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injection site discolouration, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itchy site of injection; pink circle at the site of injection; dizzy; red arm of injection; swollen arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection), VACCINATION SITE PRURITUS (itchy site of injection), DIZZINESS (dizzy) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Hypertension.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection) and DIZZINESS (dizzy). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy site of injection) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red arm of injection), VACCINATION SITE SWELLING (swollen arm of injection), VACCINATION SITE PRURITUS (itchy site of injection), DIZZINESS (dizzy) and INJECTION SITE DISCOLOURATION (pink circle at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Warmth at injection site; Headache; sluggish; Tired; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (Warmth at injection site), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No relevant Medical history Reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication included unspecified prescription eye drops used for an unknown indication.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site warmth
Clinical narrative: Warmth at injection site; Headache; sluggish; Tired; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (Warmth at injection site), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No relevant Medical history Reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.  On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). On 26-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 26-Feb-2021, SLUGGISHNESS (sluggish), FATIGUE (Tired), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication included unspecified prescription eye drops used for an unknown indication.