chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: bump; itchy; area of the injection got red; swollen; warm to the touch; pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red) and VACCINATION SITE SWELLING (swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppression. Concomitant products included PREDNISONE, PANCREATIN (CREON), CYCLOBENZAPRINE, CHLORTHALIDONE, POTASSIUM CHLORIDE, METOPROLOL, ETANERCEPT (ENBREL), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and Gabapentin for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 20-Jan-2021, the patient experienced VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch). On 13-Jan-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: bump; itchy; area of the injection got red; swollen; warm to the touch; pain in arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red) and VACCINATION SITE SWELLING (swollen) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunosuppression. Concomitant products included PREDNISONE, PANCREATIN (CREON), CYCLOBENZAPRINE, CHLORTHALIDONE, POTASSIUM CHLORIDE, METOPROLOL, ETANERCEPT (ENBREL), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and Gabapentin for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 20-Jan-2021, the patient experienced VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch). On 13-Jan-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, VACCINATION SITE INDURATION (bump), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (area of the injection got red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling of body temperature change, Headache, Myalgia, Nausea
Clinical narrative: fingers ache when he moves them; hand is swollen; During the night he was very cold and then very hot; whole body aches; headache; joints are aching; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches) and HEADACHE (headache) in a 47-year-old male patient 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 information was reported.   On 20-Jan-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 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were reported.   The patient did not take any medication for the treatment of the events. He only took sleeping pills
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fingers ache when he moves them; hand is swollen; During the night he was very cold and then very hot; whole body aches; headache; joints are aching; fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches) and HEADACHE (headache) in a 47-year-old male patient 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 information was reported.   On 20-Jan-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 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (fingers ache when he moves them), PERIPHERAL SWELLING (hand is swollen), FEELING OF BODY TEMPERATURE CHANGE (During the night he was very cold and then very hot), MYALGIA (whole body aches), HEADACHE (headache), ARTHRALGIA (joints are aching), PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            No concomitant medications were reported.   The patient did not take any medication for the treatment of the events. He only took sleeping pills
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a patient and describes the occurrence of   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 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: swollen lymph nodes on the bottom of the neck-clavicle; pain in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm) and LYMPHADENOPATHY (swollen lymph nodes on the bottom of the neck-clavicle) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm). On 18-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on the bottom of the neck-clavicle). At the time of the report, PAIN IN EXTREMITY (pain in the arm) and LYMPHADENOPATHY (swollen lymph nodes on the bottom of the neck-clavicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L201A) for COVID-19 vaccination.     The patient's past medical history included Tooth extraction. Concurrent medical conditions included Hypertension. Concomitant products included QUINAPRIL for Hypertension.    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 (headache). At the time of the report, HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash, Urticaria
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in a 59-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 17-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (heart palpitations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PALPITATIONS (heart palpitations). At the time of the report, PALPITATIONS (heart palpitations) 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.   No concomitant medications were reported.   The patient still has heart palpitations, but they are occurring less frequently.   No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: red spot is a little bit warm; left arm itching around the injection site; red spot about the size of a hardball around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Drug allergy (Allergy to ace inhibitors), Drug allergy (Allergy to Zestril), Drug allergy (Allergy to clonidine), Drug allergy (Allergy to codeine), Drug allergy (Allergy to Librium), Drug allergy (Allergy to Adalat), Drug allergy (Allergy to Trental), Drug allergy (Allergy to Cardizem), Allergy to plants (Allergy to belladonna), Drug allergy (Allergy to hydrocortisone), Drug allergy (Allergy to sulfa), Drug allergy (Allergy to Septocaine/epinephrine) and Drug allergy (Allergy to Norvasc (swelling)).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site). At the time of the report, VACCINATION SITE WARMTH (red spot is a little bit warm), VACCINATION SITE PRURITUS (left arm itching around the injection site) and VACCINATION SITE ERYTHEMA (red spot about the size of a hardball around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient mentioned that she was prescribed a lot of medications, but did not specify any.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Pregnancy test
Clinical narrative: Pregnant patient received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy. Concomitant products included FOLIC ACID, IRON, MINERALS NOS, VITAMINS NOS (PRENATE [FOLIC ACID;IRON;MINERALS NOS;VITAMINS NOS]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 08-May-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 30-Dec-2020, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2020, Pregnancy test: positive (Positive) Positive.         Patient test included Genetic with normal result . No treatment information was provided.  The patient did not experience any pregnancy related complications or other acute illnesses.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site rash
Clinical narrative: enlarged nodules on left side of neck; large rash on left arm at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of   in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm started itching; red at injection site; swollen at the injection site; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Injection site erythema, Injection site inflammation, Injection site pruritus
Clinical narrative: Pounding headache; Itchy entire arm; Injection site red; Injection site was swollen; Inflammation on the injection site; Warm to touch, injection site hot; Discomfort on the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine, Lung nodule and Cellulitis. Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE N S), ALBUTEROL SULFATE (ALBUTEROL) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot) and DISCOMFORT (Discomfort on the injection site). On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen). On 20-Jan-2021, the patient experienced HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE SWELLING (Injection site was swollen), HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm) 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 included hot and cold compress.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pounding headache; Itchy entire arm; Injection site red; Injection site was swollen; Inflammation on the injection site; Warm to touch, injection site hot; Discomfort on the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine, Lung nodule and Cellulitis. Concurrent medical conditions included Seasonal allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE N S), ALBUTEROL SULFATE (ALBUTEROL) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot) and DISCOMFORT (Discomfort on the injection site). On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE SWELLING (Injection site was swollen). On 20-Jan-2021, the patient experienced HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency and STEROIDS at an unspecified dose and frequency. At the time of the report, INJECTION SITE INFLAMMATION (Inflammation on the injection site), INJECTION SITE WARMTH (Warm to touch, injection site hot), DISCOMFORT (Discomfort on the injection site), INJECTION SITE ERYTHEMA (Injection site red), INJECTION SITE SWELLING (Injection site was swollen), HEADACHE (Pounding headache) and INJECTION SITE PRURITUS (Itchy entire arm) 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 included hot and cold compress.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: welts in small patches; itching at arm; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of  Pain in extremity (arm was sore), Urticaria (welts in small patches) and Urticaria (welts in small patches)  in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 milligram.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) administered intramuscularly, the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Malaise, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Pain in arm and leg; Neck pain; Joint pain; Muscle pain; Pain at the injection site in shoulder; Felt uncomfortable; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm and leg), MALAISE (Felt uncomfortable), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at the injection site in shoulder) and ARTHRALGIA (Joint pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DEXKETOPROFEN TROMETAMOL (DEXALGIN) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced MALAISE (Felt uncomfortable) and VACCINATION SITE PAIN (Pain at the injection site in shoulder). On 20-Jan-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm and leg). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CANNABIDIOL at an unspecified dose and frequency. On 18-Jan-2021, MALAISE (Felt uncomfortable) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Pain in arm and leg), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at the injection site in shoulder), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) 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.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in arm and leg; Neck pain; Joint pain; Muscle pain; Pain at the injection site in shoulder; Felt uncomfortable; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm and leg), MALAISE (Felt uncomfortable), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at the injection site in shoulder) and ARTHRALGIA (Joint pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DEXKETOPROFEN TROMETAMOL (DEXALGIN) for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced MALAISE (Felt uncomfortable) and VACCINATION SITE PAIN (Pain at the injection site in shoulder). On 20-Jan-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm and leg). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CANNABIDIOL at an unspecified dose and frequency. On 18-Jan-2021, MALAISE (Felt uncomfortable) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Pain in arm and leg), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at the injection site in shoulder), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) 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.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Pain
Clinical narrative: Burning on the center of his back to his down right side of the shoulder; when he stands up feel a hot pain; back is hot at the touch; A spontaneous report was received from a consumer concerning a 75-years-old, male patient who experienced burning on the center of his back to his down right side of the shoulder, back is hot at the touch, pain and when he stands up feel a hot pain.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 07 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 026L20] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient started experiencing burning in the center of his back to his down right side shoulder. His shoulder is hot at the touch. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events burning on the center of his back to his down right side of the shoulder, back is hot at the touch, pain and when he stands up feel a hot pain was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Side effects; injection site itching; injection site pain; injection site swollen; injection site redness; A spontaneous report was received from a consumer concerning a female patient who experienced injection site pain, injection site swollen, injection site redness, injection site itching.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 07 Jan 2021, approximately two days prior to the onset of the symptoms, the patient received their planned dose of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.   On 09 Jan 2021, the patient experienced injection site pain, injection site swollen, injection site redness, injection site itching. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events injection site pain, injection site swollen, injection site redness, injection site itching was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine). At the time of the report, HAEMATURIA (Went to bathroom and it was all blood/Filled the toilet with blood/Blood in urine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment and concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy; Big rash on her arm at the site of the injection; Not terribly painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Big rash on her arm at the site of the injection) and VACCINATION SITE PAIN (Not terribly painful) 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain
Clinical narrative: shooting pain in the left eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (shooting pain in the left eye) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced EYE PAIN (shooting pain in the left eye). On 18-Jan-2021, EYE PAIN (shooting pain in the left eye) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (forceps delivery Live, full -term birth) on 12-Apr-2015 and Pregnancy (no complication Live, full -term birth) on 11-Oct-2018. Concurrent medical conditions included Gestational diabetes. Concomitant products included VITAMIN B6, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), CALCIUM LEVOMEFOLATE (METHYL FOLATE), CALCIUM and DOCOSAHEXAENOIC ACID (DHA) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 13-Apr-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2020, Pregnancy test: positive (Positive) Positive. On 20-Jan-2021, Glucose tolerance test: not provided (Positive) Gestational diabetes confirmed.. On 20-Jan-2021, Ultrasound scan: normal (normal) Normal.     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.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Blisters on left foot and on the bottom of calf; This spontaneous case was reported by an other caregiver and describes the occurrence of BLISTER (Blisters on left foot and on the bottom of calf) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced BLISTER (Blisters on left foot and on the bottom of calf). The patient was treated with CHLORINE DIOXIDE, MENTHA X PIPERITA OIL (OXYFRESH FRESH BREATH FRESH MINT MOUTHWASH) for Blister, at an unspecified dose and frequency. On 14-Jan-2021, BLISTER (Blisters on left foot and on the bottom of calf) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyskinesia, Fatigue, Influenza like illness
Clinical narrative: Sore arm; could barely lift it up; body ache; very tender; swollen under arm; feels like she's getting the flu; joint pain; tired; Muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender) and PERIPHERAL SWELLING (swollen under arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Sore arm; could barely lift it up; body ache; very tender; swollen under arm; feels like she's getting the flu; joint pain; tired; Muscle aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender) and PERIPHERAL SWELLING (swollen under arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), DYSKINESIA (could barely lift it up), PAIN (body ache), TENDERNESS (very tender), PERIPHERAL SWELLING (swollen under arm), INFLUENZA LIKE ILLNESS (feels like she's getting the flu), ARTHRALGIA (joint pain), FATIGUE (tired), MYALGIA (Muscle aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Maternal exposure during pregnancy, Paraesthesia, Vaccination site mass, Vaccination site pain
Clinical narrative: huge lump on her left arm where she got the shot; golf ball size; whole arm is completely numb; tingles; pregnant; arm hurt really bad; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles), MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (arm hurt really bad) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (No medical history reported.).   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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 06-Oct-2021. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles), MATERNAL EXPOSURE DURING PREGNANCY (pregnant) and VACCINATION SITE PAIN (arm hurt really bad). On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. At the time of the report, VACCINATION SITE MASS (huge lump on her left arm where she got the shot; golf ball size), HYPOAESTHESIA (whole arm is completely numb), PARAESTHESIA (tingles) and VACCINATION SITE PAIN (arm hurt really bad) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Headache, Pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of  abdominal discomfort, diarrhea, headache, arm pain and body ache in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (ANTICID) at an unspecified dose and frequency. On 08 Jan 2021, the patient experienced headache and arm pain. On 11 Jan 2021, the patient experienced diarrhea and abdominal discomfort. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Myalgia, Sinus disorder
Clinical narrative: her back felt like it was about to break; her muscles still feel kinda sore; her sinus was messed up; she was feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included IRON, CYANOCOBALAMIN (B12-VITAMIIN), SPIRONOLACTONE, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS], ZINC and ASCORBIC ACID (VITAMINE C) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED 12 HOUR) at an unspecified dose and frequency. At the time of the report, BACK PAIN (her back felt like it was about to break), MYALGIA (her muscles still feel kinda sore), SINUS DISORDER (her sinus was messed up) and FEELING ABNORMAL (she was feeling really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) 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 (No reported medical history). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. No concomitant meds were provided. No treatment information provided.