chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a female patient of an unknown age (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (female), Anxiety and Headache. Previously administered products included for Product used for unknown indication: Metformin (First 10 weeks for getting pregnant.). Concurrent medical conditions included Hypothyroidism (Medication and well controlled), Polycystic ovarian syndrome and Gestational diabetes. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, PARACETAMOL (TYLENOL) for Headache, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) 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 18-Feb-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 an unknown date and the estimated date of delivery was 25-May-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2020, Pregnancy test: positive positive (Positive) positive. On an unknown date, Prenatal screening test: normal normal (normal) normal. On an unknown date, Ultrasound scan: normal normal (normal) 12 and 22 weeks.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the event.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Pain at injection site on right arm; slight chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at injection site on right arm) and CHILLS (slight chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (BABY ASPIRIN), MULTIVITAMIN [VITAMINS NOS] and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site on right arm) and CHILLS (slight chills). On 04-Feb-2021, VACCINATION SITE PAIN (Pain at injection site on right arm) and CHILLS (slight chills) had resolved.            Concomitant medications also include Thyroid medicine and Allergy medicine. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Treatment information was  provided.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash, Vaccination site reaction
Clinical narrative: Covid arm; rash/break out of a rash on her forearm that almost looked liked hives/rash the size of baseball; reported being tired; arm was achy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Covid arm), PAIN IN EXTREMITY (arm was achy), RASH (rash/break out of a rash on her forearm that almost looked liked hives/rash the size of baseball) and FATIGUE (reported being tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was achy) and FATIGUE (reported being tired). On 13-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm) and RASH (rash/break out of a rash on her forearm that almost looked liked hives/rash the size of baseball). At the time of the report, VACCINATION SITE REACTION (Covid arm), PAIN IN EXTREMITY (arm was achy), RASH (rash/break out of a rash on her forearm that almost looked liked hives/rash the size of baseball) and FATIGUE (reported being tired) 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: Erythema, Induration, Pruritus, Swelling, Tenderness
Clinical narrative: big red spot 3 inches across/it's red; it's itchy; it is hard; little bit tender; A little bit puffy; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (little bit tender), SWELLING (A little bit puffy), ERYTHEMA (big red spot 3 inches across/it's red), PRURITUS (it's itchy) and INDURATION (it is hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included POTASSIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), BENAZEPRIL, PANTOPRAZOLE, ATENOLOL, FUROSEMIDE, HYDROXYZINE, ATORVASTATIN, TELMISARTAN and MAGNESIUM for an unknown indication.    On 09-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 TENDERNESS (little bit tender) and SWELLING (A little bit puffy). On 17-Feb-2021, the patient experienced ERYTHEMA (big red spot 3 inches across/it's red), PRURITUS (it's itchy) and INDURATION (it is hard). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) ongoing since an unknown date at a dose of UNK dosage form. On 10-Feb-2021, TENDERNESS (little bit tender) and SWELLING (A little bit puffy) had resolved. At the time of the report, ERYTHEMA (big red spot 3 inches across/it's red), PRURITUS (it's itchy) and INDURATION (it is hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided. .     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form and OATMEAL (topical) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PRURITUS (itchiness at the bottom of her feet, palms and it is spreading to ankle, and one finger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient is also using ice as treatment for the event.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: he had reaction broke out into rash all over his body; Itching all over; Headache; fever; chill; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) 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. On 11-Feb-2021, the patient experienced RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill). At the time of the report, RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient went to the emergency room and was given an unspecified shot. The patient then left as he felt better.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Hypersensitivity, Pyrexia, Rash
Clinical narrative: Severe allergic reaction with fever; Chronic issues got worse; rash; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Severe allergic reaction with fever), CONDITION AGGRAVATED (Chronic issues got worse), RASH (rash), PYREXIA (fever) and FATIGUE (fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPERSENSITIVITY (Severe allergic reaction with fever), CONDITION AGGRAVATED (Chronic issues got worse), RASH (rash), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, HYPERSENSITIVITY (Severe allergic reaction with fever), CONDITION AGGRAVATED (Chronic issues got worse), RASH (rash), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient did not receive any treatment for the events.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated) in a 35-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and LANSOPRAZOLE for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-May-2021. On 05-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated). On 05-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and vaccinated) had resolved.            No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site swelling, Vaccination site vesicles
Clinical narrative: Local tenderness; Injection site induration; Injection site redness; Injection site swelling; Hot to touch at injection site; Blisters at the injection site/small vesicles at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), PAIN (Local tenderness), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced PAIN (Local tenderness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), PAIN (Local tenderness) and VACCINATION SITE INDURATION (Injection site induration) outcome was unknown and VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) 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.   Patient had delayed injection site reaction. She was instructed to apply cold compress.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Local tenderness; Injection site induration; Injection site redness; Injection site swelling; Hot to touch at injection site; Blisters at the injection site/small vesicles at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), PAIN (Local tenderness), VACCINATION SITE INDURATION (Injection site induration) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE INDURATION (Injection site induration), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). On an unknown date, the patient experienced PAIN (Local tenderness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), PAIN (Local tenderness) and VACCINATION SITE INDURATION (Injection site induration) outcome was unknown and VACCINATION SITE VESICLES (Blisters at the injection site/small vesicles at injection site), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) 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.   Patient had delayed injection site reaction. She was instructed to apply cold compress.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchiness in arm and hives; Itchiness in arm and hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives). On 15-Feb-2021, PRURITUS (Itchiness in arm and hives) and URTICARIA (Itchiness in arm and hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  Treatment details are also not provided.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headaches/Migraine; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches/Migraine) and PAIN IN EXTREMITY (Sore Arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Migraine and Seizure.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headaches/Migraine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, HEADACHE (Headaches/Migraine) had not resolved and PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatments for the event included Ibuprofen.   Reporter did not allow further contact
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Vaccination site erythema; Vaccination site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE ERYTHEMA (A big red mark at the injection site) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral
Clinical narrative: Headache; Numbness lips; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Numbness on the lower lip) and HEADACHE (Little headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and METOPROLOL.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness on the lower lip) and HEADACHE (Little headache). At the time of the report, HYPOAESTHESIA ORAL (Numbness on the lower lip) and HEADACHE (Little headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Swelling on the lips; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Swelling on the lips) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION COMPLICATION (Swelling on the lips). At the time of the report, VACCINATION COMPLICATION (Swelling on the lips) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported.   No treatment information was provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: Achy; Flu like symptoms; He is tired; A spontaneous report was received from a  Consumer concerning a male patient of unkown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like achy, flu like symptoms and he was tired.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17/Feb/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) for prophylaxis of COVID-19 infection.  On date or an unknown date, The patient experienced the events like achy, flu like symptoms and he was tired.    Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased
Clinical narrative: Higher cholesterol in blood tests after getting the vaccine; A spontaneous report was received from a 69-years-old female consumer, who received Moderna's COVID-9 vaccine (mRNA-1273) and experienced high blood cholesterol levels.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L20A) intramuscularly for the prophylaxis of COVID-19 infection.  On 11-FEB-2021, the patient experienced elevated blood cholesterol level after getting the vaccine.  On 11-FEB-2021, a blood test was done and the cholesterol level was elevated.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Vomiting
Clinical narrative: Dizziness; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The Concomitant medications were not reported  The treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergy). At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Feb-2021: Upon internal review on 27 May 2021, it was discovered that the patient age was incorrectly captured as 121 years and DOB mentioned in source document was 01-Jan-1900, which was a error. The patient age and narrative has been updated to unknown age with reports re-submission and significant amendment is performed for the correction.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Sore Arm; Sleepy most of the day; A spontaneous report was received from a consumer  concerning a 78-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events sore arm/pain in extremity and sleepy most of the day/somnolence.   The patient's medical history was not provided. No relevant concomitant product use was reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.  On 12 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) in the anatomical location for prophylaxis of COVID-19 infection. The route of administration was unknown.    On an unknown date, the patient experienced sore arm and was sleepy most of the day.  No treatment details were provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of the event sore arm and was sleepy most of the day were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: Tender arm; hot sweats; chills; headache; feels like a mac truck ran over her; diarrhea; fever up and down; constantly tired; no appetitie; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache) and MALAISE (feels like a mac truck ran over her) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie). At the time of the report, PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Tender arm; hot sweats; chills; headache; feels like a mac truck ran over her; diarrhea; fever up and down; constantly tired; no appetitie; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache) and MALAISE (feels like a mac truck ran over her) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie). At the time of the report, PAIN IN EXTREMITY (Tender arm), HYPERHIDROSIS (hot sweats), CHILLS (chills), HEADACHE (headache), MALAISE (feels like a mac truck ran over her), DIARRHOEA (diarrhea), PYREXIA (fever up and down), FATIGUE (constantly tired) and DECREASED APPETITE (no appetitie) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Mobility decreased; Myalgia; Radiating pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (myalgia), MOBILITY DECREASED (Could not get out of bed) and PAIN (Radiating Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (myalgia), MOBILITY DECREASED (Could not get out of bed) and PAIN (Radiating Pain). At the time of the report, MYALGIA (myalgia), MOBILITY DECREASED (Could not get out of bed) and PAIN (Radiating Pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided   The treatment information is cold packs.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Rash pruritic, Urticaria
Clinical narrative: This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by reporter. Reporter did not allow further contact.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Lymph node swollen in armpit; completely swollen elbow to shoulder, red; completely swollen elbow to shoulder, red; arm was sore in the injection area; warm to touch in the injection area; red in the injection area; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area), VACCINATION SITE ERYTHEMA (red in the injection area), LYMPHADENOPATHY (Lymph node swollen in armpit) and PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area) and VACCINATION SITE ERYTHEMA (red in the injection area). On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node swollen in armpit), PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) and ERYTHEMA (completely swollen elbow to shoulder, red). On 19-Jan-2021, PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area) and VACCINATION SITE ERYTHEMA (red in the injection area) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swollen in armpit), PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) and ERYTHEMA (completely swollen elbow to shoulder, red) 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 relevant concomitant medications were reported  No treatment information was provided.    Reporter did not allow further contact
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Lymph node swollen in armpit; completely swollen elbow to shoulder, red; completely swollen elbow to shoulder, red; arm was sore in the injection area; warm to touch in the injection area; red in the injection area; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area), VACCINATION SITE ERYTHEMA (red in the injection area), LYMPHADENOPATHY (Lymph node swollen in armpit) and PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area) and VACCINATION SITE ERYTHEMA (red in the injection area). On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph node swollen in armpit), PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) and ERYTHEMA (completely swollen elbow to shoulder, red). On 19-Jan-2021, PAIN IN EXTREMITY (arm was sore in the injection area), VACCINATION SITE WARMTH (warm to touch in the injection area) and VACCINATION SITE ERYTHEMA (red in the injection area) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swollen in armpit), PERIPHERAL SWELLING (completely swollen elbow to shoulder, red) and ERYTHEMA (completely swollen elbow to shoulder, red) 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 relevant concomitant medications were reported  No treatment information was provided.    Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Migraine
Clinical narrative: injection site redness and vaccination site swelling; red big circle at injection site; fatigued; MIGRAINE; EXTREME DIZZINESS; NAUSEATED; foggy; pressure on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).    On 09-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 DIZZINESS (EXTREME DIZZINESS) and HEADACHE (pressure on forehead). On 10-Feb-2021, the patient experienced FATIGUE (fatigued). On 11-Feb-2021, DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments for the events included, Tylenol, Ibuprofen, Benadryl.     Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site redness and vaccination site swelling; red big circle at injection site; fatigued; MIGRAINE; EXTREME DIZZINESS; NAUSEATED; foggy; pressure on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).    On 09-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 DIZZINESS (EXTREME DIZZINESS) and HEADACHE (pressure on forehead). On 10-Feb-2021, the patient experienced FATIGUE (fatigued). On 11-Feb-2021, DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments for the events included, Tylenol, Ibuprofen, Benadryl.     Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Somnolence, Vision blurred
Clinical narrative: Terible surge of sleepiness; Vision blurry; Joints ache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache). At the time of the report, SOMNOLENCE (Terible surge of sleepiness), VISION BLURRED (Vision blurry) and ARTHRALGIA (Joints ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: stomach hurts; nauseated; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts) and NAUSEA (nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD21-13068, MOD-2021-020915.; Sender's Comments: consistent with the safety profile. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Nausea is  consistent with the safety profile.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Pain, Pyrexia
Clinical narrative: I am so Sick; Hurts (Everything in Body); Fever 102 F; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache). At the time of the report, ILLNESS (I am so Sick), PAIN (Hurts (Everything in Body)), PYREXIA (Fever 102 F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Pyrexia: 102 (Inconclusive) 102 Fahrenheit.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in injection arm). The patient was treated with PARACETAMOL (TYLENOL) on 23-Jan-2021 for Pain, at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (pain in injection arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol and Ice pack; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain in extremity
Clinical narrative: Light headedness; Soreness in arm; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills) 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 DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills). At the time of the report, DIZZINESS (Light headedness), PAIN IN EXTREMITY (Soreness in arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: swollen arm; Redness; Hot to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy). On 25-Jan-2021, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: redness on injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness on injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness on injection). At the time of the report, INJECTION SITE ERYTHEMA (redness on injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the product safety profile