chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: red area below where shot was given, red area about 3 inches wide; red and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore). At the time of the report, VACCINATION SITE ERYTHEMA (red area below where shot was given, red area about 3 inches wide) and VACCINATION SITE PAIN (red and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl cream.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vertigo
Clinical narrative: Vertigo; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, VERTIGO (Vertigo), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment of the events included paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Pain in extremity
Clinical narrative: Arm is very very very sore; I can hardly walk through the house; I'm just so tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included TRAMADOL for Fibromyalgia, NAPROXEN.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired). At the time of the report, PAIN IN EXTREMITY (Arm is very very very sore), GAIT DISTURBANCE (I can hardly walk through the house) and FATIGUE (I'm just so tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Arm was sore; Four months since first dose; Tenderness behind the knee; SVT behind the knee; Superficial venous thrombosis was aggravated; Leg swelling; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee), CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated), PERIPHERAL SWELLING (Leg swelling) and PAIN IN EXTREMITY (Arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Superficial thrombosis of veins.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Leg swelling). On 17-Feb-2021, the patient experienced TENDERNESS (Tenderness behind the knee) and THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee). 17-Feb-2021, the patient experienced CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose). On 20-Feb-2021, PERIPHERAL SWELLING (Leg swelling) had resolved. At the time of the report, TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee) and CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated) outcome was unknown and PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. The patient reported that she thinks the superficial venous thrombosis was aggravated after receiving her first dose.       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter contact details were updated, patient demographic details were updated, vaccine facility details were updated and new events were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombophlebitis superficial
Clinical narrative: Arm was sore; Four months since first dose; Tenderness behind the knee; SVT behind the knee; Superficial venous thrombosis was aggravated; Leg swelling; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee), CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated), PERIPHERAL SWELLING (Leg swelling) and PAIN IN EXTREMITY (Arm was sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Superficial thrombosis of veins.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Leg swelling). On 17-Feb-2021, the patient experienced TENDERNESS (Tenderness behind the knee) and THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee). 17-Feb-2021, the patient experienced CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose). On 20-Feb-2021, PERIPHERAL SWELLING (Leg swelling) had resolved. At the time of the report, TENDERNESS (Tenderness behind the knee), THROMBOPHLEBITIS SUPERFICIAL (SVT behind the knee) and CONDITION AGGRAVATED (Superficial venous thrombosis was aggravated) outcome was unknown and PAIN IN EXTREMITY (Arm was sore) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported. The patient reported that she thinks the superficial venous thrombosis was aggravated after receiving her first dose.       Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter contact details were updated, patient demographic details were updated, vaccine facility details were updated and new events were added.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Rash
Clinical narrative: hurting a little on his chest; Rash over his Chest and back; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash over his chest and back, hurting a little on his chest.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) rash over his chest and back, hurting a little on chest.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.  On 14 Feb 2021 the outcome of event(s), rash over his chest and back, hurting a little on his chest was resolved.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe was loose; Received invalid dose; A spontaneous report was received from a consumer concerning a 50-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a loose syringe/syringe connection issue and received invalid dose/vaccine underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02-MAR-2021, The patient stated that the syringe was loose and they received an invalid dose during the administration of the second dose.  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 events, syringe connection issue and vaccine underdose were considered recovered/resolved.; Reporter's Comments: This report refers to a case of syringe connection issue and vaccine underdose for mRNA-1273, lot # Unknown with no associated AEs.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Renal pain
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062G20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back). At the time of the report, RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back) outcome was unknown.            Concomitant medication also included multiple vitamins. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient reported that even after four to five days the patient was still feeling the symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Dry Cough; Swelling in right arm; Soreness in right arm; Nausea; Vomited once; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry Cough), PERIPHERAL SWELLING (Swelling in right arm), PAIN IN EXTREMITY (Soreness in right arm), NAUSEA (Nausea) and VOMITING (Vomited once) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced COUGH (Dry Cough), PERIPHERAL SWELLING (Swelling in right arm), PAIN IN EXTREMITY (Soreness in right arm), NAUSEA (Nausea) and VOMITING (Vomited once). At the time of the report, COUGH (Dry Cough), PERIPHERAL SWELLING (Swelling in right arm), PAIN IN EXTREMITY (Soreness in right arm), NAUSEA (Nausea) and VOMITING (Vomited once) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]), LEVOTHYROXINE SODIUM (SYNTHROID), METHYLPREDNISOLONE and CIPROFLOXACIN HYDROCHLORIDE, HYDROCORTISONE (CIPROFLAXINA HC LAZAR) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details also included steroids and allergy medications.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Swollen tongue
Clinical narrative: Very little swelling of the tongue; Aching and arm hurts; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Very little swelling of the tongue), PAIN IN EXTREMITY (Aching and arm hurts) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced SWOLLEN TONGUE (Very little swelling of the tongue), PAIN IN EXTREMITY (Aching and arm hurts) and HEADACHE (Headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, SWOLLEN TONGUE (Very little swelling of the tongue), PAIN IN EXTREMITY (Aching and arm hurts) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: Pain for the arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Pain for the arthritis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Heart disease, unspecified and Blood pressure. Concomitant products included MELOXICAM for Arthritis.    On 12-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 ARTHRITIS (Pain for the arthritis). At the time of the report, ARTHRITIS (Pain for the arthritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines included medication for arthritis, heart and blood pressure medicine. No treatment information was reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02762DA) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication list was not provided. Treatment information was not provided. Patient reported that he received second dose of mRNA-1273.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Event outcome updated to recovered/resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Gastritis, Headache, Hypersensitivity, Nausea
Clinical narrative: an horrible allergy; swelling in the face; swelling of the ears; swelling of the nose; gastritis; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose) and GASTRITIS (gastritis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: an horrible allergy; swelling in the face; swelling of the ears; swelling of the nose; gastritis; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose) and GASTRITIS (gastritis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, HYPERSENSITIVITY (an horrible allergy), SWELLING FACE (swelling in the face), EAR SWELLING (swelling of the ears), SWELLING (swelling of the nose), GASTRITIS (gastritis), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Sore throat; Upset stomach; Chills; Severe headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills), HEADACHE (Severe headache) and FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills), HEADACHE (Severe headache) and FATIGUE (Fatigue). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL DISCOMFORT (Upset stomach), CHILLS (Chills), HEADACHE (Severe headache) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Gene sequencing, Pregnancy test, Ultrasound scan normal
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 30-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 to 5 glasses of wine weekly).    On 03-Mar-2021 at 2:00 PM, 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-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 03-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2020, Pregnancy test: positive (Positive) positive. On 25-Dec-2020, Ultrasound scan normal:. On an unknown date, Gene sequencing: normal (normal) normal. On an unknown date, Ultrasound scan normal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains non-significant information.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-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 12-Jan-2021 and the estimated date of delivery was 19-Oct-2021. On 19-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 19-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had three pregnancies before. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Upon internal review on 20-Jul-2021, patient, products, events, analysis tabs and regulatory reports were updated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were also reported Psychiatric Medicines, Colic Acid. Treatment details was not reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Extremely sore arm of injection; Could not sleep due to the pain of the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Extremely sore arm of injection) and PAIN IN EXTREMITY (Could not sleep due to the pain of the arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetic.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced VACCINATION SITE PAIN (Extremely sore arm of injection) and PAIN IN EXTREMITY (Could not sleep due to the pain of the arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Extremely sore arm of injection) and PAIN IN EXTREMITY (Could not sleep due to the pain of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication included blood pressure and diabetes medication.
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration
Clinical narrative: Furly white plaque on the tongue; This spontaneous case was reported by a pharmacist and describes the occurrence of TONGUE DISCOLOURATION (Furly white plaque on the tongue) 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 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced TONGUE DISCOLOURATION (Furly white plaque on the tongue). At the time of the report, TONGUE DISCOLOURATION (Furly white plaque on the tongue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Lethargy, Oropharyngeal discomfort
Clinical narrative: a little lethargic; throat had a weird scratchy tickle; fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (throat had a weird scratchy tickle), HEART RATE INCREASED (fast heart beating) and LETHARGY (a little lethargic) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat had a weird scratchy tickle) and HEART RATE INCREASED (fast heart beating). On 12-Feb-2021, the patient experienced LETHARGY (a little lethargic). The patient was treated with LEVOTHYROXINE SODIUM (SYNTHROID) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, OROPHARYNGEAL DISCOMFORT (throat had a weird scratchy tickle) and HEART RATE INCREASED (fast heart beating) had resolved. At the time of the report, LETHARGY (a little lethargic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient received the 1st dose of the vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) in a 37-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019M20A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (IVF-Transfer date: Dec 13, 2020) on 13-Dec-2020, Alcohol use (1, 2 a week) and Pregnancy (Previous delivery date:06-NOV-2017). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pre-eclampsia, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-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 31-Aug-2021. On 25-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine). On 25-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, Pregnancy test: positive (Positive) Positive. On 08-Feb-2021, Ultrasound scan: normal (normal) (Everything okay.).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  The patient had one previous pregnancy (live and full-term birth) and delivery date was 06-Nov-2017. The patient had pre-eclampsia and took aspirin to prevent that at the time of report. It was reported that there was no complications or acute illness during pregnancy to date, prenatal care was established.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: Internal review on 20-JUL-2021 resulted in updates to pregnancy details. On 01-May-2021: Follow up received on 1-MAY-2021 :  second dose  was updated
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: weird rash all over the body, it comes and it goes. The arm can be completely red one minute and clean at the other.; weird rash all over the body, it comes and it goes. The arm can be completely red one minute and clean at the other.; A spontaneous report was received from a consumer concerning himself, who is a 43-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events weird rash all over the body, it comes and it goes, the arm can be completely red one minute and clean at the other.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received first of two planned doses of mRNA-1273 (lot/batch: 02LA20A) intramuscularly for prophylaxis of COVID-19 infection.   On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving second dose the patient experienced the event weird rash all over the body, it comes and it goes. Patient also experienced the event arm can be completely red one minute and clean at the other.  Treatment for the events includes ibuprofen,  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.  The outcome of events weird rash all over the body, it comes and it goes, the arm can be completely red one minute and clean at the other was not resolved at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Myalgia, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), RASH (Rash), INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) 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) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (Itching), RASH (Rash), INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Feb-2021, PRURITUS (Itching) and RASH (Rash) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red circle around injection site) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Hypertension, Hypoaesthesia oral
Clinical narrative: Ttongue had felt numb; Metallic taste in her mouth; Blood pressure was high; Headache for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth), HYPERTENSION (Blood pressure was high) and HEADACHE (Headache for 2 days) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tromethamine).    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth), HYPERTENSION (Blood pressure was high) and HEADACHE (Headache for 2 days). At the time of the report, HYPOAESTHESIA ORAL (Ttongue had felt numb), DYSGEUSIA (Metallic taste in her mouth) and HYPERTENSION (Blood pressure was high) outcome was unknown and HEADACHE (Headache for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided  Patient experienced Fast heartbeat.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021: Contain Non significant information. Address and email were  added
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: severe headache; feeling very tired; has a sore arm; A spontaneous report was received from a consumer concerning a 58-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe headache, feeling very tired, has a sore arm.  The patient's medical history was not provided. Concomitant medications reported were Cholesterol medication, Diabetes Medication, Hypertension Medication for drug use for unknown indication.  On 2 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) severe headache, feeling very tired, has a sore arm.  Treatment details included tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe headache, feeling very tired, has a sore arm was unknown.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Covid Arm; Swelling at the site of the injection; rash at the site of the injection; A spontaneous report was received from a consumer concerning mother, who is a 92-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm, swelling at the site of the injection, rash at the site of the injection.  The patient's medical history was not provided. Concomitant medications reported were hydrocortisone ointment, metoprolol, apixaban, atorvastatin, omeprazole, clonazepam, gabapentin, tramadol, vitamin b complex, preservision ared 2 for drug use for unknown indication.  On 5 Mar 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 040A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events covid arm, swelling and rash at the site of the injection.  Treatment information was not provided.  Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.   The outcome of event covid arm, swelling at the site of the injection, rash at the site of the injection was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Hypokinesia
Clinical narrative: Was in bed all weekend.; weakness; Pain on right side of leg; Loss of appetite; Fever; Chills; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) in a 52-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.     The patient's past medical history included No adverse event (No reported medical history).   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.     Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Was in bed all weekend.; weakness; Pain on right side of leg; Loss of appetite; Fever; Chills; Headache; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite) and PYREXIA (Fever) in a 52-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.     The patient's past medical history included No adverse event (No reported medical history).   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, HYPOKINESIA (Was in bed all weekend.), ASTHENIA (weakness), PAIN IN EXTREMITY (Pain on right side of leg), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.     Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Disorientation, Dizziness, Vertigo, Vomiting
Clinical narrative: Dizziness; Vertigo; No longer maintain balance; disorientation; Vomited; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery since an unknown date and Pacemaker insertion (cardiac) since an unknown date. Concurrent medical conditions included Blood pressure high and Subdural hematoma. Concomitant products included ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited). At the time of the report, DIZZINESS (Dizziness), VERTIGO (Vertigo), BALANCE DISORDER (No longer maintain balance), DISORIENTATION (disorientation) and VOMITING (Vomited) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Email ID  was Updated
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral swelling, Vaccination site pain
Clinical narrative: swelling of the hands; tremendous headache; ache at the injected arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills). On 27-Feb-2021, PERIPHERAL SWELLING (swelling of the hands), HEADACHE (tremendous headache), VACCINATION SITE PAIN (ache at the injected arm) and CHILLS (chills) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Fax from HCP, requesting patient name, NNI.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: severe nausea; A spontaneous report was received from a consumer concerning herself, who is a 61-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20a) via unknown route for prophylaxis of COVID-19 infection.  On Mar 2021, the patient experienced the event severe nausea that keeps going and coming.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event severe nausea was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Pruritus
Clinical narrative: COVID arm; very very itchy, 3.5 inches diameter; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     No Medical History information was reported.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter). At the time of the report, DERMATITIS ALLERGIC (COVID arm) and PRURITUS (very very itchy, 3.5 inches diameter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment information was not provided.