chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Panic attack, Paraesthesia
Clinical narrative: Chest pain; Arm pit was burning; Felt tingling; Sweaty; Color of face went white; When lying down BP was higher than standing up; panic attack; Breast feeding; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty) and PALLOR (Color of face went white) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DULOXETINE from 06-Jan-2021 to an unknown date for Depression.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding). At the time of the report, CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding) 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 information provided.
Sex: M
Vaccine: COVID19
Symptoms: Injection site mass, Injection site swelling, Pruritus, Swelling
Clinical narrative: injection site got larger, around 1-1.5 inches; itchy; hard lump; small lump; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (small lump), INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE MASS (small lump). On 18-Jan-2021, the patient experienced INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump). At the time of the report, INJECTION SITE MASS (small lump), INJECTION SITE SWELLING (injection site got larger, around 1-1.5 inches), PRURITUS (itchy) and SWELLING (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia
Clinical narrative: feeling hot; bad headache; aches muscles; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), HEADACHE (bad headache) and MYALGIA (aches muscles) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FEELING HOT (feeling hot), HEADACHE (bad headache) and MYALGIA (aches muscles). At the time of the report, FEELING HOT (feeling hot), HEADACHE (bad headache) and MYALGIA (aches muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: red, raised rash on the left side of her neck which spread to her right side of her necK; red, raised rash on the left side of her neck which spread to her right side of her necK; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK). At the time of the report, RASH ERYTHEMATOUS (red, raised rash on the left side of her neck which spread to her right side of her necK) and RASH PAPULAR (red, raised rash on the left side of her neck which spread to her right side of her necK) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: fever; left arm has a pocket from swelling; redness from mid forearm to shoulder; malaise; sore arm; dizziness; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: fever; left arm has a pocket from swelling; redness from mid forearm to shoulder; malaise; sore arm; dizziness; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of   in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: redness around injection site; tender to touch; warm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included warm compresses on injection site.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: some side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (some side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (some side effects). At the time of the report, ADVERSE DRUG REACTION (some side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: joint side effects; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (joint side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHROPATHY (joint side effects). At the time of the report, ARTHROPATHY (joint side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   No treatment and laboratory information was provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Prenatal screening test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term birth) on 30-May-2018 and Alcohol use (Used alcohol rarely). Concomitant products included DOCUSATE SODIUM (COLACE) from 12-Apr-2020 to an unknown date for Constipation, METRONIDAZOLE (FLAGYL 250) from 26-Mar-2021 to 02-Apr-2021 for Gardnerella infection NOS, VITAMIN D3 from 12-Apr-2020 to an unknown date for Vitamin D deficiency, PROBIOTICS NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-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 18-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Alpha 1 foetoprotein normal: (Negative) Negative. On 28-Jan-2021, Ultrasound scan: (normal) Anatomy sonogram- Normal. On 04-Feb-2021, Prenatal screening test: (Low) Panorama test- Low risk male.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not reported by the reporter.   This case was linked to MOD-2021-082340 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: Additional info- Follow up received on 19-JAN-2021, Patient demography were updated, Lab details were added, Concomitant medication were added. Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: employee had the 1st dose and later had shingles; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (employee had the 1st dose and later had shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 02-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 HERPES ZOSTER (employee had the 1st dose and later had shingles). At the time of the report, HERPES ZOSTER (employee had the 1st dose and later had shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medication provided no treatment taken; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Head discomfort, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Stuffy nose; Stuffy head; Cough because of postnasal drip; Tightness; Wheezing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 14-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 NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing). The patient was treated with VITAMIN C [ASCORBIC ACID] for Calcium supplementation, at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] for Vitamin supplementation, at an unspecified dose and frequency; AZITHROMYCIN (Z-PAK) for Wheezing, Cough and Head discomfort, at an unspecified dose and frequency and ZINC for Supplementation therapy, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication provided. Patient used mucus relief
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Stuffy nose; Stuffy head; Cough because of postnasal drip; Tightness; Wheezing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 14-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 NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing). The patient was treated with VITAMIN C [ASCORBIC ACID] for Calcium supplementation, at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] for Vitamin supplementation, at an unspecified dose and frequency; AZITHROMYCIN (Z-PAK) for Wheezing, Cough and Head discomfort, at an unspecified dose and frequency and ZINC for Supplementation therapy, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (Stuffy nose), HEAD DISCOMFORT (Stuffy head), COUGH (Cough because of postnasal drip), CHEST DISCOMFORT (Tightness) and WHEEZING (Wheezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication provided. Patient used mucus relief
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site erythema, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine), VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the patient experienced VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received vaccine) had resolved and VACCINATION SITE REACTION (shape is change around injection site), VACCINATION SITE WARMTH (warmth), VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant information provided. No treatment information provided. Reporter did not allow further contact; Sender's Comments: This report refers to a case of product exposure during pregnancy for mRNA-1273 (lot # unknown) with AEs of Vaccination site warmth, Vaccination site reaction, Vaccination site pruritus, and Vaccination site erythema reported.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness at shoulder to elbow, rashes; itchiness at shoulder to elbow, rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (itchiness at shoulder to elbow, rashes) and PRURITUS (itchiness at shoulder to elbow, rashes) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 337K20A) for COVID-19 vaccination.     The patient's past medical history included Panic attack and Sneezing. Concomitant products included LORAZEPAM for Panic attack, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sneezing.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced RASH (itchiness at shoulder to elbow, rashes) and PRURITUS (itchiness at shoulder to elbow, rashes). At the time of the report, RASH (itchiness at shoulder to elbow, rashes) and PRURITUS (itchiness at shoulder to elbow, rashes) 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 information provided
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: lymph nodes swelling, pain (LEFT) and has pain at injection site; lymph nodes swelling, pain (LEFT) and has pain at injection site; lymph nodes swelling, pain (LEFT) and has pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site), VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site), VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site). On 19-Jan-2021, VACCINATION SITE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) outcome was unknown. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (lymph nodes swelling, pain (LEFT) and has pain at injection site) and LYMPH NODE PAIN (lymph nodes swelling, pain (LEFT) and has pain at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication nor treatment provided
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash macular, Rash pruritic
Clinical narrative: huge red blatch; huge red blatch, kind of itchy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH MACULAR (huge red blatch) and RASH PRURITIC (huge red blatch, kind of itchy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 18-Jan-2021, the patient experienced RASH MACULAR (huge red blatch) and RASH PRURITIC (huge red blatch, kind of itchy). At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH MACULAR (huge red blatch) and RASH PRURITIC (huge red blatch, kind of itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient just put ice in the zone.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vaccination site pain, Vertigo
Clinical narrative: dizziness; vertigo; bad headache; nausea; injection site was sore all weekend; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site was sore all weekend) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (injection site was sore all weekend). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection site was sore all weekend) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: having some symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having some symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having some symptoms). At the time of the report, VACCINATION COMPLICATION (having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Injection site was red; Injection site was swollen; injection site had a large welt; swollen; Red; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swollen), ERYTHEMA (Red), VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy, Pollen allergy and Allergy to animal.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced SWELLING (swollen) and ERYTHEMA (Red). On 18-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (swollen) and ERYTHEMA (Red) outcome was unknown and VACCINATION SITE ERYTHEMA (Injection site was red), VACCINATION SITE SWELLING (Injection site was swollen) and VACCINATION SITE URTICARIA (injection site had a large welt) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was sore at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore at the site of the injection) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), NIFEDIPINE and OMEPRAZOLE for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the site of the injection). On 19-Jan-2021, VACCINATION SITE PAIN (arm was sore at the site of the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Vaccination site bruising, Vaccination site pain
Clinical narrative: pregnant; bruising on injection site; tenderness on injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). On 15-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 15-Jan-2021, the patient had little bit of tenderness and bruising on the injection site for a day or two. Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs of Vaccination Site Tenderness and Vaccination Site Bruising for this female of unknown age. Patient did not provide consent for follow up.
Sex: F
Vaccine: COVID19
Symptoms: Salivary gland enlargement
Clinical narrative: salivary glands swollen - only happens when eating; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with ANTIBIOTIC for Salivary gland enlargement, at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 18-Jan-2021, the patient woke up with swollen neck, looked like swollen glands. She reported that she talked to her doctor already and figured out it was her salivary glands and called in antibiotic for her. She stated it only happened when she was eating. It was not as she thought it was. Concomitant medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bad rash on one leg below her knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bad rash on one leg below her knee) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 RASH (bad rash on one leg below her knee). At the time of the report, RASH (bad rash on one leg below her knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREGNANCY (Pregnant). At the time of the report, PREGNANCY (Pregnant) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Decreased appetite, Fatigue, Testicular pain
Clinical narrative: fatigued; no appetite; testicular pain; clammy, fatigued, no appetite, testicular pain; This spontaneous case was reported by an other caregiver and describes the occurrence of COLD SWEAT (clammy, fatigued, no appetite, testicular pain), FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 13-Jan-2021, the patient experienced COLD SWEAT (clammy, fatigued, no appetite, testicular pain). On an unknown date, the patient experienced FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain).   At the time of the report, COLD SWEAT (clammy, fatigued, no appetite, testicular pain), FATIGUE (fatigued), DECREASED APPETITE (no appetite) and TESTICULAR PAIN (testicular pain) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: hurting a little bit; redness; A spontaneous report was received from a Consumer concerning a 70 Years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness at the site of injection and was hurting a little bit.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 8 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 027L20A) in the left arm for prophylaxis of COVID-19 infection  On 14 Jan 2021, The patient experienced redness at the site where he received the shot and was hurting a little bit. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events (redness and was hurting a little bit at injection site) was not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Feeling hot, Headache
Clinical narrative: Pain "all over the place"/soreness; Wrist warm; Burning feeling; Swelling on the left arm; Pain in joint; pain "all over the place" on his rib cage; Fatigue; Headache; Swelling; Wrist itchy/itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling), PRURITUS (Wrist itchy/itchiness) and PAIN (Pain "all over the place"/soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D3 and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness).   On 12-Jan-2021, the patient experienced PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage).   The patient was treated with IBUPROFEN at an unspecified dose and frequency.   On 10-Jan-2021, FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness) had resolved.   At the time of the report, PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain, Peripheral swelling, Pruritus, Swelling
Clinical narrative: Pain "all over the place"/soreness; Wrist warm; Burning feeling; Swelling on the left arm; Pain in joint; pain "all over the place" on his rib cage; Fatigue; Headache; Swelling; Wrist itchy/itchiness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling), PRURITUS (Wrist itchy/itchiness) and PAIN (Pain "all over the place"/soreness) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN D3 and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Jan-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness).   On 12-Jan-2021, the patient experienced PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage).   The patient was treated with IBUPROFEN at an unspecified dose and frequency.   On 10-Jan-2021, FATIGUE (Fatigue), HEADACHE (Headache), SWELLING (Swelling) and PRURITUS (Wrist itchy/itchiness) had resolved.   At the time of the report, PAIN (Pain "all over the place"/soreness), FEELING HOT (Wrist warm), BURNING SENSATION (Burning feeling), PERIPHERAL SWELLING (Swelling on the left arm), ARTHRALGIA (Pain in joint) and MUSCULOSKELETAL CHEST PAIN (pain "all over the place" on his rib cage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams
Clinical narrative: vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by reporter.     On 18-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 ABNORMAL DREAMS (vivid dreams). At the time of the report, ABNORMAL DREAMS (vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      This case was linked to US-MODERNATX, INC.-MOD-2021-093473 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. US-MODERNATX, INC.-MOD-2021-093473:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Seasonal allergy, Sunburn, Tongue discomfort, Vaccination site pain
Clinical narrative: soreness at injection site; tongue was red and burning; heart felt like it was racing; Face that feels like sun burn; seasonal allergy; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  Years-old male/female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 17-JAN-2021  the patient received their first dose of mRNA-1273 intramuscularly in the left arm deltoid  After an hour, patient experienced the events  like  injection site pain, tongue redness and burning, increased heart rate, sunburn, seasonal allergy.   No Laboratory details are provided. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Diarrhoea, Headache, Lacrimation increased
Clinical narrative: headache; Loss of smell; COVID-19; Diarrhea; Watery eyes; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Runny nose), HEADACHE (headache), DIARRHOEA (Diarrhea) and ANOSMIA (Loss of smell) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075J20A) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and LACRIMATION INCREASED (Watery eyes). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHINORRHOEA (Runny nose), HEADACHE (headache) and ANOSMIA (Loss of smell). On 17-Jan-2021, RHINORRHOEA (Runny nose) and DIARRHOEA (Diarrhea) had resolved, HEADACHE (headache) and LACRIMATION INCREASED (Watery eyes) outcome was unknown. At the time of the report, COVID-19 (COVID-19) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: headache; Loss of smell; COVID-19; Diarrhea; Watery eyes; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), RHINORRHOEA (Runny nose), HEADACHE (headache), DIARRHOEA (Diarrhea) and ANOSMIA (Loss of smell) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 075J20A) 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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and LACRIMATION INCREASED (Watery eyes). On 14-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHINORRHOEA (Runny nose), HEADACHE (headache) and ANOSMIA (Loss of smell). On 17-Jan-2021, RHINORRHOEA (Runny nose) and DIARRHOEA (Diarrhea) had resolved, HEADACHE (headache) and LACRIMATION INCREASED (Watery eyes) outcome was unknown. At the time of the report, COVID-19 (COVID-19) and ANOSMIA (Loss of smell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: Rash; Pain at the site; A spontaneous report was received from a healthcare facility staff member concerning a patient who developed rash/ Rash, pain at the site/Pain at injection site.     The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided). One week prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.    Patient developed rash and pain at the site. Treatment for the event included Antibiotic.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events, rash, pain at the site were considered recovered/resolved.    The reporting [Other HCP] assessed the event(s), rash and pain at the site as Not provided.
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Tenderness
Clinical narrative: Tenderness; Electric current on left side of neck and shoulder; A spontaneous report was received from a consumer, concerning a 81 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness and electric current on left side of neck and shoulder.  The patient's medical history reported includes thyroid removal. Concomitant medications reported includes Synthroid, Lexapro and Atorvastatin.  On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tenderness and electric current on left side of neck and shoulder. Treatment medications reported includes Advil once daily on 15 Jan 2021 and 16 Jan 2021.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of event tenderness was considered resolved. The outcome of the event electric current on left side of neck and shoulder was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.