chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: reaction due to COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (reaction due to COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (reaction due to COVID-19 vaccine). At the time of the report, ADVERSE REACTION (reaction due to COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: pregnant patient received 1st dose of Moderna Covid 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant patient received 1st dose of Moderna Covid 19 vaccine) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included BUPROPION for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 17-Jul-2020 and the estimated date of delivery was 21-Apr-2021. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant patient received 1st dose of Moderna Covid 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 21-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant patient received 1st dose of Moderna Covid 19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Aug-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was previously pregnant and delivered 2 babies by full term birth on 27-Feb-2016 and 08-Jun-2018. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Oropharyngeal pain, Pain
Clinical narrative: arm soreness; sore throat; achy; joint pain; muscle pain; waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (waves of nausea). On 02-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (waves of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  Tylenol is used as treatment medication.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; sore throat; achy; joint pain; muscle pain; waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (waves of nausea). On 02-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), PAIN (achy), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and NAUSEA (waves of nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication included.  Tylenol is used as treatment medication.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: It is hot, itchy, and red; She developed a rash the size of a quarter; It is hot, itchy, and red; It is hot, itchy, and red; Arm aching at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It is hot, itchy, and red), RASH (She developed a rash the size of a quarter), VACCINATION SITE PRURITUS (It is hot, itchy, and red), VACCINATION SITE PAIN (Arm aching at the site of the injection) and VACCINATION SITE ERYTHEMA (It is hot, itchy, and red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included UTI since an unknown date. Concomitant products included NITROFURANTOIN for UTI.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm aching at the site of the injection). On 03-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It is hot, itchy, and red), RASH (She developed a rash the size of a quarter), VACCINATION SITE PRURITUS (It is hot, itchy, and red) and VACCINATION SITE ERYTHEMA (It is hot, itchy, and red). At the time of the report, VACCINATION SITE WARMTH (It is hot, itchy, and red), RASH (She developed a rash the size of a quarter), VACCINATION SITE PRURITUS (It is hot, itchy, and red) and VACCINATION SITE ERYTHEMA (It is hot, itchy, and red) had not resolved and VACCINATION SITE PAIN (Arm aching at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information include antibacterial cream
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Itches; Swollen; Real bad rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash). At the time of the report, PRURITUS (Itches), SWELLING (Swollen) and RASH (Real bad rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment for the event was not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: tested positive for COVID 19; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19) 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 reported).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (tested positive for COVID 19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, COVID-19: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided  Treatment medication was not provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain, Vaccination site reaction
Clinical narrative: Injection site reaction came back; The injection site reaction grew to be about 3-4 inches in diameter; itching at the reaction site; Localized reaction at injection site that was raised; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction came back), VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter), PRURITUS (itching at the reaction site) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history updated).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter), PRURITUS (itching at the reaction site) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised). On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Injection site reaction came back). On 27-Jan-2021, PRURITUS (itching at the reaction site) outcome was unknown. On 30-Jan-2021, VACCINATION SITE REACTION (The injection site reaction grew to be about 3-4 inches in diameter) and VACCINATION SITE PAIN (Localized reaction at injection site that was raised) outcome was unknown. At the time of the report, VACCINATION SITE REACTION (Injection site reaction came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included, Benadryl and ice for itching.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Fatigue, Infection, Mass
Clinical narrative: it was an infection because she scratched her arm.; Arm swollen, 2 and a half inches; Itching on the arm; Red swelling lump 2 1/2 inches by 3 inches/ Redness; Red swelling lump 2 1/2 inches by 3 inches; Sore arm/ Itching on arm and it hurt; Tired; 99° F fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), MASS (Red swelling lump 2 1/2 inches by 3 inches), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet count high since 2010. Concomitant products included HYDROXYUREA for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), FATIGUE (Tired) and PYREXIA (99° F fever). On 28-Jan-2021, the patient experienced MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness). On 29-Jan-2021, the patient experienced PRURITUS (Itching on the arm) and PERIPHERAL SWELLING (Arm swollen, 2 and a half inches). On 03-Feb-2021, the patient experienced INFECTION (it was an infection because she scratched her arm.). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. On 18-Feb-2021, MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.), PERIPHERAL SWELLING (Arm swollen, 2 and a half inches), FATIGUE (Tired) and PYREXIA (99° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 99 (Inconclusive) 99°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also include sulfa antibiotics for 9 days   This case was linked to MOD-2021-089948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow up was received on 24-Apr-2021 and consumer additional details were reported
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: it was an infection because she scratched her arm.; Arm swollen, 2 and a half inches; Itching on the arm; Red swelling lump 2 1/2 inches by 3 inches/ Redness; Red swelling lump 2 1/2 inches by 3 inches; Sore arm/ Itching on arm and it hurt; Tired; 99° F fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), MASS (Red swelling lump 2 1/2 inches by 3 inches), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Platelet count high since 2010. Concomitant products included HYDROXYUREA for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), FATIGUE (Tired) and PYREXIA (99° F fever). On 28-Jan-2021, the patient experienced MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness). On 29-Jan-2021, the patient experienced PRURITUS (Itching on the arm) and PERIPHERAL SWELLING (Arm swollen, 2 and a half inches). On 03-Feb-2021, the patient experienced INFECTION (it was an infection because she scratched her arm.). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. On 18-Feb-2021, MASS (Red swelling lump 2 1/2 inches by 3 inches) and ERYTHEMA (Red swelling lump 2 1/2 inches by 3 inches/ Redness) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm/ Itching on arm and it hurt), PRURITUS (Itching on the arm), INFECTION (it was an infection because she scratched her arm.), PERIPHERAL SWELLING (Arm swollen, 2 and a half inches), FATIGUE (Tired) and PYREXIA (99° F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 99 (Inconclusive) 99°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication also include sulfa antibiotics for 9 days   This case was linked to MOD-2021-089948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Follow up was received on 24-Apr-2021 and consumer additional details were reported
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site rash
Clinical narrative: Welts on left side of body and lower back; Itchiness under one breast; Rash at vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welts on left side of body and lower back), PRURITUS (Itchiness under one breast) and VACCINATION SITE RASH (Rash at vaccine site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).    On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Welts on left side of body and lower back), PRURITUS (Itchiness under one breast) and VACCINATION SITE RASH (Rash at vaccine site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, URTICARIA (Welts on left side of body and lower back) and PRURITUS (Itchiness under one breast) outcome was unknown and VACCINATION SITE RASH (Rash at vaccine site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test positive
Clinical narrative: Covid-19 antibody test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive) in a 52-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 event (No reported medical history).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive). On 02-Feb-2021, SARS-COV-2 ANTIBODY TEST POSITIVE (Covid-19 antibody test positive) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, COVID-19: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication.     The patient's past medical history included No adverse event.  Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), IBUPROFEN, ACETYLSALICYLIC ACID (BAYER LOW DOSE), ALPRAZOLAM, LOVASTATIN, AMLODIPINE and TIOTROPIUM BROMIDE (SPIRIVA).    On 02-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 VACCINATION SITE PAIN (soreness in arm at injection site). At the time of the report, VACCINATION SITE PAIN (soreness in arm at injection site) outcome was unknown.            Treatment information were not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Urticaria, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: On 19-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 HEADACHE (headache). On 22-Jan-2021, the patient experienced PRURITUS (itch every where) and URTICARIA (hive in the arm). On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS). On 21-Jan-2021, HEADACHE (headache) had resolved. On 24-Jan-2021, PRURITUS (itch every where) and URTICARIA (hive in the arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS) 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.   Concomitant medication was not reported. Treatment medication was not reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: On 19-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 HEADACHE (headache). On 22-Jan-2021, the patient experienced PRURITUS (itch every where) and URTICARIA (hive in the arm). On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS). On 21-Jan-2021, HEADACHE (headache) had resolved. On 24-Jan-2021, PRURITUS (itch every where) and URTICARIA (hive in the arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch IS), VACCINATION SITE SWELLING (Swollen IS) and VACCINATION SITE ERYTHEMA (redness in the IS) 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.   Concomitant medication was not reported. Treatment medication was not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: tiny dizzy; low fever; headache; litte chills; mild sore arm; fever 99.8F; very tired; feverish (above 100F); cold symptoms; stuffy nose; sneeze; sore arm; headache; tired; low fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), DIZZINESS (tiny dizzy), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose) and SNEEZING (sneeze) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0 or D 26L20A and 0381C20A) 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 METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for product   for unknown  indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (tired) and the first episode of PYREXIA (low fever). On 24-Jan-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze) and PYREXIA (feverish (above 100F)). On 17-Feb-2021, the patient experienced FATIGUE (very tired). On 18-Feb-2021, the patient experienced the second episode of PYREXIA (low fever), the second episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F). On 20-Feb-2021, the patient experienced DIZZINESS (tiny dizzy). At the time of the report, PAIN (body aches), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze), MYALGIA (sore arm), FATIGUE (tired), PYREXIA (feverish (above 100F)), the last episode of PYREXIA (low fever), the last episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F) had resolved and DIZZINESS (tiny dizzy) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol for headache. Action taken for mRNA-1273 was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain, Pyrexia, Sneezing
Clinical narrative: tiny dizzy; low fever; headache; litte chills; mild sore arm; fever 99.8F; very tired; feverish (above 100F); cold symptoms; stuffy nose; sneeze; sore arm; headache; tired; low fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), DIZZINESS (tiny dizzy), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose) and SNEEZING (sneeze) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0 or D 26L20A and 0381C20A) 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 METOPROLOL for Blood pressure high, ATORVASTATIN for Cholesterol, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for product   for unknown  indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (sore arm), the first episode of HEADACHE (headache), FATIGUE (tired) and the first episode of PYREXIA (low fever). On 24-Jan-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze) and PYREXIA (feverish (above 100F)). On 17-Feb-2021, the patient experienced FATIGUE (very tired). On 18-Feb-2021, the patient experienced the second episode of PYREXIA (low fever), the second episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F). On 20-Feb-2021, the patient experienced DIZZINESS (tiny dizzy). At the time of the report, PAIN (body aches), NASOPHARYNGITIS (cold symptoms), NASAL CONGESTION (stuffy nose), SNEEZING (sneeze), MYALGIA (sore arm), FATIGUE (tired), PYREXIA (feverish (above 100F)), the last episode of PYREXIA (low fever), the last episode of HEADACHE (headache), CHILLS (litte chills), MYALGIA (mild sore arm) and PYREXIA (fever 99.8F) had resolved and DIZZINESS (tiny dizzy) and FATIGUE (very tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol for headache. Action taken for mRNA-1273 was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: No specific follow-up information recorded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Arm is a little blotchy lower then the injection site, near elbow; Hot to the touch Injection Site; the injection site became Red again; Injection Site was a little Red; Sore Injection Site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow), VACCINATION SITE WARMTH (Hot to the touch Injection Site), VACCINATION SITE ERYTHEMA (Injection Site was a little Red), VACCINATION SITE PAIN (Sore Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     no medical history was found.  Concurrent medical conditions included Multiple sclerosis. Concomitant products included GLATIRAMER for Multiple sclerosis.    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 VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Sore Injection Site). On 30-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again). On 02-Feb-2021, the patient experienced RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow). On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, RASH MACULAR (Arm is a little blotchy lower then the injection site, near elbow), VACCINATION SITE WARMTH (Hot to the touch Injection Site) and VACCINATION SITE ERYTHEMA (the injection site became Red again) 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  drugs were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurts like I sprained a muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts like I sprained a muscle) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for an unknown indication.     The patient's past medical history included No adverse event (No relevant medical history reported.). Concomitant products included PRAVASTATIN and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurts like I sprained a muscle). At the time of the report, PAIN IN EXTREMITY (arm hurts like I sprained a muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient put diclofenac topical pain relief on her left deltoid but only helped temporarily.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Experienced swelled up arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site). At the time of the report, VACCINATION SITE SWELLING (Experienced swelled up arm at the injection site) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Rash, Skin mass
Clinical narrative: little bumps underside of right forearm; a little bit swollen underside of right forearm; redder underside of right forearm; Itchy underside of right forearm; developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's medical history was not reported.  The patient's past medical history included Poison ivy rash.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm). The patient was treated with TRIAMCINOLONE DIACETATE (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) (topical) on 31-Jan-2021 for Adverse event, at a dose of UNK dosage form (once) and TRIAMCINOLONE DIACETATE (TRIAMCINOLONE [TRIAMCINOLONE DIACETATE]) (topical) on 01-Feb-2021 for Adverse event, at a dose of UNK dosage form (once). At the time of the report, SKIN MASS (little bumps underside of right forearm), RASH (developed a rash a couple of hours after vaccination which was not at the injection site, but the underside of her right forearm), PERIPHERAL SWELLING (a little bit swollen underside of right forearm), ERYTHEMA (redder underside of right forearm) and PRURITUS (Itchy underside of right forearm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included low dose blood pressure medication. The patient did not come in contact with poison ivy.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chills, Feeling cold, Musculoskeletal stiffness
Clinical narrative: feel extremely cold and very chilly, and could not get warm no matter what they did; arm hurt and it is still sore today; their back bothers them, and they feel like they have been punch on the stomach and back; their arm is stiff; very chilly; Achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff) and CHILLS (very chilly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:00 PM, the patient experienced FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff), CHILLS (very chilly) and MYALGIA (Achy). At the time of the report, FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back) and CHILLS (very chilly) had resolved and MUSCULOSKELETAL STIFFNESS (their arm is stiff) and MYALGIA (Achy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. In the morning of the report, most of the side effects went away but still had aches and arm was stiff.   This case was linked to INC.-MOD-2021-090221 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-090221:dose 2
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: feel extremely cold and very chilly, and could not get warm no matter what they did; arm hurt and it is still sore today; their back bothers them, and they feel like they have been punch on the stomach and back; their arm is stiff; very chilly; Achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff) and CHILLS (very chilly) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021 at 10:00 PM, the patient experienced FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back), MUSCULOSKELETAL STIFFNESS (their arm is stiff), CHILLS (very chilly) and MYALGIA (Achy). At the time of the report, FEELING COLD (feel extremely cold and very chilly, and could not get warm no matter what they did), PAIN IN EXTREMITY (arm hurt and it is still sore today), BACK PAIN (their back bothers them, and they feel like they have been punch on the stomach and back) and CHILLS (very chilly) had resolved and MUSCULOSKELETAL STIFFNESS (their arm is stiff) and MYALGIA (Achy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. In the morning of the report, most of the side effects went away but still had aches and arm was stiff.   This case was linked to INC.-MOD-2021-090221 (E2B Linked Report).; Sender's Comments:  INC.-MOD-2021-090221:dose 2
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itching badly up on the side; Rash at inject site above and below it; slight redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching badly up on the side), VACCINATION SITE ERYTHEMA (slight redness) and VACCINATION SITE RASH (Rash at inject site above and below it) 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 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (slight redness). On 30-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching badly up on the side). 30-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at inject site above and below it). At the time of the report, VACCINATION SITE PRURITUS (itching badly up on the side), VACCINATION SITE ERYTHEMA (slight redness) and VACCINATION SITE RASH (Rash at inject site above and below it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itch; Hives on back intermittent; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itch) and URTICARIA (Hives on back intermittent) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ENALAPRIL for Hypertension, SITOSTEROL (BETA SITOSTEROL) for Prostatic hyperplasia, MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 13-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 PRURITUS (Itch) and URTICARIA (Hives on back intermittent). At the time of the report, PRURITUS (Itch) and URTICARIA (Hives on back intermittent) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow Up:Follow-up was received on 1 Apr 2021 with the addition of mail ID.; Reporter's Comments: This case concerns a 78-year-old male who experienced NS expected events of intermittent urticaria and pruritus on his back. The event occurred 8 days after the first dose of mRNA-1273. Treatment included Cortisone cream, Beta Sitosterol, Tylenol. Event outcome not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Hypertension
Clinical narrative: High blood pressure; Stomach pain; Pain in all joints; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), ABDOMINAL PAIN UPPER (Stomach pain) and ARTHRALGIA (Pain in all joints) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's medical history was not 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 HYPERTENSION (High blood pressure), ABDOMINAL PAIN UPPER (Stomach pain) and ARTHRALGIA (Pain in all joints). At the time of the report, HYPERTENSION (High blood pressure), ABDOMINAL PAIN UPPER (Stomach pain) and ARTHRALGIA (Pain in all joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is taking blood pressure medicines and cholesterol medicines as concomitant medications. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Itches and gets bigger; Warm to the touch; Red; Rush size of a quarter, then had a size of half of a dollar, and now is two and a half inches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches and gets bigger), FEELING HOT (Warm to the touch), ERYTHEMA (Red) and RASH (Rush size of a quarter, then had a size of half of a dollar, and now is two and a half inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL TARTRATE, CALCIUM and COLECALCIFEROL (D3) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rush size of a quarter, then had a size of half of a dollar, and now is two and a half inches). On an unknown date, the patient experienced PRURITUS (Itches and gets bigger), FEELING HOT (Warm to the touch) and ERYTHEMA (Red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Feb-2021, PRURITUS (Itches and gets bigger), FEELING HOT (Warm to the touch), ERYTHEMA (Red) and RASH (Rush size of a quarter, then had a size of half of a dollar, and now is two and a half inches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose and two days later, they experienced rash size of a quarter, then had a size of half of a dollar, and now was two and a half inches. The patient reported no pain but said that it was itching and was getting bigger and was red and warm to the touch.  On 15-Jul-2021, the patient reported that they began to experience reactions on 27-Jan-2021. The patient also reported that the final diagnosis for the reported reaction was hypersensitivity reaction and they received their second dose on 02-Mar-2021 and the batch number for the second dose was 0264z1a.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Additional information was received. Updated the patient initials. On 15-Jul-2021: Follow-up information was received. Updated the patient demographics. Added Concomitant medications and Treatment medications.Updated the action taken. Updated the Outcome of the events as recovered. Added events stop date.; 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.