chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm was swollen and itchy/Larger swelling, more itching; Throbbing; Overall weakness of arm; larger swelling, more itching, throbbing; larger swelling, more itching, throbbing; Overall weakness of my arm; larger swelling, more itching, throbbing; Arm was swollen and itchy; FELT LIKE BEE STING; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing) and ASTHENIA (Overall weakness of arm) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm was swollen and itchy) and ARTHROPOD STING (FELT LIKE BEE STING). On 19-Jan-2021, the patient experienced SWELLING (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm) and PRURITUS (larger swelling, more itching, throbbing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 18-Jan-2021 at an unspecified dose and frequency; PREDNISONE ongoing from 20-Jan-2021 at a dose of 20 milligram twice a day and AMOXICILLIN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Arm was swollen and itchy), ARTHROPOD STING (FELT LIKE BEE STING), VACCINATION SITE PRURITUS (Arm was swollen and itchy/Larger swelling, more itching), VACCINATION SITE PAIN (Throbbing), ASTHENIA (Overall weakness of arm), SWELLING (larger swelling, more itching, throbbing), PRURITUS (larger swelling, more itching, throbbing), PAIN (larger swelling, more itching, throbbing) and MUSCULAR WEAKNESS (Overall weakness of my arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red rash on her arm; it is itchy; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 20-Jan-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on her arm) and VACCINATION SITE PRURITUS (it is itchy). At the time of the report, RASH ERYTHEMATOUS (Red rash on her arm), VACCINATION SITE PRURITUS (it is itchy) and VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: vomiting; loss of appetite; dizziness; arm hurt; arm swollen a little bit; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm swollen a little bit) and VOMITING (vomiting) in a 79-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 reported.). Concomitant products included VITAMIN B12 NOS, ASCORBIC ACID (VITAMIN C ACID) and CALCIUM.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and PERIPHERAL SWELLING (arm swollen a little bit). On 12-Jan-2021, the patient experienced DECREASED APPETITE (loss of appetite) and DIZZINESS (dizziness). On an unknown date, the patient experienced VOMITING (vomiting). At the time of the report, DECREASED APPETITE (loss of appetite), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm swollen a little bit) and VOMITING (vomiting) 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 was provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Hot flush, Limb mass, Vaccination site pain
Clinical narrative: a bump in her left arm; it itches very bad; little tender at the injection site; swollen at injection site; Experienced her face really red and whole body was red; flashings; very bad back pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Experienced her face really red and whole body was red), HOT FLUSH (flashings), BACK PAIN (very bad back pain), LIMB MASS (a bump in her left arm) and VACCINATION SITE PRURITUS (it itches very bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rosacea.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced BACK PAIN (very bad back pain). On 09-Jan-2021, the patient experienced ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings). On 20-Jan-2021, the patient experienced LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 09-Jan-2021, ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings) had resolved. On 10-Jan-2021, BACK PAIN (very bad back pain) had resolved. At the time of the report, LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: a bump in her left arm; it itches very bad; little tender at the injection site; swollen at injection site; Experienced her face really red and whole body was red; flashings; very bad back pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Experienced her face really red and whole body was red), HOT FLUSH (flashings), BACK PAIN (very bad back pain), LIMB MASS (a bump in her left arm) and VACCINATION SITE PRURITUS (it itches very bad) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rosacea.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced BACK PAIN (very bad back pain). On 09-Jan-2021, the patient experienced ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings). On 20-Jan-2021, the patient experienced LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site). On 09-Jan-2021, ERYTHEMA (Experienced her face really red and whole body was red) and HOT FLUSH (flashings) had resolved. On 10-Jan-2021, BACK PAIN (very bad back pain) had resolved. At the time of the report, LIMB MASS (a bump in her left arm), VACCINATION SITE PRURITUS (it itches very bad), VACCINATION SITE PAIN (little tender at the injection site) and VACCINATION SITE SWELLING (swollen at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Face oedema, Heart rate, Oropharyngeal oedema
Clinical narrative: Throat tingling; Palpitations; Mild tachycardia; Facial edema; Oropharyngeal edema; Feeling faint; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema) and OROPHARYNGEAL OEDEMA (Oropharyngeal edema) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 13-Jan-2021 at 7:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021 at 7:59 AM, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint). At the time of the report, PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 158/94. On 13-Jan-2021, Heart rate: 78. On 13-Jan-2021, Oxygen saturation: 99 percent.     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 concomitants or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received contained non significant info.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Palpitations, Pharyngeal paraesthesia, Tachycardia
Clinical narrative: Throat tingling; Palpitations; Mild tachycardia; Facial edema; Oropharyngeal edema; Feeling faint; This spontaneous case was reported by an other health care professional and describes the occurrence of PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema) and OROPHARYNGEAL OEDEMA (Oropharyngeal edema) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 13-Jan-2021 at 7:54 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021 at 7:59 AM, the patient experienced PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint). At the time of the report, PHARYNGEAL PARAESTHESIA (Throat tingling), PALPITATIONS (Palpitations), TACHYCARDIA (Mild tachycardia), FACE OEDEMA (Facial edema), OROPHARYNGEAL OEDEMA (Oropharyngeal edema) and DIZZINESS (Feeling faint) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Blood pressure measurement: 158/94. On 13-Jan-2021, Heart rate: 78. On 13-Jan-2021, Oxygen saturation: 99 percent.     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 concomitants or treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received contained non significant info.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: her left arm was weaker; hurts when she tried to lift it; the soreness comeback; muscle soreness; fatigue; very mild headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle soreness), FATIGUE (fatigue), HEADACHE (very mild headache), MUSCULAR WEAKNESS (her left arm was weaker) and PAIN IN EXTREMITY (hurts when she tried to lift it) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ERGOCALCIFEROL (CALCIFEROL VIT D) and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 08-Jan-2021, the patient experienced MYALGIA (muscle soreness), FATIGUE (fatigue) and HEADACHE (very mild headache). On 19-Jan-2021, the patient experienced MUSCULAR WEAKNESS (her left arm was weaker), PAIN IN EXTREMITY (hurts when she tried to lift it) and MYALGIA (the soreness comeback). On 09-Jan-2021, MYALGIA (muscle soreness), FATIGUE (fatigue) and HEADACHE (very mild headache) had resolved. At the time of the report, MUSCULAR WEAKNESS (her left arm was weaker), PAIN IN EXTREMITY (hurts when she tried to lift it) and MYALGIA (the soreness comeback) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Injection site erythema, Pruritus, Rash
Clinical narrative: red still continous; injection site(left arm) turned very red; rash; itchy but not too severely; warm at injection site; little discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included GABAPENTIN (GABAPENTIN "PCD") and LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (little discomfort). On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site). On 20-Jan-2021, the patient experienced ERYTHEMA (red still continous). At the time of the report, DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely), VACCINATION SITE WARMTH (warm at injection site) and ERYTHEMA (red still continous) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: red still continous; injection site(left arm) turned very red; rash; itchy but not too severely; warm at injection site; little discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included GABAPENTIN (GABAPENTIN "PCD") and LISINOPRIL for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (little discomfort). On 19-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely) and VACCINATION SITE WARMTH (warm at injection site). On 20-Jan-2021, the patient experienced ERYTHEMA (red still continous). At the time of the report, DISCOMFORT (little discomfort), INJECTION SITE ERYTHEMA (injection site(left arm) turned very red), RASH (rash), PRURITUS (itchy but not too severely), VACCINATION SITE WARMTH (warm at injection site) and ERYTHEMA (red still continous) 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.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Insomnia
Clinical narrative: Back pain; Not able to sleep; chills; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and BACK PAIN (Back pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020 and Hysterectomy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 15-Jan-2021, the patient experienced BACK PAIN (Back pain) and INSOMNIA (Not able to sleep). At the time of the report, CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved, BACK PAIN (Back pain) had not resolved and INSOMNIA (Not able to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myalgia
Clinical narrative: Back pain; Not able to sleep; chills; headache; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and BACK PAIN (Back pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020 and Hysterectomy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). On 15-Jan-2021, the patient experienced BACK PAIN (Back pain) and INSOMNIA (Not able to sleep). At the time of the report, CHILLS (chills), HEADACHE (headache), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved, BACK PAIN (Back pain) had not resolved and INSOMNIA (Not able to sleep) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant patient received the first dose of moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (UNISOM [DIPHENHYDRAMINE HYDROCHLORIDE]) for Nausea, VITAMIN B6 and PRE NATAL FORMULA.    On 09-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 28-Sep-2020 and the estimated date of delivery was 05-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) 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 were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this 19-year-old female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; Hand was sore for a couple of days; ITCHING; A rash which was itchy, red and swollen at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) in a 54-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 (No medical history provided). Concomitant products included FISH OIL and VITAMINS NOS.    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 (Hand was sore for a couple of days) and PRURITUS (ITCHING). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) and the second episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection). On an unknown date, the patient experienced VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection). At the time of the report, PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the last episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment were provided
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: numbness in the tongue and lower face; tingling in the tongue and lower face; numbness and tingling in lower face; tingling in lower face; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) 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 HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face). At the time of the report, HYPOAESTHESIA (numbness and tingling in lower face) and PARAESTHESIA (tingling in lower face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included benadryl.  No concomitant medication was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: itchy at injection site; painful at injection site; red knot at injection site; This spontaneous case was reported by a consumer and describes the occurrence of   in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: dark red rash, itchy; dark red rash, itchy; dark red rash, itchy; urticaria develop in 4 staff and 1 client after injections; A spontaneous report was received from a nurse concerning a 52 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site erythema, injection site rash and injection site pruritus.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced the events injection site dark red rash that was very itchy.   Laboratory details was not provided.   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 event injection site dark red rash that was very itchy was unknown.; Sender's Comments:  MOD-2021-012249:Original Case : MOD-2021-011289 US-MODERNATX, INC.-MOD-2021-012249:same reporter, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Vaccination site erythema, Vaccination site warmth
Clinical narrative: at injection site little warm; at injection site have a bump; red at injection site; A spontaneous report was received from a consumer concerning a 30 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ( vaccination site mass, vaccination site erythema, vaccination site warmth) lists.  The patient's medical history was not provided. No relevant concomitant medications were reported.  on 14/jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch : 011L20A ) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.  Laboratory details not provided.  No treatment information is provided  action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm on the injection is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm on the injection is a little sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0121120A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm on the injection is a little sore). At the time of the report, VACCINATION SITE PAIN (arm on the injection is a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment medication were Xycal for allergies 1 pill, Albuterol inhaler aerosol for seasonal allergies.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Additional information included reporter details
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Vaccination site pain
Clinical narrative: itching turned into more of a slight prickly sensation, almost burning; itching; red rectangle 2 x 3.5 inches; arm was a bit sore; A spontaneous report was received from a Reporter concerning about a 68 years old male patient who received Moderna's 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.  Patient had Moderna first dose vaccine given to him on 08Jan2021. He developed at the injection site a little bit of a side effect. He would like to discuss this with somebody to see if it's dangerous or something he needs to be concerned about. Upon calling 22Jan2021 1003 EST: Patient confirmed he received the Moderna COVID19 vaccine on 08Jan2021 on left arm as IM injection. His arm was a bit sore. On 15Jan2021 patient states he started with the itching. Later he noticed he had a red rectangle 2 x 3.5 inches. The itching went on for about 2 days and then it subsided. On 18Jan2021, the itching was gone but the red area had increased in size. On 20Jan2021, the itching started again and the red area had increased to about 4.6 x 6 inches. Today 22Jan2021, the red area hasn't increased in size, but the itching turned into more of a slight prickly sensation, almost burning. It's not severe, not something that he can't stand, but it's noticeable. He states he never had a reaction like this before. Lot number of vaccine was not on patient's vaccination card. Consent given for safety to contact patient and his HCP. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Peripheral swelling, Pruritus, Vaccination site reaction
Clinical narrative: Reaction at the injection site; arm was swollen; Itchy/occasional itchiness over her whole body; A little bit nausea; A spontaneous report was received from a non healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea.  Medical history was not reported.  Concomitant medication was not reported.  On 12-Jan-2021, prior to the onset of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011L20A) via unknown route in unknown anatomical location for prophylaxis of COVID-19 infection.  On 21-Jan-2021, the patient experienced having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea was not provided.  The outcome of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea was not reported.  The reporter did not provide the assessment of the events having reaction at the injection site, arm is swollen, itchy/occasional itchiness over her whole body and a little bit of nausea to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm is very sore after receiving the shot; A spontaneous report was received from a non healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm is very sore after receiving the shot.   Medical history was not reported.  Concomitant medication was not reported.  On 21-Jan-2021, prior to the onset of the event arm is very sore after receiving the shot, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via intramuscular route in right arm shoulder deltoid condition for prophylaxis of COVID-19 infection.  On 21-Jan-2021, the patient experienced arm is very sore after receiving the shot.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the event arm is very sore after receiving the shot was not provided.  The outcome of the event arm is very sore after receiving the shot was not recovered.  The reporter did not provide the assessment of the event arm is very sore after receiving the shot to study drug.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Nausea
Clinical narrative: abdominal cramping; nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN (abdominal cramping) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site erythema, Vaccination site swelling
Clinical narrative: An orange, red area on the injection site; Swollen area on the injection site; red area on the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for an unknown indication.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site). On 22-Jan-2021, VACCINATION SITE ERYTHEMA (An orange, red area on the injection site), VACCINATION SITE SWELLING (Swollen area on the injection site) and INJECTION SITE ERYTHEMA (red area on the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Swelling, Vaccination site rash
Clinical narrative: red; soreness; Some swelling; itching; rash on the vaccination site; A spontaneous report was received from a medical assistant concerning a ninety-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed rash on the vaccination site, some swelling, itching, soreness and red.   The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (BATCH # 041L20A) on 13 Jan 2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   Reporter called regarding Moderna vaccine. Her patient received the vaccine on 13 Jan 2021, and today (22 Jan 2021), she had developed a rash on the vaccination site, and some swelling and itching and soreness. Reporter is patient's provider and also a CMA (Certified Medical Assistant). Vaccine was given on right arm as intramuscular injection. Second dose was due 11 Feb 2021. Patient continued to have the rash, red and itchiness. Swelling had gone down some. Consent was given for safety to contact the reporter for the patient and her HCP (healthcare provider). No further information was reported.  No treatment information was provided.  Action taken with RNA-1273 in response to the event was unknown.  The outcome of the events rash on the vaccination site, itching and red was not resolving. The outcome of some swelling was resolving. The outcome of soreness was unknown.  The reporter did not provide an assessment for the events, rash on the vaccination site, some swelling, itching, soreness and red.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: having an itchy rash; Soreness around the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 24-Jan-2021, the patient experienced VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site). At the time of the report, VACCINATION SITE RASH (having an itchy rash) and VACCINATION SITE PAIN (Soreness around the site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dermal cyst, Pain in extremity
Clinical narrative: cyst in shoulder; Arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026LZ0A and 010MZOA) for COVID-19 vaccination.     Concurrent medical conditions included BRCA1 gene mutation since 07-Apr-2014 and Allergy to antibiotic (to amoxicillin). Concomitant products included METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Shoulder pain.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder). At the time of the report, PAIN IN EXTREMITY (Arm was a little sore) and DERMAL CYST (cyst in shoulder) outcome was unknown.            No concomitant medications were reported.  Patient reported she finished 4mg Medrol dose pack few days before second dose of Moderna COVID-19 vaccine which she was taking for shoulder pain due to a cyst that ruptured and she does not think that the cyst occurred due to the Moderna COVID-19 vaccine as it was a few weeks after the shot.   This case was linked to MOD-2021-015853 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Patient information was updated, allergy to amoxicillin updated On 01-Jun-2021: patient sent MRI report which is unrelated to the case; Sender's Comments: Although the specific date was not provided.  However, based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site hypersensitivity, Vaccination site swelling
Clinical narrative: Delayed local hypersensitivity reaction; big large goose egg-size, light to medium pink,little bit swollen; big large goose egg-size, light to medium pink,little bit swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa, Clindamycin), Sunscreen sensitivity, Insect bite allergy and Drug allergy (Clindamycin). Concomitant products included CALCIUM ACETATE (CA P) and VITAMIN D NOS for an unknown indication.   On 13-Jan-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 12:15 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen). On an unknown date, the patient experienced VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction). On 26-Jan-2021, VACCINATION SITE HYPERSENSITIVITY (Delayed local hypersensitivity reaction), VACCINATION SITE SWELLING (big large goose egg-size, light to medium pink,little bit swollen) and VACCINATION SITE ERYTHEMA (big large goose egg-size, light to medium pink,little bit swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information has not been provided.   This case was linked to MOD-2021-082652, MOD-2021-082652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporters Address, Email Id provided.Patient information provided.Concomitant medications(sulfa, clindomycin, some skin product, sunscreens, insect bites) provided. Outcome of the event information provided.Outcome of the Follow up-1:The reported events were resolved on 26-JAN-2021.