chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Illness, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick), SUSPECTED COVID-19 (Covid like symptoms), ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine) and FEELING ABNORMAL (I felt horrible") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (diagnosed) in November 2020. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (Felt very sick), SUSPECTED COVID-19 (Covid like symptoms), ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine), FEELING ABNORMAL (I felt horrible"), NAUSEA ("I was nauseous the next morning"), MYALGIA (her arm was pretty sore/achy), FATIGUE ("tired"), HEADACHE (headache) and VACCINATION SITE PAIN (Arm is sore at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain in arm, at a dose of 2 dosage form. On 08-Mar-2021, MALAISE (Felt very sick) and VACCINATION SITE PAIN (Arm is sore at the site of injection) had resolved, SUSPECTED COVID-19 (Covid like symptoms) outcome was unknown. At the time of the report, ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine), FEELING ABNORMAL (I felt horrible"), NAUSEA ("I was nauseous the next morning"), MYALGIA (her arm was pretty sore/achy), FATIGUE ("tired") and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Significant Follow-up appended, events added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Product dose omission issue, Suspected COVID-19, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick), SUSPECTED COVID-19 (Covid like symptoms), ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine) and FEELING ABNORMAL (I felt horrible") in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (diagnosed) in November 2020. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MALAISE (Felt very sick), SUSPECTED COVID-19 (Covid like symptoms), ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine), FEELING ABNORMAL (I felt horrible"), NAUSEA ("I was nauseous the next morning"), MYALGIA (her arm was pretty sore/achy), FATIGUE ("tired"), HEADACHE (headache) and VACCINATION SITE PAIN (Arm is sore at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain in arm, at a dose of 2 dosage form. On 08-Mar-2021, MALAISE (Felt very sick) and VACCINATION SITE PAIN (Arm is sore at the site of injection) had resolved, SUSPECTED COVID-19 (Covid like symptoms) outcome was unknown. At the time of the report, ILLNESS ("super sick''), PRODUCT DOSE OMISSION ISSUE (Consumer chose not to get the second dose of the Moderna vaccine), FEELING ABNORMAL (I felt horrible"), NAUSEA ("I was nauseous the next morning"), MYALGIA (her arm was pretty sore/achy), FATIGUE ("tired") and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Significant Follow-up appended, events added.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnant (patient wants to sign up for pregnancy registry); This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin) and Penicillin allergy.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 06-Aug-2020 and the estimated date of delivery was 18-May-2021. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant (patient wants to sign up for pregnancy registry)) had resolved. Not Provided          Estimated date of conception was on 22-Aug-2020 and number of fetus was one. Patient wanted to sign up for pregnancy registry.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Rash
Clinical narrative: rash is itching, burning and red; rash that started at his ankles and spread up over legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (rash is itching, burning and red) and RASH (rash that started at his ankles and spread up over legs and arms) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (rash is itching, burning and red) and RASH (rash that started at his ankles and spread up over legs and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Eczema and Rash, at an unspecified dose and frequency. At the time of the report, ECZEMA (rash is itching, burning and red) and RASH (rash that started at his ankles and spread up over legs and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter.  Treatment history includes Benadryl and Topical Steroid Cream.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Live follow up received on 14-May-2021: No new information updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Red blotches on the fold of patient's neck and behind her knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotches on the fold of patient's neck and behind her knee) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH MACULAR (Red blotches on the fold of patient's neck and behind her knee). At the time of the report, RASH MACULAR (Red blotches on the fold of patient's neck and behind her knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia, Odynophagia, Oropharyngeal pain
Clinical narrative: sore throat; hard to swallow; he right side hurt while swallowing; metallic taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in the mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (hard to swallow) and ODYNOPHAGIA (he right side hurt while swallowing) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DYSGEUSIA (metallic taste in the mouth). On 31-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (hard to swallow) and ODYNOPHAGIA (he right side hurt while swallowing). At the time of the report, DYSGEUSIA (metallic taste in the mouth) and ODYNOPHAGIA (he right side hurt while swallowing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Tenderness
Clinical narrative: Vaccine exposure during pregnancy; Arm tenderness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and TENDERNESS (Arm tenderness) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-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 15-Aug-2020 and the estimated date of delivery was 13-May-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and TENDERNESS (Arm tenderness). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and TENDERNESS (Arm tenderness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Mucho dolor de cuerpo / lot of body pain; Mucho dolor de cabeza / bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Mucho dolor de cuerpo / lot of body pain) and HEADACHE (Mucho dolor de cabeza / bad headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included NAPROXEN SODIUM (ALEVE) and DICLOFENAC for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Mucho dolor de cuerpo / lot of body pain) and HEADACHE (Mucho dolor de cabeza / bad headache). At the time of the report, PAIN (Mucho dolor de cuerpo / lot of body pain) and HEADACHE (Mucho dolor de cabeza / bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not take any treatment medication.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: fever; chills; muscle aches; joint aches; Headache; fatigue; sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A. and 038A31A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin lesion. Concomitant products included STEROID ANTIBACTERIALS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness) outcome was unknown. Not Provided          No treatment medication was taken.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle aches; joint aches; Headache; fatigue; sleeplessness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A. and 038A31A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin lesion. Concomitant products included STEROID ANTIBACTERIALS for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache), FATIGUE (fatigue) and INSOMNIA (sleeplessness) outcome was unknown. Not Provided          No treatment medication was taken.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tremor
Clinical narrative: tiredness; soreness; couldn't stop shaking uncontrollably; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PAIN (soreness) and TREMOR (couldn't stop shaking uncontrollably) in a 20-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.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PAIN (soreness) and TREMOR (couldn't stop shaking uncontrollably). At the time of the report, FATIGUE (tiredness), PAIN (soreness) and TREMOR (couldn't stop shaking uncontrollably) outcome was unknown.            Patient wants to know if this is a normal side effect.   This case was linked to MOD-2021-065477, MOD-2021-065477 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Increased heartrate; Excruciating pain though the finger tips.; Rash; Tiredness; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 28-Mar-2021, TACHYCARDIA (Increased heartrate) and RASH (Rash) had resolved. On 31-Mar-2021, PAIN IN EXTREMITY (Excruciating pain though the finger tips.), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included asthma medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 - NNI
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tachycardia
Clinical narrative: Increased heartrate; Excruciating pain though the finger tips.; Rash; Tiredness; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced TACHYCARDIA (Increased heartrate), PAIN IN EXTREMITY (Excruciating pain though the finger tips.), RASH (Rash), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). On 28-Mar-2021, TACHYCARDIA (Increased heartrate) and RASH (Rash) had resolved. On 31-Mar-2021, PAIN IN EXTREMITY (Excruciating pain though the finger tips.), FATIGUE (Tiredness), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included asthma medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received on 16-JUNE-2021 - NNI
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A1A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.). On 18-Mar-2021, VACCINATION SITE REACTION (Covid-arm 8 days later with a large rash from the shoulder to the elbow and that lasted a week.) and RASH (Large rash from the shoulder to the elbow and that lasted a week.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's medical history was not provided. No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Influenza like illness, Pain
Clinical narrative: FEELING ACHY; flu like symptoms; FEELS TIRED AND WORN OUT; LOW GRADE FEVER; JOINTS SORE AND ACHY; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY) in a 60-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.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY). At the time of the report, PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) LOW GRADE FEVER.     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: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEELING ACHY; flu like symptoms; FEELS TIRED AND WORN OUT; LOW GRADE FEVER; JOINTS SORE AND ACHY; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY) in a 60-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.    On 25-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY). At the time of the report, PAIN (FEELING ACHY), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (FEELS TIRED AND WORN OUT), PYREXIA (LOW GRADE FEVER) and ARTHRALGIA (JOINTS SORE AND ACHY) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) LOW GRADE FEVER.     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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Nausea, Pain in extremity
Clinical narrative: Arm was so sore; Nauseous; Chills; Sickness; sweating; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (Arm was so sore), CHILLS (Chills) and NAUSEA (Nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031521A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ILLNESS (Sickness), HYPERHIDROSIS (sweating) and CHILLS (Chills). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was so sore) and NAUSEA (Nauseous). At the time of the report, ILLNESS (Sickness), HYPERHIDROSIS (sweating), PAIN IN EXTREMITY (Arm was so sore), CHILLS (Chills) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Lymphadenopathy, Somnolence
Clinical narrative: couldn't lift her left arm for three days; Swollen lymph nodes under her left arm; slept for 5 hours; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), SOMNOLENCE (slept for 5 hours) and LIMB DISCOMFORT (arm discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for Immunisation.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes), SOMNOLENCE (slept for 5 hours) and LIMB DISCOMFORT (arm discomfort). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased
Clinical narrative: Shortness of Breath During Observation; Fast Heart Beat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat). On 05-Mar-2021, DYSPNOEA (Shortness of Breath During Observation) and HEART RATE INCREASED (Fast Heart Beat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vaccination site pain
Clinical narrative: Tender and painful; Pain under arm on the side where she had gotten the vaccine; Enlarged lymph node that was tender, swollen, and painful.; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Tender and painful), VACCINATION SITE PAIN (Pain under arm on the side where she had gotten the vaccine) and LYMPHADENOPATHY (Enlarged lymph node that was tender, swollen, and painful.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Medical history was not provided by the Reporter.  Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LYMPH NODE PAIN (Tender and painful), VACCINATION SITE PAIN (Pain under arm on the side where she had gotten the vaccine) and LYMPHADENOPATHY (Enlarged lymph node that was tender, swollen, and painful.). At the time of the report, LYMPH NODE PAIN (Tender and painful) was resolving and VACCINATION SITE PAIN (Pain under arm on the side where she had gotten the vaccine) and LYMPHADENOPATHY (Enlarged lymph node that was tender, swollen, and painful.) 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.   Patient took Tylenol 30-40 mins after the first dose. Treatment information was not Provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchy patch on arm after first dose; Big patch on arm after first dose; Red patch on arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose). At the time of the report, VACCINATION SITE PRURITUS (Itchy patch on arm after first dose), VACCINATION SITE RASH (Big patch on arm after first dose) and VACCINATION SITE ERYTHEMA (Red patch on arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided Treatment information was not provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Tremor
Clinical narrative: couldn't stop shaking uncontrollably; soreness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (couldn't stop shaking uncontrollably), PAIN (soreness) and FATIGUE (tiredness) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (couldn't stop shaking uncontrollably), PAIN (soreness) and FATIGUE (tiredness). At the time of the report, TREMOR (couldn't stop shaking uncontrollably), PAIN (soreness) and FATIGUE (tiredness) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-065466 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain
Clinical narrative: Stomach hurts; Achy/ Sore; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach hurts) and PAIN (Achy/ Sore) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol blood excessive.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Achy/ Sore). On 29-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach hurts). At the time of the report, ABDOMINAL PAIN UPPER (Stomach hurts) and PAIN (Achy/ Sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetes medications, blood pressure medications and cholesterol medications.  No treatment has been given to the patient.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: she experienced pain in her arm; Hurting and very hot to touch at injection site; She experienced soreness of upper arm; Itchy at injection site; She experienced a swollen arm at injection site.; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical information was not provided by the Reporter.  Concomitant products included METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), VITAMIN D [VITAMIN D NOS] and ESTRADIOL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: she experienced pain in her arm; Hurting and very hot to touch at injection site; She experienced soreness of upper arm; Itchy at injection site; She experienced a swollen arm at injection site.; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical information was not provided by the Reporter.  Concomitant products included METOPROLOL, ASPIRIN [ACETYLSALICYLIC ACID], CLOPIDOGREL, CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), VITAMIN D [VITAMIN D NOS] and ESTRADIOL for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (she experienced pain in her arm), VACCINATION SITE WARMTH (Hurting and very hot to touch at injection site), PAIN (She experienced soreness of upper arm), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE SWELLING (She experienced a swollen arm at injection site.) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchy patch on arm; Big patch on arm; Slight fever; Headache; Chills; Red patch on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm) outcome was unknown.            Treatment using  Tylenol was reported   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Contact information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Itchy patch on arm; Big patch on arm; Slight fever; Headache; Chills; Red patch on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache) and CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy patch on arm), VACCINATION SITE RASH (Big patch on arm), PYREXIA (Slight fever), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Red patch on arm) outcome was unknown.            Treatment using  Tylenol was reported   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Contact information provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of the Moderna vaccine, 23 days apart from the 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna vaccine, 23 days apart from the 1st dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 002A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], COLECALCIFEROL (VITAMIN D 3), ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM, DONEPEZIL HYDROCHLORIDE (ARICEPT), LEVOTHYROXINE SODIUM (SYNTHROID), LORATADINE, PREDNISONE, MULTIVITAMINS [VITAMINS NOS], SIMVASTATIN (ZOCOR) and TOPIRAMATE (TOPAMAX) for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna vaccine, 23 days apart from the 1st dose). On 09-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna vaccine, 23 days apart from the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28Jun2021 contains no new information
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity
Clinical narrative: Pain in the arm; Rumbling of stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach) outcome was unknown.            Concomitant medications details were not reported by the reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019E21A) for COVID-19 vaccination.     Concomitant products included BETAHISTINE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with DIAZEPAM at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-065493 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the left arm) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Elbow injury and Laser therapy on 26-Mar-2021.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness on the left arm). At the time of the report, VACCINATION SITE PAIN (Soreness on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Patient mentioned that he has been receiving laser therapy by a physical therapist for months for his elbow injury that occurred an year back. Patient never had PRP injection but was advised by healthcare professional to promote healing to the elbow. Patient mentioned that he has a scheduled laser therapy in ten days.