chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: pain in the arm/arm hurt; red mark in the shoulder; red mark in the shoulder which hurt; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red mark in the shoulder), PAIN (red mark in the shoulder which hurt) and PAIN IN EXTREMITY (pain in the arm/arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood transfusion (after almost bleeding to death). Concurrent medical conditions included Stomach cancer (Five years ago, patient had stomach cancer.), Blood disorder (patient caught a rare blood disease in which white blood cells attack red blood cells.Patient takes medication to treat conditions.) and Immunocompromised.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-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 received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ERYTHEMA (red mark in the shoulder) and PAIN (red mark in the shoulder which hurt). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm/arm hurt). At the time of the report, ERYTHEMA (red mark in the shoulder), PAIN (red mark in the shoulder which hurt) and PAIN IN EXTREMITY (pain in the arm/arm hurt) outcome was unknown.            Patient qualified as immunocompromised, so received 3rd dose.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MYALGIA (Aches). At the time of the report, MYALGIA (Aches) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-303445, MOD-2021-303640 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Illness, Myalgia
Clinical narrative: sick as dog felt; Felt poorly; dry heaving; headache; myalgia; arthralgia; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache) and MYALGIA (myalgia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache), MYALGIA (myalgia) and ARTHRALGIA (arthralgia). At the time of the report, ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Retching
Clinical narrative: sick as dog felt; Felt poorly; dry heaving; headache; myalgia; arthralgia; This spontaneous case was reported by a health care professional and describes the occurrence of ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache) and MYALGIA (myalgia) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache), MYALGIA (myalgia) and ARTHRALGIA (arthralgia). At the time of the report, ILLNESS (sick as dog felt), FEELING ABNORMAL (Felt poorly), RETCHING (dry heaving), HEADACHE (headache), MYALGIA (myalgia) and ARTHRALGIA (arthralgia) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Pain in extremity, Vaccination complication
Clinical narrative: reaction; red mark in the shoulder; pain in the arm / arm hurt; pain in the shoulder; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder). At the time of the report, VACCINATION COMPLICATION (reaction), ERYTHEMA (red mark in the shoulder), PAIN IN EXTREMITY (pain in the arm / arm hurt) and ARTHRALGIA (pain in the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Penile discomfort, Prostatitis
Clinical narrative: chronic prostatitis; It's a sensation in the head of the penis when you pee.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PROSTATITIS (chronic prostatitis) and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PROSTATITIS (chronic prostatitis) and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.). At the time of the report, PROSTATITIS (chronic prostatitis) had not resolved and PENILE DISCOMFORT (It's a sensation in the head of the penis when you pee.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included for the past 6 months he has been on and off antibiotics because of chronic prostatitis. He has tried multiple different antibiotics and recently started a new drug and his urologist told him it was safe to take with the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: many patients with a rash from Moderna; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (many patients with a rash from Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (many patients with a rash from Moderna). At the time of the report, RASH (many patients with a rash from Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: her arm swollen a little bit; Vaccination site swelling; vaccination site erythema; arm is a little sore; arm itches from the shot I took; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (arm itches from the shot I took), PAIN IN EXTREMITY (arm is a little sore), PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure). Concomitant products included CHLORTALIDONE (CHLORTHALIDONE) for Blood pressure high, METFORMIN, OMEPRAZOLE, ASPIRIN [ACETYLSALICYLIC ACID], MULTIVITAMINS [VITAMINS NOS], AMITRIPTYLINE, METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL and DOCUSATE for an unknown indication.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced PRURITUS (arm itches from the shot I took) and PAIN IN EXTREMITY (arm is a little sore). On 31-Aug-2021, the patient experienced PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema). At the time of the report, PRURITUS (arm itches from the shot I took), PAIN IN EXTREMITY (arm is a little sore), PERIPHERAL SWELLING (her arm swollen a little bit), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (vaccination site erythema) outcome was unknown.            Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site bruising, Vaccination site erythema
Clinical narrative: arm turned red/ still has a red mark at the injection site; she had like a bruise; she never had her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site), VACCINATION SITE BRUISING (she had like a bruise) and PRODUCT DOSE OMISSION ISSUE (she never had her second dose) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site), VACCINATION SITE BRUISING (she had like a bruise) and PRODUCT DOSE OMISSION ISSUE (she never had her second dose). At the time of the report, VACCINATION SITE ERYTHEMA (arm turned red/ still has a red mark at the injection site) had not resolved, VACCINATION SITE BRUISING (she had like a bruise) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she never had her second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.  It was reported that patient took first dose 3 months ago and did not take second dose as she was nervous about the reactions.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms). At the time of the report, VACCINATION COMPLICATION (family and friends who were Blood Type O and got Moderna vaccine was significant in symptoms/Type O Blood recipients had lesser of a reaction/family and friends that got virus prior to or after Moderna vaccine Blood Type O was significant in symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided. Patient reported that her family and friends that all got Moderna vaccine, some had virus prior to or after, blood type O was significant in symptoms. Patient said that the type O blood recipients had lesser of reaction.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mild aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MYALGIA (Mild aches). At the time of the report, MYALGIA (Mild aches) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-303415.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have low grade fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have low grade fever after second dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (have low grade fever after second dose). At the time of the report, PYREXIA (have low grade fever after second dose) outcome was unknown.            No concomitant medication reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site rash, Vaccination site reaction
Clinical narrative: broke out at the site of injection after the 1st dose; Rash at injection site; missed the 2nd dose appointment; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose), VACCINATION SITE RASH (Rash at injection site) and PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment). On an unknown date, the patient experienced VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose) and VACCINATION SITE RASH (Rash at injection site). On 31-Aug-2021, PRODUCT DOSE OMISSION ISSUE (missed the 2nd dose appointment) had resolved. At the time of the report, VACCINATION SITE REACTION (broke out at the site of injection after the 1st dose) and VACCINATION SITE RASH (Rash at injection site) 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.   No concomitant medication was reported. No Treatment medication was reported.  On 01-Sep-2021, when the patient went to the vaccination center, the patient was told to reschedule the appointment.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: infected by Covid 19 without experiencing symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (infected by Covid 19 without experiencing symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (infected by Covid 19 without experiencing symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (infected by Covid 19 without experiencing symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Myalgia
Clinical narrative: Dry mouth; Left arm sore/ All the body is sore; chest, shoulder, and back; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back). At the time of the report, DRY MOUTH (Dry mouth) and MYALGIA (Left arm sore/ All the body is sore; chest, shoulder, and back) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (muscle aches) and pyrexia (low-fever) in a 66-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (muscle aches) and pyrexia (low-fever). At the time of the report, myalgia (muscle aches) and pyrexia (low-fever) resolved. No concomitant medications or treatment information reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Visual impairment
Clinical narrative: Eyes got "really really red"; kept seeing these little black spots; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Eyes got "really really red") and VISUAL IMPAIRMENT (kept seeing these little black spots) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Eyes got "really really red") and VISUAL IMPAIRMENT (kept seeing these little black spots). At the time of the report, OCULAR HYPERAEMIA (Eyes got "really really red") and VISUAL IMPAIRMENT (kept seeing these little black spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's lab data included colonoscopy. The patient received steroid treatment in the eye. No concomitant medications were reported.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: vaccine given to 13 year old; first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 13 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021.went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Tiny sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tiny sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Tiny sore arm). On 13-Apr-2021, PAIN IN EXTREMITY (Tiny sore arm) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: vaccine given to 15 year old; first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine given to 15 year old) and PRODUCT DOSE OMISSION ISSUE (first dose is 29Jul2021. they went back for their second dose and they were sent back to their pediatrician since they were underage and should have not received it.) 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 medications was not provided by the reporter Treatment information was not provided
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Influenza like illness, Pyrexia
Clinical narrative: flu like symptoms; slight increase with heart beat; slight fever; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEART RATE INCREASED (slight increase with heart beat), PYREXIA (slight fever) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. No treatment medications were provided. Patient received her first dose, had minimal side effects, flu like symptoms but only lasted for a day or so.  had slight fever, headache, slight increase with heart beat but didn't take anything and side effects went away pretty quickly.   This case was linked to MOD-2021-303896 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: felt lethargic for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic for 24 hours) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced LETHARGY (felt lethargic for 24 hours). On 09-Feb-2021, LETHARGY (felt lethargic for 24 hours) had resolved.            No concomitant medication listed.   No treatment information provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Herpes zoster, Inappropriate schedule of product administration, Insomnia
Clinical narrative: I felt a little bit cold & achy; Extended period of time between receiving the 1st and 2nd doses of the vaccine; I felt a little bit cold and achy; I was very tired; Shingles; Couldn't sleep; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 28-Jun-2021, the patient experienced HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep) and FATIGUE (I was very tired). On 29-Jun-2021, the patient experienced FEELING COLD (I felt a little bit cold and achy). On an unknown date, the patient experienced PAIN (I felt a little bit cold & achy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine). At the time of the report, HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy), VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (I was very tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine) had resolved.            No concomitant medication and treatment medication was reported by the reporter.   This case was linked to MOD-2021-304348.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: I felt a little bit cold & achy; Extended period of time between receiving the 1st and 2nd doses of the vaccine; I felt a little bit cold and achy; I was very tired; Shingles; Couldn't sleep; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 28-Jun-2021, the patient experienced HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep) and FATIGUE (I was very tired). On 29-Jun-2021, the patient experienced FEELING COLD (I felt a little bit cold and achy). On an unknown date, the patient experienced PAIN (I felt a little bit cold & achy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine). At the time of the report, HERPES ZOSTER (Shingles), INSOMNIA (Couldn't sleep), FEELING COLD (I felt a little bit cold and achy), PAIN (I felt a little bit cold & achy), VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (I was very tired) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Extended period of time between receiving the 1st and 2nd doses of the vaccine) had resolved.            No concomitant medication and treatment medication was reported by the reporter.   This case was linked to MOD-2021-304348.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Malaise
Clinical narrative: Stomach Ache; feel really sick; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach Ache), MALAISE (feel really sick) and HEADACHE (Headache) outcome was unknown.            No concomitant product was reported. No treatment was reported. Patient got second dose and have feel really sick.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Hve not had their 2nd dose after getting their 1st dose on 27Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-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 PRODUCT DOSE OMISSION ISSUE (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Hve not had their 2nd dose after getting their 1st dose on 27Apr2021) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: sore armpit on arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore armpit on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (sore armpit on arm). At the time of the report, AXILLARY PAIN (sore armpit on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Headache
Clinical narrative: cold and hot; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021 at 4:00 AM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (cold and hot), HEADACHE (headache) and CHILLS (Chills) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Discomfort, Feeling hot, Hypoaesthesia, Influenza
Clinical narrative: left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb; pain at vaccination site (left arm) on regular basis/left arm is still hurting; feels like it is heating up; having general discomfort; got sick with flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (got sick with flu symptoms), HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA (got sick with flu symptoms). On an unknown date, the patient experienced HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort). On 25-Mar-2021, INFLUENZA (got sick with flu symptoms) had resolved. At the time of the report, HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.         No concomitant medications were reported. No treatment medications were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vaccination site pain
Clinical narrative: left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb; pain at vaccination site (left arm) on regular basis/left arm is still hurting; feels like it is heating up; having general discomfort; got sick with flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (got sick with flu symptoms), HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INFLUENZA (got sick with flu symptoms). On an unknown date, the patient experienced HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort). On 25-Mar-2021, INFLUENZA (got sick with flu symptoms) had resolved. At the time of the report, HYPOAESTHESIA (left side of the body was numb from neck, ear, and whole left head area/left arm was numb /left arm was numb), VACCINATION SITE PAIN (pain at vaccination site (left arm) on regular basis/left arm is still hurting), FEELING HOT (feels like it is heating up) and DISCOMFORT (having general discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Magnetic resonance imaging: normal (normal) normal.         No concomitant medications were reported. No treatment medications were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Wheezing; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced WHEEZING (Wheezing). At the time of the report, WHEEZING (Wheezing) had resolved.            No concomitant product use was provided by the reporter. The patient woke up in the night wheezing. The patient walked up and down the hall a few times and it went away.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mother's leg started hurting after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (mother's leg started hurting after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (mother's leg started hurting after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (mother's leg started hurting after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication use was reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: got really really sick; more than 35 days from 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really really sick) and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (got really really sick) and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination). At the time of the report, ILLNESS (got really really sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had an adverse reaction to this vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had an adverse reaction to this vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had an adverse reaction to this vaccine). At the time of the report, VACCINATION COMPLICATION (had an adverse reaction to this vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.