chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Get full with little food; Feels like a zombie; Not well; Cannot work; Pain in the arms; Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired; Pain in the arms; Face is hot and getting hard; Muscles are tense, like balls in her thighs and arms; Chest feels like paralyzed; Lost of apetite/no hungry; Cramps in the muscles of the pelvic area; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed) and DECREASED APPETITE (Lost of apetite/no hungry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced MUSCLE SPASMS (Cramps in the muscles of the pelvic area), DECREASED APPETITE (Lost of apetite/no hungry) and NAUSEA (Nausea). On an unknown date, the patient experienced HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), CHEST DISCOMFORT (Chest feels like paralyzed), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired) and MYALGIA (Pain in the arms). At the time of the report, HOT FLUSH (Face is hot and getting hard), MUSCLE TIGHTNESS (Muscles are tense, like balls in her thighs and arms), MUSCLE SPASMS (Cramps in the muscles of the pelvic area), CHEST DISCOMFORT (Chest feels like paralyzed), DECREASED APPETITE (Lost of apetite/no hungry), EATING DISORDER (Get full with little food), FEELING ABNORMAL (Feels like a zombie), MALAISE (Not well), IMPAIRED WORK ABILITY (Cannot work), PAIN IN EXTREMITY (Pain in the arms), FATIGUE (Very tired at the beginning of the day/Tiredness goes away during the day and returns at night/hands are tired), MYALGIA (Pain in the arms) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2021: Additional information received on 06-Jun- 2021 contains significant information added new events and updated reporter information.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    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 OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.). At the time of the report, OROPHARYNGEAL PAIN (Sore throat. Went to ER this morning and received a Steriod shot. ER said it should be better in a couple of hours. Got the shot at 9:00 am. 11:11 PM now and no improvement.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Hypersensitivity, Myalgia, Vaccination site erythema
Clinical narrative: Injection site is really warm; Large red spot; Almost like an allergic reaction; A little bit of dizziness; Injection site is itching really bad; Injection site is a little bit swollen; Injection site was really red; A knot at the injection site that was kind of hard; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A knot at the injection site that was kind of hard), VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction) and DIZZINESS (A little bit of dizziness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy and Gastritis. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, BIOTIN for Vitamin supplementation, AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness). On 03-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itching, at an unspecified dose and frequency. On 27-May-2021, VACCINATION SITE MASS (A knot at the injection site that was kind of hard) and MYALGIA (Soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site is really warm), ERYTHEMA (Large red spot), HYPERSENSITIVITY (Almost like an allergic reaction), DIZZINESS (A little bit of dizziness), VACCINATION SITE PRURITUS (Injection site is itching really bad), VACCINATION SITE SWELLING (Injection site is a little bit swollen) and VACCINATION SITE ERYTHEMA (Injection site was really red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products also included centrum silver.  Patient said that after using Benadryl cream, it kind of went away but she currently has an ice pack on it with some gauze.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-Jun-2021, included fax number was updated and no new information was recorded
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not gotten the second dose yet; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose yet) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-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 (Has not gotten the second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose yet) 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 were not provided.  Treatment were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Non significant Follow up appended
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Pain
Clinical narrative: my hands and feet go numb / Most of the day I cannot feel my extremities at all; they hurt and it's so painful; I can't walk in the morning for a bit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Jun-2021 and was forwarded to Moderna on 06-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit) 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) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit). At the time of the report, HYPOAESTHESIA (my hands and feet go numb / Most of the day I cannot feel my extremities at all), PAIN (they hurt and it's so painful) and GAIT DISTURBANCE (I can't walk in the morning for a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported. Patient stated that the reaction was so bad that they did not wanted to get the second dose.  Treatment information was not provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Pain in extremity
Clinical narrative: Sluggish; It felt like a bully at school.; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy NOS.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included medications for Blood pressure and unspecified allergy.   This case was linked to MOD-2021-209019, MOD-2021-209019 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT; 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 PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT) 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.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT). In February 2021, PRODUCT DOSE OMISSION ISSUE (I TOOK MY FIRST SHOT IN FEBRUARY AND DID NOT TAKE THE SECOND SHOT) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Starting to feel numbness on the left side of my face; 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 HYPOAESTHESIA (Starting to feel numbness on the left side of my face) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Starting to feel numbness on the left side of my face). At the time of the report, HYPOAESTHESIA (Starting to feel numbness on the left side of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-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) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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 (side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 102 for 26 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 102 for 26 hours) 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) (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 PYREXIA (Fever of 102 for 26 hours). At the time of the report, PYREXIA (Fever of 102 for 26 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Gingival pain
Clinical narrative: Sore gums after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Sore gums after the 2nd 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.   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 GINGIVAL PAIN (Sore gums after the 2nd dose). At the time of the report, GINGIVAL PAIN (Sore gums after the 2nd dose) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose over 42 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040a21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN DETEMIR (LEVEMIR) and DULAGLUTIDE (TRULICITY) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago). On 13-Apr-2021, PRODUCT DOSE OMISSION ISSUE (1st dose over 42 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received 28-Jul-21: Updated narrative to reflect patient receiving guidance.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Recurring itchy rash on my abdomen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Recurring itchy rash on my abdomen) 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. No concomitant medication 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 RASH PRURITIC (Recurring itchy rash on my abdomen). At the time of the report, RASH PRURITIC (Recurring itchy rash on my abdomen) outcome was unknown.      Treatment medication was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Influenza like illness, Myalgia, Nausea
Clinical narrative: Patient was in bed until night; Received a vaccine that is past the suggested used by date; Soreness at the site of injection; Overpowering headache in the afternoon and it went downhill from there; Very high level of body ache from head to toe; Feeling nauseous; Feels like having a flu but not stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), SOMNOLENCE (Patient was in bed until night), EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date), VACCINATION SITE PAIN (Soreness at the site of injection) and HEADACHE (Overpowering headache in the afternoon and it went downhill from there) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date), VACCINATION SITE PAIN (Soreness at the site of injection), HEADACHE (Overpowering headache in the afternoon and it went downhill from there), MYALGIA (Very high level of body ache from head to toe) and NAUSEA (Feeling nauseous). On an unknown date, the patient experienced SOMNOLENCE (Patient was in bed until night). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of Aleve 2 tablets and IBUPROFEN at a dose of Ibuprofen 2 tablets. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), SOMNOLENCE (Patient was in bed until night), VACCINATION SITE PAIN (Soreness at the site of injection), HEADACHE (Overpowering headache in the afternoon and it went downhill from there), MYALGIA (Very high level of body ache from head to toe) and NAUSEA (Feeling nauseous) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: Patient was in bed until night; Received a vaccine that is past the suggested used by date; Soreness at the site of injection; Overpowering headache in the afternoon and it went downhill from there; Very high level of body ache from head to toe; Feeling nauseous; Feels like having a flu but not stomach flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), SOMNOLENCE (Patient was in bed until night), EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date), VACCINATION SITE PAIN (Soreness at the site of injection) and HEADACHE (Overpowering headache in the afternoon and it went downhill from there) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date), VACCINATION SITE PAIN (Soreness at the site of injection), HEADACHE (Overpowering headache in the afternoon and it went downhill from there), MYALGIA (Very high level of body ache from head to toe) and NAUSEA (Feeling nauseous). On an unknown date, the patient experienced SOMNOLENCE (Patient was in bed until night). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of Aleve 2 tablets and IBUPROFEN at a dose of Ibuprofen 2 tablets. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like having a flu but not stomach flu), SOMNOLENCE (Patient was in bed until night), VACCINATION SITE PAIN (Soreness at the site of injection), HEADACHE (Overpowering headache in the afternoon and it went downhill from there), MYALGIA (Very high level of body ache from head to toe) and NAUSEA (Feeling nauseous) outcome was unknown and EXPIRED PRODUCT ADMINISTERED (Received a vaccine that is past the suggested used by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) 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 MYALGIA (muscle pain). At the time of the report, MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injury, Limb discomfort, Orthostatic hypotension, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJURY (Felt like she got hit by a mack truck, it was rough), LIMB DISCOMFORT (Problems with her legs/legs feel very heavy), PAIN IN EXTREMITY (Legs are very sore) and ORTHOSTATIC HYPOTENSION (Head rushes) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter.  Concomitant products included TRAZODONE, QUETIAPINE FUMARATE (SEROQUEL), BUSPIRONE HYDROCHLORIDE (BUSPAR), BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) and CLONIDINE for an unknown indication. On 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced LIMB DISCOMFORT (Problems with her legs/legs feel very heavy) and PAIN IN EXTREMITY (Legs are very sore). On 29-May-2021, the patient experienced INJURY (Felt like she got hit by a mack truck, it was rough). On an unknown date, the patient experienced ORTHOSTATIC HYPOTENSION (Head rushes). In May 2021, INJURY (Felt like she got hit by a mack truck, it was rough) had resolved. At the time of the report, LIMB DISCOMFORT (Problems with her legs/legs feel very heavy), PAIN IN EXTREMITY (Legs are very sore) and ORTHOSTATIC HYPOTENSION (Head rushes) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling, Product administered to patient of inappropriate age
Clinical narrative: Arm swelling; Sore arm; Headache; Vaccine given to adolescent; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent), PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent). On 07-May-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 06-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to adolescent) had resolved. On 08-May-2021, PERIPHERAL SWELLING (Arm swelling), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: now right hand can not move / can not grasp anything; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (now right hand can not move / can not grasp anything) 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) (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 MOBILITY DECREASED (now right hand can not move / can not grasp anything). At the time of the report, MOBILITY DECREASED (now right hand can not move / can not grasp anything) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Slight palpitation is on and off for entire month; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Slight palpitation is on and off for entire month) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PALPITATIONS (Slight palpitation is on and off for entire month). The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In May 2021, PALPITATIONS (Slight palpitation is on and off for entire month) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had second dose on 29-MAY-2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: The injection site is still swollen; The injection site is still swollen and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, 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 VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful). At the time of the report, VACCINATION SITE SWELLING (The injection site is still swollen) and VACCINATION SITE PAIN (The injection site is still swollen and painful) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Circumoral swelling, Erythema, Pruritus, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING (Swelling around mouth), PRURITUS (Itching around body), ERYTHEMA (If he scratches the itch, it turns into a red ball shape) and RASH (Rash on body) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-May-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 06-May-2021, the patient experienced CIRCUMORAL SWELLING (Swelling around mouth), PRURITUS (Itching around body), ERYTHEMA (If he scratches the itch, it turns into a red ball shape) and RASH (Rash on body). At the time of the report, CIRCUMORAL SWELLING (Swelling around mouth), PRURITUS (Itching around body), ERYTHEMA (If he scratches the itch, it turns into a red ball shape) and RASH (Rash on body) had not resolved. No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Having a few symptoms of the side effects past 2 days and not getting better; 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 (Having a few symptoms of the side effects past 2 days and not getting better) 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. No concomitant medication 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 COMPLICATION (Having a few symptoms of the side effects past 2 days and not getting better). At the time of the report, VACCINATION COMPLICATION (Having a few symptoms of the side effects past 2 days and not getting better) outcome was unknown.     Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Fatigue, Heart rate
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded with some dizziness), MYALGIA (sore arm) and FATIGUE (Felt tired, fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  No Medical History information was reported. On 17-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (sore arm). On 20-Mar-2021, the patient experienced DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue). The patient was treated with PREDNISONE from 21-Apr-2021 to 01-May-2021 at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) on 21-Apr-2021 at an unspecified dose and frequency. On 23-Mar-2021, DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue) had resolved. At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood pressure measurement: 151/94 mmHg (Inconclusive) 151/94. On 21-Apr-2021, Body temperature: 98.1 Farad (Inconclusive) 98.1. On 21-Apr-2021, Heart rate: 86 mmHg (Inconclusive) 86. On 21-Apr-2021, Respiratory rate: 18 (Inconclusive) 18. On 26-Apr-2021, Blood pressure measurement: 144/91 mmHg (Inconclusive) 144/91. On 26-Apr-2021, Body temperature: 98.2 Farad (Inconclusive) 98.2. On 26-Apr-2021, Heart rate: mmHg. On 26-Apr-2021, Respiratory rate: 16 (Inconclusive) 16. On 03-May-2021, Blood pressure measurement: 121/79 mmHg (Inconclusive) 121/79. On 03-May-2021, Body temperature: 97.3 Farad (Inconclusive) 97.3. On 03-May-2021, Heart rate: 79 mmHg (Inconclusive) 79. On 03-May-2021, Respiratory rate: 18 (Inconclusive) 18. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-101780. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant follow-up appended.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Respiratory rate
Clinical narrative: This spontaneous case was reported by a non-health professional and describes the occurrence of DIZZINESS (lightheaded with some dizziness), MYALGIA (sore arm) and FATIGUE (Felt tired, fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.  No Medical History information was reported. On 17-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MYALGIA (sore arm). On 20-Mar-2021, the patient experienced DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue). The patient was treated with PREDNISONE from 21-Apr-2021 to 01-May-2021 at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) on 21-Apr-2021 at an unspecified dose and frequency. On 23-Mar-2021, DIZZINESS (lightheaded with some dizziness) and FATIGUE (Felt tired, fatigue) had resolved. At the time of the report, MYALGIA (sore arm) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Blood pressure measurement: 151/94 mmHg (Inconclusive) 151/94. On 21-Apr-2021, Body temperature: 98.1 Farad (Inconclusive) 98.1. On 21-Apr-2021, Heart rate: 86 mmHg (Inconclusive) 86. On 21-Apr-2021, Respiratory rate: 18 (Inconclusive) 18. On 26-Apr-2021, Blood pressure measurement: 144/91 mmHg (Inconclusive) 144/91. On 26-Apr-2021, Body temperature: 98.2 Farad (Inconclusive) 98.2. On 26-Apr-2021, Heart rate: mmHg. On 26-Apr-2021, Respiratory rate: 16 (Inconclusive) 16. On 03-May-2021, Blood pressure measurement: 121/79 mmHg (Inconclusive) 121/79. On 03-May-2021, Body temperature: 97.3 Farad (Inconclusive) 97.3. On 03-May-2021, Heart rate: 79 mmHg (Inconclusive) 79. On 03-May-2021, Respiratory rate: 18 (Inconclusive) 18. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided by the reporter. This case was linked to MOD-2021-101780. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant follow-up appended.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Migraine, Myalgia, Pain
Clinical narrative: very painful migraine after the 2nd shot; freezing; I'm still in pain; whole body hurts/body hurts more than I've ever experienced; 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 MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (Patient diabetic with injuries from an accident back in 2013).   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 MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced). At the time of the report, MIGRAINE (very painful migraine after the 2nd shot), FEELING COLD (freezing), PAIN (I'm still in pain) and MYALGIA (whole body hurts/body hurts more than I've ever experienced) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot) 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 (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot). At the time of the report, VACCINATION COMPLICATION (side effects 14 days after the second shot/non severe side effects appearing weeks after the second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Is diahrreah common side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is diahrreah common side effect?) 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 DIARRHOEA (Is diahrreah common side effect?). At the time of the report, DIARRHOEA (Is diahrreah common side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever) 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) (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 PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got second shot yesterday woke up with a fever and took 2 at 3am and felt like in need of one more.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test
Clinical narrative: it is now noticeably thinner; Hair has been thinning since I received the 2nd dose/it is now noticeably thinner; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner) and ALOPECIA (it is now noticeably thinner) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. In May 2021, the patient experienced ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner). In June 2021, the patient experienced ALOPECIA (it is now noticeably thinner). At the time of the report, ALOPECIA (Hair has been thinning since I received the 2nd dose/it is now noticeably thinner) and ALOPECIA (it is now noticeably thinner) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.