chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis, Nasal congestion, Nausea, Pain in extremity
Clinical narrative: sweating; congested; Hot flashes; Low grade fever; nausea; Pain in arm; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested) and HOT FLUSH (Hot flashes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (sleepy). On 14-Jul-2021, the patient experienced HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was given., No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: sweating; congested; Hot flashes; Low grade fever; nausea; Pain in arm; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested) and HOT FLUSH (Hot flashes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and SOMNOLENCE (sleepy). On 14-Jul-2021, the patient experienced HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (Pain in arm), SOMNOLENCE (sleepy), HYPERHIDROSIS (sweating), NASAL CONGESTION (congested), HOT FLUSH (Hot flashes), PYREXIA (Low grade fever) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was given., No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Sinusitis
Clinical narrative: Sinus Infection/ Sinus Drainage; Hoarse; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Sinusitis.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse). At the time of the report, SINUSITIS (Sinus Infection/ Sinus Drainage) and DYSPHONIA (Hoarse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: has no more arthritis in his hands and back/ free from arthritis; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (has no more arthritis in his hands and back/ free from arthritis) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (previously had a heart attack many years ago). Concurrent medical conditions included Hypertension, Post-traumatic stress disorder (PTSD) and Arthritis (Patient stated that he used to have a bad case of arthritis in his hands and back). Concomitant products included GLYCERYL TRINITRATE (NITROGLYCERIN) for Blood pressure management, ATENOLOL, LISINOPRIL and SERTRALINE HCL for Hypertensive, ASPIRIN [ACETYLSALICYLIC ACID], CHOLECALCIFEROL and ATORVASTATIN CALCIUM for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (has no more arthritis in his hands and back/ free from arthritis). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (has no more arthritis in his hands and back/ free from arthritis) had resolved.            Concomitant medications also included the same arthritis medications and medications for blood pressure and PTSD.  Patient stated that he was still taking the same arthritis medications, but his symptoms has improved.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired/felt run down; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired/felt run down) 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 23-Jul-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 FATIGUE (Felt tired/felt run down). At the time of the report, FATIGUE (Felt tired/felt run down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Myalgia, Ultrasound breast
Clinical narrative: caller received both doses of the Moderna vaccine, she only had a little soreness; she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness) and LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation and Idiopathic thrombocytopenia (remission.).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously). On an unknown date, the patient experienced MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness). At the time of the report, MYALGIA (caller received both doses of the Moderna vaccine, she only had a little soreness) and LYMPHADENOPATHY (she had her mammogram and breast ultrasound, and doctors found swollen lymph glands on the left side, she hadn't noticed them previously) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jul-2021, Mammogram: abnormal (abnormal) Swollen lymph glands on the left side. On 26-Jul-2021, Ultrasound breast: abnormal (abnormal) Swollen lymph glands on the left side.         No concomitant medications were reported.  No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling of body temperature change, Hypersomnia, Influenza, Sluggishness
Clinical narrative: I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night; I felt a little weak; flu; I was very sluggish; having hot and cold chills; Vaccination site swelling; This spontaneous case was reported by a nurse and describes the occurrence of SLUGGISHNESS (I was very sluggish), FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 05-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills). On an unknown date, the patient experienced SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu). On 10-Apr-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. On 07-May-2021, FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills) had resolved. At the time of the report, SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided. Concomitant medication information was not provided.   This case was linked to MOD-2021-068790 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night; I felt a little weak; flu; I was very sluggish; having hot and cold chills; Vaccination site swelling; This spontaneous case was reported by a nurse and describes the occurrence of SLUGGISHNESS (I was very sluggish), FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was provided by the reporter.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 05-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills). On an unknown date, the patient experienced SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu). On 10-Apr-2021, VACCINATION SITE SWELLING (Vaccination site swelling) had resolved. On 07-May-2021, FEELING OF BODY TEMPERATURE CHANGE (having hot and cold chills) had resolved. At the time of the report, SLUGGISHNESS (I was very sluggish), HYPERSOMNIA (I slept for about 3 hours in the morning and 3 more in the afternoon and then slept all night), ASTHENIA (I felt a little weak) and INFLUENZA (flu) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication information was not provided. Concomitant medication information was not provided.   This case was linked to MOD-2021-068790 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue, Vaccination site pain
Clinical narrative: second dose administered past 36 days; Not feeling well due to blood pressure and heat; Pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose administered past 36 days), MALAISE (Not feeling well due to blood pressure and heat) and VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No treatment medications were provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Was due for his second dose on 21-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was due for his second dose on 21-May-2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: Pain in Arm; Pain up her neck and up to her head that worse at night and very painful to lay in bed; Difficulty getting dressed; Lots of pain in her arms all the time/experienced this same pain in her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in Arm), NECK PAIN (Pain up her neck and up to her head that worse at night and very painful to lay in bed), MOBILITY DECREASED (Difficulty getting dressed) and PAIN IN EXTREMITY (Lots of pain in her arms all the time/experienced this same pain in her legs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Polymyalgia rheumatica. Previously administered products included for an unreported indication: PREDNISONE and STEROIDS (she was taking 60mg since from 6 years she stopped taking steroid before it she changed her dose to 1 mg.).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in Arm), NECK PAIN (Pain up her neck and up to her head that worse at night and very painful to lay in bed), MOBILITY DECREASED (Difficulty getting dressed) and PAIN IN EXTREMITY (Lots of pain in her arms all the time/experienced this same pain in her legs). The patient was treated with METHOTREXATE on 14-Jul-2021 at an unspecified dose and frequency; FOLIC ACID at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in Arm), NECK PAIN (Pain up her neck and up to her head that worse at night and very painful to lay in bed), MOBILITY DECREASED (Difficulty getting dressed) and PAIN IN EXTREMITY (Lots of pain in her arms all the time/experienced this same pain in her legs) outcome was unknown.            The concomitant medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Significant follow up received and added new events.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Caller received her 1st dose of Moderna COVID 19 vaccine in February, 2021.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: whole body feels sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (whole body feels sore) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (whole body feels sore). At the time of the report, MYALGIA (whole body feels sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chest pain, Decreased appetite, Ear pain, Headache
Clinical narrative: Light numbness in her mouth; Tingling mouth; Burning mouth; Chest pain; Apettite lost; Sweating; Loss of balance; Ear pain; Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain) and DECREASED APPETITE (Apettite lost) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0404C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache). The patient was treated with LORATADINE ongoing since an unknown date for Allergy, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia oral, Oral discomfort, Paraesthesia oral, Vaccination site pain
Clinical narrative: Light numbness in her mouth; Tingling mouth; Burning mouth; Chest pain; Apettite lost; Sweating; Loss of balance; Ear pain; Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain) and DECREASED APPETITE (Apettite lost) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0404C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache). The patient was treated with LORATADINE ongoing since an unknown date for Allergy, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Tremor, Vomiting
Clinical narrative: whole body was trembling; weak, could not stand up; throwing up; severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (whole body was trembling), ASTHENIA (weak, could not stand up), VOMITING (throwing up) and HEADACHE (severe headaches) in an adult female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (whole body was trembling), ASTHENIA (weak, could not stand up), VOMITING (throwing up) and HEADACHE (severe headaches). At the time of the report, TREMOR (whole body was trembling), ASTHENIA (weak, could not stand up), VOMITING (throwing up) and HEADACHE (severe headaches) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-053201 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On 28-Mar-2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products used were not proved by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-269057 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: soreness in her left arm; little general soreness, body pain (not crucial, not really bad); This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness in her left arm) and MYALGIA (little general soreness, body pain (not crucial, not really bad)) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced PAIN IN EXTREMITY (soreness in her left arm) and MYALGIA (little general soreness, body pain (not crucial, not really bad)). The patient was treated with DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in her left arm) and MYALGIA (little general soreness, body pain (not crucial, not really bad)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: violent reaction; she had terribly pain it last 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (violent reaction) and PAIN (she had terribly pain it last 24 hours) in an 82-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (violent reaction) and PAIN (she had terribly pain it last 24 hours). At the time of the report, VACCINATION COMPLICATION (violent reaction) outcome was unknown and PAIN (she had terribly pain it last 24 hours) had resolved.            No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-051966, MOD-2021-051966 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Left thigh warm; Sharp stabbing pain in the top of her left thigh/painful; Headache; Nausea; Intense aches all over her body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left thigh warm), PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Intense aches all over her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever). On 26-Jul-2021, the patient experienced FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of UNK dosage form. On 29-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-269014 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Left thigh warm; Sharp stabbing pain in the top of her left thigh/painful; Headache; Nausea; Intense aches all over her body; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Left thigh warm), PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful), HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Intense aches all over her body) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever). On 26-Jul-2021, the patient experienced FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of UNK dosage form. On 29-Mar-2021, HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Intense aches all over her body) and PYREXIA (Fever) had resolved. At the time of the report, FEELING HOT (Left thigh warm) and PAIN IN EXTREMITY (Sharp stabbing pain in the top of her left thigh/painful) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-269014 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Severe fatigue for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue for 4 days) 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 FATIGUE (Severe fatigue for 4 days). At the time of the report, FATIGUE (Severe fatigue for 4 days) had resolved. Not Provided          No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-066531 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Fever; Headaches; Muscle Aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills) 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 24-Jul-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 PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headaches), MYALGIA (Muscle Aches), FATIGUE (Fatigue) and CHILLS (Chills) 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.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: If it is normal to feel a little shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (If it is normal to feel a little shortness of breath) 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 DYSPNOEA (If it is normal to feel a little shortness of breath). At the time of the report, DYSPNOEA (If it is normal to feel a little shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: lots of diarrhea; experiencing cramping; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping) 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 DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping). At the time of the report, DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping) had not resolved. Not Provided          No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient stated experiencing the symptoms for about 5 days now.   This case was linked to MOD-2021-235448 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Maternal exposure during breast feeding
Clinical narrative: Maternal exposure during pregnancy; Lethargy; Severe fatigue; Tiredness; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during pregnancy), LETHARGY (Lethargy), FATIGUE (Severe fatigue) and FATIGUE (Tiredness) in a 36-year-old female patient (gravida 1, para 1) 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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during pregnancy), LETHARGY (Lethargy), FATIGUE (Severe fatigue) and FATIGUE (Tiredness). The cesarean delivery occurred, which was reported as Premature. For neonate 1, the birth weight was 2268 grams (5lbs). The outcome was reported as Pre-Term Birth NOS. Baby was conceived through IVF, Low AMH is culprit of infertility.  Water broke and chose to do a C-section. Live, pre-term birth. Length - 18 inches.  Pregnancy related complication was Baby was measuring small- labeled as IUGR. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during pregnancy) had resolved and LETHARGY (Lethargy), FATIGUE (Severe fatigue) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications was reported. Treatment medications was not provided   This case was linked to MOD-2021-256756, MOD-2021-051792 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She missed the date for her 2nd dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd 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 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd dose.). On 27-Jul-2021, PRODUCT DOSE OMISSION ISSUE (She missed the date for her 2nd dose.) had resolved.        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 by the reporter. No treatment was reported by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Vaccination site pain
Clinical narrative: sharp chest pain on the left side under their pec; Pain in that arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (sharp chest pain on the left side under their pec) and VACCINATION SITE PAIN (Pain in that arm) 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 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced VACCINATION SITE PAIN (Pain in that arm). On 27-Jul-2021, the patient experienced CHEST PAIN (sharp chest pain on the left side under their pec). On 27-Jul-2021, VACCINATION SITE PAIN (Pain in that arm) had resolved. At the time of the report, CHEST PAIN (sharp chest pain on the left side under their pec) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided by reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: first vaccine did not hurt therefore she is not sure if it was administered properly; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Patient had a  bad reaction to penicillin.). Concomitant products included AMLODIPINE for an unknown indication.    On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly). On 07-Jul-2021, PRODUCT ADMINISTRATION ERROR (first vaccine did not hurt therefore she is not sure if it was administered properly) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption
Clinical narrative: Drug rash; This spontaneous case was reported by a non-health professional and describes the occurrence of DRUG ERUPTION (Drug rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 DRUG ERUPTION (Drug rash). At the time of the report, DRUG ERUPTION (Drug rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported Treatment information was not provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Condition aggravated, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: some type of bronchitis; felt like she had the flu; sinus infection; It's gradually getting worse; fever; Sore arm; It's getting hotter and bigger; Injection arm hot; Injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse) and PYREXIA (fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Intestinal angioedema.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever), MYALGIA (Sore arm), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red). At the time of the report, BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever) and MYALGIA (Sore arm) outcome was unknown and VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient stated that she takes pain medication regularly and medications for chronic angioedema of the intestine.   This case was linked to MOD-2021-269277 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-Significant Follow Up Appended On 04-Aug-2021: Follow up information included event outcome updated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Sinusitis, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: some type of bronchitis; felt like she had the flu; sinus infection; It's gradually getting worse; fever; Sore arm; It's getting hotter and bigger; Injection arm hot; Injection arm red; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse) and PYREXIA (fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Intestinal angioedema.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever), MYALGIA (Sore arm), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red). At the time of the report, BRONCHITIS (some type of bronchitis), INFLUENZA LIKE ILLNESS (felt like she had the flu), SINUSITIS (sinus infection), CONDITION AGGRAVATED (It's gradually getting worse), PYREXIA (fever) and MYALGIA (Sore arm) outcome was unknown and VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE PAIN (Injection arm hot) and VACCINATION SITE ERYTHEMA (Injection arm red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-1 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.  Patient stated that she takes pain medication regularly and medications for chronic angioedema of the intestine.   This case was linked to MOD-2021-269277 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non-Significant Follow Up Appended On 04-Aug-2021: Follow up information included event outcome updated.