chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Rash
Clinical narrative: pain; rash on leg; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of RASH (rash on leg) and PAIN (pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced RASH (rash on leg). On an unknown date, the patient experienced PAIN (pain). The patient was treated with TRAMADOL ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, RASH (rash on leg) had not resolved and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported .   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    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) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No concomitant medication information was provided  No treatment product information was provided   Reporter did not allow further contact
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: felt heavy; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE) in an 80-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt heavy) and HEADACHE (HEADACHE) had resolved.            No concomitant medication information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-062842 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062842:First dose case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Rash
Clinical narrative: very little discomfort in my arm; steady pain in the back of my head; rash on my back, it looked similar to chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very little discomfort in my arm), HEADACHE (steady pain in the back of my head) and RASH (rash on my back, it looked similar to chicken pox) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Bronchiectasis from November 2020 to 30-Mar-2021. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced RASH (rash on my back, it looked similar to chicken pox). On an unknown date, the patient experienced PAIN IN EXTREMITY (very little discomfort in my arm) and HEADACHE (steady pain in the back of my head). On 02-Mar-2021, RASH (rash on my back, it looked similar to chicken pox) had resolved. At the time of the report, PAIN IN EXTREMITY (very little discomfort in my arm) and HEADACHE (steady pain in the back of my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were given.   This case was linked to MOD-2021-052089 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Afftected is hearing; 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 HYPOACUSIS (Afftected is hearing) 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 HYPOACUSIS (Afftected is hearing). At the time of the report, HYPOACUSIS (Afftected is hearing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscle spasms, Product dose omission issue, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Irritable bowel syndrome (previously diagnosed with IBS and Crohn's disease.) and Crohn's disease (previously diagnosed with IBS and Crohn's disease.) Concomitant products included FUROSEMIDE, METOPROLOL, LISINOPRIL, CLOPIDOGREL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes:On 28-May-2021: No specific follow-up information recorded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Irritable bowel syndrome (previously diagnosed with IBS and Crohn's disease.) and Crohn's disease (previously diagnosed with IBS and Crohn's disease.) Concomitant products included FUROSEMIDE, METOPROLOL, LISINOPRIL, CLOPIDOGREL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (recommendation to defer second vaccine dose up to 42 days), WEIGHT DECREASED (lost 20 pounds), MUSCLE SPASMS (cramping), DIARRHOEA (diarrhea), VOMITING (throwing up) and FATIGUE (felt tired of this symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information provided. Most recent FOLLOW-UP information incorporated above includes:On 28-May-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Bursitis
Clinical narrative: Bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURSITIS (Bursitis). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPO-MEDROL) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, BURSITIS (Bursitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: recieved - Non Significant information added
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: Sickness; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and COVID-19 (COVID-19) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) 1 dosage form once a day. On an unknown date, the patient experienced ILLNESS (Sickness) and COVID-19 (COVID-19). At the time of the report, ILLNESS (Sickness) and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Insomnia, Malaise
Clinical narrative: Tinnitus in right year; Dizziness; Feeling unwell; Fatigue; Severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness) and MALAISE (feeling unwell) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 19-Mar-2021, the patient experienced PALPITATIONS (heart palpitations). On 20-Mar-2021, the patient experienced INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured). On an unknown date, the patient experienced TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue). The patient was treated with TRAZODONE at a dose of 1 dosage form; ZOLPIDEM TARTRATE (AMBIEN) at a dose of 1 dosage form; CLONAZEPAM at a dose of 1 dosage form and ESZOPICLONE (LUNESTA) for Insomnia, at a dose of 1 dosage form. At the time of the report, INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.        Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added treatment medications. Added new events malaise, dizziness, fatigue. Updated action taken.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Tinnitus
Clinical narrative: Tinnitus in right year; Dizziness; Feeling unwell; Fatigue; Severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness) and MALAISE (feeling unwell) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 19-Mar-2021, the patient experienced PALPITATIONS (heart palpitations). On 20-Mar-2021, the patient experienced INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured). On an unknown date, the patient experienced TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue). The patient was treated with TRAZODONE at a dose of 1 dosage form; ZOLPIDEM TARTRATE (AMBIEN) at a dose of 1 dosage form; CLONAZEPAM at a dose of 1 dosage form and ESZOPICLONE (LUNESTA) for Insomnia, at a dose of 1 dosage form. At the time of the report, INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.        Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added treatment medications. Added new events malaise, dizziness, fatigue. Updated action taken.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information were provided by the reporter.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; Headache; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. In May 2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Body ache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Myalgia, Urine analysis
Clinical narrative: Reddish urine; Body aches; Fatigue; This spontaneous case was reported by a physician and describes the occurrence of CHROMATURIA (Reddish urine), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 30-Mar-2021, the patient experienced CHROMATURIA (Reddish urine), MYALGIA (Body aches) and FATIGUE (Fatigue). On 31-Mar-2021, CHROMATURIA (Reddish urine) had resolved. At the time of the report, MYALGIA (Body aches) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Urine analysis: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Horrible for him; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Horrible for him) 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) (Intramuscular) 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 FEELING ABNORMAL (Horrible for him). At the time of the report, FEELING ABNORMAL (Horrible for him) outcome was unknown.            No information regarding concomitant nor treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Myalgia
Clinical narrative: Fatigue; Reddish urine; Body aches; This spontaneous case was reported by a physician and describes the occurrence of CHROMATURIA (Reddish urine), MYALGIA (Body aches) and FATIGUE (Fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MYALGIA (Body aches). On 30-Mar-2021, the patient experienced CHROMATURIA (Reddish urine). On an unknown date, the patient experienced FATIGUE (Fatigue). On 02-Mar-2021, MYALGIA (Body aches) had resolved. At the time of the report, CHROMATURIA (Reddish urine) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unevaluable event; 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 UNEVALUABLE EVENT (unevaluable event) 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 UNEVALUABLE EVENT (unevaluable event). At the time of the report, UNEVALUABLE EVENT (unevaluable event) outcome was unknown.            No concomitant medications were provided No treatment information was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-130328 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-130328:same reporter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inner ear disorder
Clinical narrative: INNER EAR ISSUE FLUIDS WERE UNBALANCED; COVID; This spontaneous case was reported by a physician and describes the occurrence of INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID) in a 50-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID). At the time of the report, INNER EAR DISORDER (INNER EAR ISSUE FLUIDS WERE UNBALANCED) and COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were Provided By the Reporter. No Treatment history was provided by the reporter.   Reporter did not allow further contact
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza, Pyrexia, Retching, SARS-CoV-2 test
Clinical narrative: Flu; Dry heaves; Violent chills; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), RETCHING (Dry heaves), CHILLS (Violent chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA (Flu), RETCHING (Dry heaves), VOMITING (Vomiting) and PYREXIA (Fever). 31-Mar-2021, the patient experienced CHILLS (Violent chills). On 31-Mar-2021, RETCHING (Dry heaves), CHILLS (Violent chills) and VOMITING (Vomiting) had resolved with sequelae. On 03-Apr-2021, INFLUENZA (Flu) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal PCR.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Flu; Dry heaves; Violent chills; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), RETCHING (Dry heaves), CHILLS (Violent chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INFLUENZA (Flu), RETCHING (Dry heaves), VOMITING (Vomiting) and PYREXIA (Fever). 31-Mar-2021, the patient experienced CHILLS (Violent chills). On 31-Mar-2021, RETCHING (Dry heaves), CHILLS (Violent chills) and VOMITING (Vomiting) had resolved with sequelae. On 03-Apr-2021, INFLUENZA (Flu) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, SARS-CoV-2 test: positive (Positive) Nasopharyngeal PCR.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received their first dose of vaccine and developed a sore arm and felt tired. On 15-Jun-2021, the patient reported that the patient was fine, and the reaction settled in a few days. Reportedly, the patient received their second dose of vaccine and experienced no side effects.  No Concomitant product use was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR Report was received on 15-Jun-2021 and contains significant information. Updated the outcome of the event. Included the liner second dose was administered in the I-narrative supplement field.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: sore; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore) and INJECTION SITE PAIN (injection site pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (sore) and INJECTION SITE PAIN (injection site pain). At the time of the report, PAIN (sore) and INJECTION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Brain fog; Arm with limited mobility; Sight of injection got hard; Entire back was covered with a rash; Sight of injection swollen; Body aches; Pain in injection site arm; Joint pain; Headache; Stomach upset; Diarrhea; Shortness of breath; Hot flashes; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000, AFib since 2017, Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin) and Allergy to chemicals. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MOEXIPRIL for Blood pressure high, ALLOPURINOL for Gout, OMEPRAZOLE for Stomach upset, METOPROLOL SUCCINATE.   On 23-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Fatigue). On 24-Mar-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), MYALGIA (Body aches), INJECTION SITE PAIN (Pain in injection site arm), ARTHRALGIA (Joint pain) and CHILLS (Chills). 24-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache). On 21-Apr-2021 at 1:00 AM, the patient experienced FEELING ABNORMAL (Brain fog). 21-Apr-2021 at 1:00 AM, the patient experienced MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen). On 29-Mar-2021, ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), INJECTION SITE PAIN (Pain in injection site arm), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen) had resolved and MYALGIA (Body aches), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.    This case was linked to MOD-2021-058061 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hot flush, Injection site induration
Clinical narrative: Brain fog; Arm with limited mobility; Sight of injection got hard; Entire back was covered with a rash; Sight of injection swollen; Body aches; Pain in injection site arm; Joint pain; Headache; Stomach upset; Diarrhea; Shortness of breath; Hot flashes; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000, AFib since 2017, Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin) and Allergy to chemicals. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MOEXIPRIL for Blood pressure high, ALLOPURINOL for Gout, OMEPRAZOLE for Stomach upset, METOPROLOL SUCCINATE.   On 23-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Fatigue). On 24-Mar-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), MYALGIA (Body aches), INJECTION SITE PAIN (Pain in injection site arm), ARTHRALGIA (Joint pain) and CHILLS (Chills). 24-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache). On 21-Apr-2021 at 1:00 AM, the patient experienced FEELING ABNORMAL (Brain fog). 21-Apr-2021 at 1:00 AM, the patient experienced MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen). On 29-Mar-2021, ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), INJECTION SITE PAIN (Pain in injection site arm), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen) had resolved and MYALGIA (Body aches), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.    This case was linked to MOD-2021-058061 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Myalgia, Rash
Clinical narrative: Brain fog; Arm with limited mobility; Sight of injection got hard; Entire back was covered with a rash; Sight of injection swollen; Body aches; Pain in injection site arm; Joint pain; Headache; Stomach upset; Diarrhea; Shortness of breath; Hot flashes; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000, AFib since 2017, Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin) and Allergy to chemicals. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MOEXIPRIL for Blood pressure high, ALLOPURINOL for Gout, OMEPRAZOLE for Stomach upset, METOPROLOL SUCCINATE.   On 23-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Fatigue). On 24-Mar-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), MYALGIA (Body aches), INJECTION SITE PAIN (Pain in injection site arm), ARTHRALGIA (Joint pain) and CHILLS (Chills). 24-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache). On 21-Apr-2021 at 1:00 AM, the patient experienced FEELING ABNORMAL (Brain fog). 21-Apr-2021 at 1:00 AM, the patient experienced MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen). On 29-Mar-2021, ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), INJECTION SITE PAIN (Pain in injection site arm), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen) had resolved and MYALGIA (Body aches), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.    This case was linked to MOD-2021-058061 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Brain fog; Arm with limited mobility; Sight of injection got hard; Entire back was covered with a rash; Sight of injection swollen; Body aches; Pain in injection site arm; Joint pain; Headache; Stomach upset; Diarrhea; Shortness of breath; Hot flashes; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high since 2000, AFib since 2017, Drug allergy (allergy to trimpex), Drug allergy (allergy to macrodantin) and Allergy to chemicals. Concomitant products included RIVAROXABAN (XARELTO) for Anticoagulant therapy, MOEXIPRIL for Blood pressure high, ALLOPURINOL for Gout, OMEPRAZOLE for Stomach upset, METOPROLOL SUCCINATE.   On 23-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Fatigue). On 24-Mar-2021 at 12:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), MYALGIA (Body aches), INJECTION SITE PAIN (Pain in injection site arm), ARTHRALGIA (Joint pain) and CHILLS (Chills). 24-Mar-2021 at 12:30 PM, the patient experienced HEADACHE (Headache). On 21-Apr-2021 at 1:00 AM, the patient experienced FEELING ABNORMAL (Brain fog). 21-Apr-2021 at 1:00 AM, the patient experienced MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen). On 29-Mar-2021, ABDOMINAL DISCOMFORT (Stomach upset), DIARRHOEA (Diarrhea), DYSPNOEA (Shortness of breath), HOT FLUSH (Hot flashes), INJECTION SITE PAIN (Pain in injection site arm), HEADACHE (Headache) and CHILLS (Chills) had resolved. At the time of the report, FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Arm with limited mobility), INJECTION SITE INDURATION (Sight of injection got hard), RASH (Entire back was covered with a rash) and INJECTION SITE SWELLING (Sight of injection swollen) had resolved and MYALGIA (Body aches), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment information was provided.    This case was linked to MOD-2021-058061 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Herpes zoster
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of herpes zoster (shingles) and dyspnea (breathing problem) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jan 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 5, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 15, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced herpes zoster (shingles). On May 1, 2021, patient experienced dyspnea (breathing problem). At the time of the report, herpes zoster (shingles) and dyspnea (breathing problem) outcome: unknown. No concomitant medication or treatment information provided. Action taken with mRNA-1273 in response to the event: not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp), had a terrible headache and chills (freezing/chills). At the time of the report, ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp), had a terrible headache and chills (freezing/chills) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. This case linked to MOD-2021-065271 and MOD-2021-065300 (patient link). Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp), had a terrible headache and chills (freezing/chills). At the time of the report, ear discomfort (fluid in ear), influenza (felt like the flu), hyperhidrosis (broke into a sweat porously), fatigue (very tired) and pyrexia (102 temp), had a terrible headache and chills (freezing/chills) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. This case linked to MOD-2021-065271 and MOD-2021-065300 (patient link). Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer (patient), describes the occurrence of headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included systemic lupus erythematosus. On Feb 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue. At the time of the report, headache, myalgia (body aches), arthralgia (joint pain), nausea and severe fatigue: resolving. No concomitant medication, laboratory details or treatment information given. Patient will see a rheumatologist. Reportedly symptoms are slowly improving. Most recent follow-up information incorporated: On Jun 19, 2021: Follow-up received on Jun 19, 2021. Reported symptoms are slowly improving (outcome updated).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sore body; Fever of 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees). At the time of the report, MYALGIA (Sore body) and PYREXIA (Fever of 101 degrees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was given. No laboratory details was given. No treatment information was given.   This case was linked to MOD-2021-065271, MOD-2021-065300 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: blisters; This spontaneous case was reported by a physician and describes the occurrence of BLISTER (blisters) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 24-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLISTER (blisters). At the time of the report, BLISTER (blisters) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment was reported for this event.