chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pruritus, Vaccination site pain
Clinical narrative: Sore arm; Itching; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), CHILLS (Chills), MYALGIA (Myalgia) and VACCINATION SITE PAIN (Sore arm) 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced PRURITUS (Itching), CHILLS (Chills) and MYALGIA (Myalgia). On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, PRURITUS (Itching), CHILLS (Chills), MYALGIA (Myalgia) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided/unknown.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia, Tremor
Clinical narrative: feeling sick; feeling awful; shaking chills; chills; fever; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment for the events was not included.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feeling sick; feeling awful; shaking chills; chills; fever; headache; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (feeling sick), FEELING ABNORMAL (feeling awful), TREMOR (shaking chills), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment for the events was not included.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Pain in extremity, Pyrexia
Clinical narrative: Cough; Chills; Fever; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Esophagitis.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 11-Jan-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 12-Jan-2021, the patient experienced COUGH (Cough). On 12-Jan-2021, CHILLS (Chills) had resolved. At the time of the report, COUGH (Cough), PAIN IN EXTREMITY (Arm soreness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 99-100 f (Borderline) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Anger, Energy increased, Fatigue, Feeling abnormal, Headache
Clinical narrative: Intense anger feelings; Feeling super energized; did not feel completely back to normal two hours after injection; feel super energized yet extremely tired; Had a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FEELING ABNORMAL (did not feel completely back to normal two hours after injection), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache) 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 12-Jan-2021 at 10:25 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FEELING ABNORMAL (did not feel completely back to normal two hours after injection), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache). At the time of the report, ANGER (Intense anger feelings), ENERGY INCREASED (Feeling super energized), FATIGUE (feel super energized yet extremely tired) and HEADACHE (Had a bad headache) outcome was unknown and FEELING ABNORMAL (did not feel completely back to normal two hours after injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Flatulence, Hyperhidrosis
Clinical narrative: Body aches; Fatigue; Abdominal pain; Gas; Loose stool; She was sweaty; Sore throat; Fever; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas) and DIARRHOEA (Loose stool) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental treatment NOS (Patient had a dental procedure and received an injection of numbing agent.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). On 08-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas) and DIARRHOEA (Loose stool). On 09-Jan-2021, the patient experienced PAIN (Body aches) and FATIGUE (Fatigue). On 08-Jan-2021, HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas), DIARRHOEA (Loose stool) and PYREXIA (Fever) had resolved. At the time of the report, PAIN (Body aches) and FATIGUE (Fatigue) had not 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Abdominal pain; Gas; Loose stool; She was sweaty; Sore throat; Fever; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas) and DIARRHOEA (Loose stool) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental treatment NOS (Patient had a dental procedure and received an injection of numbing agent.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). On 08-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas) and DIARRHOEA (Loose stool). On 09-Jan-2021, the patient experienced PAIN (Body aches) and FATIGUE (Fatigue). On 08-Jan-2021, HYPERHIDROSIS (She was sweaty), OROPHARYNGEAL PAIN (Sore throat), ABDOMINAL PAIN (Abdominal pain), FLATULENCE (Gas), DIARRHOEA (Loose stool) and PYREXIA (Fever) had resolved. At the time of the report, PAIN (Body aches) and FATIGUE (Fatigue) had not 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: arm is swollen; swelling at the injection site; very red and enlarged; fever 101; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (very red and enlarged) and PYREXIA (fever 101) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (very red and enlarged) and PYREXIA (fever 101). At the time of the report, PERIPHERAL SWELLING (arm is swollen), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (very red and enlarged) and PYREXIA (fever 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature: 101° (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; Loss of smell; Loss of taste; This spontaneous case was reported by a dental hygienist and describes the occurrence of COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). The patient was treated with ASCORBIC ACID (VITAMIN C ACID) at a dose of unknown and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) at a dose of unknown. At the time of the report, COVID-19 (COVID-19), ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive Positive.     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.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of tested positive for COVID-19  and mRNA-1273 use is assessed as unlikely.  The events of loss of smell and loss of taste are also consistent with symptoms of COVID-19. hence also assessed as unrelated to mRNA-1273 use
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tension headache
Clinical narrative: Tension type headache; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension type headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2UA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 08-Jan-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced TENSION HEADACHE (Tension type headache). At the time of the report, TENSION HEADACHE (Tension type headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included paracetamol and ibuprofen.  Company Comment - Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID-19 diagnosis; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 06-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 diagnosis), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events included ibuprofen and paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the event SARS-COV-2 test positive is unlikely related to mRNA-1273. Further information is requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the event SARS-COV-2 test positive is unlikely related to mRNA-1273. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bedridden, Chills, Headache, Nausea
Clinical narrative: fever of 102 F; nausea really bad; sore arm; throwing up; upset stomach; In Bed for couple of days; body aches across shoulder and neck; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea really bad) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea really bad). At the time of the report, NAUSEA (nausea really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: fever of 102 F; nausea really bad; sore arm; throwing up; upset stomach; In Bed for couple of days; body aches across shoulder and neck; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea really bad) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea really bad). At the time of the report, NAUSEA (nausea really bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Dizziness; Mild headache; Body aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Mild headache), MYALGIA (Body aches), FATIGUE (Fatigue) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-213958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Event outcome was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 11-Jan-2021, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included Zofran and Ketorolac.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment medications were provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Little bruise around the arm; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Little bruise around the arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CONTUSION (Little bruise around the arm). At the time of the report, CONTUSION (Little bruise around the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; headache; achy pain; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (headache) and PAIN (achy pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), HEADACHE (headache) and PAIN (achy pain). At the time of the report, CHILLS (chills), HEADACHE (headache) and PAIN (achy pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pruritus
Clinical narrative: Itchiness at the site; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site). At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included serum derived bovine/protein isolate for diarrhea.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site pruritus
Clinical narrative: Bruising occurred in the area from itching so much; Itching at the site that was intense started very mild and then it increase; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Skin disorder NOS (Patient stated she has a "skin condition"), Dry skin and Itchy skin.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase). At the time of the report, CONTUSION (Bruising occurred in the area from itching so much) and VACCINATION SITE PRURITUS (Itching at the site that was intense started very mild and then it increase) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment medication not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: fever; body ache; chills; nausea; fatigue; vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting). On 25-Dec-2020, PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills) had resolved. On 27-Dec-2020, NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting) had resolved. Not Provided      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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: fever; body ache; chills; nausea; fatigue; vomiting; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea) and FATIGUE (fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Dec-2020, the patient experienced PYREXIA (fever), MYALGIA (body ache), CHILLS (chills), NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting). On 25-Dec-2020, PYREXIA (fever), MYALGIA (body ache) and CHILLS (chills) had resolved. On 27-Dec-2020, NAUSEA (nausea), FATIGUE (fatigue) and VOMITING (vomiting) had resolved. Not Provided      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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomachache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomachache) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomachache). At the time of the report, ABDOMINAL PAIN UPPER (stomachache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: Started feeling her tongue to swell; Throat and palate starting to swell; Terrible itching in extremities and torso; Left arm sore, not swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Started feeling her tongue to swell), PHARYNGEAL SWELLING (Throat and palate starting to swell), PRURITUS (Terrible itching in extremities and torso) and PAIN IN EXTREMITY (Left arm sore, not swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis and Colonoscopy. Previously administered products included for an unreported indication: SUPREP BOWEL PREP KIT (Contains PEG). Concurrent medical conditions included Blood pressure high, Thyroid disorder NOS and Hormone replacement therapy. Concomitant products included AMLODIPINE BESILATE (LODIPINE [AMLODIPINE BESILATE]) for Blood pressure high, PROGESTERONE;ESTROGENS for Hormone replacement therapy, LEVOTHYROXINE SODIUM (LEVOTIROXIN) for Thyroid disorder NOS.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced SWOLLEN TONGUE (Started feeling her tongue to swell), PHARYNGEAL SWELLING (Throat and palate starting to swell), PRURITUS (Terrible itching in extremities and torso) and PAIN IN EXTREMITY (Left arm sore, not swollen). On 11-Jan-2021, SWOLLEN TONGUE (Started feeling her tongue to swell), PHARYNGEAL SWELLING (Throat and palate starting to swell), PRURITUS (Terrible itching in extremities and torso) and PAIN IN EXTREMITY (Left arm sore, not swollen) 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.   Treatment information included diphenhydramine hydrochloride.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: sore, red knot that is tender touch at the site of injection; sore, red knot that is tender touch at the site of injection; Rash along arm; sore, red knot that is tender touch at the site of injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection). At the time of the report, VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection) had not resolved. Not Provided      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.   Te concomitant medications were not provided. The treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Vaccination site rash
Clinical narrative: High blood pressure; Rash on the injection site; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEADACHE (Headache) and VACCINATION SITE RASH (Rash on the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced HYPERTENSION (High blood pressure) and VACCINATION SITE RASH (Rash on the injection site). At the time of the report, HYPERTENSION (High blood pressure), HEADACHE (Headache) and VACCINATION SITE RASH (Rash on the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood pressure measurement: high (High) High.     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.   The concomitant medication was provided as ibuprofen. The treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   It is unclear if the increased blood pressure is being reported as an underlying condition or an event; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   It is unclear if the increased blood pressure is being reported as an underlying condition or an event
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warmness at the injection site; Itchiness at the injection site; Redness at injection site; Swelling at the injection site; soreness at injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site). On 10-Jan-2021, VACCINATION SITE WARMTH (warmness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient also stated that the itchiness and redness increased on 11 Jan 2021.  Treatment for the events included hydrocortisone and clarithromycin.    Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: nauseous; unable to sleep last night due to the pain; right arm has been hurting all day; fever; throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up) and CHILLS (chills) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up) and CHILLS (chills). On 13-Jan-2021, the patient experienced NAUSEA (nauseous). At the time of the report, INSOMNIA (unable to sleep last night due to the pain), VACCINATION SITE PAIN (right arm has been hurting all day), PYREXIA (fever), VOMITING (throwing up), CHILLS (chills) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication included Paracetamol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.